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Position Summary

The Bioanalytical (BA) function within Translational Medicine/Clinical Pharmacology is a centralized function for testing biological samples for Pharmacokinetics (PK), biomarkers, and Immunogenicity assessments during the development stage. The responsibilities of the groups include providing bioanalytical leadership on BMS drug development teams via scientific/technical expertise and strategic input; overseeing and/or performing assay development/ validation, and sample analysis; supporting regulated and non-regulated bioanalysis for toxicology and clinical studies; and preparing appropriate documentation and/or interacting with health authorities on the BA portion of regulatory filings. The BA groups utilize both internal resources and external strategic partners to ensure on-time delivery of BA data to enable key decisions for the organization.

The candidate for this position will be responsible for providing strategic oversight for LC-MS project management and leadership. Reporting to the Executive Director for Regulated Bioanalysis, the candidate will lead a team that provides bioanalytical support for BMS development projects. Key responsibilities include managing group resources, overseeing bioanalytical method development, validation, and sample analysis projects, as well as handling regulatory interactions related to BMS development candidates.  

This is an On Site Position located in our Princeton, NJ location.

Key Responsibilities

• Develop and implement bioanalytical strategies for BMS development compounds, from GLP studies through life cycle management.
• Provide leadership in authoring and reviewing regulatory filing documents, including IND, NDA/BLA, IB, and others.
• Recruit, mentor, guide, and retain scientific staff within the functional area.
• Evaluate the performance of subordinate staff and actively contribute to their technical, personal, and career development.
• Represent the bioanalytical function on Developmental Project Teams and contribute to the advancement of projects.
• Oversee internal laboratory groups and bioanalytical leads for outsourced studies, focusing on method development, validation, and sample analysis tasks.
• Assist department line management in establishing long-term goals, forecasting budgets, formulating action plans to achieve goals, and assessing success.
• Enhance the scientific credibility of BMS through contributions to scientific literature (publications and presentations), participation in extramural activities, and interactions with academic and health authorities.
• May require travels to CROs for monitoring visits.

Qualifications & Experience

• Bachelor’s Degree
  • 18+ years of academic and / or industry experience

Or

• Master’s Degree
  • 16+ years of academic and / or industry experience

Or

• Ph.D. or equivalent advanced degree in the Life Sciences
  • 13+ of academic and / or industry experience

• A PhD degree in a related field is preferred.
• Demonstrated management experience in regulated bioanalysis, including people management, project leadership, and cross-functional leadership within a bioanalytical organization (CRO or pharmaceutical company) is required.
• Strong expertise in LC/MS-based bioanalysis techniques is essential.
• In-depth knowledge of the principles of regulated bioanalysis and a thorough understanding of GxP regulations.
• Proven track record of accomplishments in team management and cross-functional leadership, with prior management experience at a CRO or pharmaceutical company.
• Well-versed