Sr. Director, Medical Affairs, Neuromuscular

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

About The Position

AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a portfolio of clinical programs for neuromuscular, central nervous system, cardiovascular, and metabolic diseases. AskBio's gene therapy platform includes Pro10™ manufacturing process and a wide range of capsids and promoters. The company's vision is to pioneer science for transformative molecular medicines, and its mission is to lead innovative science and drive clinical outcomes to transform lives. AskBio values pioneering spirit, collaboration, responsibility, continuous improvement, and integrity. The Senior Director, Global Medical Affairs, Neuromuscular will be responsible for developing and executing the Medical Affairs plan and strategies for AskBio's Neuromuscular programs. This role will serve as the Senior Medical Affairs leader on the Neuromuscular Integrated Product Team (IPT), overseeing Medical Communications and Publications, Patient Advocacy, Field medical strategy, Continuing Medical Education, HEOR, integrated evidence generation, Medical Advisory Boards, and Medical Review of Materials. A key responsibility includes developing a KOL engagement plan in collaboration with clinical operations and clinical development, focusing on KOL mapping, informing guidelines and clinical practice, and establishing metrics for actionable insights.

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 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

Nice To Haves

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 is preferred

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 (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