Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain. 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. The Role The Senior Vice President of Medical Affairs (VPMA) provides strategic and operational leadership to AskBio’s Medical Affairs team. With a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards, this individual will be responsible for the legally compliant execution of the Medical Affairs functions for development programs and in the future for approved and commercialized products. The VPMA responsibilities will include, but not limited to: Medical Communications and Publications, Patient Advocacy, Investigator-Initiated Trial program, Medical Science Liaisons group, Continuing Medical Education, Health-Economics Outcome Research (HEOR), Medical Advisory Boards and Medical Review of Commercial/Marketing Materials. The SVPMA will set the vision and direction for the team and partner with Scientific Chairs, IPTLs, Clinical Development, Regulatory Affairs, Market Access, and Marketing to develop and operationalize medical strategy for global development programs and commercial products. The incumbent will be responsible for building and guiding a Medical Affairs function ahead of the organization's first commercial launch. This position reports to the Chief Development and Medical Officer at AskBio. Major Responsibilities: Will be responsible for developing and leading the MA organization. Will be responsible for creating and updating all Medical Affairs’ related SOPs and work instructions governing medical affairs activities. Will directly hire, mentor, and retain medical leads, MSLs, and other talents. Provides medical expertise, medical support and oversight and management to all Medical Affairs functions. Service as a senior medical leader and provide strategic insights to product portfolio reviews and gating decisions. Partner with Scientific Chairs, IPTLs, Clinical Development, Regulatory Affairs, Market Access, and Marketing to formulate the overall medical strategy at the product portfolio level and also develop medical strategies and core medical messages for each clinical program Partner with IPTLs to implement medical strategies in clinical trial design and execution and serve as a senior medical representative to engage the medical and patient communities. Ensures that the highest quality, scientifically and medically accurate, and fair-balanced medical data is contained in all AskBio generated development and commercial materials, scientific publications, medical information letters and responses, etc. Provides medical review and final approval/rejection on all IIT proposals. Provides leadership and ensures the ethical, compliant, and scientifically excellent interaction and communication of medical directors, MSLs, or other departmental employees with the external medical and patient advocate community Works and communicates closely with commercial counterparts in the company to assure appropriate medical affairs support to the development and commercial organization Represents the company to outside medical/scientific experts via participation in scientific congresses, medical advisory boards, discussions regarding IITs and other medical affairs-related activities Keeps abreast of current medical/scientific progress and actively develops and maintains relationships with outside key thought leaders in various therapeutic areas Ensure the company complies with all applicable corporate, regulatory and legal policies. Provide insight to pipeline determination in clinical feasibility and translate findings from research and medical community into clinical development opportunities. Education Must possess an M.D., PhD, Pharma D, or DVM. MD with residency and fellowship training desired Medical or scientific training and product development/commercialization in CNS, CVM, or genetic disorders, desired Experience and Skills Ten plus years combined experience of clinical practice and medical affairs industry experience with at least 5 years as Medical Director or Vice President level; experience in clinical development a plus. An strategic thinker with extensive experience in developing and implementing medical strategies for products at development or commercial stage. Must have experience in late-stage clinical development, and preparing the commercial launch of at least one first in class biologics product in the U.S. Must have experience in supporting conception of new product opportunities and providing medical insights into product development teams. Must have experience and success in an integrated global program teams enviroment A strong track record in building and leading high performance medical affairs teams and in mentoring talents with an inspirational leadership style Ability to understand and respond to multiple external and internal customers' demands, manage and handle conflict constructively required A strong track record of integrity and compliance Must have a strong working knowledge of clinical development and the regulatory requirements relating to medical affairs’ activities with ethical, legal, and regulatory standards. Demonstrated communication, writing, and interpersonal skills. Track record of writing/preparing publications/presentations and presenting clinical information at Scientific Advisory Boards, Medical Advisory Boards, Scientific Congresses, etc. A strong team player and excellent collaborator Exceptional capabilities to prioritize and reach milestones with speed, high quality and within budget. Experience in gene therapy development and commercialization desired Asklepios BioPharmaceutical, Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com. Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency. Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that can potentially cure genetic diseases has never wavered. At AskBio, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease, and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. We became a wholly-owned, independently operated, subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy (CGT) platform. Our global headquarters is in Research Triangle Park, NC. Additionally, we have significant operations in Philadelphia, PA, Columbus, OH, Scotland, France, and Spain.