Vice President, Medical Affairs - CNS (Philadelphia, PA)
3S has been retained to identify and recruit experienced medical affairs candidates for a leading life sciences company. This position will report to the Chief Medical Officer and will be accountable for designing and building the Medical Affairs department to ensure strategic and operational excellence of the Medical Affairs function. The successful candidate will be responsible for medical strategy, medical information, publications, communications, building the Medical Liaison Team, and medical expert engagement for our client's organization. She/he will partner closely with colleagues in research, clinical development, commercial, corporate portfolio strategy, legal and senior management to develop and execute short and long-term strategies addressing portfolio needs.
- Oversee the design and development of medical strategies for our client's late stage assets that can be used to guide development of robust medical plans that meet the needs of patients and the business.
- Ensure future communication strategy at the portfolio level.
- Provide broad scientific/medical support for late stage (III/IV) clinical development programs.
- Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required). Responsible for all medical communication aspects of scientific and clinical studies, regulatory submissions, and post-approval market support.
- Partner with Commercial to provide strategic medical insights to shape the portfolio strategy; provides strategic medical and scientific input and day-to-day advice to the commercial team and other relevant functions. Provide medical support for access strategy, including presentations. Provide medical review of product-related materials, as required.
- Establish and maintain strong working relationships with key external stakeholders (KOLs, medical experts, medical societies and managed care organizations, patient advocacy groups, clinical/medical stakeholders).
- Build, direct, and oversee the activities of the U.S. medical science liaison functions.
- Oversee the planning and implementation of external exchange including conferences, industry groups, Ad Boards, etc.; develop or adapt internal strategies to reflect the output of external scientific boards.
- Provide oversight for medical information activities, ensuring that responses are fully reflective of current data knowledge.
- Partner with the Legal to ensure that all Medical Affairs activities are conducted in a manner that is compliant with company policies, procedures, and local regulatory/legal requirements.
- Oversee and provide guidance for budget and resourcing plans.
- Domestic and international travel required (20-25% ).
- MD, PharmD, or PhD required with minimum of 10 years of biotech/pharma industry experience. Neurology and/or Psychiatry experience required
- Demonstrable executive leadership experience in Medical Affairs in a pharmaceutical/biotech organization.
- Track record of having played a central role in product launches. Solid understanding of the US, EU, and Asian regulations that govern Medical Affairs activities as well as detailed knowledge of common local, medical practices and treatment habits.
- Advanced understanding of clinical medicine/clinical pharmacology, and associated disciplines (e.g. biostatistics) drug development principles.
- Demonstrated ability to maintain scientific credibility while being commercially supportive, and to communicate scientific results and effectively respond to data queries from customers and/or consultants.
- Ability to manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations.
- Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient.
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders, within and beyond their team, including with management and external stakeholders.
- Demonstrated ability to focus on the goal and a strong ability to analyze complex issues and drive to timely, thoughtful and realistic solutions and recommendations.
- Possesses strong written and verbal communication skills, and ability to teach and mentor others in their team.
MD, PharmD, or PhD required