Global Safety Medical Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the lead physician safety authority for designated Obesity development initiatives.

• Direct the global safety strategy for clinical development programs.

• Collaborate with Clinical Development and Translational Medicine teams to guide dose-escalation, cohort expansion, proof-of-concept, and development decisions.

• Offer medical safety leadership and engage in benefit-risk evaluations throughout the clinical development process.

• Examine and interpret emerging safety data and convey safety implications to development teams and governance committees.

• Lead the Safety Analysis Team (SAT) and Global Safety Team (GST), and engage in discussions at the Executive Safety Committee (ESC).

• Review and contribute to Safety Review Committees (SRCs), Data Monitoring Committees (DMCs), and other safety governance forums.

• Validate safety signals and spearhead signal detection, assessment, and risk evaluation activities.

• Create 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 reviews and provide strategic insights into protocol development, CRF design, Statistical Analysis Plans, Clinical Study Reports, and safety monitoring plans.

• Prepare and review safety sections of regulatory submissions such as INDs, CTAs, BLAs, NDAs, and other global submissions.

• Act as the safety representative on Evidence Generation Teams and other cross-functional development teams.

• Assist with regulatory inspections and activities related to inspection readiness.

• Collaborate with Clinical Development, Translational Medicine, Regulatory, Biostatistics, and Medical Affairs to shape development strategy and support innovative therapies.

⛳️ Requirements

• MD or DO degree from an accredited medical institution.

• Two years of clinical research experience and/or basic science research.

• Over four years of experience in the pharmaceutical industry in Drug Safety, Clinical Safety, Pharmacovigilance, or Clinical Development is preferred.

• Proven experience as a Global Safety Officer (GSO), Clinical Safety Lead, Safety Lead Physician, or similar accountable safety role.

• Hands-on experience impacting clinical development through protocol development, CRF design, safety monitoring plans, dose-escalation decisions, and benefit-risk assessments.

• Proficiency in signal detection, signal assessment, benefit-risk evaluation, risk management, and safety governance.

• Experience in supporting regulatory submissions and engaging with health authorities, including INDs, CTAs, BLAs, NDAs, MAAs, and responding to regulatory inquiries.

• Experience in presenting safety evaluations and recommendations to governance committees, development teams, and regulatory authorities.

• Strong preference for experience in supporting Obesity clinical development programs.

• Demonstrated leadership within cross-functional matrix organizations with the capability to influence development strategy and facilitate decision-making.

• Experience with both clinical development and post-marketing safety activities is preferred.

• Willingness to travel domestically and internationally up to 10% of the time.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Financial plans that provide opportunities to save for retirement or other objectives.

• Career development opportunities.

• Work/life balance.