Associate Principal Scientist, Clinical Research (Animal Health)

MSD

93d • $139,600 - $219,700

About The Position

The Associate Principal Scientist is a DVM and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies. 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.

Requirements

• Doctor of Veterinary Medicine, OR equivalent veterinary degree.
• Strong scientific writing ability.
• Principled verbal and written communications.
• Proficient in MS Office applications.
• Understanding of GCP Good Clinical Practices guidelines.
• Four years in clinical research or similar research role.
• Experience in a clinical study related role.

Nice To Haves

• Accountability.
• Biomarker Assay Development.
• Clinical Research.
• Clinical Sciences.
• Clinical Site Management.
• Clinical Study Design.
• Clinical Trials Operations.
• Computer Science.
• Design.
• Detail-Oriented.
• Ethical Compliance.
• Ethical Standards.
• GLP Regulations.
• Machine Learning.
• Marketing.
• Medical Laboratories.
• Medical Writing.
• Multiple Therapeutic Areas.
• Patient Recruitment.
• Regulatory Requirements.
• Scientific Publications.
• Stakeholder Relationship Management.

Responsibilities

• Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements.
• Provide overall leadership and support to the study team.
• Identify and select Investigators, laboratories and/or CROs.
• Apply for the necessary study permits and licenses with support of local regulatory staff.
• 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 with applicable laws and company policies.
• Plan and coordinate the monitoring and data management activities of each study.
• Prepare the Final Study Report.
• Maintain contact with all stakeholders and keep them informed of the study progress.
• Assume responsibility for certain monitoring and data management tasks.
• Develop and maintain a network of internal and external clinical and scientific contacts.
• Conduct quality control inspections of study protocol, study documentation files and reports.
• Serve as a contact and liaison with other internal departments and external partners.
• Prepare critical summaries and expert reports for management and regulatory agencies.
• Supervise trainees and provide mentorship and support to other staff.
• Provide scientific and technical support to marketing groups for key molecules/products.
• Conduct post-marketing studies.
• Prepare scientific publications as needed.

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees