Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology
Merck
12 days ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Senior Director (Sr. Principal Scientist) – Immunology
Responsibilities
- Lead strategic planning and direction of clinical research for investigational compounds in Immunology, including late-stage development.
- Manage the full clinical development cycle: choose disease indications, design studies, initiate, execute, monitor, analyze, support regulatory filings, and publication.
- Evaluate pre-clinical/translational work to create early clinical development plans and IND applications.
- Support business development assessments to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage conduct of ongoing or new clinical trials.
- Analyze/summarize clinical findings to support safety/efficacy decisions, regulatory submissions, clinical study reports, and publications.
- Participate in internal and joint internal/external research teams for new compound development.
- Supervise Clinical Scientists; collaborate cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing.
- Build scientific knowledge via scientific awareness, identifying investigators, and establishing collaborations; attend scientific meetings.
- Author development documents/budgets and facilitate global external collaborations; travel ~20% to support clinical projects.
Qualifications
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience/skills: Phase 2/3 Immunology trial design and/or execution; 3+ years clinical medicine; 5+ years industry drug development; demonstrated scientific scholarship; strong interpersonal and cross-functional collaboration.
Required skills: 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
Preferred
- Current employees/contingent workers apply via links in posting.
Application
- Apply at https://jobs.merck.com/us/en (deadline shown on posting).
Responsibilities
- Lead strategic planning and direction of clinical research for investigational compounds in Immunology, including late-stage development.
- Manage the full clinical development cycle: choose disease indications, design studies, initiate, execute, monitor, analyze, support regulatory filings, and publication.
- Evaluate pre-clinical/translational work to create early clinical development plans and IND applications.
- Support business development assessments to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings).
- Monitor and manage conduct of ongoing or new clinical trials.
- Analyze/summarize clinical findings to support safety/efficacy decisions, regulatory submissions, clinical study reports, and publications.
- Participate in internal and joint internal/external research teams for new compound development.
- Supervise Clinical Scientists; collaborate cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing.
- Build scientific knowledge via scientific awareness, identifying investigators, and establishing collaborations; attend scientific meetings.
- Author development documents/budgets and facilitate global external collaborations; travel ~20% to support clinical projects.
Qualifications
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience/skills: Phase 2/3 Immunology trial design and/or execution; 3+ years clinical medicine; 5+ years industry drug development; demonstrated scientific scholarship; strong interpersonal and cross-functional collaboration.
Required skills: 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
Preferred
- Current employees/contingent workers apply via links in posting.
Application
- Apply at https://jobs.merck.com/us/en (deadline shown on posting).