Senior Manager, Clinical Contracts

  • 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
  • Full-time

Company Description

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics.  FivePrime has a differentiated discovery platform and capabilities that is fueling a growing portfolio of development candidates.

Our pipeline includes:

  • Cabiralizumab (FPA008), an anti-CSF-1R antibody currently in development in a Phase 2 trial in pigmented villonodular synovitis (PVNS) and a Phase 2 trial in second-line pancreatic cancer 
  • FPA144, an anti-FGFR2b antibody currently in a Phase 1/3 clinical trial in FGFR2b over-expressing gastric cancer
  • FPA150, an anti-B7H4 antibody will enter Phase 1 clinical development in the first half of 2018
  • FPT155, a CD80 fusion protein, which is in IND-enabling studies

We have entered into strategic discovery and development collaborations with leading pharmaceutical and biotech companies, including Bristol-Myers Squibb, GSK, UCB and Zai Labs.

FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.

Job Description

Five Prime Therapeutics Inc. is seeking a highly-motivated clinical contracts manager to join its growing Legal Department. This is a new position that we opened to support the increase in our clinical contract volume as our preclinical and clinical pipeline continues to expand and our product candidates advance through clinical trials. This position reports to our Director and Corporate and Securities Counsel.

Responsibilities:

  • Draft and negotiate a wide variety of agreements, including confidentiality agreements, clinical trial-related agreements, master services agreements, SOWs, work orders, consulting agreements, material transfer agreements, collaboration agreements, license agreements, and other vendor and services agreements in support of Five Prime’s initiatives. 
  • Prepare clinical trial agreement template for use by US clinical trial sites and work with CROs to modify ex-US templates to address FivePrime’s needs
  • Prepare negotiation parameters from time to time for use by CROs and other vendors supporting FivePrime’s clinical development activities
  • Collaborate with internal cross-functional teams and external parties to ensure timely turnaround and negotiation of agreements and, with respect to clinical trial agreements, start-up of study sites
  • Support business development transaction activities (e.g., in- and out-licensing and collaboration transactions) from time to time, including due diligence support
  • Manage special and ad hoc projects, as needed
  • Develop strong working relationships with functional groups, in particular with the Clinical Operations group, and project teams
  • Work without close supervision, initiate new assignments and identify ways to continuously improve templates, processes and operations.

Qualifications

  • Bachelor’s degree required

  • 6+ years of relevant experience as a clinical contracts associate/ clinical contracts manager and/or corporate paralegal, including in-house in the biotech industry

  • Experience drafting and negotiating a wide range of agreements, and extensive experience
    drafting and negotiating clinical trial-related agreements, including complex
    legal provisions

  • Experience managing projects within an organization

  • Strong organizational and planning skills and a meticulous attention to detail

  • Ability to effectively prioritize and multi-task

  • Ability to maintain focus and composure amid pressure and evolving priorities

  • Ability to identify and assess risk and communicate effectively
    with internal team members, business partners and CROs

  • Excellent verbal and written interpersonal communication and relationship management skills

  • Ability to comprehend and manage business contracts and other complex documents

  • Self-motivated and able to work independently while exercising initiative, flexibility and good judgment

  • Strong desire to improve processes and grow

  • Ability to maintain and properly handle highly confidential information

Additional Information

At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.

All your information will be kept confidential according to EEO guidelines.

Privacy Policy