CAREERS

POSITION DESCRIPTION

Position Operations Manager, Facilities

Company Repare Therapeutics

Location Montreal, Quebec, Canada

Website http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as RP-6306, a first-in-class inhibitor for CCNE1-amplified tumors, and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

About the Role

Repare is seeking an Operations Manager to join its team in Montreal.  The Operations Manager will manage day-to-day responsibilities of the facilities, including space panning and design, oversee shipping/receiving, and liaise with building management. The Operations Manager will have excellent bilingual (French and English) verbal and written communication, organization skills, project management skills, and creative problem-solving skills. The candidate must have a high level of professionalism, be capable of working independently and be willing to take accountability and ownership of issues and concerns to drive exceptional results.

What You’ll Do

• Develop and implement a best-in-class facilities operations plan including developing processes, continuous improvement initiatives and tools to enhance space planning and utilization that reflects company growth projections, strategic milestones and future expansion.
• Continually assess business and operational risk associated with existing and future facilities and develop mitigation and maintenance strategies to address these risks.
• Oversee all operational and planning aspects of facilities management including maintenance and repair, functions and building systems.
• Take responsibility for optimizing all shipping and receiving activities on site including inventory management and supervision of shipping/receiving staff.
• Work with vendors and landlords to ensure Repare’s facilities are in good working order, including electrical, plumbing, HVAC, furnishings and waste management.
• Forecast, track, and manage project budgets, POs, and invoices.
• Develop effective partnerships and work collaboratively with internal business partners (HR, Finance, IT).
• Ensure compliance with safety procedures in the building.
• Establish strong relationships with key civic leaders (NEOMED, Government Officials, Code Officials, Fire Safety, etc.)

What You’ll Need

• 5-10 years of relevant, progressive work experience in Facilities or Operations.  Previous experience in a lab environment would be an asset.
• Demonstrated project management experience and excellent organizational skills to prioritize multiple work streams, deadlines, and priorities.
• Strong expertise and proven track record in process improvement.
• Strong customer orientation that enables Facilities to align business goals with customer needs and creatively problem solve to determine solutions.
• Excellent interpersonal, negotiation, influence, and communications skill with proven ability to communicate effectively across all departments and levels of the organization.
• Flexible and adaptable working style that enables work in a fast-paced working environment and work in a diplomatic and tactful manner with others.
• Bachelor’s degree in science or related field.
• Ability to read and understand blueprints, CAD drawings and other schematics.
• Bilingual; excellent verbal and written communication in French and English.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

POSITION DESCRIPTION

Position Computational Chemist

Company Repare Therapeutics

Location Montreal, Quebec, Canada

Website http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as RP-6306, a first-in-class inhibitor for CCNE1-amplified tumors, and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

About the Role

Repare Therapeutics is seeking an experienced computational chemist or medicinal chemist with extensive structure-based drug design experience to support internal drug discovery programs. The position requires scientific leadership and strong communication skills to collaborate with internal scientists and external service providers. The selected applicant must combine structure-based drug discovery and design experience, the desire to help others, resilience, and the ability to work effectively in a multidisciplinary environment. A person with a hybrid skillset and background (e.g., molecular modeling and medicinal chemistry, docking and machine learning, or docking and quantum mechanics) is preferred.  Candidates must have the ability to collaborate effectively, advance team goals, and enjoy a fast-paced, research environment.

What You’ll Do

• Apply structure-based and ligand-based methods to design small molecule inhibitors of target proteins with desired drug-like properties that meet a specified target profile.
• Help chemists prioritize proposed analogs in a timely, efficient, and independent manner.
• Facilitate an iterative cycle of inspiring the chemists and being inspired by their ideas, to create a positive feedback loop to advance the optimization of analogs.
• Participate in the development of scientific goals for specific programs.
• Interact with medicinal chemists, biologists, and DMPK colleagues to inform program strategies.

What You’ll Need

• Ph.D. degree with a minimum of 2 years relevant experience or M.Sc. degree with a minimum of 5 years of relevant experience in the field of drug discovery
• Effective communication skills, both verbal and written.
• Ability to work effectively as part of a multidisciplinary team.
• Experience with molecular modeling software (MOE, Schrödinger, Discovery Studio / Pipeline Pilot, Cresset, Optibrium, OpenEye, and/or Sybyl).
• Experience with performing docking studies is required, along with an understanding of the reliability and limitations of various computational results.
• A working knowledge of organic chemistry.
• Experience with hit discovery, hit-to-lead development, or lead optimization is an asset.

