Organon

Job Description

The Position

The Non-Clinical Operations Lead within the Non-Clinical Development Team (NCD), is responsible for operational oversight conduct outsourced non-clinical studies at contract research organizations (CROs), including toxicology, DMPK and pharmacology studies. The NCD team is comprised of drug development scientists representing toxicology, DMPK, and pharmacology, serving a key function within the Translational Medicine and Early Development (TMED) team. Non-Clinical Operations Lead will report to the Non-Clinical Safety Assessment Lead and work collaboratively with other members within the NCD team including safety assessment (toxicology) and translational sciences.

The Non-Clinical Operations Lead will work closely with non-clinical project team representatives and non-clinical management to ensure the operational aspects of outsourced contract studies are conducted with the upmost quality and compliance. Key functions of the position include direct interactions with preclinical CROs, on-site qualification of vendors, oversight and coordination of study logistics (e.g., contracts, test articles, study records, etc.), and on-site monitoring of non-clinical studies at specific milestones. Additionally, this position will interface with Quality Assurance (QA) and their representatives, contribute to the authorship of non-clinical standard operating procedures (SOPs) and policies, and serve as a liaison between non-clinical development and Organon procurement. Knowledge of the operational conduct of the various stages of in vitro and in vivo safety studies is required and a deep understanding of GLP practices is essential.

Responsibilities

• Direct engagement with preclinical CROs to oversee the conduct of non-clinical studies to support Organon’s pipeline projects, including non-clinical pharmacology, DMPK, and toxicology studies.
• Maintain collaborative CRO vendor relationship for effective conduct of non-clinical studies
• Conduct virtual and on-site qualification of new and existing non-clinical vendors and coordinate with Quality Assurance as appropriate. (travel required, as necessary).
• Conduct on-site study monitoring at key study milestones (e.g., first dose, necropsy, etc.).
• Contribute to operational responsibilities of the non-clinical function, including authorship of SOPs and/or policies, interfacing with Organon Procurement for vendor contracts and financial statements.
• Track and coordinate non-clinical resources applied to outsourced activities/studies in conjunction with department management.
• Engage and communicate effectively with non-clinical team members, supporting functions within Organon, and external vendors.
• Ensure the conduct of outsourced studies in accordance with Good Laboratory Practices (GLP)and relevant Organon Standard Operating Procedures (SOPs).

Required Education, Experience and Skills

• BS, MS, PhD, or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
• Minimum of five years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge of the operational conduct of in vitro and in vivo non-clinical studies, including toxicology, DMPK and pharmacology studies.
• Demonstrated knowledge of GLP requirements and ability to assess implementation of GLP practices.
• Experience with on-site study monitoring and qualification of vendors and facilities. Specific experience in monitoring pivotal toxicology studies is required.
• Experience with animal handling procedures and ethical practices.
• Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
• Excellent organizational and interpersonal skills.
• Ability to work independently.
• Ability to prioritize and focus on important details and adherence to procedures and SOPs.
• Travel required (Approximately 25%).

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit:

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OFCCP Pay Transparency Rule

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., 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.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$125,400.00 - $213,100.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R537189

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