Join us

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.

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

To protect the interests of all parties, Repare Therapeutics will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Repare Therapeutics, including unsolicited resumes sent to a Repare Therapeutics mailing address, email address, or directly to Repare Therapeutics employees, will be considered Repare Therapeutics property. Repare Therapeutics will not pay a fee for any placement resulting from the receipt of an unsolicited resume. Repare Therapeutics will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees.

Recruiting agencies must obtain advance written approval from Repare Therapeutics’ Finance department to submit resumes, and then only in conjunction with a valid fully-executed contract for service and in response to a specific job opening. Repare Therapeutics will not pay a fee to any Agency that does not have such agreement in place.

Principal Scientist – Clinical Bioinformatics

Position: Principal Scientist – Clinical Bioinformatics

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

From its inception, Repare has based its development strategy on precision oncology. We are seeking Principal Clinical Bioinformatician who will extend this approach to the clinic. This individual will use multi-dimensional genomic data to contextualize patient responses. Furthermore, they will collaborate with a diverse team of translational and clinical scientists to help define clinical strategy for Repare’s RP-3500 program.

 

Responsibilities:

  • Support patient selection and clinical trial enrollment based on genomic evidence
  • Analyze molecular data derived from clinical samples to discover biomarkers of response/resistance to therapy
  • Propose testable hypothesis and communicate scientific findings to a diverse clinical development team to support program decisions
  • Act as technical expert supporting clinical collaborations with top-tier academic institutions, contribute/lead writing collaboration research proposals
  • Collaborate with internal and external teams to develop and implement a state-of-the-art computational analysis platform for omics-based clinical development
  • Development of innovative analytic approaches to integrate and visualize multimodal biomarker data such as IHC, NGS, clinical response, clinical parameters, etc
  • Support design and analysis of Real-World Evidence clinical trial arms
  • Help identifying, evaluating, and managing the relationship with external vendors and CROs in the clinical genomics space
  • In collaboration with translational scientists, support development and quality assessment of clinical assays
  • In collaboration with operations team, manage transfer and availability of clinical biomarker data

 

Qualifications:

  • PhD in Bioinformatics, Computational Biology, System Biology, or related fields
  • Four (4) years or more of bioinformatics research experience in the biotech, pharmaceutical, diagnostics or related industries
  • Desired scientific experience
    • Cancer biology and cancer genomics
    • Experience working with analysis of clinical trial data
    • Experience with Real World Evidence analyses is a plus
  • Experience working closely with clinical teams to design and analyze experiments.
  • Strong hands-on programing skills (e.g. R, Python, Unix, SQL, etc)
  • Solid understanding of probability and statistics.
  • Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
  • Ability to handle multiple projects and utilize judgement to prioritize tasks

 

Associate Director/Director - Clinical Biomarker Lead

Position: Associate Director/Director – Clinical Biomarker Lead

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

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

We are seeking a Clinical 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.
  • Clinical Biomarker Lead for multiple phase clinical trials ranging phase I-II.
  • 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

  • PhD. in a life scientific discipline
  • 5-8 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. Engaging
  • 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

Associate Director/Director, Clinical Scientist

Position: Associate Director/Director, Clinical Scientist

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

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

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

RESPONSIBILITIES

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

BASIC QUALIFICATIONS

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

PREFERRED QUALIFICATIONS

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

Principal Bioinformatician

Position: Principal Bioinformatician

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

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

We are seeking Principal Bioinformatician 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 help define and implement bioinformatics strategy and mentor junior team members. They will collaborate with members of our SNIPRx® platform team to identify novel synthetic-lethal targets. Furthermore, they will collaborate with translational scientists to help identify patient populations where our drugs are efficacious and effectively lead them into the clinic.

 

Responsibilities:

  • Act as an internal thought leader on data analysis for target discovery and translational efforts
  • Mentor junior bioinformatics team members in target discovery, translational bioinformatics, or cancer genomics
  • Implement and improve analytical approaches for target and biomarker identification
  • Collaborate with and support target discovery and translational teams by helping design experiments and analyze genomic datasets
  • Collaborate with internal and external teams to develop and implement a state-of-the-art computational analysis platform for omics-based oncology drug discovery
  • Apply and develop computational, statistical, and machine learning methods to mine multi-dimensional genome-scale data sets and derive biological insights
  • Execute integrative analysis of cancer omics, clinical information and functional genomic data to support prioritization of targets and stratification of patients
  • In collaboration with discovery and translational science teams, propose testable hypotheses and experimental verification plans to support program decisions

Qualifications:

  • PhD in Bioinformatics, Computational Biology, System Biology, or related fields
  • Work experience
    • Four (4) years or more of bioinformatics research experience in the biotech or pharmaceutical industry, or
    • Six (6) years or more of post-doctoral academic bioinformatics experience in oncology target discovery, oncology translational sciences, or oncology medical genomics
  • Desired scientific experience
    • Cancer biology and cancer genomics. Experience with DNA Damage and Repair pathways is desirable.
    • Analysis of large cell line panel data such as CRISPR-Cas9 knockout screens and barcoded drug treatment screens (e.g. PRISM)
    • 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

