Associate Principal Scientist, Clinical Research (Animal Health)
Merck & Co.
This listing was originally posted on Merck & Co.'s careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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 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.
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:
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 {+ 3 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
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, 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 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 salary range for this role is
$139,600.00 - $219,700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (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
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
04/20/2026*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.
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