Associate Principal Scientist, Clinical Research
Merck
August 25, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS) – Translational Medicine
Responsibilities:
- Provide operational and scientific leadership for design, planning, and execution of early-phase clinical trials/programs with Clinical Director and cross-functional teams.
- Oversee and direct vaccine trial/program execution; manage cross-functional performance to meet objectives and resolve issues.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Perform clinical safety assessment/risk management; provide real-time oversight to identify/mitigate participant and study issues.
- Review and interpret clinical trial data; may support on-site monitoring and site training for novel endpoint/biomarker collection.
- Represent Early Stage Development; lead departmental job aids/SOPs and contribute to global clinical development procedures; identify/communicate best practices and coach/mentor junior staff.
- Technical writing: author/coordinate clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory/audit responses; develop WMA/CTD subsections; support publications and presentations.
- Project management: lead teams through study/program planning, issue escalation/mitigation, governance/advisory prep; manage projects with risk assessment and contingency planning.
Education/Experience Requirements:
- Degree in Life Sciences.
- Bachelor’s + ≥11 years related OR Master’s + ≥8 OR PhD/doctorate + ≥3 (clinical trial management/execution, site training/monitoring, medical/regulatory writing).
- At least 6 years Phase 1 OR 8 years Phase 2–3 trial experience.
Required Skills/Qualifications:
- Vaccine clinical program/trial development and milestone execution.
- Creative problem solving in ambiguity; independent regulatory judgment; rapid learning across therapeutic areas.
- Strong complex project management; cross-functional and culturally aware collaboration.
- Excellence in scientific/medical/safety writing and reporting; data-driven decision-making and escalation/mitigation planning.
- Partnering with external teams; written/oral communication.
- Working knowledge of GCP, ICH, regulatory requirements; mentor junior staff; lead/participate in cross-functional process improvement; courage and candor.
Preferred:
- Advanced degree desirable; global Phase 1, safety reporting, and NDA/WMA submission experience a plus.
Benefits (explicitly stated):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.
Responsibilities:
- Provide operational and scientific leadership for design, planning, and execution of early-phase clinical trials/programs with Clinical Director and cross-functional teams.
- Oversee and direct vaccine trial/program execution; manage cross-functional performance to meet objectives and resolve issues.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Perform clinical safety assessment/risk management; provide real-time oversight to identify/mitigate participant and study issues.
- Review and interpret clinical trial data; may support on-site monitoring and site training for novel endpoint/biomarker collection.
- Represent Early Stage Development; lead departmental job aids/SOPs and contribute to global clinical development procedures; identify/communicate best practices and coach/mentor junior staff.
- Technical writing: author/coordinate clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory/audit responses; develop WMA/CTD subsections; support publications and presentations.
- Project management: lead teams through study/program planning, issue escalation/mitigation, governance/advisory prep; manage projects with risk assessment and contingency planning.
Education/Experience Requirements:
- Degree in Life Sciences.
- Bachelor’s + ≥11 years related OR Master’s + ≥8 OR PhD/doctorate + ≥3 (clinical trial management/execution, site training/monitoring, medical/regulatory writing).
- At least 6 years Phase 1 OR 8 years Phase 2–3 trial experience.
Required Skills/Qualifications:
- Vaccine clinical program/trial development and milestone execution.
- Creative problem solving in ambiguity; independent regulatory judgment; rapid learning across therapeutic areas.
- Strong complex project management; cross-functional and culturally aware collaboration.
- Excellence in scientific/medical/safety writing and reporting; data-driven decision-making and escalation/mitigation planning.
- Partnering with external teams; written/oral communication.
- Working knowledge of GCP, ICH, regulatory requirements; mentor junior staff; lead/participate in cross-functional process improvement; courage and candor.
Preferred:
- Advanced degree desirable; global Phase 1, safety reporting, and NDA/WMA submission experience a plus.
Benefits (explicitly stated):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.