Job Description

Join us and be part of the future of veterinary medicine! Imagine designing and conducting clinical studies to develop the new veterinary products that will make animals healthier. The Associate Principal Scientist, Animal Health Clinical Research position designs, coordinates, monitors, and reports clinical laboratory and field studies that will support the regulatory approval of new investigational veterinary products. The position requires the candidate to 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.

Responsibilities

• Design and conduct clinical studies that adhere to scientific, regulatory (e.g. Good Clinical Practice (GCP), GFI #85 / VICH GL9) and ethical requirements used for support in the registration of animal health products

• Collaborate with regulatory affairs to ensure, if required, regulatory authorities are aware of the study being conducted.

• Identify and select Investigators, laboratories and/or CROs for conducting clinical studies

• Prepare a study protocol with internal Clinical Study Team members and external Study Investigators, Subject Matter Experts, and Key Opinion Leaders

• Prepare and organize data collection procedures through paper and Electronic Data Capture (EDC) modalities

• Ensure study personnel including monitors and investigators are all trained to the protocol

• Manage the investigational veterinary products or vaccine serials and control products used in the clinical study

• Ensure compliance with applicable welfare requirements governing the humane care of animals

• May act as a study Monitor responsible for monitoring and reporting on the progress of the study, verifying the data and confirming that the clinical study is conducted, recorded and reported in compliance with GCP and applicable regulatory requirements

• Author the Final Study Report

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Manage the study through setting of objectives, budget, resources, timelines

• Provide overall leadership and support to the Clinical Study Team working with Clinical Operations Managers to plan and coordinate the monitoring and data management activities of the study

• Ensure compliance of administrative aspects of the study (budgets and agreements) with the applicable laws and our Company's policies and procedures

• Communicate with all stakeholders (project manager, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress

• Represent the Global Clinical Research department in the project team

• Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields

• 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 Global Clinical Research staff

• Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request

• Prepares scientific publications according to the need of the company

Qualifications

• A Doctor of Veterinary Medicine, OR equivalent veterinary degree

• Four years' experience in clinical research or equivalent research or industry role

• Demonstrated execution excellence using innovative approaches and ownership of projects

• Experience influencing without direct authority, navigating complex organizations successfully networking and partnering with cross-functional teams

Preferred

• An advanced degree (e.g. PhD) and/or board certification by an AVMA-accredited organization

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:09/30/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R313841