Clinical Contracts Consultant
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
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.
Five Prime Therapeutics Inc. is seeking a highly-motivated clinical contracts consultant to join its Legal team for a six month project. The Clinical Contracts Consultant will 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.
- 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.
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
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
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.