Senior Principal Scientist (Senior Director), Clinical Research, GI Oncology
Merck
13 hours ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Senior Director (Sr. Principal Scientist) – Oncology Clinical Development
Responsibilities
- Plan and direct clinical research activities involving new or marketed Oncology medicines across all phases of clinical development (pre-clinical to post-licensure).
- Manage the full clinical development cycle, including study design, placement, monitoring, analysis, regulatory reporting, and publication.
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
- Develop clinical development strategies for investigational or marketed Oncology drugs.
- Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
- Monitor and manage conduct of ongoing or new clinical trials.
- Analyze and summarize clinical findings to support safety/efficacy decisions and support new drug applications, clinical study reports, or publications.
- Participate in internal and joint internal/external research project teams relevant to development of new compounds and further study of marketed compounds.
- Lead cross-functional teams (including Clinical Scientists) from drafting protocols to ensuring protocol adherence and data completeness/integrity, and interpreting aggregate data.
- Coordinate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Support the Executive Director by keeping corporate personnel informed of study progress and engaging internal/external experts on scientific questions.
- Maintain scientific knowledge through awareness of scientific developments, identifying strong investigators, establishing communications, and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20% to manage clinical research projects.
Qualifications
- M.D. or M.D./Ph.D.
- Minimum 3 years of clinical medicine experience in adult or pediatric oncology and/or hematology.
- Minimum 1 year of drug-development/pharmaceutical industry experience or biomedical research experience in academia/fellowship.
- Demonstrated record of scientific scholarship and achievement.
- Strong interpersonal and communication skills; ability to function in a large cross-functional team environment.
Preferred
- Completion of an ACGME-medical oncology, combined medical oncology/hematology, or pediatric hematology fellowship.
- Board Certified in adult or pediatric oncology (and/or hematology).
- Track record in clinical academic medicine focused on adult GI medical oncology with academic publication experience.
Required Skills
Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Reporting, Clinical Studies, Clinical Trial Development, Clinical Trials, Drug Development, Gastrointestinal Oncology, Medical Monitoring, Medical Research, Oncology, Oncology Trials, Regulatory Affairs Compliance, Research Methodologies.
Application Instructions
- Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub for current employees). Application deadline is stated on the posting (Job posting end date: 05/14/2026).
Responsibilities
- Plan and direct clinical research activities involving new or marketed Oncology medicines across all phases of clinical development (pre-clinical to post-licensure).
- Manage the full clinical development cycle, including study design, placement, monitoring, analysis, regulatory reporting, and publication.
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug (IND) applications.
- Develop clinical development strategies for investigational or marketed Oncology drugs.
- Plan clinical trials (design, operational plans, settings) based on clinical development strategies.
- Monitor and manage conduct of ongoing or new clinical trials.
- Analyze and summarize clinical findings to support safety/efficacy decisions and support new drug applications, clinical study reports, or publications.
- Participate in internal and joint internal/external research project teams relevant to development of new compounds and further study of marketed compounds.
- Lead cross-functional teams (including Clinical Scientists) from drafting protocols to ensuring protocol adherence and data completeness/integrity, and interpreting aggregate data.
- Coordinate with experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Support the Executive Director by keeping corporate personnel informed of study progress and engaging internal/external experts on scientific questions.
- Maintain scientific knowledge through awareness of scientific developments, identifying strong investigators, establishing communications, and attending scientific meetings.
- Author development documents, presentations, budgets, and position papers; facilitate global collaborations; travel ~20% to manage clinical research projects.
Qualifications
- M.D. or M.D./Ph.D.
- Minimum 3 years of clinical medicine experience in adult or pediatric oncology and/or hematology.
- Minimum 1 year of drug-development/pharmaceutical industry experience or biomedical research experience in academia/fellowship.
- Demonstrated record of scientific scholarship and achievement.
- Strong interpersonal and communication skills; ability to function in a large cross-functional team environment.
Preferred
- Completion of an ACGME-medical oncology, combined medical oncology/hematology, or pediatric hematology fellowship.
- Board Certified in adult or pediatric oncology (and/or hematology).
- Track record in clinical academic medicine focused on adult GI medical oncology with academic publication experience.
Required Skills
Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Reporting, Clinical Studies, Clinical Trial Development, Clinical Trials, Drug Development, Gastrointestinal Oncology, Medical Monitoring, Medical Research, Oncology, Oncology Trials, Regulatory Affairs Compliance, Research Methodologies.
Application Instructions
- Apply through https://jobs.merck.com/us/en (or via the Workday Jobs Hub for current employees). Application deadline is stated on the posting (Job posting end date: 05/14/2026).