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Operations Manager, Translational Medicine

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are seeking an Operations Manager within the Translational Medicine function with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. This individual will coordinate with translational researchers, clinical operations and PK team members in order to implement and maintain biomarker operational plans. This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials; Includes operational support for biomarker definition and selection, clinical testing schedules, and lab manual creation.

What You’ll Do

• Manage end-to-end sample tracking and logistics for clinical samples, working closely with the central and specialty lab vendors as well as a sample and data management vendor
• Identify, triage, and resolve biomarker sample queries to ensure sample and data integrity
• Monitor trends and quality metrics as they relate to clinical site sample collection, processing and shipment errors
• Maintenance of study specific trackers, triggering patient sample testing
• Ensure biomarker laboratory documents are filed appropriately in the eTMF
• Maintain biomarker documentation (requisition forms, analysis request forms, redacted patient files, etc.) in an organized manner
• Reviewing study specific ICFs, biomarker operations sections of clinical protocols
• Training clinical sites on biomarker operations specific to the study
• Assist with creating site and team training tools as they relate to clinical biomarker operations
• Liaise with the preclinical teams to help drive translational research projects and ensure timely data delivery
• Provide study updates during study team meetings

What You’ll Need

• Bachelor’s degree with Science focus
• Experience managing clinical labs study startup and oversight
• 3-5 years experience in biomarker operations for clinical trials
• Strong verbal and written communication skills
• Strong reasoning, detail orientation and problem-solving abilities are essential
• Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Head of Biomarker Operations

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are seeking an experienced Head of Biomarkers Operations. Reporting directly to the Head of Translational Medicine, this individual will set and execute operational strategies to support Repare’s translational medicine efforts. This leader would provide biomarker operational expertise and guidance to multiple oncology programs to implement scientifically driven clinical development plans.

What You’ll Do

• Lead a team of biomarker associates to ensure delivery of clinical biomarker data under the highest standards of quality, ethics and efficiency
• Accountable for executing exploratory and biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, analysis, data delivery process and final sample disposition)
• Authors and reviews biomarker portions of key clinical documents including Clinical Study Protocols, Informed Consents and Laboratory Reference Manuals
• Develops and maintains effective working relationships with team members, with particular focus on the biomarker scientists, clinical operations, external CROs, and external biomarker vendors, where applicable
• Proactively manages biomarker sample analysis and data delivery timelines and communicates any variances the team and implements contingencies in consultation with key stakeholders
• Primary contact for internal and external stakeholders to maintain oversight of biomarker vendor performance, issues, their resolution and coordinates any corrective action
• Coordinates data requirements with reference labs and internal data management vendor to ensure all aspects of data collection are executed with high quality, including data formatting and transfer specifications and eCRF page design. Actively partners with Data Acquisition Specialists and Data Management to oversee and coordinate biomarker data format and delivery timelines
• Partners with internal/external stakeholders in the central lab set up, providing sample collection and processing instructions, kit contents, shipping conditions and logistics for biomarker samples
• Performs ongoing biomarker vendor management including development and oversight of scope of work, budgets (invoice review & reconciliation) and performance management
• Serves as primary point of contact for laboratories performing biomarker analysis and hence supports the biomarker outsourcing process through effective vendor management

What You’ll Need

• Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
• 5-10 years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
• 3-5 years of experience in biomarker operations
• Experience leading and managing a team
• Biotech industry experience or experience working within a clinical trial setting is a must
• Critical reasoning skills including the identification and resolution of complex problems
• Planning, organizational and time management skills
• Professional interpersonal skills, excellent oral/written communication and influencing skills
• Global Vendor Management experience

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Medical Director

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are seeking a talented and highly motivated individual to join our team as a Medical Director reporting to VP, Head of Clinical Development.  In this role the Medical Director will take the lead on study design and oversee the planning and execution of clinical trials aligned with the clinical development plan.

