The Senior Medical Director (SMD), Medical Brand Development and Advocacy, Alzheimer’s Disease and Brain Health (ADBH), Global Medical Affairs (GMA) – provides medical management and accountability for the Company AD portfolio focusing on the highest medical and scientific integrity and standards, while driving innovation and providing patient focused healthcare. The SMD will provide therapeutic area expertise in AD for medical advocacy and engagement, patient journey development and special products. The SMD will collaborate with strategic publications, evidence generation, medical education, key-opinion leader (KOL) engagement initiatives, as well as ensuring global-regional, and cross-disciplinary alignment and with all GMA and non-GMA stakeholders. Under the direction of the Executive Medical Director (EMD), the role is responsible for reinforcing the GMA Scientific Platform, including post-marking research (Phase IIIb and IV) and projects related to the development of Company AD treatments. In addition, the SMD will provide support for major AD congresses, medical and scientific advisory boards, and scientific communications and publication components reflecting the overall medical strategic imperatives.
The SMD is a key member of the ADBH group responsible for developing and maintaining excellence in global medical affairs activities, building best-in class capabilities and leading activities that are necessary to generate and publish evidence that fills knowledge gaps. The individual will facilitate the appropriate and optimal use of Company medicines to improve patient outcomes and fulfill the hhc mission by utilizing expert medical and scientific knowledge in the AD therapeutic area. The SMD will be responsible for supporting and assisting in the coordination of all AD programs as they relate to the developing medical affairs functions and their tactical operationalization.
Additional aspects of the position include:
Supporting the EMD on all internal and external AD related projects as directed, and will act as said delegate when necessary
Works with commercial advocacy on specialized projects related to the growth of Company AD treatments
Collaborates with evidence generation for growth and adoption of Company AD treatments
Collaborates with regional medical teams to ensure the data generation activities are aligned with the global strategy and address the identified evidence gaps
Collaborate with internal and external stakeholders in finding innovative solutions to address the heterogeneity of AD clinical tools and presentation
Medical/Scientific subject matter expert to provide direction for assigned products including (but not limited to) scientific communications, publication planning/review, advisory boards, health outcomes plans, speaker programs, investigator-initiated research and, as necessary, CME grant reviews or other internal key business processes.
Work with the EMD to strategize, coordinate and execute annual medical plans and budgets for the global AD therapeutic area
Support the EMD in strategizing the planning, coordination, and execution of broad-based activities for the GMA team, including Phase IIIb/IV studies, educational programs, advisory boards, symposia and congresses as deemed appropriate
Provide medical insights for interpretation of trial results, final study report conclusions, publications and other ad hoc documents
Provide medical input into lifecycle management strategies for AD and neurology related products
Participate as an ad-hoc member of Company’s global launch cross-functional team for AD
Represent GMA at internal and external activities, congresses, meetings, initiatives, and workgroups during work assignments
Supports leadership in providing strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions
Strengthen Company’s medical reputation through successful management of medical dimensions of AD related products
Engage, develop, coordinate and enhance Company’s KOL and Advocacy networks at all levels
This position requires a dynamic individual with an MD or Ph.D. and 5+ years of industry experience
Board Certification in Neurology or (Geriatric) Psychiatry is highly preferred
In-depth knowledge of the neuroscience and neurobiology of neurodegeneration/dementia/cognition/supportive care diseases, including Alzheimer disease therapeutic area.
Some knowledge of KOLs (and interaction with), in the AD therapeutic area
Thorough knowledge of AD screening diagnostic tools, including: PET-imaging, MRI imaging, CSF biomarkers, blood-based biomarkers, cognitive assessments
Academic or Pharmaceutical experience with a history of senior roles related to publications and team matrixed management
Must understand and adhere to industry-related guidelines relevant to Medical Affairs, Medical Information, Medical Education, Investigator-Initiated Studies and Publications.
Continuously ensures compliance with Company policies and procedures for all activities undertaken and monitors various government and industry guidelines to best practices
Experience working on cross-functional development teams across development phases
Experience directing external agencies, vendors, CROs, and consultants in support of the development of materials and coordination of global activities
Understands ICMJE guidance/general publication practices
Understands FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
A thorough understanding of clinical research methodology and interpretation
Advanced written and verbal communication skills and a flexible interactive style that engages cross-disciplinary colleagues with varying viewpoints to meet and exceed shared objectives
Strong interpersonal, team building and communication skills
Excellent management skills in a highly matrixed and fast-paced environment