Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology
Merck
13 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Clinical Director (Principal Scientist) responsibilities:
- Plan and direct clinical research activities in the Immunology therapeutic area across all phases (pre-clinical to post-licensure).
- Manage the full clinical development cycle for assigned studies: study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
- Plan clinical trials based on clinical development strategy.
- Provide medical oversight and ensure conduct of ongoing/new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions and deliverables such as new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams for new and marketed compounds.
- Support business development assessments of external opportunities.
- Engage with cross-functional teams (e.g., commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects; keep teams informed of study progress for company and competitor drugs.
- Provide internal/external expert scientific opinion within area of responsibility.
- Maintain scientific knowledge (methods, findings), identify strong investigators, build relationships with clinical investigators, and attend scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations.
- Travel ~20% to manage future/ongoing clinical research projects.
Education:
- M.D. or M.D./Ph.D.
Required experience/skills:
- Industry or senior faculty academia experience.
- 3+ years clinical medicine; 1+ year industry drug development or academic biomedical research.
- Demonstrated scientific scholarship; proven clinical medicine track record.
- Strong interpersonal skills and ability to work in teams.
- Provide expert opinion on relevant scientific questions.
Preferred:
- Board Certified/Eligible in Rheumatology (or related).
- Prior clinical research experience and prior publication.
Required skills (examples): Allergy and Immunology, Clinical Development, Clinical Documentation/Reporting, Clinical Research/Trial Planning/Support, Drug Development, Ethical Standards, Leadership, Regulatory Requirements, Rheumatology.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline stated on the posting. Requisition ID: R389093.
- Plan and direct clinical research activities in the Immunology therapeutic area across all phases (pre-clinical to post-licensure).
- Manage the full clinical development cycle for assigned studies: study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
- Plan clinical trials based on clinical development strategy.
- Provide medical oversight and ensure conduct of ongoing/new clinical trials for investigational or marketed drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions and deliverables such as new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams for new and marketed compounds.
- Support business development assessments of external opportunities.
- Engage with cross-functional teams (e.g., commercialization, regulatory affairs, statistics, manufacturing) to manage clinical development projects; keep teams informed of study progress for company and competitor drugs.
- Provide internal/external expert scientific opinion within area of responsibility.
- Maintain scientific knowledge (methods, findings), identify strong investigators, build relationships with clinical investigators, and attend scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations.
- Travel ~20% to manage future/ongoing clinical research projects.
Education:
- M.D. or M.D./Ph.D.
Required experience/skills:
- Industry or senior faculty academia experience.
- 3+ years clinical medicine; 1+ year industry drug development or academic biomedical research.
- Demonstrated scientific scholarship; proven clinical medicine track record.
- Strong interpersonal skills and ability to work in teams.
- Provide expert opinion on relevant scientific questions.
Preferred:
- Board Certified/Eligible in Rheumatology (or related).
- Prior clinical research experience and prior publication.
Required skills (examples): Allergy and Immunology, Clinical Development, Clinical Documentation/Reporting, Clinical Research/Trial Planning/Support, Drug Development, Ethical Standards, Leadership, Regulatory Requirements, Rheumatology.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline stated on the posting. Requisition ID: R389093.