Associate Principal Scientist, Clinical Research

MSD•Rahway, NJ

22h•Hybrid

About The Position

The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. The role may also oversee several effectiveness studies within a project and participate as the clinical representative on project teams. The position designs and conducts clinical studies supporting registration of animal health products, ensuring scientific, regulatory, ethical, and Good Clinical Practice requirements are met. The role leads study planning and execution, including setting objectives, budgets, resources, and timelines; developing protocols and related documentation; selecting investigators, laboratories, and CROs; coordinating permits, materials, monitoring, and data management; and preparing final study reports. The Associate Principal Scientist maintains communication with stakeholders and external partners, may represent Global Clinical Research on project teams, and contributes to regulatory submissions, scientific publications, post-marketing studies, and marketing-group support. The position also supervises trainees and mentors other Global Clinical Research staff. The position is based primarily in Rahway, New Jersey, with hybrid work arrangements and 25% travel. Domestic relocation is listed; visa sponsorship is not available. The role is regular employment, with annual bonus and long-term incentive eligibility if applicable. The posted primary-location salary range is $142,400–$224,100.

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 Microsoft 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, ethical standards, 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, resources, timelines, and study 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 required 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 administrative study 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 follow 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.
May serve as the Global Clinical Research representative on project teams.
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.
Serve as a contact and liaison with internal departments and external partners, including universities and regulatory authorities.
Prepare critical summaries and expert reports for management and/or regulatory agency submissions.
Supervise trainees and mentor and support other Global Clinical Research staff.
Provide scientific and technical support to marketing groups for key molecules or products and provide clinical research expertise as requested.
Conduct post-marketing studies.
Prepare scientific publications according to company needs.