Director, Nonclinical Development
Organon
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Job summary
Organon is seeking a Director of Nonclinical Development to provide expert nonclinical support across Women's Health, General Medicines, and Biosimilars. The role teams with Regulatory, Safety, and CMC, contributing to global regulatory submissions and product lifecycle management.
You will author nonclinical sections, participate in agency interactions, and guide risk assessments related to CMC activities, while leading cross-functional groups to ensure GLP/GCP compliance and regulatory success.
Qualifications
- 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 10 years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge across nonclinical disciplines in context of drug development, including toxicology, DMPK and pharmacology.
- Demonstrated knowledge of nonclinical development and regulatory guidelines (GxP) for drug substances/products.
Responsibilities
- Serve as the Nonclinical representative on asset development teams (ADTs) for lifecycle management.
- Author and review nonclinical CTD modules, briefing books, or other regulatory communications for regional/global submissions.
- Provide scientific input (toxicology, pharmacology, DMPK) for Organon products and ADTs.
- Prepare and review nonclinical/CMC documentation to support regulatory submissions.
- Support regulatory activities for global products and annual reporting of nonclinical activities.
Skills
Education
Job description
The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs in Organon's portfolio of products across Women's Health, General Medicines, and Biosimilars. This position will report to the Executive Director, Translational Sciences and Nonclinical Development and work collaboratively with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, chemistry, manufacturing and control (CMC), medical affairs and business development as necessary. To that aim, this position will serve as the nonclinical representative on asset development teams (ADTs) to support life-cycle management of products in Organon's portfolio. This position will also be responsible for contributing to, and reviewing, nonclinical modules for regional regulatory submissions and renewals for global submissions. Additionally, author and review briefing books, investigator brochures, and other regulatory documents as applicable. This position will also support toxicological risk assessments associated with CMC activities.
- Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in Organon's portfolio.
- 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.
- Nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities support of the Organon Women's Health, General Medicines and Biosimilars product portfolio.
- Nonclinical toxicology liaison with CMC and Occupational Safety to conduct risk assessments to inform mitigation strategies in accordance with regional and/or global regulatory requirements. 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.
- Provide scientific and nonclinical input (toxicology, pharmacology, DMPK) for Organon products and ADTs.
- Prepare, contribute to and/or review the nonclinical or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
- Support Regulatory activities for global products such as, annual reporting of nonclinical activities and literature, support new regional drug applications, regional license renewals, 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. Provide nonclinical support for occupational and environmental risk assessments.
- Support the established product portfolio in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).
- 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 10 years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge across nonclinical disciplines in context of drug 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.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
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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.
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.
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.
$152,300.00 - $259,200.00
Regular
No relocation
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
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Requisition ID: R541643
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