Senior Director, Nonclinical Development

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead all facets of nonclinical development, including staffing, supervision, work direction, goal establishment, and prioritization.

• Manage the formulation of the nonclinical regulatory strategy, design experiments, interpret data, and present results both orally and in writing.

• Supervise the evaluation and approval of all preclinical protocols and final reports for nonclinical development studies, ensuring data quality and integrity at preclinical sites.

• Clearly communicate preclinical discoveries to project teams, senior management, regulatory bodies, and other external stakeholders.

• Oversee the research and drafting of regulatory study documents associated with new and complex product development (e.g., IND/NDA preclinical sections).

• Represent Viatris and the Global Pharmacology and Toxicology team in discussions with regulatory agencies.

• Provide technical assistance to various departments within the organization concerning pharmacology and toxicology.

⛳️ Requirements

• A minimum of a Bachelor's degree (or equivalent) along with 15 years of experience.

• A DVM, PhD, or a degree in a biomedical discipline, or a PharmD is preferred, with at least 10 years of relevant pharmaceutical experience.

• Expert knowledge of pharmaceutical drug development requirements for regulatory submissions is essential.

• In-depth expertise in product development, analytical sciences, and clinical operations is required.

• A comprehensive understanding of GMP, GLP, GCP, and the Global Regulatory process for both Brand/Specialty and generic product approvals is necessary.

• The ideal candidate should be team-oriented and possess outstanding organizational, verbal and written communication, and computer skills.

• Must be capable of interacting with individuals from diverse backgrounds, skills, and interests, while maintaining a productive and collaborative working relationship.

• The ability to provide guidance to the Research and Development, Regulatory, and Business Development project teams, comprehend technical issues, and offer suitable recommendations for solutions is required.

🏝️ Benefits

• Competitive salaries

• Benefits

• Inclusive environment