To be successful in this role, the individual must be self-motivated, able to work well with cross-functional teams and external collaborators, be able to influence decision-making, and be able to operate within pre-specified timelines. The individual is expected to possess outstanding communication skills (both verbal and written), a strong work ethic, and a high degree of professional integrity. The candidate will be expected to develop positive collaborations with contract research organizations, academic institutions, and nonprofit organizations. Role flexible dependent upon qualifications.

What You’ll Do

Be Responsible for Design Protocol and Strategy

• Collaboration in the design of clinical studies to meet the stated objectives
• Approve and be accountable for protocols and amendments
• Approve informed consents
• Provide medical input into investigational site feasibility
• Participate in the review and approval processes for data capture and review
• Organize expert panels or consultant or advisory board meetings to provide input into clinical development plans, protocols and data analyses

Provide Study Team with Medical Expertise including protocol training for investigators, issue and audit responses and resolution, inspection readiness and reviewing Informed Consent Forms (ICFs)

Be Accountable for Safety Across the Study(s).

• Ensures development of and adherence to Safety Review Plan.
• Performs and documents regular review of individual subject safety data, and performs review of cumulative safety data
• Collaborate with safety team regarding SAE reporting
• Review individual subject data (including AEs and other safety data), SAEs, and potentially clinically important findings as well as determining if follow up is needed
• Provide responses to questions on safety: reviews literature as needed to respond to safety questions or those posed by other individuals or bodies involved with the study

Own the Review of Study Level Data including requesting additional tables or analyses.

• Perform reviews and procedures required for database finalization
• Authors Clinical Study Reports
• Authors clinical sections of regulatory documents (e.g., Investigator Brochure (IB), IND Annual Reports)

Provides medical information for inclusion in reports submitted to regulatory authorities and supports the authoring of regulatory documents.

Under direction, prepare and deliver reports of clinical trial results to Repare executives as well as to regulatory authorities and external medical and scientific committees or conferences.

What You’ll Need

• MD with training and experience in oncology
• Knowledge of Good Clinical Practice
• Minimum of 5 years experience in conduct of clinical trials
• Experience in targeted therapy treatments
• Experience in assessment of adverse events and safety among hospitalized patients participating in therapeutic clinical trials is preferred
• Skilled in protocol design, interpretation, and medical monitoring
• General therapeutic area knowledge
• Excellent written and oral communication

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Manager/Senior Manager, Clinical Data Management

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are currently seeking a Manager/Senior Manager Clinical Data Management.  The level of this position will reflect the experience and seniority of the candidate. This role will be a key member of the Clinical Team and will ensure clinical data collection is aligned with the clinical trial requirements, promotes consistency across the REPARE portfolio and achieves high quality data for analysis and reporting.

You will, in close collaboration with the Biometrics Vendor partner and the Clinical Team, be accountable for clinical data management start-up activities across one or more trial drug programs. You will be responsible for the planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data. You will provide oversight of the Biometric Partner and the services they provide to Repare related to data management start-up activities. Further, the Manager/Senior Manager, Clinical Data Management will support the development and optimization of processes and tools to enable success of the Clinical Development Organization.

What You’ll Do

• Maintaining a close collaboration with internal key stakeholders, such as translational and clinical scientists, project leaders, and biostatisticians and programmers.
• Providing input to trial design, protocols and amendments to ensure protocol enables proper data collection to support analysis and reporting needs.
• Responsible for timely and high-quality data management deliverables supporting the portfolio.
• Confirms asset and study level strategies and services are being implemented at the study level and ensuring consistency across trials, CROs and vendors.
• Conducts oversight of data management activities performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Repare’s obligations and business objectives.  Activities include from protocol synopsis through database release and submission.
• Serves as a first point of contact for CROs DM partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.
• Serves as an expert for clinical data management best practices.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones.
• Other related tasks as needed

What You’ll Need

• Minimum of 6 years’ experience as a data management lead in the pharmaceutical/CRO industry across all trial phases within the oncology therapeutic area.
• In depth understanding of the complex and interdependent relationships between protocol development, data collection and analysis and reporting in complex oncology trial.
• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.
• Proficient experience using commercial clinical data management systems and/or EDC products (Medidata Rave/Veeva preferred).
• Knowledge of CDISC requirements; understanding of data collection requirements in oncology trials is required; understanding of SDTM requirements.
• Experience utilizing clinical review and analysis software (jReview preferred).
• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies.
• Extensive hands-on experience with clinical data management practices within oncology.
• Knowledge of medical terminology, local laboratory reference ranges, preferably within oncology
• Knowledge of dictionary structures (MedDRA, WHO Drug, etc.).
• Ability to develop strong and productive working relationships with internal and external key stakeholders.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
• Proven experience in DM vendor oversight to meet aggressive timelines of high-quality data deliverables.
• Ability to handle multiple development programs simultaneously.
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.
• Contribute to the growth and development of the DM team.

