Senior Medical Director - ReqCode 4014BR
Vertex - Cambridge, MA
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Vertex Pharmaceuticals is currently searching for a Senior Medical Director to join the Cystic Fibrosis Clinical Development team to assist with the advancement of several programs currently in the drug development process.
The Senior Medical Director serves as Medical Monitor for Clinical Trials, ensuring compliance with GCP regulations and monitoring the safety of enrolled subjects. Generally works on multiple trials or more than one program at a time comprised primarily of Phase I, Phase II, or Phase III studies. In this position you provide program level clinical support across multiple programs. Depending on experience level, the Senior Medical Director could potentially oversee development strategy for any one of our exciting compound(s), align with the broader strategy and needs.
- Develops Clinical Protocols, Investigator's Brochures and clinical development plans (in coordination with Clinical Program Manager) with emphasis on scientific and safety matters, with minimal guidance
- Represents Vertex to outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums
- Serves on the Clinical Sub-Team and represents Clinical Development on Core Teams
- Acts as Program physician and assumes responsibility for scientific and clinical aspects of Program including in depth data review
- Provides Clinical Development input to the Development Core Team
- Participates in the preparation of regulatory documents including IND safety reports and annual reports and the clinical section of IND's and CTA's; provides scientific and clinical input and content review
- Utilizes novel and creative methods to resolve clinical development problems independently
- Acts as liaison between clinical development department and internal regulatory affairs for assigned programs
- Interacts with regulatory agencies as needed on issues of relatively limited space or complexity
- Manages 1-2 Associate Directors on Cystic Fibrosis Clinical Development team
- Mentors Clinical Program Managers as needed
- M.D., D.O, or ex-US medical degree, and 4-7 years of Pharmaceutical or Biotech experience in clinical development.
- 5-8 year's academic clinical research experience Board certified in Internal Medicine, Pulmonary, Immunology
- Working knowledge of biostatistics, clinical pharmacology and pharmacokinetics
- Complete understanding of the drug development process
- Subspecialty training Internal Medicine, Pulmonary, Immunology
- Excellent oral and written communication skills
- Abreast of all regulatory updates and changes and disseminates information effectively and appropriately. ... To view the rest of this job posting or to apply for this position please click the APPLY NOW button