VP, Pharmacology & Toxicology

Location
San Diego, CA, US
Posted
Oct 15, 2019
Ref
172326
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
We are seeking a head of Pharmacology/Toxicology to lead a team in executing early clinical drug development activities evaluating the pharmacology and toxicology of antibody therapeutics focused primarily, but not exclusively, on immune-inflammatory diseases. As a key member of the development team, this role liaises with Discovery Project Team Leaders. The VP, Pharmacology & Toxicology serve as a Development project team leader, where appropriate, and work collaboratively with the executive management to develop strategies for key programs, and strengthen the capabilities of the company.

This position reports to the Chief Medical Officer.

Some responsibilities include:
  • Crafting the pre-clinical and clinical pharmacological strategies, including dose escalation, contributing to stopping rules, and risk-benefit to ascertain that compounds are entered into man safely, efficiently and with scientific validity.
  • Overseeing the development and validation of quantitative in vivo assays to enable pharmacological characterization of therapeutic antibodies
  • Establishing collaboration with CROs and/or academic institutions to develop in vivo pharmacology models to permit progression into the clinic of therapeutic antibodies
  • Providing strategic and tactical direction to multiple project teams
  • Preparing study reports for regulatory submission on development candidates
  • Contributing to new project ideas and in vivo proof-of-concept studies to enable the initiation of new antibody projects
  • Leading the Development project team and oversee the transition from discovery to clinical development of new antibodies


Requirements

Education & Experience
  • PhD in Pharmacology or related science with a minimum of 15 years' experience in a drug-discovery setting of a biopharmaceutical company, accompanied by at least 5 years of proven leadership experience.
  • Extensive experience in developing quantitative in vivo pharmacodynamic assays and preclinical disease models to assess target engagement and efficacy in a range of inflammatory/autoimmune conditions
  • Proven track record of making major contributions to the discovery of one or more marketed or in-development medicines
  • Prior experience of working across diverse therapeutic areas is highly desirable
  • Sound theoretical and experimental background in biology coupled with a solid foundation in quantitative pharmacology


Skills & Knowledge
  • Expert knowledge of pharmacokinetics, toxicology, and formulation
  • Ability to perform randomized controlled clinical trial principles, methodology and procedures
  • Skilled at statistical data collection, editing, validation and analysis techniques
  • Proven managerial competence with previous experience in directly managing teams