Senior Director, Medical Affairs, Neuromuscular

🔥 6 minutes ago

🗽 New York – Remote

🗽 New York – Remote

⏰ Full Time

🟠 Senior

👔 Director

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Asklepios BioPharmaceutical, Inc. (AskBio)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

📋 Description

• Be a functional leader in the medical team with matrixed responsibility to IPT leadership; serve as co-leader of the IPT branding sub-team • Partner with Pipeline Commercial, Clinical Development, Clinical Operations, Corporate Communications, R&D, and other functions to develop and implement global Medical Affairs strategies for the Neuromuscular programs while maintaining the highest level of industry compliance, patient centricity and scientific standards • Collaborate with clinical study teams to enable recruitment and retention of clinical studies • Execute and support Medical Affairs activities including key opinion leader engagement, congress planning, advisory boards, publication planning, generation of standard response letters, post marketing data generation and HEOR analysis • Establish relationships and facilitate interactions with thought leaders and advocacy partners (professional and patient organizations) including scientific collaborations, speaker training, advisory boards, and regional/national/international conferences • Develop KOL engagement plan in collaboration with clinical operations and clinical development (incl. KOL mapping based on the needs of the early development program). • Develop congress strategy, including tactical execution about strategic planning of KOL meetings, impact of sessions, competitive intelligence and collection of insights feeding into clinical development program and generation of post-congress debrief reports. • Develop publication plans by conducting data gap analysis to inform publication strategy and publication mapping/planning and provide oversight of all publications including posters, abstracts, and manuscripts at the global level to ensure appropriate dissemination of scientific messages • Partner with internal and external stakeholders to review and edit publications and external communications to ensure content is scientifically accurate and of high quality • Lead the development and execution of medical educational initiatives in support of defined educational strategies • Develop Scientific platform to inform the development of publication plan, communication plan, proactive and reactive slide decks for KOL and advocacy engagements • Lead the medical review process for the Neuromuscular therapeutic area • Lead and execute global scientific engagement strategy and drive excellence in scientific engagement with all key stakeholders • Serve as scientific/clinical knowledge expert for Neuromuscular therapeutic area(s) and disease states to internal and external stakeholders • In collaboration with the External Affairs Team, support external initiatives in alignment with program and product strategies. • Generate a compelling strategy around not only patient advocacy but also professional advocacy • Develop and manage budgets and timelines for all Neuromuscular medical affairs initiatives as described in the Medical Affairs plan and in alignment with IPT’s overarching program strategy • Develop, execute and/or support Therapeutic Area Scientific/Clinical Advisory Board meetings

🎯 Requirements

• Doctorate level or higher degree and 12+ years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development • OR Medical Degree (MD) with 8+ years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development • US, Global and major EU experience • Significant experience in developing medical strategies and publication plans in early stages of product life cycle (pipeline medical affairs) • Significant experience in advisory board planning from needs assessment, recruiting/contracting KOLs, determining the objectives of the Ad board, running the Ad board and finalizing the report is needed • Experience with phase I-IV clinical research • Strong understanding of drug development and commercialization concepts • Experience driving transformation within your organization in a cross-functional capacity • Successful product launch experience • Technical skills covering end to end lifecycle management, launch planning and execution, and disease area shaping • Experience creating high quality integrated evidence and scientific external engagement packages • Track record working within large, complex organizations influencing R&D and partnering with and understanding the global landscape • Cross-functional senior leadership experience leading strategies for different cross-functional medical affairs teams • Proficient in presenting new ideas, initiatives, and business rationale to Board and C-level leaders to gain alignment and update on progress • Track record for attracting and developing talent and optimizing team performance in direct and matrixed leadership roles • ~25% travel (Primarily US and Europe)

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options