Clinical Development Medical Director- Pain
Vertex Pharmaceuticals
4 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.
Key Duties And Responsibilities:
- Lead the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents with minimal guidance.
- Serve on cross-functional Study Execution Teams (SET) for assigned trials to achieve efficient, high-quality study execution.
- Participate in preparation of regulatory documents (e.g., IND/CTA clinical sections, safety and annual reports, regulatory authority and Ethics Committee/IRB responses).
- Provide scientific/clinical input to study documents and analysis plans (ICF, CRF, SAP, CPAP, CSR); act as liaison between Translational Medicine/Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Operations).
- Represent Vertex to outside medical professionals in development of clinical protocols and study conduct.
- Perform other duties as assigned.
Knowledge And Skills:
- Excellent oral and written communication.
- Collaborative in fast-paced, matrix environment; function independently as appropriate.
- Build alliances across functions using end-to-end drug development thinking.
- Board certification/eligibility in a medical, pediatric or surgical subspecialty.
Education And Experience:
- MD, DO or equivalent ex-US medical degree.
- Board certification/eligibility in a specialty field highly desired.
- Typically 10 years of basic or clinical research experience (academic or industrial) or equivalent combination.
- Experience analyzing research data/publications; working knowledge of biostatistics, GCP, scientific/clinical research methods, and clinical study design.
Pay Range:
- $240,000 - $360,000
The Clinical Development Medical Director will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.
Key Duties And Responsibilities:
- Lead the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents with minimal guidance.
- Serve on cross-functional Study Execution Teams (SET) for assigned trials to achieve efficient, high-quality study execution.
- Participate in preparation of regulatory documents (e.g., IND/CTA clinical sections, safety and annual reports, regulatory authority and Ethics Committee/IRB responses).
- Provide scientific/clinical input to study documents and analysis plans (ICF, CRF, SAP, CPAP, CSR); act as liaison between Translational Medicine/Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Operations).
- Represent Vertex to outside medical professionals in development of clinical protocols and study conduct.
- Perform other duties as assigned.
Knowledge And Skills:
- Excellent oral and written communication.
- Collaborative in fast-paced, matrix environment; function independently as appropriate.
- Build alliances across functions using end-to-end drug development thinking.
- Board certification/eligibility in a medical, pediatric or surgical subspecialty.
Education And Experience:
- MD, DO or equivalent ex-US medical degree.
- Board certification/eligibility in a specialty field highly desired.
- Typically 10 years of basic or clinical research experience (academic or industrial) or equivalent combination.
- Experience analyzing research data/publications; working knowledge of biostatistics, GCP, scientific/clinical research methods, and clinical study design.
Pay Range:
- $240,000 - $360,000