Viatris · 1 week ago
Senior Director Nonclinical Development
United States
Full-time
Remote
Director/Executive
$151K/yr - $314K/yr
15+ years expViatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. The Senior Director Nonclinical Development will oversee all aspects of nonclinical development, including regulatory strategy, data interpretation, and communication with project teams and regulatory agencies.
BiotechnologyHealth CareLife SciencePharmaceutical
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)
Qualification
Required
Minimum of a Bachelor's degree (or equivalent) and 15 years of experience
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
Preferred
DVM, PhD or in a biomedical discipline or PharmD degree preferred with 10 years of relevant pharmaceutical experience preferred
A combination of experience and/or education will be taken into consideration
Benefits
Competitive salaries
Benefits
An inclusive environment
Company
Viatris
Viatris is a global pharmaceutical company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2020-11-17IPO
Leadership Team
Scott A. Smith
Chief Executive Officer
Doretta Mistras
Chief Financial Officer
Recent News
legacy.thefly.com
2026-01-21
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