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: eTMF Specialist- Clinical Operations

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are seeking an enthusiastic Trial Master File (TMF) specialist to join our growing Clinical Operations team. This is a great opportunity to join Repare as a member of the clinical operations teams, supporting multiple clinical research studies in the eTMF world. This individual will be responsible to deliver controlled and quality trial master file documents for the purposes of regulatory and health authority inspections at the program and/or study level.

What You’ll Do

• Work cross-functionally across study teams and serves as primary contact for study teams regarding eTMF related processes and activities.
• Lead eTMF kick-off meeting for new studies, ensuring roles are assigned as per eTMF SOP. Drives the creation of eTMF Plans, and Study-specific Master Lists.
• Assist in creation, maintenance and archival of the eTMF in accordance with Standard Operating Procedures, ICH-GCP, EMA, and FDA regulations.
• Independently conducts Quality Control (QC) review of clinical, regulatory, safety, IRB, supply chain, labs, statistics & vendor study documentation in the eTMF to assess completeness of the eTMF.
• Review for adequacy of documentation, accuracy of filing based on the Master List and reference model, consistency with naming conventions, and completeness of metadata Responsible for timely resolution of QC findings and tracking progress.
• Function as eTMF representative on Clinical Study Teams for multiple projects
• Support the study teams and vendors to resolve discrepancies and ensure timely completion of internal tasks related to eTMF deliverables.
• Provide Study teams with relevant reports and outputs to support TMF Quality.
• Actively works to collect feedback to promote end user adoption, acceptance, and an active user community for the TMF.
• May support by inspection activities as directed by management.
• Other related tasks as needed

What You’ll Need

• Bachelor’s degree required and 2+ years’ experience working in a clinical research (clinical operations) environment in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF.
• Veeva Vault Clinical experience preferred.
• Working knowledge of ICH-GCP, FDA, and EMA/MHRA regulations.
• Experience working with the TMF Reference Model, understanding of regulatory documents and TMF Content.
• Experience with metrics, reporting, and/or business intelligence tools desired.
• Excellent organizational skills, able to multi-task in an extremely fast-paced environment.
• Ability to support several projects simultaneously, flexible working style and attention to detail are essential.

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Clinical Trial Manager/Senior Clinical Trial Manager

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

We are seeking a Clinical Trial Manager/Senior Clinical Trial Manager with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. The individual will be a self-starter that is effective in working independently as well as a collaborative team member. The successful candidate will ensure the Company’s clinical trial(s), in support of its innovative clinical pipeline, are managed to the highest quality to ensure safety and effectiveness of products in adherence with all applicable regulations.

What You’ll Do

• Lead cross-functional trial team to ensure delivery of complex clinical trials and manages protocol execution
• Oversee CROs and vendors to ensure timelines, goals and deliverables are met with quality, within budget, and in accordance with SOPs, GCP and all applicable laws and regulations.
• Provide input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
• Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
• Identify and anticipate operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Head of Clinical Operations as necessary.
• Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems.
• Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
• Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal.
• Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.
• Serve as functional area reviewer of global clinical / regulatory submissions.
• Present study status reports of operational execution activities to senior management.
• Provide study specific mentor and training for in-house Clinical Research Associate(s).
• Participate in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates).
• Perform other duties as assigned

What You’ll Need

• Bachelor’s degree in a life science or a health-related field is preferred, Advanced degree highly preferred
• Five (5) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization (oncology experience highly preferred), global trial experience highly preferred
• Solid understanding of the clinical trial database life cycle including, data collection, review and analysis, CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
• Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management
• Excels in a fast-paced, high-growth company environment with minimal direction and a high-degree of independence and able to adjust workload based on changing priorities
• Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
• Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
• Ability to handle multiple projects and utilize judgement to prioritize tasks
• Ability to contribute as a team member in a dynamic, fast-paced biotech environment

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Head of Biometrics

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

The Head of Biometrics will work with the Clinical Development Team to provide statistical expertise and leadership across the portfolio. This individual will be responsible for leading the Biometrics Team, overseeing the data sciences, biostatistics, programming, and data management capabilities.

