Medical Director, Medical Safety at Jobgether – United States

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Medical Director, Medical Safety in United States.

This role is a key global safety leadership position responsible for shaping and overseeing the benefit-risk profile of investigational and marketed medicines across their full lifecycle. The Medical Director, Medical Safety acts as the scientific and clinical safety authority, ensuring robust pharmacovigilance strategies that support both regulatory compliance and patient safety worldwide. You will work at the center of cross-functional collaboration, partnering with clinical development, regulatory affairs, and safety operations teams to evaluate emerging data and translate it into actionable safety insights. The role involves high-impact decision-making, including signal detection, risk management, and safety reporting across global submissions. You will also engage with health authorities and internal governance bodies to ensure transparency and consistency in safety communications. This is a highly visible role offering the opportunity to directly influence the safe development and use of innovative therapies for serious diseases.

You will be responsible for leading global safety strategy and ensuring comprehensive evaluation of the benefit-risk profile for assigned products throughout development and post-marketing stages. You will provide medical expertise across safety surveillance, regulatory submissions, and cross-functional decision-making forums.

• Lead safety evaluation and medical review of clinical, regulatory, and scientific documentation across the product lifecycle
• Contribute to global regulatory submissions including INDs, NDAs, BLAs, MAAs, CTDs, and associated safety sections
• Serve as the safety representative on global regulatory and core development teams
• Support and guide signal detection, evaluation, validation, and interpretation of safety trends and risks
• Oversee preparation of aggregate safety reports, periodic safety updates, and regulatory safety communications
• Collaborate on Risk Management Plans (RMPs), REMS activities, and benefit-risk mitigation strategies
• Ensure consistency of Company Core Safety Information across labeling and regulatory documentation
• Provide medical safety expertise for literature review, coding guidance (MedDRA, WHO Drug), and data interpretation
• Participate in or lead Safety Management Teams (SMTs) and cross-functional governance forums

This role requires strong clinical and pharmacovigilance expertise combined with deep knowledge of drug development and global regulatory frameworks. The ideal candidate brings a physician background and proven experience in safety or medical affairs within a complex, matrixed environment.

• MD degree required; medical licensure preferred
• 2–5+ years of experience in clinical development, medical affairs, or pharmacovigilance/drug safety
• Strong understanding of drug development and global regulatory requirements (FDA, EMA, ICH, CIOMS)
• Experience with safety signal detection, aggregate safety reporting, and benefit-risk assessment
• Familiarity with safety databases (e.g., ARISg, Argus) and clinical data systems preferred
• Knowledge of MedDRA and WHO Drug coding strongly preferred
• Excellent communication skills with ability to influence cross-functional and external stakeholders
• Strong organizational skills with ability to manage multiple priorities in a fast-paced environment
• Leadership mindset with ability to drive alignment and decision-making across teams

• Competitive base salary ranging from $256,000 to $384,000 USD depending on experience and qualifications
• Annual discretionary bonus and long-term equity incentive opportunities
• Comprehensive medical, dental, and vision insurance coverage
• 401(k) retirement savings plan
• Generous and flexible paid time off policies
• Strong focus on work-life balance and employee well-being
• Exposure to global regulatory interactions and high-impact drug safety programs
• Opportunity to contribute to innovative therapies addressing serious and underserved diseases