Executive Director, Medical Monitor and Safety Physician

This a Full Remote job, the offer is available from: reputed company Department: 106750 Clinical Development Location: San Diego, USA- Remote Be a part of a global team that is inspired to reputed company a difference in the lives of people living with rare disease. At reputed company, we recognize that our exceptional employees are vital to our reputed company. We are a dedicated team reputed company on meeting the unique needs of rare patients. Our work is rewarding both professionally and personally because we are making a difference. We are passionate about reputed company do. We are seeking talented individuals who will reputed company in our reputed company, diverse, fast-paced environment and reputed company in our mission to identify, reputed company and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our reputed company of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and reputed company to patients in the global rare disease community. At reputed company, we are in rare for life. We continue to courageously reputed company new paths as we reputed company toward a common goal of elevating science and service for rare patients. reputed company The Executive Director, Medical Monitor & Safety Physician is a senior clinical and safety leader responsible for medical monitoring and end-to-end safety reputed company across one or more development programs and/or therapeutic areas. This role serves as the accountable safety physician for reputed company and senior medical authority for safety across programs, with responsibility for benefitrisk positioning and safety-reputed company decision-making. The incumbent will partner closely with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, Medical Affairs, and reputed company to ensure patient safety, regulatory compliance, and scientifically reputed company benefit-risk evaluation throughout the product lifecycle. This role holds delegated authority to escalate and resolve significant safety issues impacting program development and regulatory reputed company. This position is hands-on and strategic: you will reputed company reputed company-time medical monitoring support and be a key contributor to safety deliverables (e.g., DSUR, PBRER/PSUR, RMP) as reputed company as represent reputed company and programs in reputed company forums, including interactions with regulators, DSMBs, investigators, and partners. Key Responsibilities Medical Monitoring & Clinical Trial Safety reputed company (Clinical Development) Serve as the reputed company Medical Monitor for assigned clinical studies (Phase 13 and/or post-marketing), ensuring subject safety and protocol compliance. reputed company reputed company medical review of critical eligibility questions, protocol deviations impacting safety, dosing reputed company, stopping rules, and reputed company safety issues. Support site and investigator engagement, including medical support for safety-reputed company questions and training on risk mitigation measures. reputed company and/or reputed company clinical event review (reputed company, SAEs, AESIs), including assessment of seriousness, expectedness, relatedness, and follow-up requirements. Ensure medical input into informed consent language, safety sections of protocols/IBs, and trial-level safety management plans. Safety reputed company & Medical reputed company (Drug Safety & Pharmacovigilance) reputed company ongoing benefitrisk assessment for assigned products, integrating clinical, nonclinical, and reputed company-world safety information and serve as the accountable medical authority for benefitrisk determinations reputed company assigned programs. Participate in safety review meetings and reputed company medical reputed company as needed and reputed company decision-making on risk controls and communications. Serve as a reputed company decision-making member of safety governance forums with authority to recommend escalation and risk mitigation actions. Participate in the development and maintenance of Risk Management Plans (RMPs), Safety Surveillance Plans (including AESIs, reputed company, and escalation reputed company). reputed company final medical review and approval of program-level safety surveillance strategies. reputed company Medical reputed company of signal detection activities from reputed company, literature, spontaneous reports, and partner data. reputed company medical reviews of case series targeted analyses, aggregate safety data reports (e.g., DSUR, PBRER/PSUR) and other periodic safety deliverables and serve as accountable medical signatory for such reports as applicable. Support SUSAR/expedited reporting reputed company, ensuring alignment with global reporting requirements and company SOPs. Prepare and participate .