The specific areas of focus for this role includes the planning, study design, conduct, analysis and interpretation of clinical trials across programs. The individual will be accountable for biometrics and data management resource and budget oversight, identifying and implementing appropriate technology requirements, process, and standard operating procedure implementation. In addition, the individual will provide statistical expertise on regulatory interaction for meetings, responses, and meeting preparation.

What You’ll Do

• Provide statistical leadership, oversight, and expertise across the organization
• Provide strategic statistical input in study design and execution of all clinical trials
• Lead, manage, and develop employees in the Biometrics Team
• Organize, and oversee or execute biometrics activities for clinical projects in support of product development and regulatory approvals
• Responsible and accountable for deliverables from the Biometrics Team including timeliness, high quality and according to regulatory and departmental standards
• Ensure statistical, programming, and data management work is performed according to Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), 21 CRF part 11, international regulatory requirements and standard operating procedures
• Represent Repare Therapeutics in meetings with regulatory authorities to support statistical endpoints, analyses, and study related issues
• Responsible for the statistical and data integrity, adequacy and accuracy in the company’s clinical studies, development plans and projects.
• Define and execute the strategic vision for the Biometrics Team.
• Establish organizational and operational structure for the Biometrics department and provides supporting business case
• Establishes standards for technology and resources used within the department including policy, practices, and operating procedures
• Network and collaborate with external thought-leaders and influences internal and external decisions to ensure quality of study designs and analyses, appropriateness of inferences, conclusions, and claims
• Collaborate with researchers and thought leaders in the strategic planning of clinical development programs and the publication of study data
• Be able to conduct independent research and resolve statistical methodological issues
• Recruit, develop, and retain talent to meet department functional goals and business objectives
• Contribute to the development of clinical strategy and goals
• Collaborate with Clinical Development, Regulatory Affairs, Pharmacovigilance, Clinical Pharmacology and Translational partners across the company

What You’ll Need

• PhD in Biostatistics or Statistics with a minimum of 15 years of experience in the pharmaceutical or biotechnology industry, preferably in oncology
• Prior management experience in statistics, programming, and data management is required (at least 5 years of supervisory experience)
• Demonstrated ability to hire, oversee, and build effective teams
• Demonstrated successful leadership experience including project and people management
• Strong knowledge of clinical trial design as applicable to oncology, with a proven capability to provide strategic input in a cross-functional environment
• Strong knowledge of ICH, GCP, and drug development regulations pertinent to statistics
• Strong knowledge and technical experience in SAS applications and CDISC requirements
• Good knowledge of software applications for statistics and programming (SAS, EAST, R, S-plus, etc.)
• Good knowledge of database platforms (e.g., RAVE), CDASH, and overall build requirements Extensive experience in contributing to and acting as statistical lead in NDAs/BLAs submission, including significant interaction with both FDA and EMEA
• Excellent writing and communication skills and demonstrated leadership capabilities
• Excellent interpersonal skills and demonstrates an ability to critically problem solve
• Demonstrates an ability to take complex statistical concepts and explain them in simple forms to non-statisticians

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Senior Executive Assistant

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

About Repare Therapeutics

We’re a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. So, if you’re ready to work on scientific breakthroughs where your desire to be part of a collaborative team of scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives, let’s talk.

About the Role

The Senior Executive Assistant will be a dynamic individual excited to join a growing international administrative team. The position will be responsible for managing complex calendars, travel schedules, and projects for three (3) Cambridge based executives. The ideal candidate will be a self-starter, a team player, organized and have strong attention to detail, and have excellent multi-tasking skills.

