Senior Director, Medical Affairs – MD Required

🕒 Maio 15

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Capricor Therapeutics, Inc.

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2005

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Capricor Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico que desenvolve terapias baseadas em células e exossomos, focada em medicina de precisão para distrofia muscular de Duchenne e outras doenças graves. A empresa avança com células derivadas de cardiosferas alogênicas (CDCs) e plataformas de exossomos em um pipeline de múltiplas etapas, incluindo terapia celular investigativa (deramiocel) e abordagens para carregar oligonucleotídeos terapêuticos em exossomos. A Capricor enfatiza o desenvolvimento centrado no paciente, pesquisa translacional e parcerias estratégicas para trazer novos medicamentos biológicos aos pacientes.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• Health insurance • Professional development