Director, Safety Physician & Medical Monitoring

Innoviva Specialty Therapeutics•Waltham, MA

About The Position

The Director, Safety Physician / Medical Monitor will provide medical and strategic leadership for safety oversight across both marketed and investigational products, including post-marketing clinical studies. This role serves as the medical authority for product safety, ensuring proactive risk management, regulatory compliance, and scientific rigor throughout the product lifecycle. The Director partners cross-functionally with Clinical Development, CMC, Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Commercial teams to ensure patient safety remains central to development and commercialization strategies.

Requirements

MD or DO is required. Additional advanced degree (for e.g. MPH, PhD) is a plus.
7 plus years of relevant experience in drug safety, clinical safety and/or benefit-risk management within the biotechnology or pharmaceutical industry or 5 plus years with an additional advanced degree such as MPH or PhD
Strong knowledge of global pharmacovigilance regulations, GCP, and regulatory safety reporting requirements.
Demonstrated ability to review and/or prepare scientific or regulatory documents from large volumes of scientific data
Strong knowledge and understanding of domestic & international PV and regulatory guidelines
Drug safety database and MedDRA coding knowledge required
Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, and Adobe Acrobat computer skills
Excellent communication skills (verbal and written), with the ability to convey complex medical and safety information clearly to diverse audiences.
Highly organized, self-directed, and detail-oriented, with strong analytical, critical thinking, and problem-solving skills.

Nice To Haves

Clinical Patient Care experience preferred
Demonstrated experience serving as a Medical Monitor in clinical development programs preferred.

Responsibilities

Serve as Medical Monitor for assigned clinical trials, including post-marketing studies, providing ongoing medical oversight of patient safety, protocol adherence, and emerging safety trends.
Conduct medical review and assessment of adverse events (pre-marketing and post-marketing), including SAEs, AESIs, laboratory signals, and special safety topics; determine causality and expectedness.
Provide medical input into protocol development, safety monitoring plans, stopping rules, eligibility criteria, statistical analysis plans, and risk mitigation strategies.
Lead or contribute to the preparation and review of safety sections of Investigator Brochures, protocols, informed consent forms, SAPs, CSRs, NDAs/BLAs/MAAs/CTDs, and regulatory responses.
Prepare, review, and maintain Company Core Safety Information (CCSI) and Company Core Data Sheets (CCDS); lead determination of the Adverse Reactions section and contribute to other safety-relevant labeling updates.
Provide medical review and oversight of aggregate safety reports, including PSURs, PBRERs, DSURs, ASRs, and integrated safety summaries.
Assess safety issues arising from clinical trials, spontaneous reports, literature, quality complaints, or post-marketing data, and contribute to benefit-risk evaluations and regulatory decision-making.
Collaborate cross-functionally with Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs, CMC, Quality, and other stakeholders to identify, evaluate, and manage safety signals, including participation in Health Hazard Assessments and risk management activities.
Oversee signal detection activities and provide medical recommendations for potential safety concerns.
Provide medical expertise in responses to Health Authority queries, inspections, and senior management safety inquiries.
Liaise with investigational sites as needed to address safety-related issues.
Ensure quality and accuracy of safety data within the safety database, including oversight of MedDRA and WHO Drug coding in collaboration with Data Management and PV Operations.
Contribute to the development and implementation of project-specific procedures and medical review workflows in compliance with company SOPs and global regulatory requirements.
Support inspection readiness, audit activities, and continuous improvement initiatives within the safety function.
Provide expert medical advice across programs and contribute to strategic safety planning to support timely and high-quality delivery of clinical and commercial objectives.
Perform additional duties as assigned consistent with the scope and level of the role.