Sr. Director, Medical Affairs, Neuromuscular

About the role

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Senior Director, Global Medical Affairs, Neuromuscular is responsible for the development and delivery of the Medical Affairs plan and strategies for AskBio's Neuromuscular programs. This individual will serve as the Senior Medical Affairs leader on the Neuromuscular Integrated Product Team (IPT).

Responsibilities

• 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, including 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 the 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 a scientific platform to inform the development of publication plans, communication plans, 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 patient advocacy and 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 with increasing responsibilities, complexity, and accountability OR Medical Degree (MD) with 8+ years’ experience working in the biopharmaceutical industry in Global Medical Affairs and/or Development with increasing responsibilities, complexity, and accountability.
• 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.
• 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).

Preferred Qualifications

• MD or equivalent is preferred.
• Specialty clinical training and patient care experience in neurology and/or neuromuscular therapeutic area.
• Experience with Gene Therapy, rare disease, immunology, neuroscience, and/or neuromuscular therapeutic areas.