Senior Director, Bioanalysis

Beeline Medicines•Boston, MA

8d•$249,000 - $268,750•Hybrid

About The Position

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. We are seeking an experienced Senior Director, Bioanalysis to lead bioanalytical strategy and execution across small molecule and biologics programs. This role will be responsible for the development, validation, and oversight of bioanalytical assays supporting pharmacokinetics (PK), toxicokinetics (TK), and immunogenicity across preclinical and clinical studies, including Phase 1–3. The ideal candidate will bring deep expertise in bioanalysis together with a familiarity of DMPK and PK interpretation, enabling close partnership across Clinical Pharmacology, Translational Sciences, and Regulatory to support program decisions and regulatory submissions.

Requirements

Ph.D. in Bioanalytical Chemistry, Pharmacokinetics, Biochemistry, Pharmaceutical Sciences, or related discipline (or MS with significant relevant industry experience)
12+ years of relevant experience in bioanalysis supporting drug development within pharmaceutical and/or biotechnology industry
Deep expertise in bioanalysis across preclinical and clinical development
Strong experience with LC-MS/MS assays for small molecules, ligand-binding and/or hybrid assays for biologics, and Immunogenicity assays, including ADA and neutralizing antibody methods
Experience overseeing bioanalytical work across multiple programs and development stages
Strong understanding of regulatory expectations for bioanalytical method validation, sample analysis, and reporting
Experience interpreting PK/TK data and applying bioanalytical results to broader development questions
Experienced in cross-functional collaboration with Clinical Development, Regulatory Affairs, and Translational Medicine teams to integrate clinical pharmacology strategy — including PK/PD, dose selection, and modeling — into program-level decision-making
Demonstrated ability to set strategic direction for clinical pharmacology operations, including study design, data interpretation, and regulatory strategy, while maintaining accountability for quality, compliance, and delivery across competing program priorities
Exceptional ability to synthesize complex PK/PD, exposure-response, and modeling and simulation data and communicate findings clearly to cross-functional audiences ranging from bench scientists to senior R&D leadership, clinical teams, and health authorities
Establishes and models a culture of scientific rigor and open communication within the clinical pharmacology team, ensuring data interpretations, assumptions, and limitations are transparently conveyed and appropriately documented across regulatory and internal deliverables

Responsibilities

Lead bioanalytical strategy across preclinical and clinical-stage programs for small molecules and biologics
Oversee development, qualification, validation, transfer, and lifecycle management of assays for: Small molecules PK/TK using LC-MS/MS, Biologics PK assay using ligand-binding and/or hybrid assay platforms, Immunogenicity assays, including ADA and neutralizing antibody assessments
Provide scientific oversight for bioanalytical activities supporting preclinical and clinical programs
Select and manage external bioanalytical partners and ensure high-quality, timely execution
Support investigations and root cause analyses for any out-of-specification (OOS) results, deviations, or process failure
Review and approve assay plans, validation reports, sample analysis plans, data packages, and final study reports
Partner closely with Clinical Pharmacology and translational sciences to support PK/TK interpretation and sampling strategy.
Contribute to study design and execution across preclinical toxicology, clinical pharmacology, and clinical development
Author and review bioanalytical contributions to IND, NDA, and BLA submissions and support responses to health authorities
Ensure bioanalytical activities are conducted in compliance with applicable GLP, GCP, and global regulatory guidance
Perform other duties and responsibilities as assigned