Senior Director Nonclinical Development

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🕒 Julho 31, 2025

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Viatris

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2020

💊 Farmacêutico

⚕️ Seguro de Saúde

Pharmaceuticals • Healthcare Insurance

Viatris é uma empresa global de saúde comprometida em ampliar o acesso a medicamentos de alta qualidade para pacientes no mundo todo. Oferece um portfólio diversificado de produtos, incluindo marcas e genéricos, e atua em diversas áreas terapêuticas que abrangem tanto doenças não transmissíveis quanto infecciosas. A Viatris opera com o objetivo de assegurar um fornecimento confiável de medicamentos, garantindo que os pacientes recebam os tratamentos de que precisam, quando e onde precisam. A empresa é dedicada ao empoderamento em saúde, promovendo uma vida mais saudável ao longo das diferentes fases da vida, apoiada por sua plataforma global de saúde. Suas operações se baseiam em um forte compromisso com sustentabilidade, governança corporativa e conformidade regulatória em diferentes regiões.

Descrição

• 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).

🎯 Requisitos

• 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.

🏖️ Benefícios

• Competitive salaries • Comprehensive benefits • Inclusive environment