Clinical Development Associate Medical Director-Nephrology
Vertex Pharmaceuticals
August 24, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- Serve as Medical Lead for clinical trials; oversee study safety/subject monitoring and scientific integrity as internal primary Medical Monitor. May support other clinical development projects.
Key Duties and Responsibilities:
- Develop study protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents.
- Serve on cross-functional Study Execution Teams (SET) to ensure efficient, high-quality study execution.
- Support regulatory submissions (e.g., IND/CTA clinical sections, IND safety/annual reports), and respond to regulators/Ethics Committees/IRBs.
- Provide scientific/clinical input to informed consent forms, clinical research forms, analysis/statistical plans, clinical pharmacology plans, and clinical study reports.
- Liaison between Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Development Execution).
- Represent the company to external medical personnel in protocol development, study conduct, and external reporting.
- Perform other assigned Clinical Development duties.
Knowledge and Skills (Required/Preferred):
- Strong oral and written communication; collaborative matrix work; independent function as appropriate.
- Global clinical research and regulatory interaction experience (plus).
- Familiarity with research data, biostatistics, pharmacology/PK, GCP, study design, ethics committee/IRB review, and preparation/presentation of manuscripts/abstracts/posters.
- Board certification/eligibility and clinical training in relevant specialty (highly desired).
Education and Experience:
- MD, DO or equivalent ex-US medical degree.
- Typically 8 years basic or clinical research experience (academic or industry) or equivalent.
Compensation:
- Pay range: $204,000 - $306,000; eligible for annual bonus and annual equity awards.
- Serve as Medical Lead for clinical trials; oversee study safety/subject monitoring and scientific integrity as internal primary Medical Monitor. May support other clinical development projects.
Key Duties and Responsibilities:
- Develop study protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents.
- Serve on cross-functional Study Execution Teams (SET) to ensure efficient, high-quality study execution.
- Support regulatory submissions (e.g., IND/CTA clinical sections, IND safety/annual reports), and respond to regulators/Ethics Committees/IRBs.
- Provide scientific/clinical input to informed consent forms, clinical research forms, analysis/statistical plans, clinical pharmacology plans, and clinical study reports.
- Liaison between Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Development Execution).
- Represent the company to external medical personnel in protocol development, study conduct, and external reporting.
- Perform other assigned Clinical Development duties.
Knowledge and Skills (Required/Preferred):
- Strong oral and written communication; collaborative matrix work; independent function as appropriate.
- Global clinical research and regulatory interaction experience (plus).
- Familiarity with research data, biostatistics, pharmacology/PK, GCP, study design, ethics committee/IRB review, and preparation/presentation of manuscripts/abstracts/posters.
- Board certification/eligibility and clinical training in relevant specialty (highly desired).
Education and Experience:
- MD, DO or equivalent ex-US medical degree.
- Typically 8 years basic or clinical research experience (academic or industry) or equivalent.
Compensation:
- Pay range: $204,000 - $306,000; eligible for annual bonus and annual equity awards.