Operations Director

Position Title: Director, Nonclinical Development

Assignment Duration: 12 months

Work Schedule: 40 hours/week

Work Arrangement: Remote

Position Summary:

The Director, Nonclinical Development is responsible for providing nonclinical subject matter expertise to support programs in our organization'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.

Background & Context:

To that aim, this position will serve as the nonclinical representative on asset development teams (ADTs) to support life-cycle management of products in our organization'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.

Key Responsibilities:

* Serve as the Nonclinical representative on ADTs in the development and execution of life-cycle management activities for products in our organization'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 our organization's portfolio.

* Nonclinical point of contact for Regulatory, Safety, and Pharmacovigilance activities support of our organization's 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 our organization 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 organization Standard Operating Procedures (SOPs).

Qualification & Experience:

* Master's, 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 our organization 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.