5 years clinical safety and risk management experience
Proven track record of strategic influence on clinical studies
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while line managing a team of safety physicians and scientists
Job Summary
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while line managing a team of safety physicians and scientists.
This role requires setting safety team goals aligned to therapeutic area and product strategy, ensuring high-quality delivery of Risk Management Plans and Periodic Safety Reports.
The successful candidate must collaborate across a matrixed environment to influence cross-functional leaders on decision-making regarding clinical development and medical affairs.
Matching Summary
The Global Safety Program Lead is accountable for the overall safety strategy, delivery, and oversight of assigned assets while line managing a team of safety physicians and scientists.
Skills & Requirements
Must-have
Medical degree or equivalent in biomedicine
5 years clinical safety and risk management experience
Proven track record of strategic influence on clinical studies
Thorough knowledge of global pharmacovigilance standards
Experience with global regulatory submissions and agencies
Nice-to-have
PhD in scientific discipline
Industry conference speaking experience
Demonstrated expertise in specific disease area
Independent judgment based on leading-edge knowledge
Experience supporting in-licensing opportunities
Key Requirements
Medical degree or equivalent
5+ years pharmaceutical/biotech safety experience
Global regulatory submission experience
Leadership and mentoring capability
Willingness to travel domestically and internationally