Associate Principal Scientist, Clinical Research
Merck
June 24, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS)
Responsibilities
- Provide operational and scientific leadership for early-phase (Phase 1/1b) clinical trial design, planning, and execution across Immunology programs.
- Oversee strategic direction/execution of Immunology programs; manage cross-functional teams to achieve trial objectives.
- Ensure GCP/ICH and regulatory compliance; deliver high-quality data.
- Oversee clinical safety assessment and risk management; monitor trials in real time and mitigate participant, design, data, or conduct issues.
- Review/interpret trial data; may support on-site monitoring and supervise novel endpoint/biomarker collection.
- Lead development of job aids/SOPs and support global clinical development procedures; communicate best practices; coach/mentor junior staff.
- Author technical/regulatory documents (protocols, investigator brochures, clinical study reports, health authority updates, regulatory responses) and coordinate WMA/CTD sections; develop operational documents (site monitoring plans, manuals, risk language, informed consents).
- Lead study/program planning and execution activities (governance, escalation/mitigation, presentations) with risk assessments and contingency planning.
Education/Qualifications
- Degree in Life Sciences: Bachelor’s + ≥11 years, OR Master’s + ≥8 years, OR PhD/doctorate + ≥3 years (e.g., trial management/execution, site training/monitoring, medical/regulatory writing).
- Required: ≥6 years early phase/translational medicine clinical research; immunology early patient trial/program experience (e.g., Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
Skills (Required)
- GCP/ICH/regulatory knowledge; scientific/medical safety writing and reporting; clinical risk management; clinical study design/trials operations; biomarker/immunogenicity assays; strong project management, communication, analytical/problem-solving, independent judgment, and mentoring.
Preferred
- Advanced degree; global Phase 1 patient trials, safety reporting, and NDA/WMA submission experience.
Benefits
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid time off, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).
Responsibilities
- Provide operational and scientific leadership for early-phase (Phase 1/1b) clinical trial design, planning, and execution across Immunology programs.
- Oversee strategic direction/execution of Immunology programs; manage cross-functional teams to achieve trial objectives.
- Ensure GCP/ICH and regulatory compliance; deliver high-quality data.
- Oversee clinical safety assessment and risk management; monitor trials in real time and mitigate participant, design, data, or conduct issues.
- Review/interpret trial data; may support on-site monitoring and supervise novel endpoint/biomarker collection.
- Lead development of job aids/SOPs and support global clinical development procedures; communicate best practices; coach/mentor junior staff.
- Author technical/regulatory documents (protocols, investigator brochures, clinical study reports, health authority updates, regulatory responses) and coordinate WMA/CTD sections; develop operational documents (site monitoring plans, manuals, risk language, informed consents).
- Lead study/program planning and execution activities (governance, escalation/mitigation, presentations) with risk assessments and contingency planning.
Education/Qualifications
- Degree in Life Sciences: Bachelor’s + ≥11 years, OR Master’s + ≥8 years, OR PhD/doctorate + ≥3 years (e.g., trial management/execution, site training/monitoring, medical/regulatory writing).
- Required: ≥6 years early phase/translational medicine clinical research; immunology early patient trial/program experience (e.g., Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
Skills (Required)
- GCP/ICH/regulatory knowledge; scientific/medical safety writing and reporting; clinical risk management; clinical study design/trials operations; biomarker/immunogenicity assays; strong project management, communication, analytical/problem-solving, independent judgment, and mentoring.
Preferred
- Advanced degree; global Phase 1 patient trials, safety reporting, and NDA/WMA submission experience.
Benefits
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid time off, compassionate and sick days.
Application
- Apply at https://jobs.merck.com/us/en (deadline listed on posting).