Associate Principal Scientist, Clinical Research (Animal Health)

Job Description

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 Companys 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.

Education:

Doctor of Veterinary Medicine OR equivalent veterinary degree

Skills Required:

• Strong scientific writing ability

• Principled verbal and written communications

• Proficient in MS Office applications

• Understanding of GCP Good Clinical Practices guidelines.

Competencies Required:

• Four years in clinical research or similar research role.

• Experience in a clinical study related role.

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

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