Associate Principal Scientist, Clinical Research
Merck
August 25, 2026
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Provide operational and scientific leadership for early-phase clinical trial/program design, planning, and execution.
- Oversee, set strategic direction for, and execute vaccine trials and programs; manage cross-functional performance to meet objectives.
- Ensure compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Lead clinical safety assessment and risk management; provide real-time oversight of ongoing trials to mitigate participant, study design, data, and conduct issues.
- Review and interpret trial data; may participate in on-site monitoring and supervise novel endpoint/biomarker collection processes.
- Represent Early Stage Development; lead development of departmental job aids/SOPs and global clinical development procedures; identify/broadcast best practices; coach/mentor junior staff.
- Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, and other clinical/regulatory documents (including WMA/CTD subsections); develop study operational documents (monitoring plans, lab manuals, risk language, informed consents).
- Lead project management for study/program planning, execution, issue escalation/mitigation, governance, and advisory meeting prep; manage risks/contingencies under accelerated timelines.
Education/Qualifications:
- Degree in Life Sciences (BS + ≥11 years; MS + ≥8 years; PhD + ≥3 years). Related experience: 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.
- Experience developing/implementing/managing vaccine clinical programs.
Required Skills:
- Creative problem-solving; independent judgment on regulations/guidelines/investigator interactions.
- Rapid therapeutic-area scientific knowledge; advanced project management.
- Excellence in scientific/medical/safety writing and reporting.
- Data-driven decisions; proactively identify/escalate/plan mitigations.
- Partner effectively with external teams; strong written/oral communication and analytical skills.
- Working knowledge of GCP/ICH/regulatory requirements; mentor junior staff; lead/participate in cross-functional improvements; act with courage and candor.
Preferred Skills:
- Advanced degree; global Phase 1 trials, safety reporting, NDA/WMA submission experience.
Benefits (if applicable):
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid holidays/vacation, and compassionate/sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.
- Provide operational and scientific leadership for early-phase clinical trial/program design, planning, and execution.
- Oversee, set strategic direction for, and execute vaccine trials and programs; manage cross-functional performance to meet objectives.
- Ensure compliance with GCP, ICH, and regulatory requirements; deliver high-quality data.
- Lead clinical safety assessment and risk management; provide real-time oversight of ongoing trials to mitigate participant, study design, data, and conduct issues.
- Review and interpret trial data; may participate in on-site monitoring and supervise novel endpoint/biomarker collection processes.
- Represent Early Stage Development; lead development of departmental job aids/SOPs and global clinical development procedures; identify/broadcast best practices; coach/mentor junior staff.
- Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, and other clinical/regulatory documents (including WMA/CTD subsections); develop study operational documents (monitoring plans, lab manuals, risk language, informed consents).
- Lead project management for study/program planning, execution, issue escalation/mitigation, governance, and advisory meeting prep; manage risks/contingencies under accelerated timelines.
Education/Qualifications:
- Degree in Life Sciences (BS + ≥11 years; MS + ≥8 years; PhD + ≥3 years). Related experience: 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.
- Experience developing/implementing/managing vaccine clinical programs.
Required Skills:
- Creative problem-solving; independent judgment on regulations/guidelines/investigator interactions.
- Rapid therapeutic-area scientific knowledge; advanced project management.
- Excellence in scientific/medical/safety writing and reporting.
- Data-driven decisions; proactively identify/escalate/plan mitigations.
- Partner effectively with external teams; strong written/oral communication and analytical skills.
- Working knowledge of GCP/ICH/regulatory requirements; mentor junior staff; lead/participate in cross-functional improvements; act with courage and candor.
Preferred Skills:
- Advanced degree; global Phase 1 trials, safety reporting, NDA/WMA submission experience.
Benefits (if applicable):
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid holidays/vacation, and compassionate/sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.