VP, NonClinical Safety and Pathobiology
Gilead Sciences
August 25, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Key Responsibilities:
- Design, implement, oversee, and analyze nonclinical programs supporting drug development candidates from research to registration.
- Ensure patient safety through exhaustive nonclinical evaluations.
- Ensure global compliance with regulations governing nonclinical study conduct for clinical trials, registration, and new drug approvals.
- Perform pathobiology characterization of animal models and clinical specimens to advance translational understanding.
- Manage and mentor a group of Ph.D.-level toxicologists and pathologists; develop and implement cutting-edge scientific technologies and drug development strategies.
- Prepare and review regulatory documents including INDs/IMPDs, Investigator Brochures, and NDAs/MAAs.
- Communicate successfully cross-functionally to accomplish company goals.
- Solve highly complex problems requiring scientific assessment and evaluation of business intangibles.
Knowledge/Required Skills:
- Experience conducting nonclinical programs and preparing/submitting/approving nonclinical sections of regulatory filings across development stages.
- In-depth knowledge of nonclinical drug discovery/development and regulatory environments in the US, EU, and AsiaPac.
- Recognized expert inside and outside the company.
- Strong leadership/management, organizational, technical, scientific creativity, and critical thinking skills.
- Oversight of discovery screening studies, GLP toxicity studies, nonclinical regulatory documentation, issue resolution, impurity qualification, and environmental assessments.
Education & Experience Requirements:
- Ph.D. in pharmacology/toxicology/pathology or related field; significant experience with a reputation as a leader.
- DABT and/or DACVP and/or ERT preferred.
- Knowledge of global regulatory guidelines for nonclinical safety studies (quality/compliance).
- At least 20 years’ experience in pharmaceutical R&D or contract research organizations.
- Ability to collaborate across global stakeholder networks.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Application Instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.
- Design, implement, oversee, and analyze nonclinical programs supporting drug development candidates from research to registration.
- Ensure patient safety through exhaustive nonclinical evaluations.
- Ensure global compliance with regulations governing nonclinical study conduct for clinical trials, registration, and new drug approvals.
- Perform pathobiology characterization of animal models and clinical specimens to advance translational understanding.
- Manage and mentor a group of Ph.D.-level toxicologists and pathologists; develop and implement cutting-edge scientific technologies and drug development strategies.
- Prepare and review regulatory documents including INDs/IMPDs, Investigator Brochures, and NDAs/MAAs.
- Communicate successfully cross-functionally to accomplish company goals.
- Solve highly complex problems requiring scientific assessment and evaluation of business intangibles.
Knowledge/Required Skills:
- Experience conducting nonclinical programs and preparing/submitting/approving nonclinical sections of regulatory filings across development stages.
- In-depth knowledge of nonclinical drug discovery/development and regulatory environments in the US, EU, and AsiaPac.
- Recognized expert inside and outside the company.
- Strong leadership/management, organizational, technical, scientific creativity, and critical thinking skills.
- Oversight of discovery screening studies, GLP toxicity studies, nonclinical regulatory documentation, issue resolution, impurity qualification, and environmental assessments.
Education & Experience Requirements:
- Ph.D. in pharmacology/toxicology/pathology or related field; significant experience with a reputation as a leader.
- DABT and/or DACVP and/or ERT preferred.
- Knowledge of global regulatory guidelines for nonclinical safety studies (quality/compliance).
- At least 20 years’ experience in pharmaceutical R&D or contract research organizations.
- Ability to collaborate across global stakeholder networks.
People Leader Accountabilities:
- Create inclusion, develop talent, and empower teams.
Application Instructions:
- For current Gilead employees and contractors: apply via the Internal Career Opportunities portal in Workday.