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

Flagship Pioneering, Inc.•Cambridge, MA

8h•$148,000 - $203,500

About The Position

Pioneering Medicines is seeking a highly skilled and motivated scientist to join their DMPK team as the Bioanalytical Lead at the Principal Scientist or Senior Principal Scientist level. This role is responsible for leading and executing bioanalytical strategies across the drug discovery and development portfolio, which includes small molecules, peptides, and biologics. A key aspect of this role is the management of outsourced bioanalytical work, as 100% of this is handled externally. The ideal candidate will possess strong CRO management experience and the ability to oversee and drive high-quality outsourced bioanalytical programs. Additionally, this individual will serve as an operations lead for ADME and PK studies as needed. The role requires deep expertise in LC-MS/MS bioanalysis, a strong understanding of ligand binding assays and immunogenicity assessment, and the capability to manage complex operational activities across multiple concurrent programs.

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 guidance.
Proven experience managing outsourced bioanalytical programs and CRO relationships.
Experience supporting clinical bioanalysis and method transfers to clinical CROs.
Demonstrated ability to manage complex operational activities across multiple programs simultaneously in a fast-paced environment.
Strong organizational skills with experience coordinating legal and financial documentation including CDAs, MSAs, SOWs, and POs.
Excellent communication and cross-functional collaboration skills.

Nice To Haves

Familiarity with immunogenicity assay strategy and ADA method development is a plus.
Experience with both non-GLP and GLP studies across discovery through IND-enabling and clinical stages.
Experience working in a biotech or drug discovery environment supporting multiple internal and partnered programs simultaneously.
Experience serving as operations lead for ADME and/or PK studies.
Experience with AI/ML tools to drive efficiency and innovation in bioanalysis and DMPK operations.

Responsibilities

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.
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.
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.