Associate Principal Scientist, Clinical Research
Merck
Summary
The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. The Associate Principal Scientist can also be responsible for several effectiveness studies within a project, participating as the clinical representative in project teams as assigned.
Job description
Responsibilities
- Design and conduct clinical studies that adhere to scientific, regulatory, and ethical requirements used for support in the registration of animal health products.
- Design and organize paper and Electronic Data Capture clinical studies by setting objectives, budget, resources, timelines, and study protocol/related documentation.
- Provide overall leadership and support to the clinical study team.
- Identify and select Investigators, laboratories, and/or CROs.
- Apply for the necessary study permits and licenses with the support of local regulatory staff within the specified study timeline.
- Train the study team on the Study Protocol.
- Ensure the timely selection and ordering of study materials.
- Ensure compliance of administrative aspects of the study (budgets and agreements) with the applicable laws and our company's policies and procedures.
- Plan and coordinate the monitoring and data management activities of each study.
- Ensure that the study is conducted according to legal requirements, Good Clinical Practice, and the applicable internal policies and procedures.
- Prepare the Final Study Report.
- Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance, etc.) and keep them informed of the study progress.
- May serve as the Global Clinical Research representative in the project team.
- Assume responsibility for certain monitoring and data management tasks (e.g., User Acceptance Test 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 to management and/or for submission to regulatory agencies.
- Supervise trainees and provide mentorship and support to other Global Clinical Research staff.
- Provide scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
- Conduct post-marketing studies.
- Prepare scientific publications according to the needs of the company.
Qualifications
- Doctor of Veterinary Medicine, OR equivalent veterinary degree.
- Four (4) 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.
- Proficient in MS Office applications.
- Understanding of Good Clinical Practice guidelines.
Requirements
- Doctor of Veterinary Medicine, OR equivalent veterinary degree
- Four (4) 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
- Proficient in MS Office applications
- Understanding of Good Clinical Practice guidelines
- 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
- Veterinary Research
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.