CAREERS

Position: Research Scientist – Biochemical & Cellular Assays

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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 individual should have knowledge in developing and running biochemical & cell-based assays to support lead identification and lead optimization activities. A good understanding of assay miniaturization and automation is an asset. Candidates must have the ability to communicate clearly, collaborate and enjoy a fast-paced and hands-on research environment.

What You’ll Do

• Develop & perform target-based assay both in biochemical and cell-based systems to support structure-activity relationship (SAR) studies on various target screens.
• Establish procedures for each assay and be responsible for calculating and reporting data and procedures in an electronic lab book;
• Critically analyze and interpret data, and effectively document and communicate results to a variety of audiences;
• Execute a wide array of technical methods including molecular biology and cell culture: cell culture, cloning, PCR, QPCR, western blot.
• Good organizational and time-management skills including the ability to manage several projects simultaneously
• Ability to work as a team member in a dynamic, fast-paced biotech environment where you can make a clear impact.

What You’ll Need

• MSc Degree in cell biology, molecular biology, biotechnology or biochemistry.
• Strong analytical capabilities and willingness to learn new in vitro & cellular techniques and assay automation
• Knowledge and experience in data analysis and reporting
• Experience in drug discovery in a pharmaceutical/ biotechnology/contract research organization setting (CRO)/ academic platform is an asset
• Hands-on experience with miniaturization and automation is also an asset
• Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
• Outstanding organizational skills (lab book, experimental design, reagent cataloging, etc.)
• Ability to handle multiple projects and utilize judgement to prioritize tasks
• Excellent teamwork approach – work as part a cross-functional team including biologists, medicinal chemists and structural biologists

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: Pharmacology Associate Scientist

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

About Repare Therapeutics

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 PKMYT1 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

The pharmacology department is seeking scientist at our Montreal site to assume a hands-on role as part of a scientific team responsible for assessing the in vivo pharmacology of novel pre-clinical anticancer compounds.  The scientist will be involved in routine evaluations of the pharmacokinetics and efficacy of Repare’s novel drug candidates, establishing efficacy, PK/PD relationships.

What You’ll Do

• To interface with the DMPK department to evaluate the pharmacokinetics of Repare’s candidate oncology agents through blood sampling by multiple routes.
• To prepare drug formulations and dosing solutions and drug administrations (multiple routes).
• To assist pharmacology team members in the evaluation of candidate anti-tumor compounds including tumor inoculations, animal health monitoring, drug administrations.
• To take on lab management responsibilities including ordering of supplies and maintaining inventory of stocks and samples and routine maintenance of equipment.
• To maintain detailed laboratory notes, sample records and protocols.
• To assist with necropsies, terminal bleeds and tumor and tissue sample harvest from treated animals for the purposes of identifying drug-target engagement and monitoring tumor and tissue PK.
• The successful candidate may be required to work non-standard hours from time to time, including occasional weekend and statutory holidays as required by on-going experiments.

What You’ll Need

• DEC in Animal Health Technology or BSc. in biological sciences with at least 2yrs of relevant experience.
• Experience in rodent handling (mouse and rat), restraint and blood draws from tail vein, cardiac puncture is essential.
• Experience in drug administration by multiple routes (e.g. i.v., p.o., i.p.) is essential.
• Experience with portal vein canulation and sampling is an asset.
• A background in oncology with rodent tumor models is a definite asset.
• Experience in pre-clinical drug discovery in an industrial, GLP setting (CRO or other) is also an asset.
• Availability on weekends is an asset.
• Ability to communicate in an open, clear, timely and consistent manner.
• Outstanding organizational skills (lab book, experimental design, etc.).
• 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: Pharmacology Animal Technician

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

About Repare Therapeutics

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 PKMYT1 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

The pharmacology department is seeking scientist at our Montreal site to assume a hands-on role as part of a scientific team responsible for assessing the in vivo pharmacology of novel pre-clinical anticancer compounds.  The scientist will be involved in routine evaluations of the pharmacokinetics and efficacy of Repare’s novel drug candidates, establishing efficacy, PK/PD relationships.

