Associate Principal Scientist, Clinical Research (Animal Health)

MSD

23d•Hybrid

About The Position

JOB DESCRIPTION SUMMARY Primary activities include but are not limited to: 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. MAJOR ACTIVITIES AND RESPONSIBILITIES Briefly describe the major activities of the position. Indicate the approximate percentage of time spent on each activity. Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion. Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and the study protocol/related documentation. 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 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, GCP, 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 keeps them informed of the study progress. May be the GCR representative in the project team. Assume responsibility for certain monitoring and data management tasks (e.g., User Acceptance Test of electronic CRFs) Monitor clinical studies under the leadership of other Scientists. Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields. Conduct quality control inspections of study protocol, study documentation files and reports. Serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities. Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies. Supervise trainees and provide mentorship and support to other GCR staff. Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request. Conducts post-marketing studies. Prepares scientific publications according to the need of the company.

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.
Accountability
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
Good Clinical Practice (GCP)
Machine Learning (ML)
Marketing
Medical Laboratories
Medical Writing
Multiple Therapeutic Areas
Patient Recruitment
Regulatory Requirements
Scientific Publications
Scientific Writing
Stakeholder Relationship Management

Responsibilities

Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements by the setting of objectives, budget, resources, timelines, and the study protocol/related documentation.
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 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, GCP, 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 keeps them informed of the study progress.
May be the GCR representative in the project team.
Assume responsibility for certain monitoring and data management tasks (e.g., User Acceptance Test of electronic CRFs)
Monitor clinical studies under the leadership of other Scientists.
Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
Conduct quality control inspections of study protocol, study documentation files and reports.
Serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities.
Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.
Supervise trainees and provide mentorship and support to other GCR staff.
Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
Conducts post-marketing studies.
Prepares scientific publications according to the need of the company.