Coordinator, Clinical Biomarker Operations (CBO)

Position: Coordinator, Clinical Biomarker Operations (CBO)

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

 

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

 

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

Responsibilities:

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

Qualifications:

  • Bachelor’s degree with Science focus
  • Experience managing clinical labs study startup and oversight
  • 1-3 years experience in clinical operations with a focus on clinical laboratory management
  • Strong verbal and written communication skills
  • Excellent interpersonal and organizational skills
  • Ability to deal with competing priorities
  • Strong reasoning, detail orientation and problem-solving abilities are essential
  • Ability to work on teams and on multiple concurrent projects, and works well under general direction with tight timelines

Associate Director/Director of Quantitative Pharmacology

POSITION DESCRIPTION

Position: Associate Director/Director of Quantitative Pharmacology

Company: Repare Therapeutics

Location: Cambridge, MA, USA / Remote

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.

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

 

KEY RESPONSIBILITIES

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

 

QUALIFICATIONS

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

Research Scientist – Enzymology

 

POSITION DESCRIPTION

Position: Research Scientist – Enzymology

Company: Repare Therapeutics

Location: Montreal, Quebec, Canada

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

 

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

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

We are seeking a highly motivated and team-oriented research scientist to join our biology department and help advance our portfolio of synthetic lethal (SL) cancer therapies. The individual should have extensive knowledge in enzymology, assay development/ optimization and biochemistry-related techniques. The scientist should provide expertise in designing biochemical assays and be able to conduct experiments aimed at biophysical characterization of lead compounds in support of lead ID/Opt activities. The candidate will lead part of a drug discovery program and oversee assay execution capabilities (internally & outsourced). Expertise in cell culture is an asset. Candidates must have the ability to communicate clearly, collaborate and enjoy a fast-paced and hands-on research environment.

 

RESPONSIBILITIES

  • Perform enzyme kinetic analyses and MOA studies to characterize diverse biological enzyme systems, including kinases, polymerases & various DNA repair enzymes.
  • Design and develop medium-to-high throughput biochemical (ie. enzymatic, binding) microplate assays to identify and characterize small-molecule modulators using a variety of techniques and detection methods, including FP, FRET, TR-FRET, BRET, HRTF, mass spectrometric, chromogenic, luminescence and radiometric.
  • Apply a range of biochemical and biophysical techniques to characterize the molecular interaction of novel small molecules with their protein target(s), including radiolabeled binding assays, fluorescence polarization assay, differential scanning fluorimetry (or thermal shift assay), surface plasmon resonance (SPR/Biacore) and isothermal titration calorimetry (ITC)
  • Develop assays using purified-component and cell-based systems configured to identify authentic small-molecule modulators and predict their activity in vivo.
  • Work closely with project teams and external CROs to deploy biochemical assays for high-throughput screening and to drive SAR development.
  • Oversee outsourcing of recombinant protein production & assay development to external CROs and monitor results
  • Execute experiments in a timely, efficient, and independent manner
  • Present clearly and succinctly in a variety of internal settings
  • Good organizational and time-management skills including the ability to manage several projects simultaneously
  • Excellent teamwork approach – work as part a cross-functional team including biologists, medicinal chemists and structural biologists

QUALIFICATIONS

  • PhD or M.Sc. in Biochemistry or related discipline with strong background in enzyme kinetics. Biopharmaceutical industry experience is highly preferred
  • Advanced knowledge and demonstrable track record in enzymology and enzyme inhibitor mechanism-of-action studies
  • Skilled in data analysis and interpretation of various enzyme kinetic models
  • Knowledge of biophysical methods for enzyme studies (e.g. UV/VIS/Fluorescence spectrometry, Mass Spectrometry, Fluorescence polarization)
  • Industrial experience in developing robust enzyme-based assays to support HTS or medicinal chemistry efforts with a successful record of compound progression is an asset
  • Skilled in data analysis and reporting (IC50, EC50, assay variability assessment etc.)
  • Strong understanding of protein expression & purification systems
  • Experience with computer software relevant to laboratory research and data interpretation
  • Effective communicate skills, both verbally and written
  • Ability to work in a fast-paced and team-oriented environment

Clinical Trial Manager/Senior Clinical Trial Manager

Position: Clinical Trial Manager/Senior Clinical Trial Manager

Company: Repare Therapeutics

Location: Cambridge, Massachusetts, USA

Website: http://www.reparerx.com/

 

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

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

We are seeking 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
  • Solid understanding of the clinical trial database life cycle including, data collection, review and analysis, CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures
  • Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management
  • Excels in a fast-paced, high-growth company environment with minimal direction and a high-degree of independence and able to adjust workload based on changing priorities
  • Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis
  • Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner
  • Ability to handle multiple projects and utilize judgement to prioritize tasks
  • Ability to contribute as a team member in a dynamic, fast-paced biotech environment
Browse...

PDF Only, Maximum size 10MB

Please wait...