Join us

At Repare Therapeutics, we are always looking for highly innovative and collaborative individuals who are passionate about discovering revolutionary cancer treatments.

If you are interested in joining the Repare Therapeutics team, please fill out the form below and submit your CV.

Head of Regulatory Affairs & Quality Assurance

POSITION DESCRIPTION

Position: Head of Regulatory Affairs & Quality Assurance

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA or Montreal, Quebec, Canada

Website: http://www.reparerx.com/

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

We are seeking a Director/Senior Director of Regulatory Affairs & QA at Repare that will oversee the global strategy and execution of the regulatory affairs objectives for the organization providing regulatory strategies for company’s regulatory applications at all stages of development. Ensuring that all activities within the organization are conducted according to the appropriate internal and external quality standards, and that there is adherence to all applicable regulatory requirements. Interfacing with Clinical to ensure studies are following global guidelines and establishing phase-appropriate RA/QA practices and procedures and overseeing their effective and efficient implementation.

Leading and promoting the organization’s philosophy in quality of development and services and in maintaining a work environment that fosters learning, open communication, collaboration, integration, and teamwork. This position will serve as lead for all aspects of Regulatory Affairs and Quality Assurance with emphasis on compliance with GMP, GLP and GCP requirements and standards. The Director/Senior Director will identify, recruit, and manage staff within Regulatory Affairs and external consultants as needed.

 

RESPONSIBILITIES

  • Develops clinical and diagnostic regulatory strategies for all Repare programs in development.
  • Coordinates, writes, compiles, as appropriate, document packages for regulatory submissions from development, manufacturing, preclinical and clinical areas per regulations/guidelines and company SOPs to support regulatory applications.
  • Oversee the establishment, maintenance, and successful implementation of Regulatory & Quality processes and procedures.
  • Develop, Lead, and manage a Regulatory function that complies with appropriate regulations and guidelines and demonstrates operational efficiency.
  • Reviews and approves investigator site regulatory documents (i.e. investigator documents, Informed Consents, IRB/EC documents) according to US FDA requirements and/or country requirements for initiation of clinical sites and drug shipments.
  • Ensure all interactions with Agency personnel (US/Ex-US) are conducted to the highest degree of professionalism.
  • Establish credibility and confidence with key internal and external colleagues through regular communication and the highest degree of professionalism.
  • Create effective team resource plans, structures and processes (including quality management) and institute appropriate SOPs.
  • Lead and manage quality programs which instill personal accountability for accuracy, consistency, and completeness for all operations and departments.
  • Manage key relationships and strategic discussion with large pharmaceutical partners, ensuring program advancement, quality discussions, and desirable outcomes.
  • Ensure Company maintains audit-ready status and lead/support any investigations.
  • Represent RA/QA, both staff and function, at the Repare Cross-functional Leadership Team (XLT) and R&D Leadership Team.
  • Ensure that suppliers and external vendors meet all applicable requirements through the development, implementation, and execution of the Supplier Audit program.
  • Develop and execute the RA/QA operating budget and manage department efforts to control costs.

 

QUALIFICATIONS

  • Minimum 10 years combined experience in Regulatory Affairs & Quality.
  • Minimum 5 years of experience in regulatory oncology in a leadership capacity.
  • Excellent working knowledge of US and EU regulations and guidelines.
  • Successful regulatory filings associated with full life-cycle development: IND/NDA/MAA CTA, amendments, and experience with companion diagnostics are an absolute must.
  • Minimum of a bachelor’s degree in a life science required. MS or PhD degree is preferred.
  • Proven ability to find and create solutions for problems in an innovative way.
  • Strong influencing skills and the ability to build strong interpersonal relationships.
  • Superb oral and written communication skills with the proven ability to shape and frame to diverse audiences.
  • Well-developed interpersonal and problem-solving skills with demonstrated leadership and organizational skills.

Senior Research Scientist – biochemical & cellular assays

POSITION DESCRIPTION

Position: Senior Research Scientist – biochemical & cellular assays

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

Repare Therapeutics develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. Repare integrates insights from several fields of cell biology including DNA repair and synthetic lethality, combining a proprietary, high throughput, CRISPR‐enabled gene editing target discovery method with high‐resolution protein crystallography, computational biology, drug discovery and clinical informatics.  Repare was founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies.  The company has assembled a seasoned team of industry veterans and a world-class Advisory Board to support the development of next generation precision oncology, small-molecule therapeutics.  Repare Therapeutics is a 2017 “Fierce 15” start-up backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com).

