Job Description
The Position
The Non-Clinical Safety Assessment Lead will oversee non-clinical activities and safety assessments for Organon Research and Development (R&D) programs ranging from discovery through late-stage development. This is a scientific leadership position that includes management responsibilities of the non-clinical development scientists, who directly contribute to implementation and execution of Organon’s pipeline assets and portfolio of established brands (general medicines). This position will report to the Vice President, Translational Medicine and Early Development (TMED). As part of the Non-Clinical Development (NCD) team, the Non-Clinical Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the Organon portfolio, including pipeline assets, life-cycle management of approved products, business development activities, and contributions to risk assessments and information requests from health authorities for the general medicines portfolio.
The NCD team is comprised of non-clinical drug development scientists representing the disciplines of toxicology, DMPK, and pharmacology, within Translational Medicine and Early Development (TMED). The Non-Clinical Safety Assessment Lead will work closely with the Translational Sciences Lead to ensure that R&D programs are adequately supported across non-clinical disciplines, including technical expertise and development strategy. Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls (CMC), medical affairs and business development are critical to the success of the role.
Responsibilities
Lead all aspects of non-clinical safety assessment for pipeline programs and the general medicines portfolio, utilizing internal subject matter expertise and leveraging expert consultants and contract organizations to meet current and future business needs.
Management and oversight of Non-Clinical Development (NCD) project representatives on asset development teams (ADTs) to support the R&D pipeline programs. Management responsibilities include coaching, professional and scientific development, engaging and motivating employees, performance and talent management assessments
Serve as a subject matter expert and an effective technical and strategic leader for non-clinical development in business development, discovery and asset development teams.
Oversight of non-clinical input into life-cycle management of and required reporting and maintenance activities for the general medicines portfolio of products within Women’s Health, General Medicines, and Biosimilars. Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
Oversight and/or review non-clinical CTD modules, briefing books, or other regulatory communications for regional regulatory submissions or renewals for the general medicines portfolio of products.
Support Drug Safety and Pharmacovigilance with activities such as review of non-clinical 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.
Oversee collaborations with CMC 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.
Actively participate in external professional and scientific organizations to establish Organon’s expertise and leadership in preclinical sciences. Promote staff engagement in the external scientific community through presentations, publications, and active participation in professional organizations.
Support the product portfolio in line with animal welfare standards, Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs).
Required Education, Experience and Skills
PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.
Board certification in toxicology preferred (e.g., DABT, ERT).
A minimum of 15 years of non-clinical drug development experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge background in toxicology. Demonstrated expertise in non-clinical safety assessment and toxicology is required.
Demonstrated competency in related fields, including pharmacology, DMPK, bioanalytics, translational sciences, and clinical pharmacology.
Direct experience and demonstrated track record in leading non-clinical development activities or teams in support of early- through late-stage drug development programs (i.e., support for IND-enabling projects, clinical-stage programs, and submission of marketing applications).
Development experience with small molecules is essential. Experience with additional modalities is preferred (eg, peptides, antibodies, gene or cell therapies, or drug-device combinations).
Extensive experience with review and authoring non-clinical sections of regulatory dossiers (e.g., INDs, NDAs) and product labels.
First-hand experience with agency interactions (face-to-face or virtual meetings, briefing books, and response documents).
Direct experience managing junior and senior level non-clinical scientists.
Experience in working in and/or leading project teams (preferably global project teams).
Demonstrated knowledge and experience in toxicological risk assessments for drug substance and drug product impurities in accordance with related regulatory guidelines.
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.
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
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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.
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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)
$225,200.00 - $382,900.00Annualized 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Remote WorkShift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1