Senior Director, Medical Affairs – MD Required

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Capricor Therapeutics, Inc.

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

Gegründet 2005

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

Biotechnology • Pharmaceuticals • Science

Capricor Therapeutics, Inc. ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das zell- und exosombasierte Therapeutika entwickelt, mit einem Fokus auf Präzisionsmedizin für die Duchenne-Muskeldystrophie und andere schwerwiegende Erkrankungen. Das Unternehmen fördert allogene kardiosphärenabgeleitete Zellen (CDCs) und Exosomplattformen in einer Pipeline mit mehreren Entwicklungsstufen, einschließlich der Erprobung von Zelltherapien (Deramiocel) und Ansätzen zur Beladung von therapeutischen Oligonukleotiden in Exosomen. Capricor legt großen Wert auf patientenorientierte Entwicklung, translationale Forschung und strategische Partnerschaften, um neuartige biologische Arzneimittel zu den Patienten zu bringen.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

• Health insurance • Professional development