Associate Principal Scientist (DVM/PhD) responsible for designing, coordinating, monitoring, and reporting clinical laboratory and field studies to support regulatory approval of new companion animal and livestock products. Leads clinical study teams; may manage multiple effectiveness studies.
Major activities/responsibilities:
- Design/organize paper and Electronic Data Capture (EDC) clinical studies (objectives, budget, resources, timelines, protocols).
- Lead and support study teams; identify/select investigators, laboratories, and/or CROs.
- Obtain study permits/licenses; train teams on the protocol; ensure study materials are selected/ordered.
- Plan/coordinate monitoring and data management; ensure compliance with legal requirements, GCP, and internal policies.
- Prepare final study reports; maintain stakeholder communication (regulatory, quality, project leadership).
- Perform monitoring/data management tasks (e.g., UAT of electronic CRFs); conduct quality control inspections.
- Liaison with internal/external partners; prepare expert/regulatory summaries; supervise/mentor trainees.
- Support marketing on clinical expertise; conduct post-marketing studies; prepare scientific publications.
Education: Doctor of Veterinary Medicine (DVM) or equivalent veterinary degree.
Skills/Qualifications (required):
- 4 years in clinical research or similar role; experience in clinical study-related role.
- Strong scientific writing; verbal/written communications; MS Office; understanding of GCP.
Required skills (high level): clinical study design/operations, clinical site management, regulatory requirements, medical writing/scientific publications, stakeholder relationship management, ethical/GCP/GLP compliance.
Benefits (if applicable): annual bonus/long-term incentive (if applicable); comprehensive benefits including 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).