 

Repare Therapeutics is seeking a highly motivated and team-oriented research scientist to join our biology department and help advance our portfolio of synthetic lethal cancer therapies. The individual should have extensive knowledge in developing and running biochemical &/or cell-based assays to support lead identification and lead optimization activities. A good understanding of assay miniaturization and automation is needed. Candidates must have the ability to communicate clearly, collaborate and enjoy a fast-paced and hands-on research environment.

 

RESPONSIBILITIES

  • Independently develop complex target-based assays in both biochemical and/or cell-based systems to support structure-activity relationship (SAR) studies on various target screens
  • Program and use specialized equipment (ie. plate readers, robotic reagent dispensing) for assay miniaturization needs
  • Knowledge of enzymology and protein-protein interaction is an asset
  • Establish procedures for new assays and be responsible for calculating and reporting data and procedures in an electronic lab book
  • Critically analyze and interpret data using various software, and effectively document and communicate results to a variety of audiences
  • Execute a wide array of technical methods including molecular biology (cloning, PCR, QPCR, western blot) and/or cell culture
  • 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

 

QUALIFICATIONS

  • MSc or PhD Degree in cell biology, molecular biology, biotechnology or biochemistry;
  • At least 5 years of experience in drug discovery in a pharmaceutical/ biotechnology/contract research organization setting (CRO)/ academic platform
  • Strong knowledge and experience in data analysis and reporting is required
  • Hands-on experience with miniaturization and automation is a must
  • Strong analytical capabilities with understanding of early drug discovery is essential
  • Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
  • Outstanding organizational skills (lab book, experimental design, reagent cataloging, etc.)
  • Excellent teamwork approach – work as part a cross-functional team including biologists, medicinal chemists and structural biologists

Senior Research Scientist – Biology

POSITION DESCRIPTION

Position: Senior Research Scientist – Biology

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

Repare Therapeutics develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. Repare integrates insights from several fields of cell biology including DNA repair and synthetic lethality, combining a proprietary, high throughput, CRISPR‐enabled gene editing target discovery method with high‐resolution protein crystallography, computational biology, drug discovery and clinical informatics.  Repare was founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies.  The company has assembled a seasoned team of industry veterans and a world-class Advisory Board to support the development of next generation precision oncology, small-molecule therapeutics.  Repare Therapeutics is a 2017 “Fierce 15” start-up backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com).

 

Repare Therapeutics is seeking a highly motivated and team-oriented research scientist to join our biology department and help advance our portfolio of synthetic lethal cancer therapies. The individual should have substantial experience in cell-based assays and functional experience in molecular biology and biochemistry. The candidate will be responsible for establishing cellular, biochemical, and mechanism of action (MoA) studies to profile small molecule compounds and to validate novel targets in cancer. Candidates must have the ability to communicate clearly, collaborate and enjoy a fast-paced and hands-on research environment.

 

RESPONSIBILITIES

  • Independently develop & execute cellular and biochemical assays in support of target ID/validation and Lead ID/Lead Opt activities
  • Interrogate the mechanism of action of small molecules inhibitors on cell proliferation, cell cycle & apoptosis endpoints using various methods
  • Perform target validation studies using shRNA/siRNA & CRISPR technology
  • Execute a wide array of technical methods including molecular biology (cloning, PCR, QPCR, western blot) and cell culture (cancer cell lines, primary cells & animal tissue processing etc.)
  • Establish procedures for new assays and be responsible for calculating and reporting data and procedures in an electronic lab book
  • Critically analyze and interpret data using various software, and effectively document and communicate results to a variety of audiences

 

QUALIFICATIONS

  • MSc or PhD Degree in cell biology, molecular biology, biotechnology or biochemistry;
  • At least 3 years of experience in drug discovery in a pharmaceutical/ biotechnology/contract research organization setting (CRO)/ academic platform
  • Knowledge in DNA repair & cancer biology is an asset
  • Knowledge and experience in data analysis and reporting is required
  • Strong analytical capabilities with understanding of early drug discovery is essential
  • Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
  • Outstanding organizational skills (lab book, experimental design, reagent cataloging, etc.)
  • Excellent teamwork approach – work as part a cross-functional team including biologists, medicinal chemists and structural biologists