What You’ll Do

• Manage complex and demanding calendars proactively and ability to resolve conflicts, coordinating with rest of the admin team as well as external partners where needed
• Make travel arrangements, obtains appropriate travel documentation and process expense reports on a timely basis
• Coordinate and attend team leadership meetings as needed; proactively manages agendas and necessary materials, coordinates logistics, take minutes and captures action items
• Coordinate team functions or events, including room bookings, meals, etc.
• Partner with HR function in support of recruiting and employee experience
• Develop and maintain professional working relationships with internal and external parties
• Prepare data for presentations as needed
• Ensure the confidentiality of all reports, correspondence, materials, etc.
• Perform other duties as assigned and seeks out opportunities to support assigned executives’ team as bandwidth allows
• Engage and partner with the broader administrative team to identify best practices and opportunities for improvement

What You’ll Need

• Minimum of Associate degree and 5 years of experience as AA/EA for executives
• Strong sense of accountability and ownership to job responsibilities
• Demonstrated ability to be flexible, take initiative, anticipate needs, and respond appropriately
• Advance experience with Microsoft Office Suite (Outlook, Word, Excel, Visio, Teams and PowerPoint)

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Principal Scientist – Clinical Bioinformatics

Company: Repare Therapeutics

Location:  Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover highly targeted cancer therapies. Novel patient populations for compounds under development are identified in a data-driven process called STEP². The Company’s pipeline includes two clinical programs: RP-3500, a potential leading ATR inhibitor; and RP-6306, a first-in-class PKMYT1 inhibitor; as well as pre-clinical assets such as a Polθ inhibitor.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives. From its inception, Repare has based its development strategy on precision oncology.

We are seeking a Principal Scientist – Clinical Bioinformatics who will extend this approach to the clinic. This individual will use genomic and clinical biomarker data to contextualize patient responses. They will develop and/or apply computational methods to analyze whole genome and panel-based sequencing of patient samples to uncover genomic signatures. Furthermore, they will collaborate with a diverse team of translational and clinical scientists to analyze and interpret data generated from Repare’s RP-6306 program.

Responsibilities:

• Develop innovative approaches to integrate and visualize multi-dimensional biomarker data such as IHC, ctDNA, genomics, clinical response, clinical parameters, etc
• Support patient selection and clinical trial enrollment based on genomic evidence
• Lead the development and/or application of computational approaches to analyze custom and off-the shelf DNA-sequencing based molecular diagnostics (including WGS and panel-based sequencing) used for prospective and retrospective analysis of patient samples and to uncover genomic signatures
• Analyze molecular data derived from clinical samples to discover biomarkers of response/resistance to therapy
• Collaborate with internal and external teams to develop and implement a state-of-the-art computational analysis platform for omics-based clinical development
• In collaboration with operations team, manage transfer and availability of clinical biomarker data
• Utilize public and proprietary clinico-genomic databases to better understand patient populations
• Propose testable hypothesis and communicate scientific findings to a diverse clinical development team to support program decisions

Minimum Qualifications:

• PhD in Bioinformatics, Computational Biology, Cancer Genomics, Cancer Biology, or related fields
• Preferred experience:
  • Two (2) years or more of bioinformatics research experience in the biotech, pharmaceutical or diagnostics, with a focus on oncology translational science, clinical genomics or genomic diagnostics; or equivalent post-doctoral experience
• Desired scientific experience
  • Precision oncology drug development
  • DNA damage and DNA repair biology
  • Clinical genomics or diagnostics; especially whole genome sequencing
  • Variant interpretation
• Passion for analyzing multi-dimensional translational data from clinical trials
• Experience working closely with diverse biology, translational and clinical teams to design and analyze experiments.
• Strong hands-on programing skills (e.g. R, Python, Unix, SQL, etc)
• Solid understanding of probability and statistics.
• Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
• Ability to handle multiple projects and utilize judgement to prioritize tasks
• Proficiency in communicating ideas and presenting complicated analyses to diverse audiences is required

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Contracts Manager

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes two clinical programs: RP-3500, a potential leading ATR inhibitor; and RP-6306, a first-in-class PKMYT1 inhibitor; as well as pre-clinical assets such as a Polθ inhibitor.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives. From its inception, Repare has based its development strategy on precision oncology.