What You’ll Do

• To interface with the DMPK department to evaluate the pharmacokinetics of Repare’s candidate oncology agents through blood sampling by multiple routes.
• To prepare drug formulations and dosing solutions and drug administrations (multiple routes).
• To assist team members in the evaluation of candidate anti-tumor compounds including tumor inoculations, animal health monitoring, drug administrations.
• To take on lab management responsibilities including ordering of supplies and maintaining inventory of stocks and samples and routine maintenance of equipment.
• To maintain detailed laboratory notes, sample records and protocols.
• To assist with necropsies, terminal bleeds and tumor and tissue sample harvest from treated animals for the purposes of identifying drug-target engagement and monitoring tumor and tissue PK.
• The successful candidate may be required to work non-standard hours from time to time, including weekend and statutory holidays as required by on-going experiments.

What You’ll Need

• DEC in Animal Health Technology, BSc., or MSc in biological sciences. A background in oncology is a definite asset.
• Experience in rodent handling (mouse and rat), and blood draws from tail vein, cardiac puncture is essential including tumor implantation and measurement.
• Experience in drug administration by multiple routes (e.g. i.v., p.o., i.p.), tissue perfusion is essential.
• Experience with portal vein canulation and sampling is an asset.
• Experience in pre-clinical drug discovery in an industrial, GLP setting (CRO or other) is also 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: Senior Scientist – In vitro/In vivo Biologist/Pharmacologist

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

About Repare Therapeutics

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 PKMYT1 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

The Pharmacology department is seeking an experienced scientist at our Montreal site to assume both strategic and hands-on roles as part of a scientific team responsible for assessing the in vitro/ in vivo pharmacology and efficacy of novel pre-clinical anticancer compounds.  The scientist will be part of a core drug development team and be responsible for the selection and characterization of oncology study models, evaluation of drug efficacy and tolerability, the evaluation of dose scheduling and drug combinations strategies with targeted agents / immuno-oncology therapeutics and support the ongoing clinical trials of Repare drug candidates.  The position will involve the discovery of pharmacodynamic (PD) markers and establishment of assays to measure target-mediated signaling pathways and the development of pharmacokinetic/PD/efficacy relationships to help guide clinical study design.

What You’ll Do

• To represent the pharmacology department as part of the core program development team in the evaluation and advancement of lead molecules through the development pipeline into clinical trials.
• To design the in vivo pharmacology drug development plan. To select and develop the appropriate animal models and design studies to evaluate Repare’s clinical drug candidates for efficacy, tolerability and target engagement.
• To manage internal and outsourced research studies to local and international CROs.
• To communicate results at project team and company wide review meetings and be involved in the coordination and preparation of presentations, reports and manuscripts for publication in peer-reviewed journals.
• Responsibilities will also involve some hands on work:
• To design, implement and carry out PD assays to quantitatively track target engagement in blood and/or tumor tissues by western blot, ELISA, bead proximity, IHC, qRT-PCR or other means.
• To carry out some animal experimentation including tumor cell inoculations, drug administrations (multiple routes), animal health monitoring, anesthesia, blood samplings (multiple routes), necropsies, and to monitor tumor progression through a variety of modalities including caliper measurements and luminescence imaging.
• To harvest tumor and tissue samples from treated animals to help establish PK/PD/efficacy and toxicity relationships in vivo for Repare’s pre-clinical drug candidates and drug combinations. To process blood and tissue samples for monitoring PD markers, hematological and tissue toxicities.
• To maintain detailed laboratory notes and protocols.
• The successful candidate may be required to work non-standard hours from time to time, including occasional weekend and statutory holidays as required by on-going experiments.
• The level of position and responsibilities will be adjusted according to the candidate’s background and experience level.

