Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology
Merck
13 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Senior Director (Sr. Principal Scientist) – Immunology clinical research.
Responsibilities:
- Lead strategic planning and direction of clinical research for investigational immunology compounds, managing the full clinical development cycle (indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication).
- Evaluate pre-clinical/translational work to create early clinical plans and IND strategies.
- Support business development assessments for external opportunities to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage ongoing/new clinical trials.
- Analyze/summarize clinical findings to inform safety/efficacy decisions and support regulatory submissions, clinical study reports, and publications.
- Participate in internal and external research project teams.
- Supervise Clinical Scientists; work cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing.
- Maintain scientific knowledge by tracking new methodologies/findings, identifying strong investigators, building external collaborations, and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20%.
Qualifications:
- M.D., D.O., M.D./Ph.D., or D.O./PhD.
- Experience designing and/or executing Phase 2 or 3 immunology trials.
- 3+ years clinical medicine; 5+ years industry drug development.
- Demonstrated scientific scholarship; strong interpersonal skills and cross-functional collaboration.
Skills (Required): Clinical Development, Clinical Documentation, Clinical Immunology, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Sciences, Clinical Studies, Clinical Trial Development, Data Analysis, Drug Development, Hiring, Ophthalmology, Rare Diseases, Scientific Consulting, Strategic Planning.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R389095.
Responsibilities:
- Lead strategic planning and direction of clinical research for investigational immunology compounds, managing the full clinical development cycle (indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication).
- Evaluate pre-clinical/translational work to create early clinical plans and IND strategies.
- Support business development assessments for external opportunities to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage ongoing/new clinical trials.
- Analyze/summarize clinical findings to inform safety/efficacy decisions and support regulatory submissions, clinical study reports, and publications.
- Participate in internal and external research project teams.
- Supervise Clinical Scientists; work cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing.
- Maintain scientific knowledge by tracking new methodologies/findings, identifying strong investigators, building external collaborations, and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20%.
Qualifications:
- M.D., D.O., M.D./Ph.D., or D.O./PhD.
- Experience designing and/or executing Phase 2 or 3 immunology trials.
- 3+ years clinical medicine; 5+ years industry drug development.
- Demonstrated scientific scholarship; strong interpersonal skills and cross-functional collaboration.
Skills (Required): Clinical Development, Clinical Documentation, Clinical Immunology, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Sciences, Clinical Studies, Clinical Trial Development, Data Analysis, Drug Development, Hiring, Ophthalmology, Rare Diseases, Scientific Consulting, Strategic Planning.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R389095.