Associate Director, Pharmacokinetics

Location
South San Francisco, CA, United States
Posted
Aug 01, 2018
Ref
743999674455929
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
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

FivePrime Therapeutics, Inc. is searching for a motivated and ambitious clinical pharmacologist with strong pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation experience to join our Clinical Pharmacology team within the Clinical Development organization. The Associate Director will lead clinical pharmacology and PK/PD modeling and simulation efforts for projects from the pre-IND setting to pivotal trials and registration. He/she will represent the clinical pharmacology function within the project team structure, sitting on project teams to guide clinical pharmacology and PK/PD modeling and simulation strategy, and to work within relevant sub-teams to ensure tactical alignment and execution. This position will report into the Director of Clinical Pharmacology.

Responsibilities:

 

 

  • Lead in study design, study execution, data interpretation and report writing for FivePrime molecules pertaining to PK and PK/PD assessment in research/clinical development
  • Drive the customized clinical pharmacology and modeling and simulation plan and provide high-quality scientific knowledge/insight for each molecule
  • Write, review, and edit relevant sections of regulatory documents - IND, IMPD, CTA, CSR, BLA etc. and support interaction with global health authorities
  • Write and present scientific publications on relevant topics - abstracts, posters, oral presentations and manuscripts
  • Manage resources including consultants and CROs
  • Participate in the due diligence activities and provide sound scientific analysis augmented by industrial experience.


Qualifications

 

 

 

  • Ph.D. in Pharmaceutical Sciences, Pharmacology, Quantitative PK/PD or related discipline with a focus on PK and PK/PD modeling and simulation
  • Background with 8+ years' experience in PK study design, PK analysis, population PK analysis, PK/PD modeling and simulation, impact of immunogenicity, and report writing for large molecules within the biopharmaceutical industry
  • Require hands-on experience using PK/PD software including Phoenix WinNonlin and NONMEM and proficient in R, SAS, MATLAB or other similar programming languages with relevant high-quality publications
  • Demonstrated leadership skills and the ability to manage consultants and CROs is a plus
  • Possess working experience and up-to date knowledge of global regulatory requirements
  • Understanding of oncology drug development for biologics with immune cancer therapy
    experience is a plus
  • Collaborate effectively in cross-functional team settings
  • Exhibit solid interpersonal and written communication skills
  • Be able to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic


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.