Associate Principal Scientist, Clinical Research
Merck
August 25, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS) – Responsibilities:
- Provide operational and scientific leadership for early-phase clinical trials and programs with the Clinical Director and cross-functional teams.
- Oversee, strategically direct, and execute vaccine trials/programs; manage cross-functional team performance to achieve objectives.
- Ensure trial execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Provide real-time trial oversight, clinical safety assessment, and risk management; identify/mitigate participant, study design, data, and conduct issues.
- Review/interpret clinical trial data; may participate in on-site monitoring, including site training for complex endpoint/biomarker collection.
- Lead development of departmental job aids/SOPs; contribute to global clinical development procedures; share best practices and coach/mentor junior staff.
Technical Writing & Communications:
- Author clinical protocols, investigator brochures, clinical study reports, health authority updates, and regulatory/audit responses.
- Coordinate WMA/CTD subsections; develop operational documents (monitoring plans, manuals, risk language, informed consents).
Project Management:
- Lead teams through study planning, development, execution, issue escalation/mitigation, governance, and advisory preparation; manage risk and 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, site training/monitoring, medical/regulatory writing).
- At least 6 years Phase 1 OR 8 years Phase 2–3 clinical trial experience.
- Vaccine program/trial experience; working knowledge of GCP/ICH/regulatory requirements.
Required Skills:
- Vaccine program execution; independent judgment on regulations/investigators; data-driven decision-making; complex problem-solving; scientific/medical safety writing; strong communication; mentoring; cross-functional leadership.
Preferred:
- Advanced degree; global Phase 1 trials, safety reporting, and NDA/WMA submission experience.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Provide operational and scientific leadership for early-phase clinical trials and programs with the Clinical Director and cross-functional teams.
- Oversee, strategically direct, and execute vaccine trials/programs; manage cross-functional team performance to achieve objectives.
- Ensure trial execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Provide real-time trial oversight, clinical safety assessment, and risk management; identify/mitigate participant, study design, data, and conduct issues.
- Review/interpret clinical trial data; may participate in on-site monitoring, including site training for complex endpoint/biomarker collection.
- Lead development of departmental job aids/SOPs; contribute to global clinical development procedures; share best practices and coach/mentor junior staff.
Technical Writing & Communications:
- Author clinical protocols, investigator brochures, clinical study reports, health authority updates, and regulatory/audit responses.
- Coordinate WMA/CTD subsections; develop operational documents (monitoring plans, manuals, risk language, informed consents).
Project Management:
- Lead teams through study planning, development, execution, issue escalation/mitigation, governance, and advisory preparation; manage risk and 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, site training/monitoring, medical/regulatory writing).
- At least 6 years Phase 1 OR 8 years Phase 2–3 clinical trial experience.
- Vaccine program/trial experience; working knowledge of GCP/ICH/regulatory requirements.
Required Skills:
- Vaccine program execution; independent judgment on regulations/investigators; data-driven decision-making; complex problem-solving; scientific/medical safety writing; strong communication; mentoring; cross-functional leadership.
Preferred:
- Advanced degree; global Phase 1 trials, safety reporting, and NDA/WMA submission experience.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).