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Senior Medical Director, Global Medical Affairs Strategy
at Vertex
Boston, MA

Senior Medical Director, Global Medical Affairs Strategy
at Vertex
Boston, MA

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Description

Job Description:

The Senior Medical Director, Global Medical Affairs Strategy will provide leadership within the Cystic Fibrosis therapeutic area, and will be primarily responsible for developing the medical strategy and medical plan as well overseeing execution of the medical plan. You would lead a global medical affairs team that includes Clinical Development, North American and International Medical Affairs organizations, HEOR/Market Access, Marketing, Regulatory, and Medical and Corporate Communications to ensure that scientific and medical strategies are aligned with broader corporate and patient needs. You would be expected to have a strong dedication to achieving corporate and medical objectives while maintaining the highest ethical, regulatory and scientific standards. Are you ready to lead the most dynamic team at Vertex?

Responsibilities:
  • Drive strategic alignment within the program working across teams and partnering with other key functions at Vertex such as Commercial, Regulatory, Market Access, HEOR, and Corporate Communications.
  • Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans.
  • Responsible for medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and/or marketed compounds.
  • Leads development of Study Protocols, Global Launch Plans, Lifecycle Management Plans and other key study documents in conjunction with other line functions and with minimal guidance.
  • May serve on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve high-quality study execution
  • Function as medical monitor for assigned Vertex clinical trials as necessary.
  • Lead and direct Global Medical Affairs vision, strategy and plans within the Brand.
  • Develop and continue maintaining the highest scientific and medical expertise ensuring GMA employees are acknowledged internally and externally as experts
  • Prioritize people development by establishing opportunities for team members through implementation of growth plans, training opportunities and relevant on the job challenges
  • Develop effective team communication, analysis and documentation of performance of medical affairs activities and knowledge through the application of appropriate governance, reporting systems and structures.
  • Systematically assess medical education needs and implement appropriate medical education programs for commercial teams and other functions
  • Participate in the preparation of documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for designated trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
  • Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), and clinical study reports (CSR)
  • Partner effectively the Global Communications team to develop and execute aligned strategies/tactics for improving our scientific communication efforts.
  • Partner with global leaders to provide insights on current focused therapeutic area issues and questions
  • Set up and lead Steering Committee meetings and advisory boards.
  • Partner with external investigators on collaborative studies and with external registries on non-interventional studies using secondary data.
  • Review investigator-initiated proposals and other research grants.
  • Provide medical input and guidance to Early Access Programs and individual IND (early access) requests.
  • Align Global Medical Affairs objectives with those of Clinical Development and Commercial operations to ensure programs meet the needs of all partners#LI-AO1

Qualification:

  • Medical Degree (MD or DO) with board certification in relevant specialty (internal medicine, pulmonary medicine; experience in orphan diseases is a plus.)
  • At least 5-7 years of clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics; and GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
  • Experience as a team leader
  • Experience in Medical Affairs within the biotechnology or pharmaceutical industry and experience conducting Phase 3b/4 studies and/or non-interventional studies
  • Deep understanding of global Medical, Regulatory and Commercial environments
  • Possess understanding of government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange and communication with customers.
  • Excellent strategic skills with the ability to influence decisions, both internally and externally
  • Ability to work and adapt in a fast-pace and evolving environment, and the proven track record of working effectively in diverse multi-cultural teams involving multi-functional disciplines
  • Ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts
  • Possess the skill to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner
  • Extensive regulatory and compliance experience leading a Medical Affairs organization
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
  • Previous Clinical Operations experience (design and implementation of clinical trials)
  • Confirmed ability to manage budget and resources
  • Strong business insight
  • Ability to build partnership access between HQ and affiliates
  • Flexibility and passion to adapt to changing conditions
  • Demonstrates an energy and enthusiasm which brings a positive approach to all challenges
  • Sense of ethics and responsibility
  • Travel required up to 25%

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