Senior Principal Scientist, Clinical Research, Immunology - Ophthalmology
Merck
13 days ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Senior Director (Sr. Principal Scientist)
Responsibilities:
- Strategically plan and direct clinical research for investigational Immunology compounds through the full clinical development cycle (indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication).
- Evaluate pre-clinical/translational work to develop early clinical plans and IND applications.
- Support business development assessments to expand 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 support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and external research project teams.
- Supervise Clinical Scientists; collaborate with commercialization, regulatory, statistics, and manufacturing teams.
- Maintain scientific expertise by tracking new methods/findings, identifying investigators, building external collaborations (e.g., rheumatology, gastroenterology, dermatology, pulmonary, rare diseases), and attending scientific meetings.
- Author development documents/budgets; facilitate global collaborations; travel ~20%.
Qualifications:
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience: phase 2/3 Immunology clinical trials (design/execution); 3+ years clinical medicine; 5+ years industry drug development; demonstrated scientific scholarship.
Required/Preferred 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, Scientific Consulting, Strategic Planning, Hiring, Rare Diseases.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline listed on posting; Requisition ID: R389095.
Responsibilities:
- Strategically plan and direct clinical research for investigational Immunology compounds through the full clinical development cycle (indication selection, study design, initiation, execution, monitoring, analysis, regulatory filing, and publication).
- Evaluate pre-clinical/translational work to develop early clinical plans and IND applications.
- Support business development assessments to expand 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 support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and external research project teams.
- Supervise Clinical Scientists; collaborate with commercialization, regulatory, statistics, and manufacturing teams.
- Maintain scientific expertise by tracking new methods/findings, identifying investigators, building external collaborations (e.g., rheumatology, gastroenterology, dermatology, pulmonary, rare diseases), and attending scientific meetings.
- Author development documents/budgets; facilitate global collaborations; travel ~20%.
Qualifications:
- Education: M.D., D.O., M.D./Ph.D, or D.O./PhD.
- Experience: phase 2/3 Immunology clinical trials (design/execution); 3+ years clinical medicine; 5+ years industry drug development; demonstrated scientific scholarship.
Required/Preferred 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, Scientific Consulting, Strategic Planning, Hiring, Rare Diseases.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline listed on posting; Requisition ID: R389095.