Senior Director Nonclinical Development

Senior Director Nonclinical Development page is loaded## Senior Director Nonclinical Development locations:
United States Remote Office time type:
Praca na pełny etatposted on:
Opublikowano ponad 30 dni temujob requisition :
R5661251

Mylan Inc.

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
* * Access* – Providing high quality trusted medicines regardless of geography or circumstance;
* * Leadership* – Advancing sustainable operations and innovative solutions to improve patient health; and
* * Partnership* – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the Senior Director Nonclinical Development role will make an impact:

Key responsibilities for this role include:
* 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).The minimum qualifications for this role are:
* 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…