Senior Director Nonclinical Development

Role Summary

Senior Director Nonclinical Development

Responsibilities

• 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).

Qualifications

• 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. However, a combination of experience and/or education will be taken into consideration.
• 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.
• The successful candidate 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.
• Position functions autonomously. Position directly supervises employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Ability to read and interpret comprehensive and intricate research documents. Ability to write scientific reports and technical correspondence. Ability to work with executives and communicate abstract concepts. Ability to present to a high level of the organization and groups outside of the organization.
• Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis. Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.
• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel maybe required. May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms. Sedentary lifting requirements.
• Normal office situation.
• Proficiency in speaking, comprehending, reading and writing English is required.

Education

• Not specified beyond degree requirements in qualifications.