Senior Director, Nonclinical Development Strategy

1100 Mylan Pharmaceuticals Inc.; United States; Remote; USD 151,000 - 314,000; Full time

Job summary

Viatris seeks a Senior Director of Nonclinical Development to lead all aspects of nonclinical activities, including strategy, design, data interpretation, and regulatory submissions. The role requires interfacing with project teams, senior management, and regulators to ensure data quality and project success.

The successful candidate will provide guidance across pharmacology/toxicology, regulatory science, and development programs, while mentoring teams and managing budgets and SOP alignment.

Qualifications

• Minimum of a Bachelor’s degree and 15 years of experience.
• DVM, PhD or PharmD preferred with 10 years of relevant pharmaceutical experience.
• Must possess expert knowledge of regulatory drug development requirements for submissions.
• Must possess expert in-depth knowledge of product development, analytical sciences, and clinical operations.
• Broad knowledge of GMP, GLP, GCP and global regulatory processes.

Responsibilities

• Direct all aspects of nonclinical development including staffing, supervising, providing work direction, goal setting, prioritization.
• 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.
• Communicate preclinical findings to project teams, senior management, regulators and external partners.
• Oversee regulatory study documents for IND/NDA preclinical sections and related work.
• Represent Viatris in meetings with regulatory agencies.
• Provide technical support to departments regarding pharmacology and toxicology.
• Assist in the development and adherence to departmental budget.

Skills

Team leadership

Oral and written communication

Regulatory knowledge

Toxicology/pharmacology

Education

Bachelor's degree

DVM/PhD/PharmD preferred

Job description

Viatris seeks a Senior Director of Nonclinical Development to lead all aspects of nonclinical activities, including strategy, design, data interpretation, and regulatory submissions. The role requires interfacing with project teams, senior management, and regulators to ensure data quality and project success.

The successful candidate will provide guidance across pharmacology/toxicology, regulatory science, and development programs, while mentoring teams and managing budgets and SOP alignment.