Senior Director, Medical Affairs – MD Required

📋 Description

• Formulate and implement medical affairs strategies that align with the company's objectives, focusing on evidence generation, scientific exchange, and providing medical insights to cross-functional teams.

• Establish and nurture robust relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and patient advocacy groups in Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), and related areas through local, national, and international meetings, one-on-one site visits, and advisory boards.

• Partner with the Chief Medical Officer (CMO) to develop and maintain high-integrity, compliant processes for engaging HCPs and KOLs, ensuring compliance with regulatory standards (e.g., FDA, ICH).

• Develop and enhance the clinical scientific and value narrative for deramiocel through internal discussions, external expert feedback, and data analysis to facilitate program advancement.

• Lead scientific communications, which include publications, congress presentations, and responses to medical inquiries, while managing vendors as necessary.

• Provide medical expertise to assist with commercialization readiness initiatives, which encompass training, payer interactions, and real-world evidence projects.

• Collaborate across clinical development, regulatory affairs, commercial, and quality teams to drive business outcomes and team success.

• Identify and implement opportunities for continual improvement in medical affairs operations, promoting a culture of innovation and compliance.

• Stay informed about emerging scientific data, competitive landscapes, and therapeutic trends in neurology, myology, cardiology, and rare diseases to shape strategic direction.

⛳️ Requirements

• MD is required, with expertise in neurology, myology, cardiology, or a closely related discipline, and demonstrated clinical scientific proficiency.

• Extensive experience and a commitment to excellence in medical affairs, with a proven history in biotechnology or pharmaceuticals.

• Experience in a small company setting, thriving in dynamic and resource-limited environments.

• A passionate "can-do" attitude with evidence of high emotional intelligence (EQ) and collaborative teamwork.

• Outstanding communication, presentation, and interpersonal skills to effectively engage stakeholders at every level.

• Strong knowledge of regulatory compliance, including cGMP, ICH, and FDA guidelines.

• Ability to work autonomously, manage multiple tasks, and meet stringent deadlines in a fast-paced environment.

• Willingness to travel up to 30-40% for meetings, site visits, and conferences.

🏝️ Benefits

• Health insurance

• Professional development