Associate Principal Scientist, Clinical Research
Merck
August 25, 2026
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS)
Responsibilities
- Provide operational and scientific leadership for the design, planning, and execution of early-phase clinical trials and programs with the Clinical Director and cross-functional teams.
- Oversee vaccine trials/program execution; manage cross-functional performance to meet trial objectives and address issues.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; provide real-time oversight to identify/mitigate participant, study design, data, or conduct issues.
- Review and interpret clinical trial data; may support on-site monitoring and site training for complex endpoint/biomarker collection.
- Represent Early Stage Development on early/product development teams; lead departmental job aids/SOPs and global procedure development.
- Drive best practices, adoption of new procedures, and junior team coaching/mentoring.
- Author/coordinate clinical and regulatory documents: protocols, investigator brochures, clinical study reports, health authority updates, responses to regulators, and audit/inspection responses; develop WMA/CTD subsections.
- Develop study operational documents (e.g., site monitoring plans, operations/lab manuals, risk language, informed consents).
- Lead teams through study planning/execution activities (program overviews, issue escalation/mitigation, governance, advisory meeting prep) and manage timelines with risk/contingency planning.
Education/Experience Requirements
- Degree in Life Sciences.
- Bachelor’s +11 years OR Master’s +8 years OR PhD/doctorate +3 years (clinical trial management/execution; clinical site training/monitoring; medical/regulatory writing).
- At least 6 years Phase 1 OR at least 8 years Phase 2–3 clinical trial experience.
- Vaccine clinical program/trial experience; strong GCP/ICH/regulatory knowledge.
Skills/Qualifications (Required)
- Creative, results-driven approach; navigate ambiguity.
- Independent judgment on regulations/guidelines and investigator interactions.
- Ability to quickly build therapeutic-area knowledge; excellent complex project management.
- Excellence in scientific/medical/safety writing and reporting.
- Data-driven decision-making; proactively identify/escalate/mitigate issues.
- Strong communication (written/oral), analytical/problem-solving skills; mentor junior staff.
Preferred
- Advanced degree desirable; global Phase 1 trials, safety reporting, and NDA/WMA submission experience a plus.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
Responsibilities
- Provide operational and scientific leadership for the design, planning, and execution of early-phase clinical trials and programs with the Clinical Director and cross-functional teams.
- Oversee vaccine trials/program execution; manage cross-functional performance to meet trial objectives and address issues.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; provide real-time oversight to identify/mitigate participant, study design, data, or conduct issues.
- Review and interpret clinical trial data; may support on-site monitoring and site training for complex endpoint/biomarker collection.
- Represent Early Stage Development on early/product development teams; lead departmental job aids/SOPs and global procedure development.
- Drive best practices, adoption of new procedures, and junior team coaching/mentoring.
- Author/coordinate clinical and regulatory documents: protocols, investigator brochures, clinical study reports, health authority updates, responses to regulators, and audit/inspection responses; develop WMA/CTD subsections.
- Develop study operational documents (e.g., site monitoring plans, operations/lab manuals, risk language, informed consents).
- Lead teams through study planning/execution activities (program overviews, issue escalation/mitigation, governance, advisory meeting prep) and manage timelines with risk/contingency planning.
Education/Experience Requirements
- Degree in Life Sciences.
- Bachelor’s +11 years OR Master’s +8 years OR PhD/doctorate +3 years (clinical trial management/execution; clinical site training/monitoring; medical/regulatory writing).
- At least 6 years Phase 1 OR at least 8 years Phase 2–3 clinical trial experience.
- Vaccine clinical program/trial experience; strong GCP/ICH/regulatory knowledge.
Skills/Qualifications (Required)
- Creative, results-driven approach; navigate ambiguity.
- Independent judgment on regulations/guidelines and investigator interactions.
- Ability to quickly build therapeutic-area knowledge; excellent complex project management.
- Excellence in scientific/medical/safety writing and reporting.
- Data-driven decision-making; proactively identify/escalate/mitigate issues.
- Strong communication (written/oral), analytical/problem-solving skills; mentor junior staff.
Preferred
- Advanced degree desirable; global Phase 1 trials, safety reporting, and NDA/WMA submission experience a plus.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.