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
[https://www.viatris.com/en/careers] 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 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.
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