Associate Principal Scientist, Clinical Research
Merck
June 24, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities
- Provide operational and scientific leadership for early-phase clinical trial design, planning, and execution with the Clinical Director and cross-functional teams.
- Lead Immunology programs (multiple Phase 1 and 1b trials) across programs/developmental stages; manage cross-functional performance to meet objectives.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; monitor trials in real time to identify/mitigate participant, study design, data, or conduct issues.
- Review/interprete clinical trial data; support on-site monitoring and site training for complex, novel endpoint/biomarker collection.
- Represent Early Stage Development on cross-functional teams; lead/participate in global clinical development procedures; develop job aids/SOPs; share best practices; mentor junior staff.
Technical Writing & Communications
- Author/coordinate protocols, investigator brochures, clinical study reports, health authority updates, and regulatory responses (including to audits/inspections).
- Develop WMA/CTD subsections and study operational documents (site monitoring plans, operations/lab manuals, risk language, informed consents).
Project Management
- Lead study/program planning, issue escalation/mitigation, governance/advisory preparations, and risk/contingency planning under accelerated timelines.
Qualifications
- Education: 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).
- Required: ≥6 years early phase/translational medicine clinical research; immunology clinical program/trial experience (incl. Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines; GCP/ICH/regulatory knowledge; scientific/medical safety writing/reporting excellence; complex project management; data-driven independent judgment; mentor junior staff; effective written/oral communication.
Preferred
- Advanced degree; global Phase 1 trials, safety reporting, NDA/WMA submission experience.
Benefits (if applicable/explicitly stated)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, 401(k), paid holidays/vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
- Provide operational and scientific leadership for early-phase clinical trial design, planning, and execution with the Clinical Director and cross-functional teams.
- Lead Immunology programs (multiple Phase 1 and 1b trials) across programs/developmental stages; manage cross-functional performance to meet objectives.
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Oversee clinical safety assessment and risk management; monitor trials in real time to identify/mitigate participant, study design, data, or conduct issues.
- Review/interprete clinical trial data; support on-site monitoring and site training for complex, novel endpoint/biomarker collection.
- Represent Early Stage Development on cross-functional teams; lead/participate in global clinical development procedures; develop job aids/SOPs; share best practices; mentor junior staff.
Technical Writing & Communications
- Author/coordinate protocols, investigator brochures, clinical study reports, health authority updates, and regulatory responses (including to audits/inspections).
- Develop WMA/CTD subsections and study operational documents (site monitoring plans, operations/lab manuals, risk language, informed consents).
Project Management
- Lead study/program planning, issue escalation/mitigation, governance/advisory preparations, and risk/contingency planning under accelerated timelines.
Qualifications
- Education: 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).
- Required: ≥6 years early phase/translational medicine clinical research; immunology clinical program/trial experience (incl. Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines; GCP/ICH/regulatory knowledge; scientific/medical safety writing/reporting excellence; complex project management; data-driven independent judgment; mentor junior staff; effective written/oral communication.
Preferred
- Advanced degree; global Phase 1 trials, safety reporting, NDA/WMA submission experience.
Benefits (if applicable/explicitly stated)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits incl. medical/dental/vision, 401(k), paid holidays/vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.