Senior Director Nonclinical Development

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July 31

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Viatris

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Pharmaceuticals • Healthcare Insurance

Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Direct all aspects of nonclinical development including staffing, supervising, providing work direction, goal setting, prioritization, etc. • Oversee the development of the nonclinical regulatory strategy, design of experiments, interpretation of data and oral and written presentation of results. • Oversee the review and approval of all preclinical protocols and final reports for nonclinical development studies and ensure data quality and integrity for preclinical sites. • Effectively communicate preclinical findings to project teams, senior management, regulators and other external partners. • Oversee the research and construction of regulatory study documents for new and complex product development (i.e., IND/NDA preclinical sections etc.). • Represent Viatris and Global Pharmacology and Toxicology in meetings with regulatory agencies. • Provide technical support to various departments within the company with respect to pharmacology and toxicology. • May perform and serve as a reviewer on toxicological risk assessments for various health based exposure limits (HBELs), such as ADEs, PDEs, ADIs and OELs. • Assist in the development and adherence to departmental budget. • Review for comprehension relevant Standard Operational Procedures (SOPs).

🎯 Requirements

• Minimum of a Bachelor's degree (or equivalent) and 15 years of experience. • DVM, PhD or in a biomedical discipline or PharmD degree preferred with 10 years of relevant pharmaceutical experience preferred. • Must possess expert knowledge of pharmaceutical drug development requirements for regulatory submissions. • Must possess expert in-depth knowledge of product development, analytical sciences, and clinical operations. • Must have broad knowledge of GMP, GLP, GCP and the Global Regulatory process for Brand/Specialty and generic product approval. • Must be team-oriented and have exceptional organizational, oral and written communication, and computer skills. • Must be able to interface with others of diverse backgrounds, skills, and interests and to maintain a productive and cooperative working relationship. • Must have the ability to provide guidance to the Research and Development, Regulatory, and Business Development project teams, to understand technical problems and to make appropriate recommendations for solutions.

🏖️ Benefits

• Competitive salaries • Comprehensive benefits • Inclusive environment