- Provide input into study protocols, investigator brochures, and other study related documents in conjunction with other line function
- Serve on the cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution
- Participation in the preparation of regulatory documents in support of regulatory submissions, including the clinical section of IND's/NDA's and CTA's, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and ethics committees/IRBs, and other documents, as appropriate
- Provide scientific and clinical input to study-related documents and analysis plans, including informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR)
- Liaison between Clinical Development and other internal groups within Vertex (e.g., Regulatory Affairs and Clinical Development Execution) for assigned studies, as well as represent Vertex to outside medical personal in the development of clinical protocols and study conduct
- Perform other duties, as assigned, related to pain clinical programs.
- MD, DO or the international equivalent
- Board certification/eligibility in anesthesiology, surgery (surgical subspecialty) neurology, psychiatry, internal medicine or another relevant medical field is highly desired; clinical development/experience in neuropathic pain is a plus
- Minimum of 3 years of basic or clinical research experience in an academic or industrial setting designing and executing clinical trials and working with cross-functional teams with experience in analysis of research data and publications scientific
- Ability to work collaboratively in a fast-paced, team-based, matrixed environment and to function independently, as appropriate
- Utilize novel and creative methods to independently resolve clinical development problems
- Working knowledge of GCP, biostatistics, data management, clinical operations and clinical pharmacokinetics to support trial design and execution
- Experience in analysis of research data and publications
- Excellent verbal and written communication skills
- A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
- Ability to travel (25%) to support program activities as needed
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Clinical Development, Associate Medical Director, Pain - Boston, United States - Vertex Pharmaceuticals, Inc
Description
Job DescriptionGeneral Summary:
Vertex Pharmaceuticals is searching for an Associate Medical Director who will be assigned to clinical trials within the Pain Program.
You will work as part of multidisciplinary cross-functional study teams on clinical trial design and execution and serving as the primary or back-up Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials.
You will work on multiple clinical trials and may also participate in selected projects in the Pain clinical development program.
Key Duties and Responsibilities:
Education and Experience:
Hybrid:
work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid#LI-BS1
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.
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
