Pioneering Medicines: Principal Scientist / Senior Principal Scientist, Bioanalytical Lead - Drug Metabolism & Pharmacokinetics

About the role

We are looking for a highly skilled and motivated scientist to join our DMPK team as the Bioanalytical Lead at the Principal Scientist or Senior Principal Scientist level. This role will be responsible for leading and executing bioanalytical strategies across our drug discovery and development portfolio, spanning small molecules, peptides, and biologics. Given that 100% of our bioanalytical work is outsourced, the ideal candidate must have strong CRO management experience and the ability to oversee and drive high-quality outsourced bioanalytical programs. In addition to bioanalytical leadership, this individual will also be expected to serve as operations lead for ADME and PK studies as needed. The ideal candidate brings deep expertise in LC-MS/MS bioanalysis, a strong working knowledge of ligand binding assays and immunogenicity assessment, and the ability to manage complex operational activities across multiple concurrent programs.

Responsibilities

• Scientific & Bioanalytical
• Lead bioanalytical strategy and execution for non-GLP and GLP PK, TK, and clinical studies across small molecule, peptide, and biologic programs
• Develop, qualify, and validate LC-MS/MS methods for small molecules and peptides in biological matrices
• Develop and validate LBA/hybrid LC-MS methods for biologics including PK and ADA assays
• Serve as the Clinical Bioanalytical Lead for assigned programs, including oversight of method transfer to clinical CROs and clinical laboratories
• Provide scientific and strategic bioanalytical guidance to cross-functional program teams and platform companies
• Collaborate with DMPK, Clinical Pharmacology, Toxicology, and CMC teams to ensure integrated bioanalytical support
• Contribute to regulatory submissions including IND filing and clinical study reports
• Support development and implementation of innovative bioanalytical tools and workflows including digital and AI/ML-based solutions
• CRO & Outsourcing Management
• Manage all outsourced bioanalytical activities across 100% externally executed portfolio serving as the primary scientific and operational interface with CROs
• Identify, evaluate, and qualify CRO partners for bioanalytical services including LC-MS/MS, LBA, hybrid LC-MS, and immunogenicity assays
• Oversee CRO study execution, data quality, timelines, and deliverables to ensure alignment with program requirements and regulatory standards
• Coordinate with legal and finance on CDAs, MSAs, SOWs, and POs with CROs and external partners
• Manage vendor relationships, performance metrics, and issue resolution across the CRO network
• Operational & Portfolio Management
• Coordinate and manage DMPK operational activities across the entire internal and partnered portfolio including PK, ADME, BA, and immunogenicity studies
• Serve as operations lead for ADME and PK studies as needed, in addition to primary bioanalytical responsibilities
• Manage study scheduling, sample management, material shipment, handling, and logistics across multiple concurrent programs
• Track and manage program timelines, deliverables, and budgets to ensure continuity across the portfolio
• Support development and maintenance of DMPK operational tools, databases, and automated workflows to drive efficiency

Requirements

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or related field with 8+ years of industry experience (Principal Scientist), or 10+ years of industry experience (Senior Principal Scientist); or MS with 15+ years of relevant experience
• Deep expertise in LC-MS/MS bioanalysis for small molecules and peptides
• Strong working knowledge of LBA platforms (MSD, ELISA) and hybrid LC-MS methods for biologics
• Experience with GLP bioanalytical method validation per FDA/EMA g

Additional Information

Principal Scientist / Senior Principal Scientist, Bioanalysis Bioanalytical Lead | Drug Metabolism & Pharmacokinetics Note: Level will be commensurate with experience, skill set, and qualifications. What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner? ABOUT PIONEERING MEDICINES Pioneering Medicines, Flagship Pioneering's in-house drug development unit, is dedicated to conceiving and developing a broad portfolio of life-changing treatments for patients built from Flagship's innovative platforms. Harnessing the drug development expertise of its team together with the power of Flagship's multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship's bioplatform companies. Within Flagship's Innovation Supply Chain partnerships, Pioneering Medicines works with external collaborators to apply its unique approach to partners' R&D priorities. These partnerships are highly co-creative strategic alliances that accelerate therapeutic innovation by bringing together partners spanning the full spectrum of drug discovery, development, and production.

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