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 DESCRIPTION

Position: Junior DMPK Scientist

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

We now have an exciting opening at our Montreal site for a contract position in the Drug Metabolism and Pharmacokinetics group.   This position is an excellent opportunity to learn drug discovery with a leading precision oncology company.  The successful candidate will possess hands-on laboratory skills and will have the opportunity develop expertise with numerous in vitro assay techniques and mass spectrometry.  A critical component of the job will be the close collaboration with DMPK scientists as well as supporting various laboratory operations.

Note: This is a 6-month contract position, with the possibility of renewal up to 12 months

What You’ll Do

• Conduct established ADME/DMPK assays.
• Schedule and organize studies with various CROs.
• Maintain laboratory equipment including mass spectrometers, HPLC and pre-formulation tools.
• Manage inventories and order consumables as needed.

What You’ll Need

• in Chemistry, Biochemistry, Biology or related fields with some experience in ADME/DMPK in an industrial setting.
• Recent graduates (MSc, BSc) and co-op students in a related field with a keen interest to learn new techniques are encouraged to apply.
• Ability to communicate in an open, clear, timely and consistent manner.
• Outstanding organizational skills (planning, ordering, documentation in lab notebooks etc..).
• Ability to multitask and utilize judgement to prioritize tasks.
• Ability to contribute as a team member in a dynamic, fast-paced biotech environment.
• Experience in pre-clinical drug discovery, formulation or bioanalytical mass spectrometry is considered 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: Associate Director/Director of Quantitative Pharmacology

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 Associate Director/Director of Quantitative Pharmacology reports to the Head of Nonclinical Development and serves as an integral contributor to all the preclinical and clinical development projects at Repare.

What You’ll Do

• Partner with Head of Nonclinical Development, Program Team leaders and R&D staff to lead the pharmacometrics and quantitative PK/PD strategy for Repare’s discovery and development programs
• As a member of the Repare’s project teams, the individual will be responsible for applying model-based approaches to support compartmental and mechanism-based PK/PD analysis, evaluation of FIH dose and regimen recommendations.
• Develop and execute strategies for mid-stage and late-stage Oncology programs to support regulatory questions and filings
• Provide due-diligence and strategic regulatory advice/evaluations for oncology drug development programs
• The successful incumbent will utilize a range of computational approaches (PK/PD, PBPK, pharmacometrics, systems-based, informatics). The scope of project responsibility will range from late discovery through registration.

What You’ll Need

• A Ph.D. in Pharmacology, Biology, Engineering, Mathematics or related field with 5+ years of relevant experience in modeling and simulation.
• Excellent understanding of PK (NCA, compartmental) and PK/PD principles.
• Expertise in the application of Phoenix WinNonlin, PBPK related software, and R is required.
• Experience with PopPK model development with regulatory reporting is a plus.
• Superior communication skills (both written and oral) and attention to detail
• Strong organizational skills
• Leads by example and highly collaborative with the proven ability to work in a cross-functional internal and external teams
• Must be able to prioritize work effectively to ensure progression of multiple department and corporate timelines
• Pro-active in identifying opportunities along with strong problem solving and negotiation skills
• A strategic thinker who can generate ideas and opportunities and turn them into successful results

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: 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: 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: 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.