Executive Medical Director, Translational Medicine

Job Description

The Executive Medical Director, Translational Medicine, Early Development will be a strategically minded, hands-on early clinical development expert with the responsibility for overseeing the transition of projects from research into clinical development, and for developing strategy for early clinical development of novel therapies including application of biomarkers in Phase 1b/2a studies. Success depends on the integrity, knowledge, imagination, creativity, skill, diversity and teamwork focus of the candidate. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. The individual will collaborate with talented and dedicated colleagues across R&D, Clinical & Quantitative Pharmacology, and other key stakeholder functions. This position will be a critical element in Vertex's approach to creating an effective bridge between discovery research and clinical development.

Key Duties and Responsibilities:

• Leading a group of physician-scientists involved in clinical research
• Work closely with other functional experts across the organization
• Provide medical leadership and translational medicine expertise on cross-functional Project Teams
• Co-chair of Protocol Review Committee (ePPRC) and Dose Escalation Meetings (DEM) meetings for Phase 1 SAD/MAD studies
• Develop early clinical development plans that are innovative, safe, efficient and create a foundation for decision making
• Provide clinical and translational leadership to drive the design and interpretation of Phase 1-2a studies, in close collaboration with experts in Clinical Biomarkers, Clinical Pharmacology, Modeling & Simulation, and Clinical Operations
• Work with teams to ensure effective execution of Phase 1-2a studies
• Collaborate with Global Patient Safety to perform safety evaluations in early development programs
• Support exploratory biomarker efforts in collaboration with Clinical Biomarkers and Research groups to aid in clinical and project decision making
• Engage with external academic and industry partners in planning and executing strategy and clinical studies
• Engage with external scientific and medical experts to bring insight to development programs
• Work with colleagues across the research and clinical organizations to foster an end-to-end view of drug development, with a focus on improving patient care
• Serve as a people manager and mentor within the organization to young new-to-industry physicians
• Have financial accountabilities and human resource responsibilities for assigned staff

Knowledge and Skills:

• Global clinical research experience, and experience interacting with regulatory authorities is highly desired
• Ability to work collaboratively in a fast-paced, matrix environment
• Ability to work independently to resolve challenges
• Enterprise-wide thinking and ability to work in ambiguity
• Excellent oral and written communication skills
• Board certification/eligibility in a specialty is highly desired

Education and Experience:

• MD, DO or equivalent ex-US medical degree required + PhD (highly desired)
• 15+ years of translational medicine/translational research experience, including time managing clinical trials and clinical development programs
• Strong record of basic and/or translational research productivity
• Experience with design, execution, and analysis of Phase 1-2a, first-in-human and POM/POC clinical studies
• Experience across multiple therapeutic areas and modalities
• Effective at building alliances across functions
• Excellent interpersonal communication skills, able to drive collaborations across a matrixed organization
• People-management experience required

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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