Senior Director, Medical Affairs – CNS
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. 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 therapeutics for Pompe disease, Parkinson’s disease, and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
We have an opportunity for a Senior Director, Medical Affairs – CNS to join the AskBio team and be part of our continued success!
The Senior Director, Medical Affairs – CNS, reporting to the Vice President, Medical Affairs, will be responsible for development and delivery of the CNS Medical Affairs strategies for AskBio’s CNS clinical development and pipeline programs. This is a US-based, remote position with the ability to travel to meetings and conferences up to 35% of the time, post-pandemic.
- Partner with R&D, Clinical Development, Clinical Operations, Corporate Communications, and other functions to develop and implement global Medical Affairs strategies for the CNS gene therapy programs while maintaining the highest level of industry compliance, patient centricity and scientific standards.
- 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.
- 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 publication plan and provide oversight of all publications including posters, abstracts, manuscripts at the global level to ensure appropriate alignment between relevant teams.
- Lead the development and execution of Medical educational initiatives in support of new technology, studies, indications, and products.
- Partner with technical experts to review and edit publications and external communications to ensure content is scientifically accurate and of high quality, and lead the medical review process for the therapeutic area.
- Serve as scientific/clinical knowledge expert for company products and related therapeutic area(s) to internal stakeholders.
- Support Patient Advocacy initiatives in alignment with program and product strategies, in collaboration with the Director, Patient Advocacy and Clinical Development Program Lead.
- Manage external agencies and medical writing contractors supporting the publication and medical communication planning and development activities.
- Develop and manage budgets and timelines for all CNS/Neuromuscular medical affairs initiatives as described in the Medical Affairs plan.
- Develop, execute and/or support Therapeutic Area Scientific and Clinical Advisory Board meetings.
- Attend and support key external medical/scientific meetings.
Required Education & Experience
- Advanced Degree (M.D. / Ph.D.,/ Pharm.D.) in Medicine and/or a medical sciences field (preferably in CNS/metabolic disorders).
- 10+ years industry experience, especially in Medical Affairs, in a variety of settings and therapeutic areas with Phase I-IV research.
- Strong therapeutic area knowledge including significant experience in developing medical strategic and publication plans.
- Track record of developing new KOL networks within specialty therapeutics areas.
Preferred Experience & Skills
- Previous experience in Neuroscience, rare disease and/or gene therapy and MSL and/or medical communications.
- Understanding of drug development and commercialization concepts.
- Excellent analytical, communication and presentation skills and solid experience in translating medical/clinical information in relation to AskBio’s technologies and development programs into medical affairs strategies.
- Ability to plan, prioritize, and execute multiple projects; ability to multitask and work both independently and with cross-functional teams.
- Strong interpersonal skills for effective professional communications with internal and external stakeholders.