Sr. Director, Clinical Pharmacology Lead

South San Francisco, California, United States
Oct 12, 2019
Biotech Bay
Required Education
Position Type
Full time
About Principia Biopharma:

We are a late-stage biopharmaceutical company dedicated to bringing transformative oral therapies to patients with significant unmet medical needs in immunology and oncology. Our proprietary Tailored Covalency ® platform enables us to design and develop reversible and irreversible covalent small molecule inhibitors with potencies and selectivities that we believe will rival those of injectable biologics yet maintain the convenience of a pill. Our strategy is to advance the development of our proprietary drug candidates, and for certain programs, use collaborations and partnerships as strategic tools to maximize the value of those assets.

The primary responsibilities:
  • Reporting into the Chief Medical Officer
  • Independently represent Clinical Pharmacology on product development teams
  • Accountable for designing and executing both the clinical pharmacology and pharmacometrics strategy for products in development from entry into human thru Phase IV
  • Ensure adequate consideration and implementation of all aspects of clinical pharmacology, Pharmacokinetics (PK) and Pharmacokinetics / Pharmacodynamics (PK/PD) including model-based development approaches for drug development projects in all phases
  • Design, execute and coordinate core clinical pharmacology studies aligned with the overall development and submission strategy for assigned projects
  • Drive quantitative PK/PD activities to support clinical study design and dose/schedule selection for First in Human and other exploratory clinical studies in close alignment with other functions
  • Closely interact with other functions to define the best use of biomarker concepts in conjunction with modelling and simulation approaches for development projects
  • Independently evaluate and report clinical pharmacology related results, and modify the project plan based on emerging data
  • Constantly look for innovative approaches in the field of clinical pharmacology and pharmacometrics to ensure optimal utilization of resources and appropriate strategies to support program decision making in a timely and cost effective way
  • Coordinate and provide oversight of external vendors and outsource partners to ensure deliverables meet program objectives
  • Lead and manage the preparation of clinical pharmacology sections of major clinical and regulatory documents (e.g. Common Technical Documents (CTDs), New Drug Applications (NDAs), Investigational New Drugs (INDs)),and provide global clinical pharmacology submission support for all countries / regions including the US, Europe, Asia Pacific, and others as required
  • Participate in in-licensing and out-licensing activities as needed

  • Ph.D., M.D. or Pharm.D. with 7 or more years' experience in the area of clinical pharmacology, pharmacometrics, and drug development in the pharmaceutical industry
  • Strong background and demonstrated expertise in clinical pharmacology, PK and PK/PD including model-based drug development as evidenced by major regulatory submission experience (e.g. NDAs, CTDs, INDs), scientific publications and presentations at major meetings
  • Proven ability to manage strategic, scientific and operational aspects of development projects from a clinical pharmacology perspective
  • Evidence of leadership skills to direct, influence, and steer a team of experts
  • Capable of working independently, with excellent verbal and written communication skills
  • Ability to collaborate and work effectively in cross-functional teams
  • Working understanding of pharmacometrics, including non-compartmental analysis, population PK/PD, and physiologically-based pharmacokinetics (PBPK); hands on experience with Phoenix, NONMEM, R, and other data analysis software would be a plus but not required

Principia Biopharma is an equal opportunity employer.