Senior Director, Medical Affairs – MD Required

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement medical affairs strategies that align with the company's objectives, encompassing evidence generation, scientific dialogue, and medical contributions 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 domains through local, national, and international meetings, one-on-one site visits, and advisory boards.

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

• Develop and enhance the clinical scientific narrative and value proposition for deramiocel through internal discussions, insights from external experts, and data analysis to facilitate program advancement.

• Direct scientific communications, including publications, congress presentations, and medical information responses, while supervising vendors as necessary.

• Offer medical expertise to aid commercialization readiness efforts, including training, interactions with payers, and real-world evidence initiatives.

• Collaborate across functions with clinical development, regulatory affairs, commercial, and quality teams to enhance business impact and team achievement.

• Identify avenues for ongoing improvement in medical affairs operations, promoting a culture of innovation and adherence to compliance.

• Keep abreast of emerging scientific information, competitive dynamics, and therapeutic trends in neurology, myology, cardiology, and rare diseases to guide strategic direction.

⛳️ Requirements

• MD degree required, with experience in neurology, myology, cardiology, or a closely related discipline, demonstrating clinical scientific proficiency.

• Extensive experience and commitment to excellence in medical affairs, showcasing a successful track record in biotechnology or pharmaceuticals.

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

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

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

• Strong grasp of regulatory compliance, including cGMP, ICH, and FDA regulations.

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

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

🏝️ Benefits

• Health insurance

• Professional development