Executive Director - Non-Clinical Safety Assessment Lead

Non-Clinical Safety Assessment Lead

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 Organons 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 Womens 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 Organons 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.