Responsibilities
- develop and execute medical affairs strategies aligned with company goals, including evidence generation, scientific exchange, and medical input into cross-functional teams.
- build and maintain strong relationships with hcps, kols, and patient advocacy organizations in dmd, becker muscular dystrophy (bmd), and related fields through local, national, and international meetings, 1:1 site visits, and advisory boards.
- collaborate with the cmo to establish high-integrity, compliant processes for hcp and kol engagement, ensuring adherence to regulatory guidelines (e.g., fda, ich).
- create and refine the clinical scientific and value story for deramiocel through internal consultations, external expert input, and data analysis to support program progression.
- lead scientific communications, including publications, congress presentations, and medical information responses, while overseeing vendors as needed.
- provide medical expertise to support commercialization readiness activities, including training, payer interactions, and real‐world evidence initiatives.
- work cross‐functionally with clinical development, regulatory affairs, commercial, and quality teams to drive business impact and team success.
- identify opportunities for continuous improvement in medical affairs operations, fostering a culture of innovation and compliance.
- monitor emerging scientific data, competitive landscape, and therapeutic trends in neurology, myology, cardiology, and rare diseases to inform strategy.
- perform such other duties as may be assigned from time to time.
requirements
- md required, with experience in neurology, myology, cardiology, or a closely related field, and demonstrated clinical scientific competence.
- deep experience and commitment to excellence in medical affairs, with a proven track record in biotechnology or pharmaceuticals.
- experience working in a small company environment, thriving in dynamic, resource‐constrained settings.
- passionate "can‐do" mentality with evidence of high emotional intelligence (eq) and collaborative teamwork.
- exceptional communication, presentation, and interpersonal skills to engage stakeholders at all levels.
- strong understanding of regulatory compliance, including cgmp, ich, and fda guidelines.
- ability to work independently, multi‐task, and meet aggressive deadlines in a fast‐paced environment.
- willingness to travel up to 30‐40% for meetings, site visits, and conferences.
preferred qualifications
- previous experience with dmd, bmd, or other muscle or cardiomyopathic indications.
- experience with pre‐launch or commercialization activities in a medical affairs capacity.
- experience with complex cell or gene therapy (atmp) products.
work environment and physical demands
- professional office (san diego) or remote work environment.
- prolonged periods of computer use for planning, documentation, and reporting.
- occasional travel may be required for meetings, site visits, and stakeholder engagement.
- ability to lift office materials up to 20 pounds.
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