Lead Research Scientist

Viatris; United States; Remote; USD 95,000 - 193,000; Full time

Job summary

An established industry player seeks a Lead Research Scientist to drive impactful clinical pharmacology initiatives. This role involves leading scientific discussions, training staff, and collaborating on assay development. As a key player in clinical trials, you will leverage your expertise to solve complex challenges and ensure compliance with regulatory standards. Join a forward-thinking company that values innovation and teamwork, where your contributions will enhance healthcare outcomes for patients worldwide. If you are passionate about making a difference in the healthcare landscape, this opportunity is perfect for you.

Qualifications

• Ph.D. with 3 years or Master's with 6 years in Clinical Pharmacology.
• In-depth knowledge of US CFR, SOPs, and Health Authority regulations.

Responsibilities

• Lead PK scientific discussions and provide scientific feedback.
• Train CRO staff and collaborate with Bioanalytical Lab.

Skills

Analytical Skills

Problem Solving

Communication Skills

Presentation Skills

Statistical Design Concepts

Education

Doctorate degree (Ph.D.)

Master's degree

Tools

Microsoft Office Suite

PK Statistical Program

Sigma Plot

Job description

Mylan Pharmaceuticals 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 Lead Research Scientist role will make an impact:

Key responsibilities for this role include:

• Serves as PK scientific lead responsible for assembly, understanding and presenting study-specific information regarding the drug product for projects assigned. Applies scientific methodology and proposes solutions to formulation/bioequivalence hurdles based on interpretation of previous results of BA, BE and/or PK studies or information gathered from other sources. Provides scientific feedback to other departments as needed.

• Create and/or Review Protocols for Early Phase Clinical Studies. Assemble review of literature, reporting and summarization with respect to PK characterization.

• Train CRO staff (or CRAs) on Protocol, answer questions on study design, and monitor studies and/or collaborate with Clinical Research Associates (CRAs) to ensure studies are monitored and conducted appropriately from a Clinical Pharmacology perspective. Ensure study documentation is written accurately.

• Collaborate with Bioanalytical Lab regarding assay development, moieties to be measured, suitable assay range, sample handling procedures and study execution.

• Assist Program Manager, Quality Specialist and Product Development regarding planning of all aspects of clinical trial conduct and subsequent reporting timelines.

• Review data in collaboration with Statistics for: subject exclusion, time deviations and PK characteristics. Review study results, develop and prepare discussion section with appropriate interpretation of the data. This requires integrating theories and rationale to support conclusion(s) and their meaning(s).

• Assume responsibility for preparation and assembly of final Early Phase Clinical reports, assist in preparation and review of electronic submissions, and review and signoff of final Early Phase Clinical reports.

• Assume responsibility in generating answers to Health Authority questions or addressing Citizen's Petitions with respect to Clinical Pharmacology and clinical trial related queries. Recommend and prepare data presentations and additional statistical information, as required.

• Assist supervisor as needed.

• Perform other duties as assigned.

The minimum qualifications for this role are:

• Doctorate degree (Ph.D.). with at least 3 years of experience or Master's degree with 6 or more years of experience working in Clinical Pharmacology or clinical trials preferred. Clinical Pharmacology or Industrial Pharmacy background, preferred. However, a combination of experience and/or education will be taken into consideration.

• Must possess in-depth knowledge of US CFR, SOPs and Health Authority (ex. FDA, EMA, TGA, TPD, PMDA) regulations and industry guidance.

• Must possess strong analytical and complex problem solving skills. Must possess strong writing, communication, and presentation skills. Must be able to manage multiple projects, have strong computer skills and a working knowledge of Microsoft Office Suite, PK Statistical Program, and Sigma Plot. Experience with physiological based pharmacokinetic (PBPK) modeling, model informed drug development (MIDD), and/or population PK analysis is desirable.

• Position reports directly to Director or above. There are no direct reports to this position. Position acts as a corporate resource. Position functions primarily independently with supervision as needed.

• Registered Pharmacist, considered desirable.

• 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 equations, apply technical mathematical concepts, and perform complex computations. Ability to understand and interpret statistics. Ability to use and understand mathematical modeling in order to draw appropriate conclusion(s). Must have a good understanding of statistical design concepts.

• 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.Periodic travel may be 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.

• Remote home office situation. Work closely with others.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $95,000 - $193,000.

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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