Sr. Medical Director, Clinical Development-Type 1 Diabetes
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POST DATE 7/2/2020
END DATE 8/15/2020
Vertex Pharmaceuticals Inc (US)
JOB DESCRIPTIONIn June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat and even cure several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
Vertex/VCGT is searching for an experienced Sr. Medical Director to assist in managing assets in its development portfolio related to Type 1 Diabetes, and potentially other related VCGT disease areas. This is an excellent opportunity for a motivated drug developer to substantially shape the Endocrinology pipeline at VCGT. The Sr. Medical Director will provide medical and development leadership for cross-functional teams, and assist with the clinical development strategy, clinical trial strategy, design and execution, and serve as the Medical Lead and primary Medical Monitor for Type 1 Diabetes clinical trials.
* Provide medical and development leadership for cross-functional teams, including for external innovation/business development
* Prepare the clinical development plans, in conjunction with other relevant functional areas
* Serve as Medical Monitor for the assigned studies assessing issues related to protocol conduct and subject safety.
* Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
* Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
* Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
* Interface with regulatory authorities as appropriate
* Act as liaison between clinical development and other internal groups at Vertex/VCGT for assigned studies
* Represent Vertex/VCGT to outside medical personal in the development of clinical protocols and study conduct
* MD, or DO
* Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
* Global clinical research experience and experience interacting with regulatory authorities
* Represent Vertex/VCGT to outside stakeholders, including patient advocacy groups
* Board certification/eligibility in endocrinology, or another relevant specialty area, is highly desired.
* Clinical development and/or clinical experience in rare disease, cell therapy, transplantation, medical devices.