Associate Principal Scientist, Clinical Research
Merck
June 24, 2026
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Early Clinical Scientist (ECS)
Responsibilities:
- Provide operational and scientific leadership for early-phase clinical trial design, planning, and execution in collaboration with Clinical Director and cross-functional teams.
- Oversee and execute Immunology programs (multiple Phase 1 and 1b trials), manage cross-functional performance to meet objectives, and ensure GCP/ICH/regulatory compliance.
- Conduct clinical safety assessment and real-time oversight of ongoing trials; review/interpret trial data and support site monitoring/training for novel endpoint/biomarker collection.
- Represent Early Stage Development on product and early development teams; lead departmental job aids/SOPs; develop and promote global clinical procedures; coach/mentor junior staff.
- Author and coordinate clinical/regulatory documents (protocols, investigator brochures, study reports, health authority updates, regulatory/audit responses; WMA/CTD subsections); develop study operational documents.
- Lead study and program project management (planning, issue escalation/mitigation, governance/advisory preparation) with risk assessments and contingency planning.
Qualifications:
- Degree in Life Sciences.
- Bachelor’s + ≥11 yrs related experience, OR Master’s + ≥8 yrs, OR PhD/doctorate + ≥3 yrs (e.g., trial management/execution, clinical site training/monitoring, medical/regulatory writing).
Required:
- ≥6 yrs early-phase/translational medicine clinical research; immunology clinical program/trial experience (incl. early patient trials such as Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
- Strong clinical research execution, scientific/medical/safety writing, data-driven decision-making, independent judgment on regulations/investigator interactions.
- Working knowledge of GCP/ICH/regulatory requirements; effective communication; ability to mentor.
Preferred:
- Advanced degree; global Phase 1 patient trials and safety reporting; NDA/WMA submission experience.
Benefits/Compensation:
- Salary range: $142,400.00–$224,100.00; bonus and long-term incentive eligibility (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid time off.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply by the deadline stated on the posting.
Responsibilities:
- Provide operational and scientific leadership for early-phase clinical trial design, planning, and execution in collaboration with Clinical Director and cross-functional teams.
- Oversee and execute Immunology programs (multiple Phase 1 and 1b trials), manage cross-functional performance to meet objectives, and ensure GCP/ICH/regulatory compliance.
- Conduct clinical safety assessment and real-time oversight of ongoing trials; review/interpret trial data and support site monitoring/training for novel endpoint/biomarker collection.
- Represent Early Stage Development on product and early development teams; lead departmental job aids/SOPs; develop and promote global clinical procedures; coach/mentor junior staff.
- Author and coordinate clinical/regulatory documents (protocols, investigator brochures, study reports, health authority updates, regulatory/audit responses; WMA/CTD subsections); develop study operational documents.
- Lead study and program project management (planning, issue escalation/mitigation, governance/advisory preparation) with risk assessments and contingency planning.
Qualifications:
- Degree in Life Sciences.
- Bachelor’s + ≥11 yrs related experience, OR Master’s + ≥8 yrs, OR PhD/doctorate + ≥3 yrs (e.g., trial management/execution, clinical site training/monitoring, medical/regulatory writing).
Required:
- ≥6 yrs early-phase/translational medicine clinical research; immunology clinical program/trial experience (incl. early patient trials such as Phase 1b in rheumatology/dermatology/gastroenterology) under accelerated timelines.
- Strong clinical research execution, scientific/medical/safety writing, data-driven decision-making, independent judgment on regulations/investigator interactions.
- Working knowledge of GCP/ICH/regulatory requirements; effective communication; ability to mentor.
Preferred:
- Advanced degree; global Phase 1 patient trials and safety reporting; NDA/WMA submission experience.
Benefits/Compensation:
- Salary range: $142,400.00–$224,100.00; bonus and long-term incentive eligibility (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid time off.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply by the deadline stated on the posting.