What You’ll Need

• PhD in biological sciences and minimum of 4 years relevant experience or an MSc with 7 years of equivalent relevant experience.
• Experience in oncology is essential, DNA repair and/or chromatin remodeling an asset.
• Experience in small animal handling, preferentially in carrying out pre-clinical rodent oncology models with drug delivery experience.
• A strong background in cell biology, and quantitative cell-based growth and viability assay development using various modalities.
• Experience in pre-clinical drug discovery in an industrial setting is a strong asset.
• Diverse expertise in DNA damage and repair, cell cycle assays and biochemical techniques or in a drug development environment is an asset
• Ability to communicate in an open, clear, timely and consistent manner in project team meetings and internal company presentations.
• Outstanding organizational skills (lab book, experimental design, documentation etc.).
• Ability to handle multiple projects and utilize judgement to prioritize tasks.
• Ability to contribute as an initiator and 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: Senior Scientist, Analytical Development

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 Scientist, Analytical Development will be the analytical lead to support both drug substance and drug product development across various clinical development stages. In addition to providing top-tier expertise in analytical development, the successful candidate will manage external contract labs, collaborating closely with chemical process, formulation, QA, and regulatory to assure adherence to phase-appropriate regulatory and quality requirements.

The position reports the head of the Analytical Development department.

What You’ll Do

• Works with external partners to develop analytical methods for drug substance and drug product, and oversees phase-appropriate validation, testing, and data receipt.
• Coordinates formal and informal stability studies, applies statistical methods of analysis and trending, and guides project team activities based on stability outcomes.
• Establishes phase-appropriate specifications and control strategies for materials, and authors justification of specification documents.
• Critically reviews and approves methods and protocols, authors development reports, and contributes to the preparation of the analytical sections of regulatory submissions.
• Troubleshoots analytical issues at external sites, conducts systematic process risk assessments, and collaborates with Quality to manage out-of-specification results.
• Effectively and professionally represents the Analytical Development function on cross functional project teams, collaborating to define phase-appropriate development strategies and meet overall program goals and timelines.

What You’ll Need

• Ph.D. with 3+ years working experience or MS degree with 8+ years working experience of relevant analytical experience in the pharmaceutical industry, including direct experience with solid oral dosage forms.
• Extensive practical experience in analytical techniques, including HPLC, GC. dissolution, and various impurity identification techniques.
• A well-grounded foundation in other characterization techniques including MS, NMR, UV, IR spectroscopy, and XRPD, DSC, PSD, TGA.
• Proven track record in leading analytical development activities for both drug substance and drug product across both early and late phases of clinical development.
• Strong oral and written communication skills, with experience in preparing protocols, technical reports, and regulatory filings.
• Good knowledge of regulatory (ICH, FDA, EMA) and compendial guidance and practical experience in meeting requirements in a phase-appropriate manner.
• Strong problem-solving skills and proven ability overcome analytical challenges while working within project timelines.
• Experience in developing aggressive but realistic timelines for functional activities and demonstrated success in delivering results according to integrated program plans.
• Ability to contribute leadership, independent judgement, and an enthusiastic attitude to our fast-paced and dynamic 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: Senior Biostatistician

Company: Repare Therapeutics

Location: Cambridge, MA, USA

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

About Repare Therapeutics

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 currently seeking a Senior Biostatistician who will report to the PMO Head and will work with the Preclinical, Clinical Development and Finance Teams to support cross-functional project teams in the planning and execution of multiple Repare projects to ensure projects meet objectives and deliverables.

What You’ll Do

• Develops statistical analysis plans for assigned programs and clinical trials in compliance with regulatory standards and in collaboration with other key functional areas.
• Provide statistical input to a wide variety of scientific, clinical development and regulatory document types including protocols, synopses, regulatory submissions and response, and scientific publications and presentations.

• Provide specifications, overseeing programming deliverables, QC the key results of statistical programmers.
• Perform adhoc statistical analyses as needed
• Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses.
• Support the preparation of publications, including manuscripts, posters, and oral presentations
• Keep abreast of new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.

What You’ll Need

• PhD in Statistics or other relevant discipline with experience in pharma or biotech environment, MS with relevant experience may be considered as well.
• Experience in Oncology is preferred
• Strong programming skills in SAS and/or R
• Comfortable in a fast-paced, collaborative small company environment, and able to adjust workload based upon changing priorities.
• Able to collaborate with and effectively influence others.
• Be science and data driven while at the same time, creative and flexible in strategic thinking and problem solving.

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, 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 Associate Director/Director, Clinical Scientist 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.