Research Scientist - Pharmacology

POSITION DESCRIPTION

Position: Research Scientist – Pharmacology

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

 

We are seeking an experienced scientist at our Montreal site to assume a hands-on role as part of a scientific team responsible for assessing the in vivo pharmacology and efficacy of novel pre-clinical anticancer compounds.  The scientist will be involved in evaluating drug combinations of Repare drug candidates with targeted agents and with immuno-oncology therapeutics, establishing detailed efficacy, PK/PD relationships and therapeutic window.

 

RESPONSIBILITIES

  • To identify, develop and implement clinically relevant rodent models in which to evaluate the in vivo efficacy of novel anticancer compounds.
  • To maintain and expand cancer cell lines in culture in preparation for tumor inoculation.
  • To prepare drug formulations and dosing solutions.
  • To carry out all aspects of animal experimentation including tumor inoculations, drug administrations (multiple routes), animal health monitoring, anesthesia, surgeries, blood samplings (multiple routes), necropsies, and to monitor tumor progression through a variety of modalities including caliper measurements and luminescence imaging.
  • To perform 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.
  • To maintain detailed laboratory notes, sample records and protocols. To compile, summarize and graph data for presentations.
  • 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.

 

QUALIFICATIONS

  • DEC in Animal Health Technology, BSc., or MSc in biological sciences with at least 2yrs of relevant experience. A background in oncology is a definite asset.
  • Experience in small animal handling, preferentially in carrying out pre-clinical rodent oncology models including tumor implantation and measurement is essential.
  • Experience in drug administration by multiple routes (e.g. i.v., s.c, p.o., i.p.), tissue perfusion and blood sampling by multiple routes is essential.
  • Experience in pre-clinical drug discovery in an industrial, GLP setting (CRO or other) is an asset.
  • Ability to communicate in an open, clear, timely and consistent manner.
  • Outstanding organizational skills (lab book, experimental design, etc.).
  • Bilingual French/English (spoken and written) is an asset.
  • 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.

 

Senior Research Scientist - Pharmacology

 

POSITION DESCRIPTION

Position: Senior Research Scientist – Pharmacology

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair, cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

 

We are seeking an experienced scientist at our Montreal site to assume both a leadership and hands-on role as part of a scientific team responsible for advancing Repare’s drug and target discovery pipelines.  The scientist will develop and characterize both immunocompromised and syngeneic mouse models in which to validate novel cancer drug targets using various gene editing technologies.  They will be involved in assessing the in vivo pharmacology and efficacy of novel pre-clinical anticancer compounds and evaluate drug combinations with targeted agents and immuno-oncology therapeutics.

 

RESPONSIBILITIES

  • To identify and implement clinically relevant rodent tumor models in which to evaluate the in vivo efficacy of novel anticancer compounds and perform target validation studies.
  • To implement various genetic knock-out technologies in vivo, in tumor models, for the purposes of target validation.
  • To design and execute experiments to evaluate the efficacy, PK/PD relationships and toxicity of candidate drug compounds and drug combinations in the selected in rodent cancer models.
  • To evaluate target engagement and mechanism of action from in vivo tumor samples.
  • To represent pharmacology at pre-clinical drug development project team meetings.
  • To communicate results at project team and other meetings and be involved in the coordination and preparation of presentations, reports and manuscripts for publication in peer-reviewed journals.
  • To maintain detailed laboratory notes and protocols.
  • The level of position responsibilities will be adjusted according to the candidate’s background and experience level.
  • 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.

 

QUALIFICATIONS

  • MSc or PhD in biological sciences and minimum of 3 years experience in rodent models of cancer.
  • Experience in small animal handling, including drug administration and blood sampling through multiple routes, necropsies, and minor surgery is essential.
  • Experience in oncology, immune-oncology, DNA repair and/or chromatin remodelling is essential.
  • In vitro techniques such as cell culture, ELISA, western blotting, IHC and FACS analysis are a definite asset.
  • Experience in pre-clinical drug discovery, preferably in an industrial setting an asset.
  • Ability to communicate in an open, clear, timely and consistent manner.
  • Outstanding organizational skills (lab book, experimental design, documentation etc.).
  • Ability to handle multiple projects and utilize judgement to prioritize tasks.
  • Bilingual French/English (spoken and written) is an asset.
  • Ability to contribute as a team member in a dynamic, fast-paced biotech environment.

