Director, Bioanalysis

Summary

Join Arvinas, a clinical-stage biotechnology company, as a seasoned bioanalytical scientist contributing expertise in small molecule bioanalysis to all stages of drug development. This role involves regulated bioanalysis for nonclinical GLP and clinical programs, reporting to the Vice President of Nonclinical Sciences. A hybrid or remote work arrangement within the US is possible. The position requires significant experience in bioanalysis within the biopharmaceutical industry, focusing on small molecules and LC/MS/MS. Arvinas offers a competitive compensation and benefits package, including medical, vision, dental, and life insurance.

Requirements

• 10+ years of direct experience in bioanalysis in the biopharmaceutical industry or CROs supporting pharmaceutical development, with a focus on small molecules
• Expertise on LC/MS/MS based bioanalytical science including theoretical background and practical problem-solving skills
• In-depth knowledge of current regulatory requirements and up-to-date knowledge of evolving regulatory landscape for GLP bioanalysis
• General knowledge of drug discovery and development process
• Experience in bioanalytical outsourcing

Responsibilities

• Contribute to the formulation and execution of bioanalytical strategy supporting all facets of Arvinas bioanalytical needs from a project, portfolio, or functional levels
• Participate in the non-regulated bioanalytical support for in vitro ADME, preclinical in vivo PK, ADME, and PK/PD studies, DRF toxicology studies and regulated and GLP-compliant bioanalytical work for GLP toxicology and clinical pharmacology
• Contribute to bioanalysis outsource strategy; evaluate, recommend, or select bioanalytical CROs to ensure timely and stage-appropriate bioanalytical support of Arvinas projects
• Serve as Arvinas SME and oversee the development, qualification, or validation of bioanalytical methods for various matrices and species
• Serve as Arvinas representative to coordinate all facets of bioanalysis and ensure timely delivery of high-quality bioanalytical results to support project progression and decision-making
• Ensure high quality and regulatory compliance for all Arvinas regulated bioanalytical work
• Stay up to date with the scientific advance and evolving domestic (FDA) and international (ICH, etc.) regulatory landscape for bioanalysis for the pharmaceutical industry

Preferred Qualifications

• Previous experience with ligand binding assays and immunogenicity assays to support biological and ADC development
• Ph.D. in chemistry, pharmaceutical science, or related scientific discipline
• Master’s Degree with an equivalent combination of education and experience

Benefits

• Group medical, vision and dental coverage
• Group and supplemental life insurance