Executive Director, Medical Safety Strategy & Benefit-Risk Management

About the Company

Globally-recognized biopharmaceutical company

Industry Biotechnology

Type Public Company

Founded 1988

Employees 501-1000

Categories

Pharmaceuticals Medicine Manufacturing Chemical Products Biotechnology Biopharmaceuticals Biotechnology and Pharmaceuticals Drug Manufacturing & Research Healthcare Outsource Services Medical

Specialties

biotechnology orphan disease state pharmaceuticals chronic lung infections and pulmonary

Business Classifications

B2B

About the Role

The Company is seeking an Executive Director for Medical Safety Strategy and Benefit-Risk Management. The successful candidate will be responsible for leading the global medical safety strategy for all investigational and marketed products, with a strong focus on integrating new technologies and processes to enhance patient safety. This role requires providing strategic direction, oversight, and leadership in the assessment of benefit-risk profiles, safety signal detection, and communication. The Executive Director will also be involved in the development and review of risk management plans, and will ensure the group's activities are in compliance with company and regulatory policies.

Applicants must have a medical degree, with advanced training in a relevant field, and a minimum of 10 years' experience in drug development, including at least 8 years in a safety-related position. The role demands a leader with the ability to influence organizational change, a global perspective, and significant experience in global pharmacovigilance. The ideal candidate will have a proven track record in safety-related regulatory submissions, strong leadership capabilities, and the ability to mentor and coach high-performing teams. Responsibilities also include overseeing external partnerships, maintaining audit readiness, and participating in cross-functional initiatives to promote a culture of safety and continuous improvement.

Hiring Manager Title VP, DSPV

Travel Percent Less than 10%

Functions

CEO/President Non-Profit Management Strategy General Management Operations