Req ID 10171BR

Department Global Strategy

Posting location Boston, MA

Job Title/Position Title Medical Director

Posting Job Title Medical Director, Global Strategy, Global Medical Affairs

Job Description The Medical Director, Global ORKAMBI strategy will provide medical support for the Cystic Fibrosis therapeutic area, and will be primarily responsible for developing the medical strategy and medical plan as well as executing against the medical plan for ORKAMBI. He/she will work closely with a cross-functional group 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. 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

- Support strategic alignment of ORKAMBI 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 ORKAMBI tactical plans

- Support development of Study Protocols, Life Cycle Management Plans and other key study documents in conjunction with other line functions and with limited guidance

- 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 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)

- 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

- 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 stakeholders.

#LI-RS1

Minimum Qualifications - Medical Degree (MD or DO) with board certification in relevant specialty

- Strong knowledge of internal medicine, pulmonary medicine, and/or other relevant speciality. Experience in orphan diseases is a plus.

- At least 3-5 years of clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies

- Experience in Medical Affairs within the biotechnology or pharmaceutical industry and/or experience conducting Phase 3b/4 studies and/or non-interventional studies 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

- Proven 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

Full-Time or Part-Time Full-Time

Company Information

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and offices around the world. For several consecutive years, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the Company, please visit www.vrtx.com.

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 [email protected].