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Organon · 2 months ago

Associate Director - Non-Clinical Operations Lead

USA - New Jersey - Jersey City

Full-time

Onsite

Lead/Staff, Director/Executive

$125K/yr - $213K/yr

5+ years exp

Organon is a global healthcare company focused on providing health solutions for women and their communities. The Non-Clinical Operations Lead will oversee outsourced non-clinical studies, ensuring quality and compliance while collaborating with various teams and CROs.

Health CareMedical DevicePharmaceuticalWomen's

H1B Sponsor Likely

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)

Qualification

Non-clinical studies oversightGLP practices knowledgeVendor qualification experiencePharmacology knowledgeToxicology experienceDMPK knowledgeEffective communicationOrganizational skillsInterpersonal skillsWork independently

Required

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%)

Benefits

Retirement savings plan

Paid vacation and holiday time

Paid caregiver/parental and medical leave

Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans

Company

Organon

Glassdoor3.9

Organon offers medicines and other products to assist treat a wide range of ailments and diseases.

Founded in 2020

Jersey City, New Jersey, USA

10001+ employees

https://www.organon.com

H1B Sponsorship

Organon has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (6)

2024 (8)

2023 (5)

2022 (4)

2021 (11)