Position Overview:

We are seeking a talented and highly motivated individual to join our team as a Contracts Manager.  The successful candidate will be responsible for managing and administering a wide range of R&D and G&A business contracts common to the biotech and pharmaceutical industry including, but not limited to, accurately annotating and maintaining all agreements in the company’s contract management system and monitoring post-execution contractual obligations; and supporting and/or leading routine form contract agreements and related documentation in accordance with established contract policies and procedures.  Role flexible dependent upon qualifications.

Responsibilities:

• Oversee and manage contract life cycle for a variety of contract types, including non-disclosure agreements, research and development agreements, consulting agreements, and master services agreements.
• Assist in maintaining a centralized database of contracts and monitoring performance obligations under such contracts.
• Ensure contract editing, review, approval, and execution occurs in a timely manner in accordance with corporate guidelines.
• Track expirations, terminations, renewals, amendments and administer related activities, including closeout.
• Resolve issues and solve problems throughout the life cycle of the contract.
• Disseminate information to appropriate employees regarding contract status.
• Coordinate with members of Finance team to ensure compliance with budgetary procedures.
• Assist in developing and implementing new policies and procedures.
• All other duties as assigned.

Requirements:

• Bachelor’s degree. Paralegal certification or JD is a plus.
• 5+ years related work experience in biotech, pharma, or academic technology transfer, preferably experience in a role with similar responsibilities.
• Experience at reviewing, updating, and drafting contract language.
• Excellent data management skills and proof-reading ability.
• Strong attention to detail and analytical skills.
• Ability to work on multiple projects simultaneously.
• Ability to work both independently and with others.
• Ability to operate in a fast moving, team-oriented, collaborative environment with tight deadlines.

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Principal Scientist – Clinical Bioinformatics

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes two clinical programs: RP-3500, a potential leading ATR inhibitor; and RP-6306, a first-in-class PKMYT1 inhibitor; as well as pre-clinical assets such as a Polθ inhibitor.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives. From its inception, Repare has based its development strategy on precision oncology.

We are seeking an Associate Director – Discovery Bioinformatics with the passion and desire to become part of a fast-paced, innovative team committed to developing breakthrough cancer therapies. The individual will be a self-starter that is effective in working independently as well as managing a small team of scientists. The successful candidate will help define and implement the company’s discovery bioinformatics strategy. They will collaborate with members of our SNIPRx® platform team to identify novel synthetic-lethal targets and expand patient populations. Furthermore, they will collaborate with translational scientists to help identify patient populations where our drugs are efficacious and effectively lead them into the clinic.

Responsibilities:

• Manage and develop a team of two bioinformatics scientists specialized in the analysis of CRISPR screens and providing support for discovery programs
• Be an internal thought leader on biomarker identification based on drug response experiments
• Design, implement and improve analytical approaches for target and biomarker identification based on cell line response to drug treatment
• Collaborate with and support target discovery and translational teams in the design of experiments and analysis of genomic datasets
• Lead the interactions with internal and external teams to develop and implement a state-of-the-art computational analysis platform for omics-based oncology biomarker discovery
• Develop and apply computational, statistical, and machine learning methods to mine multi-dimensional genome-scale data sets and derive biological insights
• Execute integrative analyses of cancer omics, clinical information and functional genomic data to support prioritization of targets and stratification of patients

Qualifications:

• PhD in Bioinformatics, Computational Biology, System Biology, or related fields
• Work experience
  • Four (4) years or more of bioinformatics research experience in the biotech or pharmaceutical industry, or
  • Six (6) years or more of post-doctoral academic bioinformatics experience in oncology target discovery, oncology translational sciences, or oncology clinical genomics
• Desired scientific experience
  • Cancer biology and cancer genomics. Experience with DNA Damage and Repair pathways is desirable.
  • Analysis of drug response data. Experience with multiplexed experiments (e.g. PRISM) and/or sophisticated approaches (e.g. GR50) is desirable.
  • Analysis of large cell line panel data such as CRISPR-Cas9 knockout screens
  • Familiarity with large genomic datasets such as the Cancer Dependency Map, The Cancer Genome Atlas, Genotype-Tissue Expression (GTEx).
• Experience working closely with biology teams to design and analyze experiments.
• Strong hands-on programing skills (R, Python, Unix, SQL, etc).
• Solid understanding of probability and statistics.
• Management experience highly desirable.
• Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis.
• Ability to handle multiple projects and utilize judgement to prioritize tasks.

