Global Safety Program Lead/Sr Medical Director

The Global Safety Program Lead/Sr Medical Director is accountable for the safety strategy, delivery, and oversight of assigned assets, working with safety physicians and scientists to develop, implement, and apply safety strategy at asset and study level. The role involves generating opportunities and value for the asset or indication to optimize benefit risk and maintain a competitive advantage, line managing a team of safety physicians and/or scientists, and representing the Company at governance and other forums where safety is involved.

Requirements

• Medical degree or equivalent degree in biomedicine or science
• 5 years extensive relevant clinical, safety and risk management experience in the pharmaceutical, biotech, CRO industry, academia or Health Authorities
• Proven track record of successful clinical safety delivery with demonstrated examples of strategic influence to clinical studies/programs
• Ability to collaborate across a matrixed environment and influence cross-functional leaders on decision-making
• Thorough knowledge and understanding of pharmacovigilance & safety deliverables, standards and processes at a global level
• Experience of global regulatory submissions and interacting with major regulatory agencies
• Demonstrated ability to successfully lead, coach, and mentor other safety medical directors/scientists

Benefits

• Qualified retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage