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Sr. Director, Medical Affairs, Neuromuscular

External
askbio logoAskbio · Remote
Full-timeRemoteToday
ComplianceLeadershipStrategic Planning
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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 company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson's disease, and Pompe disease. AskBio's gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what's right in every situation. Make clear commitments and follow through. Position Summary The Senior Director, Global Medical Affairs, Neuromuscular is responsible for development and delivery of the Medical Affairs plan and strategies for AskBio's Neuromuscular programs. This individual will be the Senior Medical Affairs leader on Neuromuscular Integrated Product Team (IPT). The responsibilities will include but are not limited to: Medical Communications and Publications, Patient Advocacy, Field medical strategy, Continuing Medical Education, Health-Economics Outcomes Research (HEOR), Integrated evidence generation, Medical Advisory Boards and Medical Review of Materials. KOL engagement plan in collaboration with clinical operations and clinical development. This plan should start with KOL mapping based on the needs of the early development program (thinking through the lens of how the KOLs will potentially inform guidelines and clinical practice). The KOL engagement plan should have metrics attached to it and actionable insights generated monthly. Job 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 con


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