Vertex Pharmaceuticals

Job Description

The Medical Director, Global Strategy, will provide medical support for the Cystic Fibrosis (CF) therapeutic area, participating in development and execution of the of the medical strategy and plan. He/she will partner with the Executive Medical Director, Global Strategy, to deliver Global Medical Affairs activities for CF and will work closely with a cross-functional group that includes Clinical Development, North American and International Medical Affairs, 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. This person must have the ability to work effectively in a highly matrixed environment and have a successful track record of developing project strategies and translating and executing tactics. He/she is expected to have a strong commitment to achieving corporate and medical objectives while maintaining the highest ethical, regulatory and scientific standards

Key Responsibilities

• Responsible for strategic alignment of the assigned clinical program, working cross functionally and partnering with other key functions as outlined
• Provide input and contribute to the global Therapeutic Area strategic imperatives, Medical Affairs objectives and annual brand tactical plans
• Support development of Life Cycle Management Plans, Study Protocols and other key study documents in conjunction with other line functions and with limited guidance
• Align Global Medical Affairs objectives with those of Clinical Development and Commercial operations to ensure programs meet the needs of all stakeholders. 
• Serve on cross-functional study execution teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution and to function as medical lead and medical monitor for global phase 3b/4 clinical trials.
• Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
• Responsible for alignment on and communication of medical interpretation of data (clinical trials, registries, published literature, etc.) for in-development and/or marketed compounds
• Provide 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) as appropriate
• Work with the Global Communications team to develop and execute aligned strategies/tactics for maximizing our scientific communication efforts.
• Serve as promotional reviewer for global commercial pieces.
• Partner with global thought leaders to provide insights on current focused therapeutic area issues and questions
• Partner with external registries on non-interventional studies using secondary data, as appropriate.
• Review investigator-initiated proposals and other research grants, as appropriate.
• Provide medical input and guidance to Early Access Programs and individual IND (early access) requests.

Minimum Qualifications 

• Medical Degree (MD or DO) with board certification in relevant specialty
• 10 years of experience or the equivalent combination of education and experience following terminal degree
• At least 3 years of experience in a biopharma role, with experience in analysis of research (pre-clinical and clinical) data and publications; working knowledge of GCP, biostatistics as well as scientific and clinical research methods, and clinical study design
• Strong knowledge of internal medicine, pediatrics, pulmonary medicine and/or other relevant specialty. Experience in orphan diseases is a plus.
• Experience in Medical Affairs within the biotechnology or pharmaceutical industry is a significant plus
• Good 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
• Excellent written and oral communication skills; high-level negotiation skills
• Ability to work and adapt in a fast-pace and evolving environment, as well as 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 ability to engage in positive dialogues, influence outcomes and resolve conflicts in a constructive manner 

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.