The Director, Early Development in Global Medical Affairs will assist with the strategy and medical support for Vertex compounds in early development. He/she will work closely with a cross-functional group that includes Research, Clinical Development, Commercial, Health Economics and Outcomes, and Corporate Communications. This person must have the ability to work effectively in a highly matrix environment and have a successful track record of developing project strategies and executing project details. He/she is expected to have a strong commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards.
General Responsibilities and Required Skills:
· Provide medical affairs input into the early development programs/activities and execute the medical communication plans for these programs
· Work cross functionally and partner with other key functions at Vertex such as Clinical Development, Commercial, Health Economics and Outcomes, Research and Regulatory to provide input into the clinical development, commercialization and life-cycle management plans for products in early development
· Partner with Thought Leaders and other external groups to gather information on current therapeutic area issues and early clinical development trials
Key Responsibilities:
· Develop scientific communication platforms for early development compounds with cross-functional team members including mechanism of action scientific stories, scientific platforms and publication plans
· Work with cross-functional teams to development internal and external communication plans for early development programs
· Provide medical support to clinical trial investigators in collaboration with clinical development and operations
· Develop global external engagement plans (including Thought Leaders) for early development programs that expand during clinical development
· Lead the development of content for advisory boards and summarize key takeaways from the meetings with cross-functional team members
· Conduct medical reviews of advisory board content, medical education projects and medical information responses
· Provide guidance on HCP, patient and payer needs and promote medical differentiation of products
· Contribute to the clinical development, commercialization and life cycle plans for early development compounds
· Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for early development compounds and competitive landscape
· Leverage medical expertise and research knowledge to support Regulatory strategies and product labeling
· Provide medical input and product expertise to Medical Information group
· If required, manage or mentor staff within Medical Affairs
Position Qualifications:
- PharmD/PhD/MD with a minimum of 7 years of pharmaceutical industry experience
- Possesses knowledge of drug development process
- Experience in medical affairs in working in a therapeutic area/medical director role and interest in the neurology and oncology therapeutic areas (experience in these areas is a plus)
- Broad understanding of Global Medical, Regulatory and Commercial environments
- Experience with managing external agencies and project timelines/budgets
- Demonstrated ability to build alignment through strategic partnerships
- Excellent written and oral communication skills
- Ability to work in a fast-pace and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
- Ability to manage tight deadlines and project budgets in a changing, fast pace environment
- Demonstrated ability in driving results to a positive outcome. The ideal candidate will have a track record of delivering outstanding results
- Proven ability to develop internal relationships in a highly matrix environment, as well as external relationships with Thought Leaders and industry experts
- Possess understanding of government and industry guidelines, regulations, laws, etc. for appropriate scientific/medical exchange and communication with customers