Senior Principal Scientist, Clinical Research, Immunology
Merck
9 days ago
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Responsibilities:
- Strategically plan and direct clinical research activities for investigational compounds in Immunology (late-stage), including disease indication selection, study design, initiation, execution, monitoring, analysis, regulatory filings, and publication.
- Evaluate pre-clinical and translational work to create early clinical development plans and Investigational New Drug (IND) applications.
- Provide clinical development support for business development assessments of external opportunities to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings) accordingly.
- Monitor and manage ongoing and new clinical trials for investigational drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams relevant to new compound development.
- Supervise Clinical Scientists; partner cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Maintain scientific knowledge by staying current on new methodologies, identifying strong investigators, building external collaborations (Rheumatology, Gastroenterology, Dermatology, pulmonary disease), and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations; travel ~20% to manage clinical research projects.
Qualifications:
- MD, DO, MD/PhD, or DO/PhD.
- Phase 2/3 clinical trial design and/or execution experience in Immunology (Rheumatology, Gastroenterology, or Dermatology).
- 3+ years clinical medicine experience.
- 5+ years industry drug development experience.
- Demonstrated scientific scholarship and achievement.
- Strong interpersonal skills and ability to work collaboratively cross-functionally.
Required Skills:
Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development, Clinical Trials, Dermatology, Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance, Rheumatology.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Strategically plan and direct clinical research activities for investigational compounds in Immunology (late-stage), including disease indication selection, study design, initiation, execution, monitoring, analysis, regulatory filings, and publication.
- Evaluate pre-clinical and translational work to create early clinical development plans and Investigational New Drug (IND) applications.
- Provide clinical development support for business development assessments of external opportunities to grow the Immunology pipeline.
- Develop clinical development strategies and plan clinical trials (design, operational plans, settings) accordingly.
- Monitor and manage ongoing and new clinical trials for investigational drugs.
- Analyze and summarize clinical findings to support safety/efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams relevant to new compound development.
- Supervise Clinical Scientists; partner cross-functionally with commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Maintain scientific knowledge by staying current on new methodologies, identifying strong investigators, building external collaborations (Rheumatology, Gastroenterology, Dermatology, pulmonary disease), and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global external collaborations; travel ~20% to manage clinical research projects.
Qualifications:
- MD, DO, MD/PhD, or DO/PhD.
- Phase 2/3 clinical trial design and/or execution experience in Immunology (Rheumatology, Gastroenterology, or Dermatology).
- 3+ years clinical medicine experience.
- 5+ years industry drug development experience.
- Demonstrated scientific scholarship and achievement.
- Strong interpersonal skills and ability to work collaboratively cross-functionally.
Required Skills:
Clinical Development, Clinical Medicine, Clinical Research Management, Clinical Studies, Clinical Trial Development, Clinical Trials, Dermatology, Drug Development, Gastroenterology, Inflammatory Bowel Diseases, Pharmaceutical Industry, Regulatory Compliance, Rheumatology.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).