Safety Director Jobs

About The Position

Requirements

• MD or DO degree from an accredited medical school.
• At least 2 years of clinical research experience and/or basic science research.
• Demonstrated experience serving as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or equivalent accountable safety leader.
• Direct experience influencing clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments.
• Expertise in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance.
• Experience supporting regulatory submissions and interactions with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responses to regulatory questions.
• Experience presenting safety assessments and recommendations to governance committees, development teams, and regulatory authorities.
• Demonstrated leadership in cross-functional matrix organizations, with the ability to influence development strategy and drive decision-making.

Nice To Haves

• At least 4 years of pharmaceutical industry experience in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development.
• Experience supporting Obesity clinical development programs.
• Experience with both clinical development and post-marketing safety activities.

Responsibilities

• Serve as the accountable physician safety leader for assigned Obesity development programs.
• Lead global safety strategy for clinical development programs.
• Partner with Clinical Development and Translational Medicine teams on dose-escalation, cohort expansion, proof-of-concept, and development decisions.
• Provide medical safety leadership and contribute to benefit-risk evaluations throughout clinical development.
• Review and interpret emerging safety data and communicate safety implications to development teams and governance committees.
• Lead Safety Analysis Teams (SATs) and Global Safety Teams (GSTs), and participate in Executive Safety Committee (ESC) discussions.
• Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.
• Validate safety signals and lead signal detection, assessment, and risk evaluation activities.
• Develop and maintain Core Safety Information, including Core Data Sheets and informed consent safety language.
• Prepare and review Risk Management Plans (RMPs), risk minimization strategies, and aggregate safety reports.
• Lead safety review and provide strategic input into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.
• Prepare and review safety sections of regulatory submissions, including INDs, CTAs, BLAs, NDAs, and other global submissions.
• Serve as the safety representative on Evidence Generation Teams and other cross-functional development teams.
• Support regulatory inspections and inspection readiness activities.
• Undertake domestic and international travel of up to 10%.

Benefits

• Health and welfare plans for staff and eligible dependents.
• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.
• Career development opportunities.