What You’ll Do

• 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 and support 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

What You’ll Need

• B.Sc. or equivalent (at minimum) in life science, nursing, pharmacy, medical laboratory technology or other health/medical related area. Other degrees/certifications considered if commensurate with related clinical research experience (e.g. diploma/associate degree RN, certified medical technologist)
• Postgraduate qualifications highly desirable
• Minimum of 3 years of experience in clinical research and drug development, preferably at pharmaceutical industry.
• Prior Oncology Drug Development experience is required.
• 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.

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, Statistical Programming

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 SAS programmer who is a self-starter with advanced technical skills and managerial skills.

Reporting to the Head of statistical programming, the candidate will be responsible for the development, maintenance of statistical programming functions to support various projects.  The candidate will have a chance to involve developing an overall strategy for the programming group, updating the SAS programming Infrastructure, and coordinating the effort across studies to identify, develop and implement departmental standards, applications, processes, and training. The candidate provides timely support to the project teams on statistical programming matters according to the project strategies and is responsible for addressing administrative functions required for project management and milestones, identifying, and communicating changes in project requirements that may affect key deliverables at the project level.

What You’ll Do

• Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.
• Develop SAS programs that support regulatory requests, ISS/ISE analyses, commercial requests, and biostatistical ad-hoc analysis.
• Manage the programming activities on one or multiple projects, done internally and/or externally by CROs.
• Review SDTM/ADAM specs and datasets and define reviewer’s guide for multiple studies.
• May have to create SAS utility macros; write and implement test plans to support SAS macro development.
• Perform quality review on SAS programs generated by other Statistical Programmers.
• Function as a positive role model for setting high expectations for quality, creativity, and project ownership.
• Works collaboratively with Biostatistics, Data Management, Clinical Operation, Global Drug Safety, Medical Writing, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical analysis and reporting.
• Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers)
• Work with Biometrics team and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate, working collaboratively as part of a team.
• Be attentive to detail and have the ability to independently resolve a variety of issues without close supervision.
• Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
• Identify new tools to increase efficiency and quality as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.

What You’ll Need

• Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering or related field (MS preferred).
• Minimum of 5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
• Advanced SAS programming skills and experience in other statistical software, such as R and S-Plus.
• Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies.
• Self-directed, technically strong, and a recognized leader maintaining a strategic prospective regarding statistical programming processes, management of statistical programming projects.
• Excellent organizational skills and ability 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: Associate Director of Regulatory Affairs

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 of Regulatory Affairs will work with the Head of Regulatory Affairs and will be responsible for developing regulatory strategies to advance Repare’s oncology portfolio. To be successful in this role, the individual must be self-motivated, and ability to work both independently as well as a collaborative team member and be able to operate within pre-specified timelines. Role and title can be flexible dependent upon qualifications and experience.

What You’ll Do

• Work closely and collaboratively with cross-functional teams and subject matter experts to develop, implement, and execute regulatory strategies to advance Repare’s portfolio.
• Responsible for leading, providing guidance on content, authoring and ensuring timely submission of INDs, CTAs, briefing packages, PsPs, orphan drug applications, agency responses, DSURs, fast track and breakthrough designations and any other regulatory documents.
• Provide advice and support to ensure that CMC, clinical and nonclinical ​aspects are aligned, while ensuring compliance with applicable regulatory requirements.
• Act as resource for team on evolving regulatory requirements and regulatory precedents.
• Provide regulatory insights, anticipate risk, and propose regulatory mitigation plans.
• Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.

What You’ll Need

• Experience in oncology drug development preferred.
• 6+ years of relevant experience in pharmaceutical regulatory affairs. Advanced scientific degree a plus.
• Ability to understand scientific issues as it relates to regulatory requirements and strategic impact.
• Ability to be flexible, with a “can do” attitude, and bring individual and teams together for common objectives.
• Ability to interpret regulations, guidelines, polices and precedents related to drug development in the US and outside.
• Must have experience filing INDs, CTAs; experience with marketing applications a plus.
• Ability to achieve high performance goals and meet deadlines in a fast-paced 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: Manager/Senior Manager, Clinical Data Management

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 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 Director/Senior Director, 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.

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: Associate Principal – Discovery 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 Principal – 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.

What You’ll Do:

• 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

What You’ll Need:

• 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.