Associate Principal Scientist, Clinical Research
Merck
June 24, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS)
Responsibilities
- Provide operational and scientific leadership for design, planning, and execution of early-phase clinical trials/programs (Immunology programs; multiple Phase 1 and 1b trials).
- Ensure trial execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; provide real-time trial oversight to mitigate participant, study design, data, and conduct issues.
- Review/interpret clinical trial data; may support on-site monitoring, including site training for novel endpoint/biomarker collection.
- Lead development of departmental job aids/SOPs; support global clinical development procedure teams; identify/broadcast best practices; coach/mentor junior staff.
- Technical writing: author clinical protocols, investigator brochures, clinical study reports, health authority updates, regulatory/audit responses; coordinate WMA/CTD subsections; develop study operational documents (monitoring plans, manuals, risk language, informed consents).
- Project management: lead teams for study/program planning, issue escalation/mitigation, governance/advisory prep, risk assessments, and contingency planning.
Qualifications
- Education: Degree in Life Sciences; BS + ≥11 yrs OR MS + ≥8 yrs OR PhD/doctorate + ≥3 yrs (clinical trial management/execution, site training/monitoring, medical & regulatory writing).
Required Experience/Skills
- ≥6 yrs early phase/translational medicine clinical research.
- Immunology clinical program/trial experience, including early patient trials (e.g., Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
- Working knowledge of GCP/ICH/regulatory requirements; strong scientific/medical/safety writing and reporting; complex project management; data-driven independent judgment; effective communication; mentor junior staff.
Preferred
- Advanced degree; global Phase 1 safety reporting and NDA/WMA submission experience.
Benefits / Compensation (if applicable)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate & sick days).
- Salary range: $142,400–$224,100.
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: as stated on the posting.
Responsibilities
- Provide operational and scientific leadership for design, planning, and execution of early-phase clinical trials/programs (Immunology programs; multiple Phase 1 and 1b trials).
- Ensure trial execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; provide real-time trial oversight to mitigate participant, study design, data, and conduct issues.
- Review/interpret clinical trial data; may support on-site monitoring, including site training for novel endpoint/biomarker collection.
- Lead development of departmental job aids/SOPs; support global clinical development procedure teams; identify/broadcast best practices; coach/mentor junior staff.
- Technical writing: author clinical protocols, investigator brochures, clinical study reports, health authority updates, regulatory/audit responses; coordinate WMA/CTD subsections; develop study operational documents (monitoring plans, manuals, risk language, informed consents).
- Project management: lead teams for study/program planning, issue escalation/mitigation, governance/advisory prep, risk assessments, and contingency planning.
Qualifications
- Education: Degree in Life Sciences; BS + ≥11 yrs OR MS + ≥8 yrs OR PhD/doctorate + ≥3 yrs (clinical trial management/execution, site training/monitoring, medical & regulatory writing).
Required Experience/Skills
- ≥6 yrs early phase/translational medicine clinical research.
- Immunology clinical program/trial experience, including early patient trials (e.g., Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
- Working knowledge of GCP/ICH/regulatory requirements; strong scientific/medical/safety writing and reporting; complex project management; data-driven independent judgment; effective communication; mentor junior staff.
Preferred
- Advanced degree; global Phase 1 safety reporting and NDA/WMA submission experience.
Benefits / Compensation (if applicable)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits (medical/dental/vision, retirement/401(k), paid holidays/vacation, compassionate & sick days).
- Salary range: $142,400–$224,100.
Application
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Deadline: as stated on the posting.