Director of Clinical Pharmacology About the Company Join a successful therapeutics company that specializes in machine learning-powered biomedicines, making a real impact in the biotechnology industry. 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 We are searching for a dynamic Director of Clinical Pharmacology to spearhead the strategy and execution of global Phase 2/3 studies, especially focusing on respiratory indications and aligning with global regulatory standards. This pivotal role positions you as the subject matter expert for interactions with regulatory agencies on clinical pharmacology topics, including INDs, BLAs, and pediatric plans. Your responsibilities will encompass designing and overseeing modeling and simulation efforts, leading the development of global pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), and exposure-response strategies. Successful collaboration with cross-functional teams to optimize clinical trial design and endpoints is essential. The ideal candidate will possess a PhD, PharmD, or MD in a related field, along with a minimum of 12 years' experience in clinical pharmacology within the biotech or pharmaceutical sector, particularly in late-stage development and global regulatory interactions. A proven track record of leading clinical pharmacology deliverables in regulatory engagements with agencies such as the FDA, EMA, PMDA, and NMPA is critical. Strong expertise in PK/PD modeling and simulation, a solid background in pediatric development, and experience in respiratory indications are highly valued. Furthermore, the role demands excellent communication skills, the ability to build and lead a high-performing team, and a dedication 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