Director of Analytics

Title: Director / Senior Director – Bioanalytical Development (DMPK, Bioanalysis)Type: Contract (12 Months, Extension Possible)Location: Remote to Hybrid | Bedford, MAOne of my Clients is seeking a seasoned leader in Bioanalytical Development to support the Quantitative & Clinical Pharmacology (QCP) function. This is a high-impact contract role responsible for driving the development, validation, and execution of PK bioanalytical strategies across nonclinical and clinical programs. You will play a critical role in enabling lead optimization, candidate selection, and regulatory submissions, while partnering cross-functionally with Translational Biology, Clinical Operations, and Nonclinical Development teams.🚀 Key ResponsibilitiesLead bioanalytical strategy and execution for PK assays, with a focus on oligonucleotide therapeutics (siRNA, ASOs, conjugates)Design, develop, and validate high-sensitivity methods (LC-MS/MS, hybrid-ELISA, qPCR)Develop and validate ligand-binding assays for large molecule PK and immunogenicityOversee assay lifecycle from early development through regulatory submissionAct as the primary technical lead for CROs, ensuring quality, data integrity, and timely deliveryProvide subject matter expertise across study design, sample management, and data interpretationAnalyze and report PK, immunogenicity, and ADME/DMPK data across programsEnsure compliance with GLP/GCP standards and global regulatory requirements (including ICH M10)🎯 QualificationsPh.D. in Analytical Chemistry, Biochemistry, Medicinal Chemistry, or related field7+ years of industry experience in PK bioanalysis within biotech/pharmaStrong hands-on experience in oligonucleotide bioanalytical method developmentExpertise in LC-MS/MS, hybridization assays, and ligand-binding assays (ELISA/MSD)Experience supporting clinical and nonclinical studies, including CRO oversightSolid understanding of drug development (ADME, PK/PD, translational research)Proven experience working in GLP/GCP environments and supporting regulatory submissions⚠️ Additional NotesThis role will begin as remote and transition to a hybrid model (2 days/week onsite) in the later phase of the assignment💡 Why This Role?This is a leadership opportunity to drive bioanalytical strategy for cutting-edge oligonucleotide programs in a fast-paced, collaborative environment with direct impact on clinical advancement and regulatory success.