Senior Director Nonclinical Development
Viatris
August 20, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Senior Director, Nonclinical Development
Key Responsibilities:
- Direct all aspects of nonclinical development including staffing, supervising, work direction, goal setting, and prioritization.
- Oversee nonclinical regulatory strategy, design of experiments, interpretation of data, and oral/written presentation of results.
- Review and approve preclinical protocols and final reports; ensure data quality and integrity for preclinical sites.
- Communicate preclinical findings to project teams, senior management, regulators, and external partners.
- Oversee research and construction of regulatory study documents for new/complex product development (e.g., IND/NDA preclinical sections).
- Represent the company and Global Pharmacology and Toxicology in meetings with regulatory agencies.
- Provide technical support to internal departments regarding pharmacology and toxicology.
- May serve as reviewer on toxicological risk assessments for HBELs (e.g., ADEs, PDEs, ADIs, OELs).
- Assist in departmental budget development and adherence.
- Review Standard Operational Procedures (SOPs) for comprehension.
Minimum Qualifications:
- Bachelor’s degree (or equivalent) and 15 years of experience; DVM/PhD/biomedical discipline/PharmD preferred with 10 years of relevant pharmaceutical experience preferred.
- 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 global regulatory process for brand/specialty and generic approvals.
- Team-oriented with exceptional organization, oral/written communication, and computer skills; ability to guide R&D/Regulatory/Business Development teams.
- Autonomous functioning; direct supervision experience and related HR responsibilities.
- Ability to read/interpret complex research documents; write scientific reports and technical correspondence; present to executives and external groups.
- Ability to solve complex problems requiring independent judgment.
- English proficiency (speaking, comprehending, reading, writing).
Salary Range:
- $151,000 - $314,000.
Application Instructions:
- Not provided.
Key Responsibilities:
- Direct all aspects of nonclinical development including staffing, supervising, work direction, goal setting, and prioritization.
- Oversee nonclinical regulatory strategy, design of experiments, interpretation of data, and oral/written presentation of results.
- Review and approve preclinical protocols and final reports; ensure data quality and integrity for preclinical sites.
- Communicate preclinical findings to project teams, senior management, regulators, and external partners.
- Oversee research and construction of regulatory study documents for new/complex product development (e.g., IND/NDA preclinical sections).
- Represent the company and Global Pharmacology and Toxicology in meetings with regulatory agencies.
- Provide technical support to internal departments regarding pharmacology and toxicology.
- May serve as reviewer on toxicological risk assessments for HBELs (e.g., ADEs, PDEs, ADIs, OELs).
- Assist in departmental budget development and adherence.
- Review Standard Operational Procedures (SOPs) for comprehension.
Minimum Qualifications:
- Bachelor’s degree (or equivalent) and 15 years of experience; DVM/PhD/biomedical discipline/PharmD preferred with 10 years of relevant pharmaceutical experience preferred.
- 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 global regulatory process for brand/specialty and generic approvals.
- Team-oriented with exceptional organization, oral/written communication, and computer skills; ability to guide R&D/Regulatory/Business Development teams.
- Autonomous functioning; direct supervision experience and related HR responsibilities.
- Ability to read/interpret complex research documents; write scientific reports and technical correspondence; present to executives and external groups.
- Ability to solve complex problems requiring independent judgment.
- English proficiency (speaking, comprehending, reading, writing).
Salary Range:
- $151,000 - $314,000.
Application Instructions:
- Not provided.