Clinical Development Associate Medical Director- gMG
Vertex Pharmaceuticals
5 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- Serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
- Provide oversight and accountability for the study, serving as the internal primary Medical Monitor responsible for monitoring the safety of enrolled subjects and ensuring scientific integrity.
- May participate in other projects to support the clinical development program.
Key Duties And Responsibilities:
- Participate in development of Study Protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents with minimal guidance.
- Serve on cross-functional Study Execution Teams (SET) for assigned trials to support efficient, high-quality execution.
- Prepare regulatory documents for submissions, including clinical sections of INDs/CTAs, IND safety reports and annual reports; respond to regulatory authorities and Ethics Committees/IRBs.
- Provide scientific/clinical input to study documents and analysis plans (e.g., informed consent forms, research forms, statistical analysis plans, clinical pharmacology analysis plans, clinical study reports).
- Liaise between Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies.
- Represent the company to outside medical personnel regarding protocols, study conduct, and external reporting of results.
Knowledge And Skills:
- Strong oral and written communication; collaborative in a fast-paced matrix environment; ability to work independently.
- Global clinical research experience and regulatory authority interaction (plus).
- Familiarity with research data analysis, biostatistics, pharmacology/pharmacokinetics, GCP, clinical study design, ethics committee/IRB review, manuscript/abstract/poster/oral presentation preparation, and drug/device clinical development.
- Board certification/eligibility and clinical training in a relevant medical specialty (highly desired).
Education And Experience:
- MD, DO, or equivalent ex-US medical degree.
- Typically 8 years of basic or clinical research experience in academic or industry settings (or equivalent education/experience).
- Serve as the Medical Lead for clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
- Provide oversight and accountability for the study, serving as the internal primary Medical Monitor responsible for monitoring the safety of enrolled subjects and ensuring scientific integrity.
- May participate in other projects to support the clinical development program.
Key Duties And Responsibilities:
- Participate in development of Study Protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents with minimal guidance.
- Serve on cross-functional Study Execution Teams (SET) for assigned trials to support efficient, high-quality execution.
- Prepare regulatory documents for submissions, including clinical sections of INDs/CTAs, IND safety reports and annual reports; respond to regulatory authorities and Ethics Committees/IRBs.
- Provide scientific/clinical input to study documents and analysis plans (e.g., informed consent forms, research forms, statistical analysis plans, clinical pharmacology analysis plans, clinical study reports).
- Liaise between Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies.
- Represent the company to outside medical personnel regarding protocols, study conduct, and external reporting of results.
Knowledge And Skills:
- Strong oral and written communication; collaborative in a fast-paced matrix environment; ability to work independently.
- Global clinical research experience and regulatory authority interaction (plus).
- Familiarity with research data analysis, biostatistics, pharmacology/pharmacokinetics, GCP, clinical study design, ethics committee/IRB review, manuscript/abstract/poster/oral presentation preparation, and drug/device clinical development.
- Board certification/eligibility and clinical training in a relevant medical specialty (highly desired).
Education And Experience:
- MD, DO, or equivalent ex-US medical degree.
- Typically 8 years of basic or clinical research experience in academic or industry settings (or equivalent education/experience).