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Operations Manager, Nonclinical Development

Company: Repare Therapeutics Inc.
Location: Cambridge
Posted on: June 6, 2021

Job Description:

Position: Operations Manager, Nonclinical Development

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 Pol inhibitor programs.

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

About the Role

We are seeking an Operations Manager, Nonclinical Development 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 nonclinical development team members, translational researchers, and clinical operations team members in order to implement and maintain pharmacokinetic sample operational plans. This position requires a combination of scientific and project management expertise as they will be responsible for the oversight of nonclinical development outsourced activities supporting IND-enabling studies as well as within clinical trials; Includes operational support for CRO selection and contracting, bioanalytical method development, coordination and oversight of GLP and clinical bioanalysis.

What You'll Do

  • Manage end-to-end sample tracking and logistics for nonclinical and clinical samples, working closely with the central and bioanalytical lab vendors as well as a sample and data management vendor in collaboration with internal colleagues
  • Identify, triage, and resolve 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 nonclinical assays and date meet appropriate FDA/EMA/GCP/ICH guidelines
  • Collaborate with internal and CRO quality organizations to implement appropriate SOPs, audits readiness plans, and vendor qualifications
  • Manage contracts and relationships with key CRO partners
  • Collaborate with the other operations functions, clinical and biomarker operations, to insure seamless sample analysis and data delivery

What You'll Need

  • Bachelor's degree with Science focus
  • Experience managing bioanalytical labs study startup and oversight
  • 3-5 years experience in biopharma with a focus on bioanalytical/pharmacokinetic laboratory management and/lor operations
  • 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

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.

Keywords: Repare Therapeutics Inc., Cambridge , Operations Manager, Nonclinical Development, Other , Cambridge, Massachusetts

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