Organon
Associate Director, Non-Clinical Safety Assessment
Organon, Plymouth Meeting, Pennsylvania, United States, 19462
Associate Director, Non-Clinical Safety Assessment
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Job Description The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team is accountable for representing the non-clinical safety function (i.e., toxicology) on asset development teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead. The NCD team comprises non-clinical drug development scientists representing toxicology, DMPK, pharmacology, and translational sciences and serves as a key function within the Translational Medicine and Early Development (TMED) team spanning discovery through early clinical development. The Representative is expected to participate in cross‑functional development programs with early and late‑clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls (CMC), medical affairs, and business development.
The Representative is responsible for strategic and technical contributions to development programs, contributing to the design, oversight and execution of the non‑clinical toxicology strategy for pipeline R&D products. The role may also contribute to business development activities and existing products (e.g., life‑cycle management) within the Organon portfolio. The Representative will review and author non-clinical and clinical modules for regulatory submissions, briefing books, and other regulatory documents as applicable.
Responsibilities
Serve as the Non‑Clinical Safety Assessment (toxicology) representative on interdisciplinary asset development teams (ADTs).
Plan and execute non‑clinical safety studies and assessments at appropriate stages to support asset progression through development and meet project timelines.
Serve as a subject‑matter expert in the non‑clinical field in meetings with internal/external stakeholders.
Author and review non‑clinical CTD modules for regulatory submission (e.g., IND, NDA), briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon portfolio.
Provide scientific and strategic non‑clinical safety (toxicological) input into Organon’s pipeline programs, business development activities, and existing product portfolio as an ADT representative.
Serve as a subject‑matter expert and/or provide technical area expertise for non‑clinical development issues.
Coordinate non‑clinical pharmacology and toxicology studies at Contract Research Organizations (CROs) with Non‑Clinical Operations.
Assist in the preparation and review of study protocols and research reports.
Authorship of non‑clinical sections of IND, CTA, NDA, MAA, and relevant regulatory documents for assets in the Organon portfolio.
Ensure that non‑clinical studies are conducted in compliance with relevant regulations, guidelines, and animal welfare standards.
Author or review non‑clinical, early‑clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
Contribute to regional or global product label reviews and updates, as appropriate.
Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
Support the product portfolio in line with Good Laboratory Practices (GLP) 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 a plus (e.g., DABT, ERT).
A minimum of five to seven years of experience in the pharmaceutical or biotech industry with extensive and in‑depth knowledge of non‑clinical safety assessment and drug development, including a strong background in toxicology with competency in DMPK and pharmacology.
Demonstrated knowledge of non‑clinical development as well as drug substance and drug product impurity‑related regulatory guidelines and GxP requirements.
Experience reviewing and authoring non‑clinical sections of regulatory dossiers (e.g., NDAs) and product labels with first‑hand experience with agency interactions (meetings, briefing books, and response documents).
Experience working in project teams (preferably global project teams).
Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
Excellent organizational and interpersonal skills.
Ability to manage multiple projects and shifting priorities.
Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
Ability to analyze and report results from literature reviews and preclinical and clinical studies.
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
Organon 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.
EEO Statement For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement 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 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.
Additional Information 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
Regular
Relocation:
No relocation
VISA Sponsorship:
N/A
Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Number Of Openings:
1
Requisition ID:
R537011
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing
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Get AI-powered advice on this job and more exclusive features.
Job Description The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team is accountable for representing the non-clinical safety function (i.e., toxicology) on asset development teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead. The NCD team comprises non-clinical drug development scientists representing toxicology, DMPK, pharmacology, and translational sciences and serves as a key function within the Translational Medicine and Early Development (TMED) team spanning discovery through early clinical development. The Representative is expected to participate in cross‑functional development programs with early and late‑clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls (CMC), medical affairs, and business development.
The Representative is responsible for strategic and technical contributions to development programs, contributing to the design, oversight and execution of the non‑clinical toxicology strategy for pipeline R&D products. The role may also contribute to business development activities and existing products (e.g., life‑cycle management) within the Organon portfolio. The Representative will review and author non-clinical and clinical modules for regulatory submissions, briefing books, and other regulatory documents as applicable.
Responsibilities
Serve as the Non‑Clinical Safety Assessment (toxicology) representative on interdisciplinary asset development teams (ADTs).
Plan and execute non‑clinical safety studies and assessments at appropriate stages to support asset progression through development and meet project timelines.
Serve as a subject‑matter expert in the non‑clinical field in meetings with internal/external stakeholders.
Author and review non‑clinical CTD modules for regulatory submission (e.g., IND, NDA), briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon portfolio.
Provide scientific and strategic non‑clinical safety (toxicological) input into Organon’s pipeline programs, business development activities, and existing product portfolio as an ADT representative.
Serve as a subject‑matter expert and/or provide technical area expertise for non‑clinical development issues.
Coordinate non‑clinical pharmacology and toxicology studies at Contract Research Organizations (CROs) with Non‑Clinical Operations.
Assist in the preparation and review of study protocols and research reports.
Authorship of non‑clinical sections of IND, CTA, NDA, MAA, and relevant regulatory documents for assets in the Organon portfolio.
Ensure that non‑clinical studies are conducted in compliance with relevant regulations, guidelines, and animal welfare standards.
Author or review non‑clinical, early‑clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.
Contribute to regional or global product label reviews and updates, as appropriate.
Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.
Support the product portfolio in line with Good Laboratory Practices (GLP) 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 a plus (e.g., DABT, ERT).
A minimum of five to seven years of experience in the pharmaceutical or biotech industry with extensive and in‑depth knowledge of non‑clinical safety assessment and drug development, including a strong background in toxicology with competency in DMPK and pharmacology.
Demonstrated knowledge of non‑clinical development as well as drug substance and drug product impurity‑related regulatory guidelines and GxP requirements.
Experience reviewing and authoring non‑clinical sections of regulatory dossiers (e.g., NDAs) and product labels with first‑hand experience with agency interactions (meetings, briefing books, and response documents).
Experience working in project teams (preferably global project teams).
Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel.
Excellent organizational and interpersonal skills.
Ability to manage multiple projects and shifting priorities.
Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.
Ability to analyze and report results from literature reviews and preclinical and clinical studies.
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
Organon 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.
EEO Statement For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement 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 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.
Additional Information 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
Regular
Relocation:
No relocation
VISA Sponsorship:
N/A
Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Number Of Openings:
1
Requisition ID:
R537011
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing
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