About the position
The Product Toxicology Lead within the Non-Clinical Development Team (NCD), is responsible for providing non-clinical toxicology expertise to existing products and life-cycle management of programs in the Organon portfolio as well as supporting toxicological assessments associated with chemistry, manufacturing and control (CMC) activities. This position will report to the Executive Director, Translational Sciences and Non-Clinical Development and work collaboratively with other members within the NCD sub-function, as necessary. 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. Cross-functional interactions are expected across early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, CMC, medical affairs and business development. To that aim, the Product Toxicology Lead will serve as an active member and primary nonclinical representative on asset development teams (ADTs) to support the life-cycle management as well as regulatory- and safety-driven activities for existing products in Organon's portfolio of Women's Health, General Medicines, and Biosimilars. The Product Toxicology Lead will also collaborate with CMC to assess process manufacturing impurities, degradants, and/or extraneous matters and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. This position will also be responsible for contributing to and reviewing nonclinical and clinical modules for regional regulatory submissions and renewals globally and contributes to the authoring and review of briefing books and other regulatory documents, as applicable.
Responsibilities
- Serve as the Non-Clinical Lead on asset development teams (ADTs) to support the life-cycle management as well as regulatory- and safety-driven activities for existing products in Organon's portfolio of Women's Health, General Medicines, and Biosimilars.
- Non-clinical toxicology liaison with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements.
- Author and review of nonclinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon portfolio.
- Provide scientific and nonclinical (toxicology, pharmacology, DMPK) input into existing products.
- Serve as non-clinical point of contact for Regulatory, Safety, and Pharmacovigilance activities support of the Organon Women's Health, General Medicines and Biosimilars product portfolio.
- Track and coordinate nonclinical development resources, in conjunction with department management, to support application of nonclinical development resources to activities across the Organon portfolio of products.
- Prepare, contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide.
- Support Regulatory activities for global products such as, annual reporting of nonclinical activities and literature, support new regional drug applications, regional license renewals, author or co-author responses to questions from global Heath Authorities.
- Support Drug Safety and Pharmacovigilance with activities such as review of nonclinical literature for new risks, signal evaluation for issues identified through pharmacovigilance or communications through Health Authorities, and author responses to regulatory inquiries, as appropriate.
- Contribute to regional or global product label reviews and updates, as appropriate.
- Collaborate with CMC and Occupational Safety to evaluate process manufacturing impurities and/or degradants and conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements.
- Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
- Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).
Requirements
- PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
- Board certification in toxicology a plus (e.g., DABT, ERT).
- A minimum of seven to ten years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge of nonclinical development, including toxicology, DMPK and pharmacology.
- Demonstrated technical and scientific knowledge in nonclinical sciences with a particular emphasis on supporting late-stage drug development and life-cycle management.
- Demonstrated knowledge of nonclinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements.
- Extensive experience with review and authoring nonclinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents).
- Experience in working in project teams (preferably global project teams).
- Exemplifies leadership qualities including effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
- Excellent organizational and interpersonal skills.
- Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
- Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address challenges associated with life-cycle management and CMC activities.
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
