Associate Principal Scientist, Clinical Research
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 be responsible for several effectiveness studies within a project and participate as the clinical representative on project teams as assigned. This position designs and conducts clinical studies that meet scientific, regulatory, and ethical requirements supporting registration of animal health products. It leads and supports study teams, coordinates study planning and execution, oversees study compliance and reporting, and maintains relationships with internal and external stakeholders. The role may also represent Global Clinical Research on project teams, support marketing groups with scientific and technical expertise, conduct post-marketing studies, and prepare scientific publications. The position is based in Rahway, New Jersey, with a hybrid work arrangement and 25% travel. Domestic relocation is available; visa sponsorship is not. The role is a regular employee position with a day shift.
Requirements
- Doctor of Veterinary Medicine or equivalent veterinary degree.
- Four years in clinical research or a similar research role.
- Experience in a clinical study-related role.
- Strong scientific writing ability.
- Principled verbal and written communications.
- Proficiency in MS Office applications.
- Understanding of Good Clinical Practice guidelines.
- Skills listed as required: Biomarker Assay Development, Clinical Site Management, Clinical Study Design, Clinical Trials Operations, Detail-Oriented, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Scientific Writing, and Veterinary Research.
Responsibilities
- Design and conduct clinical studies that adhere to scientific, regulatory, and ethical requirements supporting registration of animal health products.
- Design and organize paper and Electronic Data Capture clinical studies by setting objectives, budgets, resources, timelines, study protocols, and related documentation.
- Provide overall leadership and support to the clinical study team.
- Identify and select investigators, laboratories, and/or CROs.
- Apply for necessary study permits and licenses, with support from local regulatory staff, within the specified study timeline.
- Train the study team on the Study Protocol.
- Ensure timely selection and ordering of study materials.
- Ensure administrative aspects of studies, including budgets and agreements, comply with applicable laws and company policies and procedures.
- Plan and coordinate monitoring and data management activities for each study.
- Ensure studies are conducted according to legal requirements, Good Clinical Practice, and applicable internal policies and procedures.
- Prepare the Final Study Report.
- Maintain contact with stakeholders, including the project leader, regulatory affairs, and quality assurance, and keep them informed of study progress.
- May serve as the Global Clinical Research representative on the project team.
- Assume responsibility for 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 in relevant fields.
- Serve as a contact and liaison with other internal departments on specific projects and with external partners such as universities or regulatory authorities.
- Prepare critical summaries and expert reports for management and/or submission to regulatory agencies.
- Supervise trainees and provide mentorship and support to other Global Clinical Research staff.
- Provide scientific and technical support to marketing groups for key molecules/products and provide clinical research expertise upon request.
- Conduct post-marketing studies.
- Prepare scientific publications according to company needs.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employee and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
