Executive Director, Clinical Pharmacology

About the Company

Successful therapeutics company specializing in machine learning-powered biomedicines

Industry Biotechnology

Type Privately Held, VC-backed

Founded 2018

Employees 201-500

Funding $200+ million

Categories

Biotechnology Health Care Medical Product Research

About the Role

The Company is seeking an Executive Director of Clinical Pharmacology to lead the strategy and execution of global Ph2/3 studies, with a focus on respiratory indications and global regulatory alignment. The successful candidate will be the subject matter expert for regulatory agency interactions on clinical pharmacology topics, including INDs, BLAs, and pediatric plans. This role involves designing and overseeing modeling and simulation efforts, leading the development of global PK, PK/PD, and exposure-response strategies, and collaborating with cross-functional teams to optimize clinical trial design and endpoints. The Executive Director will also be responsible for driving the pediatric strategy, guiding bioanalytical strategy, and providing clinical pharmacology oversight across development stages.

The ideal candidate will have a PhD, PharmD, or MD in a related field, with at least 12 years' of experience in clinical pharmacology within biotech or pharma, including late-stage development and global regulatory interactions. A proven track record in leading clinical pharmacology deliverables in regulatory agency engagements, particularly with the FDA, EMA, PMDA, and NMPA, is essential. Deep expertise in PK/PD modeling and simulation, strong background in pediatric development, and experience in supporting respiratory indications are highly valued. The role also requires excellent communication skills, the ability to build and lead a high-performing team, and a commitment to fostering scientific excellence and collaborative innovation.

Hiring Manager Title Head of Clinical Pharmacology

Travel Percent Less than 10%

Functions

Medical Care/Hospital Administration Non-Profit Management