Senior Scientist, Pharmacokinetics
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.
FivePrime Therapeutics, Inc. is seeking a motivated and ambitious clinica pharmacologist with strong PK/PD modeling experience to join our clinical development team. This position will report to Director of Clinical Pharmacology.
The position will be responsible in the design, analysis, interpretation, and reporting of PK data and the PK/PD relationship for nonclinical and clinical studies. The role requires the candidate to work collaboratively with the related cross-functional teams to identify first in human dose, the maximum tolerated dose, recommend Phase 2 dose and schedule of a molecule in a given program. The candidate will work within the project team structure, sitting on core or clinical development project teams to guide clinical pharmacology and PK/PD modeling strategy, and to work within relevant sub-teams to ensure tactical alignment and execution.
- Participate in study design, study execution, interpretation and report writing for FivePrime molecules that pertaining to PK and PK/PD assessment in research/development
- Provide high-quality scientific knowledge/insight and drive the customized clinical pharmacology plan for each molecule
- Drive timely execution of defined clinical pharmacology plans, with appropriate quality controls and high quality written report production
- Write, review and edit relevant sections of regulatory submissions - IND, IMPD, CTA, CSR, BLA etc.
- Lead writing of scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
- Work collaboratively with research and development sciences on PK and PK/PD aspects of nonclinical studies
- Participate in the due diligence process delivering sound scientific analysis augmented by industrial experiences and attention to details
- Maintain up-to-date knowledge of evolving PK/PD regulatory requirements and climate in US and Europe (Asia knowledge a plus)
- Other projects when assigned
- Ph.D. or Pharm D in Pharmaceutical Sciences, Quantitative Pharmacokinetic/Pharmacodynamic or related discipline with a focus on pharmacokinetics and PK/PD modeling and simulation
- At least 6+ years’ experience in PK study design, PK analysis, population PK analysis, PK/PD modeling and report writing for large molecules
Hands-on experience using PK/PD software including Phoenix WinNonlin and NONMEMand proficient in R, SAS, MATLAB or other similar programming languages with relevant publications
- Broad understanding of drug development especially immune cancer therapy
Experience with and demonstrated ability to manage consultants and CROs is a plus
- Working knowledge of regulatory guidance for PK analysis and clinical pharmacology
Ability to collaborate effectively cross-functionally and in a team setting
- Excellent interpersonal and written communication skills in English (other language isa plus)
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
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.