Vice President, Medical Affairs, Regulatory Affairs & Clinical Operations

Vice President, Medical Affairs, Regulatory Affairs & Clinical Operations

About the Company

An innovative, patient-focused biotechnology company.

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is in search of a Vice President for Medical Affairs, Regulatory Affairs, and Clinical Operations. This executive leadership role is pivotal in driving the strategic vision and execution of global regulatory strategies for product development, clinical studies, and commercialization. The successful candidate will be responsible for leading multidisciplinary teams, ensuring compliance with global regulatory requirements, and fostering continuous innovation in a fast-paced environment. Key responsibilities include the preparation and maintenance of regulatory submissions, serving as the primary liaison with regulatory agencies, and providing strategic oversight of clinical trial planning and execution. The role also involves leading medical affairs functions, building strategic partnerships with key opinion leaders, and supporting evidence generation and medical education. Applicants for the Vice President position at the company should hold an advanced degree in a relevant field, with a medical degree being preferred. A minimum of 15 years' progressive leadership experience in biotechnology, pharmaceuticals, or related fields is required, with at least 10 years in regulatory affairs leadership. The ideal candidate will have a proven track record in regulatory submissions, agency interactions, and supporting products through commercialization. Expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements is essential. The role demands a leader with the ability to manage, coach, and develop functional teams, oversee departmental budgets, and foster a culture of compliance, innovation, and results. Cross-functional collaboration and a passion for advancing cancer therapies are also key attributes for this high-impact position.

Functions

• Operations
• Medical Care/Hospital Administration