Senior Director Nonclinical Development

$151,000 - $314,000/Yr

Mylan - Canonsburg, PA

Full-time - Senior

Canonsburg, PA

Food and Beverage Retailers

About the position

The Senior Director of Nonclinical Development at Viatris is responsible for overseeing all aspects of nonclinical development, including staffing, regulatory strategy, and data integrity. This role involves direct supervision of employees, communication of preclinical findings, and representation of the company in regulatory meetings. The position requires a strong background in pharmaceutical drug development and the ability to lead diverse teams effectively.

Responsibilities

• Direct all aspects of nonclinical development including staffing, supervising, providing work direction, goal setting, and prioritization.
• Oversee the development of the nonclinical regulatory strategy, design of experiments, interpretation of data, and presentation of results.
• Review and approve all preclinical protocols and final reports for nonclinical development studies, ensuring data quality and integrity.
• Effectively communicate preclinical findings to project teams, senior management, regulators, and external partners.
• Oversee the research and construction of regulatory study documents for new and complex product development.
• Represent Viatris and Global Pharmacology and Toxicology in meetings with regulatory agencies.
• Provide technical support to various departments regarding pharmacology and toxicology.
• Perform and serve as a reviewer on toxicological risk assessments for health-based exposure limits.
• Assist in the development and adherence to departmental budget.
• Review relevant Standard Operational Procedures (SOPs) for comprehension.

Requirements

• Minimum of a Bachelor's degree (or equivalent) and 15 years of experience; DVM, PhD, or PharmD preferred with 10 years of relevant pharmaceutical experience.
• Expert knowledge of pharmaceutical drug development requirements for regulatory submissions.
• In-depth knowledge of product development, analytical sciences, and clinical operations.
• Broad knowledge of GMP, GLP, GCP, and the Global Regulatory process for Brand/Specialty and generic product approval.
• Exceptional organizational, oral and written communication, and computer skills.
• Ability to interface with diverse backgrounds and maintain productive working relationships.
• Ability to provide guidance to project teams and make appropriate recommendations for solutions.
• Ability to read and interpret comprehensive research documents and write scientific reports.

Nice-to-haves

• Experience in regulatory submissions for complex product development.
• Familiarity with international regulatory requirements.

Benefits

• Competitive salary
• Excellent benefits
• Inclusive work environment
• Opportunities for professional growth and advancement