 

Research Scientist – Target Discovery

 

POSITION DESCRIPTION

Position: Research Scientist – Target Discovery

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

Repare develops novel precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining proprietary CRISPR‐enabled genome-wide synthetic lethal (SL) screens for target discovery and patient selection biomarkers with high‐resolution protein crystallography, computational biology and clinical informatics. Founded by leading experts at the forefront of DNA damage and repair, cancer biology, and high-throughput CRISPR screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

 

We now have an outstanding opportunity available for a motivated Ph.D. or M.Sc.-level research scientist who would like to get in early and grow with the company. The successful candidate will be an expert in at least one of the following research areas: DNA repair, epigenetics, cancer biology, cell/molecular biology, synthetic lethality, immuno-oncology, and/or genome engineering. The candidate will become a vital member of our SNIPRx™ platform team where he/she will contribute both experimentally and intellectually to design and execute new SL campaigns and to generate a pool of validated drug targets to advance our portfolio. A critical component of the job will be the close collaboration with internal drug discovery and computational biology teams.

 

RESPONSIBILITIES

  • Become a crucial intellectual and technical leader on our SNIPRx™ target discovery platform
  • Stay up to date on current literature and attend conferences to establish yourself as a key opinion leader within the company
  • Utilize CRISPR/Cas9 genome editing and other cell biology tools to generate and characterize cell line models for SL screens, target validation, and mechanism of action studies
  • Design and execute CRISPR-enabled genome-wide screens
  • Fully characterize cancer cell line panels: expanding, banking, and confirming loss-of-function or gain-of-function gene mutations by sequencing, qPCR, immunoblotting, and functional assays
  • Apply skill set to identify and fully validate new SL targets
  • Plan and execute experiments to uncover mechanisms underlying SL interactions
  • Facilitate the development of computational biology tools by working closely with our bioinformatics team

QUALIFICATIONS

  • M.Sc. or Ph.D. in Molecular Genetics, Cancer Biology, Cell and Molecular Biology, Immunology or related fields
  • Theoretical or hands-on experience in genome editing techniques (CRISPR, TALENs, ZFNs, etc.) to generate gene knockout and knock-in cell lines
  • Experience in functional genomics (especially RNAi or CRISPR screens) is highly desired
  • Expertise in cell and molecular biology techniques required (proliferation assays, microscopy, cytogenetics, PCR, immunoblotting, etc.)
  • Experience in lentiviral or retroviral packaging and cell line transductions would be 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
  • Ability to work as a team member in a dynamic, fast-paced biotech environment where you can make a clear impact

Clinical Trial Manager / Senior Clinical Trial Manager

POSITION DESCRIPTION

Position: Clinical Trial Manager/Senior Clinical Trial Manager

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

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.

 

RESPONSIBILITIES

  • Leads cross-functional trial team to ensure delivery of complex clinical trials and manages protocol execution.
  • Oversees 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.
  • Provides input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
  • Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
  • Identifies and/or anticipates 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.
  • Serves 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).
  • Participates in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates).
  • Performs other duties as assigned

QUALIFICATIONS

  • 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
  • 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

 

 

Associate Director/Director, Clinical Scientist

POSITION DESCRIPTION

Position: Associate Director/Director, Clinical Scientist

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

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

 

RESPONSIBILITIES

  • Contribute to the development of clinical strategies and trial execution
  • Perform ongoing review and analysis of study safety and efficacy data
  • Provide support as needed for scientific issues that may arise during study execution
  • Collaborate with the Clinical Operations group to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol safety, Case Report Forms (CRFs), etc.
  • Collaborate with the Regulatory group Drafting of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports, CSRs and other FDA submissions, including scientific advice, IND, EoP2, pre-NDA/BLA meetings, NDA/BLA and MAA documents
  • Develop relationships with appropriate consultants
  • Understand the asset’s biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature
  • Understand and support creation 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

QUALIFICATIONS

  • 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.

