Senior Director, ADME

Key Responsibilities:
- Serve as the ADME subject matter expert, with deep expertise in metabolism
- Define and execute ADME strategies in collaboration with functional area leads
- Design, oversee, and interpret nonclinical ADME studies (in vitro and in vivo)
- Manage CROs, including vendor selection, study design, protocol development, and report review
- Ensure ADME data are scientifically sound and aligned with regulatory expectations
- Support clinical development via ADME input, including DDI risk assessment, PBPK modeling, and human ADME (mass balance) study design and interpretation
- Integrate nonclinical and emerging clinical PK data to inform ADME strategy and study design
- Author and review ADME sections of regulatory submissions (IND/CTA, NDA) and support regulatory interactions

Qualifications:
- Ph.D. in Pharmacokinetics, Drug Metabolism, Pharmaceutical Sciences, or related discipline (or equivalent experience)
- 15+ years of ADME experience in pharmaceutical or biotechnology drug development
- Experience supporting both nonclinical and clinical programs

Required Skills:
- Deep expertise in drug metabolism
- Strong experience designing and interpreting ADME studies

Preferred Skills:
- Working knowledge of transporters and broader ADME sciences
- Experience with PBPK modeling and human ADME (mass balance) studies

Core Competencies:
- Strong scientific judgment and attention to detail
- Hands-on, execution-focused approach
- Effective communicator within technical and cross-functional teams
- Ability to operate in a fast-paced, dynamic environment

Benefits:
- Full-time employees: flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) offerings
- Additional voluntary benefits and mental health benefits via Employee Assistance Program

Application Instructions:
- Apply via the Madrigal Careers site on an ongoing basis.