Head of Toxicology/ADME - Non-Clinical

Hiring Manager: VP, Non-clinical and Diligence
Date Opened: February 2019

Position Summary:

The Head of Toxicology/ADME will be responsible for the design, execution and completion of externalized toxicology and ADME studies required to advance programs across the portfolio.

Roles & Responsibilities:

  • Develop appropriate strategy for all toxicology and ADME studies across all pipeline programs in collaboration with other functions including, but not limited to, Clinical, CMC, Regulatory and external consultants and partners

  • Manage study execution and completion with CROs in collaboration with external Toxicology consultants as needed

  • Develop and manage toxicology and ADME study budget and timelines

  • Interface with all project teams to ensure toxicology and ADME requirements enable pipeline asset development (pre- and post IND/CTA)

  • Ensure effective integration of study results into development strategy and regulatory filings

  • Participate in project team meetings and contribute to overall asset development plans

  • Effective management of CROs and external team of toxicology and ADME consultants

Qualifications:

  • Ph.D. in toxicology or related discipline (DVM)

  • At least 10 years in biotech/pharma in a toxicology role, working across multiple therapeutic areas

  • Demonstrated experience effectively managing external resources (CROs, consultants)

  • Experience in cross-functional teams and shared decision making

  • Demonstrated experience with global regulatory filings (IND/IMPD/CTA, NDA, DSUR, etc.)

  • Strong technical writing skills

  • Ability to perform in fast-paced, dynamic, constantly evolving environment

  • Excellent communication and organizational skills and attention to detail

  • Strong time management skills; ability to prioritize multiple tasks efficiently

  • Ability to think creatively and work proactively

  • Flexibility in developing strategy best suited to individual assets

  • Strong team player: demonstrated ability and willingness to work on a team, assist team members as needed and accomplish tasks required to achieve goals