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

POSITION DESCRIPTION

Position: Senior Clinical Trial Associate

Company: Repare Therapeutics

Location: Cambridge, MA, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

About the Role

We are seeking a clinical operations professional to join our growing Clinical Operations organization. This role will be key in supporting the execution and oversight of clinical trials. This is a great opportunity to join Repare as a key member of the clinical operations teams, supporting multiple clinical research studies. This individual will partner across the team and facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.

What You’ll Do 

• Works closely with Clinical Trial Manager (CTM), study teams, and Clinical Research Organizations (CRO) to support clinical study activities on one or more trials
• Provides support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols
• Participates in the preparation and maintenance of study manuals, site tools, templates, source documents, guidelines, newsletters, etc.
• Responsible for set-up, filing, maintenance, reconciliations and archiving of the electronic Trial Master File (TMF) by collecting and QCing essential documents from clinical sites and vendors, uploading documents to the TMF and managing the TMF vendor for assigned clinical projects according to ICH-GCP
• Assists with maintaining study status updates (examples include IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.)
• Interacts with CROs, vendors, and other external partners to provide information and resolution for specific requests and issues
• Assists CTM with agendas and meetings minutes for clinical operations meetings
• Responsible for the oversights of study team roster maintenance and vendor contact lists
• Assists CTM with logistics coordination for investigator meetings and external vendor meetings
• Supports ad-hoc activities as needed, as agreed with CTM

What You’ll Need

• Bachelor’s degree (scientific or healthcare discipline preferred) plus at least 2-5 years in clinical operations or drug development
• Proven experience in the oversight of the operational aspects of clinical studies
• Experience managing complex oncology trials
• Familiarity and experience with clinical trial eTMF requirements and practices
• Knowledge of ICH GCP
• Excellent organizational as well as problem-solving skills as well as the ability to work independently
• Ability to work in a fast pace, cross-functional, start-up environment

We are committed to building an inclusive culture of belonging that not only embraces the diversity of our people but also reflects the diversity of the communities in which we work and those that we serve. We know that the happiest and highest performing teams include people with diverse perspectives and ways of solving problems, so we strive to attract and retain talent from all backgrounds and create workplaces where everyone feels empowered to bring their full, authentic selves to work.

Repare Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.

Position: Associate Director/Director, Clinical Scientist

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs.

Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.

We are seeking a Clinical Scientist, Associate Director/Director, to play a pivotal role in supporting key oncology programs. This position will report to the Head of Clinical Sciences. The Clinical Scientist will be responsible for providing scientific support for all clinical development activities. If desired the Clinical Scientist may also share or gain experience in our diagnostics development. This role offers a unique opportunity to progress your career by working on novel therapies in the DNA repair field, novel clinical trial designs and innovative approaches to global oncology drug development.

RESPONSIBILITIES

• Contribute to the development of clinical strategies and trial execution
• Perform ongoing review and analysis of study safety and efficacy data
• Provide support as needed for scientific issues that may arise during study execution
• Collaborate with the Clinical Operations group to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), etc.
• Collaborate with the Regulatory group Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents
• Develop relationships with appropriate consultants
• Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
• Understand and support creation of competitor landscape, medical need, regulatory strategy
• Perform literature searches and summarize the relevant scientific, drug development and medical literature to support document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
• Provide scientific/medical supportive materials to in-house staff and external consultants in the indications being studied
• Write abstracts and present data at scientific meetings, both internally and externally.
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines

BASIC QUALIFICATIONS

• Bachelor’s degree in life sciences or related discipline (at minimum)

PREFERRED QUALIFICATIONS

• Advanced degree (e.g. MS, PhD, PharmD)
• Minimum of 3 years of experience in a pharmaceutical industry or CRO environment in drug development
• Prior Oncology Drug Development experience is required.
• Experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.
• Proven track record of working with investigators, site staff, external experts, Contract Research Organizations and vendors
• Demonstrated ability to work in matrix teams and in a fast-paced environment.
• Excellent management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
• Strong Analytical ability.
• Excellent interpersonal and decision-making skills.
• Ability to work independently and enthusiasm to deliver the program objectives in a timely manner. Negotiation and influential skills are advantageous.
• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.