Associate Principal Scientist, Clinical Research

Merck•Rahway, NJ

8h•$142,400 - $224,100•Hybrid

About The Position

The Associate Principal Scientist, Clinical Research, is the primary clinical study team leader with overall responsibility for a study. The role may also oversee several effectiveness studies within a project and serve as the clinical representative on project teams. This position designs and conducts clinical studies supporting registration of animal health products, ensuring scientific, regulatory, and ethical requirements are met. The role leads study planning and execution, including setting objectives, budgets, resources, timelines, protocols, and related documentation. It coordinates investigators, laboratories, contract research organizations, permits, study materials, monitoring, data management, and study-team training. The Associate Principal Scientist ensures compliance with applicable laws, Good Clinical Practice, and company policies; prepares final study reports and regulatory summaries; and communicates study progress to stakeholders. The position also contributes clinical research expertise to project and marketing teams, builds internal and external scientific networks, liaises with departments and external partners, mentors staff, conducts post-marketing studies, and prepares scientific publications. The position is hybrid, based primarily in Rahway, New Jersey, and requires 25% travel. Domestic relocation is available; visa sponsorship is not available.

Requirements

Doctor of Veterinary Medicine or equivalent veterinary degree.
Four years of experience in clinical research or a similar research role.
Experience in a clinical study-related role.
Strong scientific writing ability.
Principled verbal and written communication skills.
Proficiency in MS Office applications.
Understanding of Good Clinical Practice guidelines.
Skills in biomarker assay development, clinical site management, clinical study design, clinical trials operations, attention to detail, ethical compliance and standards, Good Clinical Practice, medical writing, multiple therapeutic areas, patient recruitment, scientific writing, and veterinary research.

Responsibilities

Design and conduct clinical studies that meet scientific, regulatory, and ethical requirements and support registration of animal health products.
Design and organize paper and electronic data capture clinical studies, including setting objectives, budgets, resource needs, timelines, protocols, and related documentation.
Provide overall leadership and support to the clinical study team.
Identify and select investigators, laboratories, and/or contract research organizations.
Apply for necessary study permits and licenses with support from local regulatory staff within the study timeline.
Train the study team on the study protocol.
Ensure timely selection and ordering of study materials.
Ensure study administrative matters, including budgets and agreements, comply with applicable laws and company policies and procedures.
Plan and coordinate study monitoring and data management activities.
Ensure studies are conducted according to legal requirements, Good Clinical Practice, and applicable internal policies and procedures.
Prepare final study reports.
Maintain contact with stakeholders, including project leaders, regulatory affairs, and quality assurance, and keep them informed of study progress.
Represent Global Clinical Research on project teams when assigned.
Perform certain monitoring and data management tasks, such as user acceptance testing of electronic case report forms.
Develop and maintain a network of internal and external clinical and scientific contacts and key opinion leaders.
Liaise with internal departments and external partners, including universities and regulatory authorities, on specific projects.
Prepare critical summaries and expert reports for management and/or regulatory agency submissions.
Supervise trainees and provide mentorship and support to Global Clinical Research staff.
Provide scientific and technical support to marketing groups for key molecules and products and provide clinical research expertise upon request.
Conduct post-marketing studies.
Prepare scientific publications according to company needs.