Non-Clinical Pharmacokinetic Consultant
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 seeks a Non-Clinical Pharmacokentic Consultant to support IND filings. We seek a consultant with strong analytical and communication skills who can work cross-functionally to deliver results. Responsibilities include and are not limited to the following:
Responsibility of overall strategy and support in design, execution and analysis of drug metabolism and pharmacokinetic studies.
PK lead for nonclinical and early clinical projects
Contributes expert pharmacokinetic input into key nonclinical and regulatory documents including study protocols, reports, IND/IMPD/NDA’s within agreed timelines, and meeting all regulatory requirements with guidance from the project team.
Performs or oversees nonclinical PK and PK/PD analysis using a variety of tools and approaches.
Integrates, interprets and reports data to project teams.
Assure rapid and effective communication of data to teams and management.
A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field with a specific focus on pharmacokinetics is essential.
Experience using Phoenix WinNonlin is required, and experience with more sophisticated modeling programs is a bonus.
Minimum 5 years pharmaceutical industry experience in the conduct of pharmacokinetic support
Experience as a team member on interdisciplinary and matrixed project teams, with special experience on bio-therapeutics projects (recombinant
proteins or monoclonal antibodies) is essential
Experience in preparing PK reports appropriate for regulatory submission and authoring relevant components of regulatory filing documents
Strong written, presentation and verbal communication skills are essential
Demonstrated ability to work in a matrix environment
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.