 

Clinical Biomarker Operations Manager

POSITION DESCRIPTION

Position: Clinical Biomarker Operations Manager

Company: Repare Therapeutics

Location: Cambridge, Massachussetts, USA

Website: http://www.reparerx.com/

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

We are seeking a Clinical Biomarker Operations Manager to provide biomarker operational expertise and guidance to multiple oncology programs to implement scientifically driven clinical development plans. This individual will be the single point of contact on the translational team, clinical operations, and with CRO partners on all aspects of biomarker operations. They will ensure the timely and efficient delivery of all biomarker operational aspects of clinical studies, including company collaboration and academic collaboration studies, in accordance with the appropriate quality standards including GCP and applicable regulations.

RESPONSIBILITIES

  • Accountable for executing exploratory and companion diagnostic 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 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 operational team, diagnostic partners, external CROs, and external biomarker vendors, where applicable.
  • Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level
  • 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
  • Serves as the single point of contact for status of clinical trial samples and biomarker data
  • 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

QUALIFICATIONS

  • 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+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
  • Extensive clinical development experience with evidence of working in teams running clinical studies
  • Biotech industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus
  • Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples
  • Project management skills
  • Critical reasoning skills including the identification and resolution of complex problems
  • Detail oriented with the ability to work independently and manage multiple competing priorities
  • Planning, organizational and time management skills
  • Highly flexible in a fast pace global matrix environment
  • Professional interpersonal skills, excellent oral/written communication and influencing skills
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Creates team culture and promotes team spirit.
  • Global Vendor Management experience

Good knowledge of GCP

Clinical Biomarker Lead, Oncology Synthetic Lethality

POSITION DESCRIPTION

Position: Clinical Biomarker Lead, Oncology Synthetic Lethality

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

Repare Therapeutics is a 2017 “Fierce 15” drug discovery company backed by tier-one strategic and institutional biotechnology investors (http://www.reparerx.com). Repare develops novel, precision oncology drugs that target specific vulnerabilities of tumor cells. This is accomplished by combining a proprietary, high throughput, CRISPR‐enabled drug target discovery platform with an experienced team of small molecule drug discovery scientists, structural and computational biologists.  Founded by leading experts at the forefront of DNA damage and repair cancer biology and genome-scale synthetic lethal screening technologies, Repare has assembled a seasoned team of industry veterans and a world-class Advisory Board.

We are seeking a Clinical Biomarker Lead that will be accountable for delivery of robust, scientifically driven biomarkers in drug development programs for synthetic lethal drug targets in oncology. This individual will have the opportunity to impact an industry-leading portfolio of Synthetic Lethal Drug Programs from inception of drug candidate and throughout clinical development.

 

RESPONSIBILITIES

  • Identify, develop and implement cutting edge science and technological advances into biomarker and companion diagnostic (CDx) strategies to guide indication selection, patient enrichment, and combination strategies.
  • Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives. Measure target engagement reliably and quantifiably to inform clinical decisions for selecting therapeutically relevant doses and schedules.
  • Understand key cancer pathway interactions and feedback mechanisms in clinical samples to guide rational drug combinations.
  • Define novel mechanisms of resistance targeted therapies by studying tumors at relapse
  • Provide input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms
  • Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
  • Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy. Point contact for resolving study biomarker issues.
  • Manage effective working relationships with clinical operations, clinical science, biology leads, bioinformatics and regulatory functions.
  • Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs.
  • Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations).

 

QUALIFICATIONS

  • Ph.D. in a life scientific discipline
  • 3-5 years in biotechnology, pharmaceutical industry or clinical setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
  • Extensive experience in the development of clinical biomarkers with a proven track record of success.
  • Highly experienced in oncology translational research on molecularly targeted therapies, with proven track record of high-impact contributions to biomarker discovery and/or assay development.
  • Experience in conducting clinical trials, conducting biomarker analyses on various clinical sample types and working as part of a clinical study team.
  • Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms.
  • Experience with developing and validating fit for purpose clinical assays
  • Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
  • Strong interpersonal skills and ability to thrive in a matrix environment.
  • Experience in managing research collaborations, contract laboratories and budgets.
  • Dependable and trustworthy, willing to take ownership and responsibility.
Browse...

PDF Only, Maximum size 10MB

Please wait...