The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Executive Medical Director, Global Development

About the Company

Pioneering developer & manufacturer of innovative therapeutic medicines

Industry Biotechnology

Type Public Company

Founded 1980

Employees 10,001+

Categories

Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Genomics Therapeutics Clinical Care Patient Management Healthcare Life Sciences Personalized Medicine Medicine Chemical Products

Specialties

biologics human therapeutics and development of novel products

Business Classifications

B2C Mobile

About the Role

The Company is seeking an Executive Director for Clinical Development in Rare Disease. This pivotal role involves leading the scientific strategy, planning, and execution of all aspects of clinical drug development within the rare disease therapeutic area. The successful candidate will be responsible for the full scope of clinical drug development activities, from the design and execution of Phase 2 to Phase 4 studies. They will serve as the principal representative for global development in this therapeutic area, engaging with executive leadership, development partners, and global regulatory agencies. The role also includes global development leadership of one or more assets and requires strong people management skills. The Executive Director will work closely with the cross-functional product team to advance clinical programs and contribute to the overall product strategy.

Candidates for this role at the company should have an MD or DO from an accredited medical school, with a minimum of 5 years' of industry or academic research and 6 years' of managerial experience. A PhD, MBBS, or equivalent, with an accredited residency in a relevant sub-specialty, and board certification, is preferred. The ideal candidate will have a solid understanding of biostatistics, regulatory, clinical pharmacology, and pre-clinical toxicology approaches, as well as knowledge of Good Clinical Practices, FDA regulations, and international regulatory requirements. Strong leadership attributes, including the ability to inspire, accelerate, integrate, and adapt, are essential. The role demands a candidate who can effectively present complex medical and clinical concepts, analyze and interpret datasets, and drive innovation in projects.

Hiring Manager Title Vice President, Global Clinical Development

Travel Percent Less than 10%

Functions

Medical Care/Hospital Administration Non-Profit Management