The successful candidate will be a strategically minded, hands-on translational medicine and early clinical development expert with the responsibility for transitioning projects from research into clinic development, and for the translational and early clinical development strategy for specific diseases of the nervous system, respiratory system, kidney and blood. 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 Research, Preclinical and Pharmaceutical Sciences, and Global Medicines Development and Medical Affairs.
The Associate Director/Director will:
- Work closely with other functional experts across the organization
- Provide medical leadership and translational medicine expertise on cross-functional Project Teams
- Develop early clinical development plans that are innovative, safe and create a foundation for decision making
- Be responsible for Phase 0, First-in-Human, Proof-of-Mechanism and Phase 1 studies throughout development, including validation of innovative clinical biomarkers to support decision making
This position will be a critical element in Vertex s approach to create an effective bridge between discovery research and clinical development.
- Provide clinical and translational leadership to drive the design and interpretation of Phase 0-2a studies, in close collaboration with experts in Clinical Pharmacology, Clinical Biomarkers, Biostatistics, Modeling & Simulation, and Clinical Operations
- Work with teams to ensure effective execution of Phase 0-2a studies within the portfolio
- Responsible in collaboration with Global Patient Safety for safety evaluation in early development programs
- Support exploratory biomarker efforts to aid in clinical and project decision making
- Provide clear and timely communication and interpretation of study results to department and organizational governance, functional area experts and development review committees
- 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
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
- MD or MD/PhD required
- Strong record of basic and/or translational research productivity required
- Board certified or eligible in a medical or pediatric subspecialty preferred
- Early clinical development experience in an industry setting preferred
- Experience with design, execution, and analysis of Phase 0-2a clinical studies preferred
- Effective at building alliances across functions, based on end-to-end drug development thinking and experience
- Excellent interpersonal communication skills, able to drive collaborations across a matrixed organization
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