Lead Research Scientist

April 9

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Viatris

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Viatris is a global healthcare company committed to improving access to high-quality medicines for patients worldwide. They offer a diverse range of products including brands and generics, and focus on various therapeutic areas that address both noncommunicable and infectious diseases. Viatris operates with a goal of providing reliable medication supply, ensuring that patients receive the treatments they need when and where they need them. The company is dedicated to healthcare empowerment, facilitating healthier living through various stages of life, supported by their global healthcare gateway. Their operations are grounded in a strong commitment to sustainability, corporate governance, and regulatory compliance across different geographies.

Pharmaceuticals • Generics • Anesthesia & Pain Management • CNS • Cardiovascular

10,000+ employees

Founded 2020

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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. • 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.

🎯 Requirements

• 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. • Must possess in-depth knowledge of US CFR, SOPs, and Health Authority 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.

🏖️ Benefits

• Competitive salaries • Inclusive environment