Senior Director of Medical Affairs (Women's Health)

Senior Director, Clinical & Medical Affairs (Specialty Women's Health) Location: Remote (US), travel as needed Our client is a growing specialty pharmaceutical organization entering a pivotal stage of development and commercialization. As the company continues to expand its medical affairs capabilities, they are seeking a strategic and hands-on Senior Director of Medical Affairs to lead medical strategy, field medical excellence, and cross-functional scientific engagement efforts. This individual will provide leadership for all Medical Affairs, Clinical Development and Pharmacovigilance activities performed by the company. Key Responsibilities Develop and execute the global and US Medical Affairs strategy aligned with corporate objectives. Serve as a medical affairs lead for pipeline and/or commercial products across all stages of the product lifecycle. Provide scientific and clinical leadership for internal stakeholders, ensuring medical integrity across all activities. Recruit, develop, and mentor a high-performing Medical Science Liaison (MSL) team. Oversee publication strategy, congress planning, and medical communication initiatives. Lead investigator-sponsored research (ISR) programs and collaborate on post-marketing evidence generation efforts. Develop SOPs for functional areas that meet FDA regulations and ICH/GCP guidance and practices Identify opportunities for real-world evidence, health economics, outcomes research, and patient-focused research. Seletion and management of Vendors who have been chosen to provide clinical pharmacology, pharmacovigilance, and med info services. Qualifications Advanced scientific or clinical degree required (MD, PharmD, or PhD) Women's Health experience absolute must 5+ years of industry experience in Medical Affairs and/ or Clinical Development Strong understanding of compliance, regulatory considerations, and industry standards governing Medical Affairs activities. Proven track record of developing productive relationships with KOLs, investigators, and healthcare providers. Exceptional communication, influencing, and executive presentation skills. #J-18808-Ljbffr EPM Scientific