Senior Director Nonclinical Development

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

About Mylan Inc. Viatris

Mylan Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. 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, Hiring and Workplace

• 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.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $151,000 - $314,000.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.