Bioanalytical Lead, London

Overview

In this Bioanalytical Lead role, you will define and drive the bioanalytical strategy across small molecules, biologics, and ADCs, bridging AI-driven discovery with wet-lab execution. You’ll manage CROs, oversee assay design and validation, and ensure data feeds back into predictive models to advance candidates toward IND. You’ll lead cross-functional work with regulatory and translational teams, shaping preclinical strategies in a fast-paced, AI-first environment.

Pay / Benefits

• hybrid working model (office 3 days/week)

Responsibilities

• Define and execute bioanalytical strategies across modalities from discovery to preclinical development (non-GLP and GLP).
• Oversee design, validation, and transfer of PK, PD, and ADA assays at external labs.
• Collaborate with AI/ML scientists to feed bioanalytical data back into predictive models.
• Lead biomarker assay strategies, including AI-identified biomarkers for preclinical proof-of-concept.
• Select, qualify, and manage global CRO partners with focus on data quality and timelines.
• Coordinate complex global logistics for samples, cold-chain, and regulatory compliance.
• Serve as the primary technical contact for CROs and troubleshoot assay issues.
• Author and review regulatory documents (IND sections, IBs) and represent bioanalytical function in cross-functional teams and with regulators.

Key requirements

• Ph.D. in Biochemistry, Analytical Chemistry, Pharmacology, or related field with 5+ years biotech/pharma experience; OR BS/MS with 8+ years of equivalent experience.
• Proven track record leading bioanalytical strategies across small molecules, biologics, and ADCs.
• Deep knowledge of GLP/non-GLP regulations, FDA/EMA bioanalytical guidelines, and ICH guidelines.
• Experience with analytical platforms (LC-MS/MS, LBA, flow cytometry).
• Biomarker assay development and validation experience.
• Global sample shipping logistics, biosafety, and chain-of-custody handling.
• Experience writing bioanalytical sections for IND submissions.

• Excellent communication and influencing abilities
• Cross-functional collaboration
• Agility in a fast-paced environment
• LC-MS/MS
• LBA (ligand-binding assays)
• Flow cytometry

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