Senior Director, Medical Affairs

Job Title: Senior Director, Medical Affairs Job Number: 37360 Location: San Diego, CA Job Description We are looking for a Senior Director of Medical Affairs with strong biotechnology experience, preferably in rare diseases or cell therapy. This role will be central to establishing and expanding the medical affairs function as the company moves its lead programs forward after recent clinical progress. The person in this position will shape the scientific strategy, lead clinical messaging, and build relationships with healthcare professionals, key opinion leaders, and patient advocacy groups. They will also ensure that all stakeholder interactions follow compliant, high-integrity standards. The Senior Director will guide cross-functional collaboration between clinical development and commercialization, helping generate evidence and partnerships needed to drive program success and maintain medical excellence. Responsibilities Design and implement medical affairs plans that support company objectives, including evidence generation, scientific exchange, and contributions to cross-functional initiatives. Establish and strengthen relationships with healthcare professionals, key opinion leaders, and patient advocacy groups through meetings, site visits, and advisory boards at local, national, and global levels. Partner with the CMO to develop compliant, high-integrity processes for engaging HCPs and KOLs in line with regulatory standards such as FDA and ICH guidelines. Develop and enhance the clinical and value narrative by integrating internal insights, external expert feedback, and data analysis to support program advancement. Oversee scientific communications, including publications, conference presentations, and medical information responses, while managing external vendors when necessary. Provide medical guidance for commercialization readiness, including training programs, payer engagement, and real-world evidence efforts. Collaborate across teams—clinical development, regulatory, commercial, and quality—to drive strategic outcomes and organizational success. Identify and implement improvements in medical affairs operations, promoting innovation while maintaining compliance. Stay informed on new scientific developments, competitive activity, and trends across neurology, myology, cardiology, and rare diseases to guide strategy. Carry out additional responsibilities as needed. Required Skills The required qualifications are: Medical degree (MD) required, with expertise in neurology, myology, cardiology, or a related specialty, along with strong clinical and scientific proficiency. Extensive experience in medical affairs with a consistent record of success in the biotechnology or pharmaceutical industry. Background working in smaller organizations, with the ability to succeed in fast-moving, resource-limited environments. A proactive, solutions-oriented mindset combined with strong emotional intelligence and a collaborative approach to teamwork. Excellent communication, presentation, and relationship-building skills, with the ability to effectively engage diverse stakeholders. Solid knowledge of regulatory requirements, including cGMP, ICH, and FDA standards. Self-motivated with the ability to manage multiple priorities and meet tight deadlines in a high-paced setting. Willingness to travel approximately 30–40% for meetings, site visits, and conferences. Preferred Qualifications Experience supporting product launches or commercialization efforts within Medical Affairs. Familiarity with advanced therapies such as cell or gene therapy (ATMPs). Salary: $300,000 – $350,000 a year #J-18808-Ljbffr