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Compensation
Salary undisclosedDescription
Your mission
We are seeking a highly innovative and experienced Bioanalytical Lead to bridge the gap between our predictive AI design platform and wet-lab preclinical execution.
In this role, you will define the overarching bioanalytical strategy across our expanding portfolio, covering small molecules, advanced biologic formats, and Antibody-Drug Conjugates (ADCs) in both non-GLP and GLP environments. You will collaborate closely with the drug design teams, design robust bioanalytical assays, manage global Contract Research Organizations (CROs), and lead the logistical execution required to rapidly advance our candidates toward IND submission.
As the Bioanalytical Lead, you will serve as the technical expert for our diverse portfolio of computationally designed therapeutic candidates. As part of the preclinical development function, this is a high-impact leadership role responsible for building the bridge between Isomorphic’s AI-driven discovery engine and the effective execution of our robust preclinical strategies, alongside safety and DMPK. The successful candidate will be forward thinking, thrive in fast-paced, agile environment and ready to embrace Iso’s AI-first mindset and challenge the status quo. With a broad range of internal and external stakeholders, candidates will be expected to have exceptional communication and influencing skills.
Bioanalytical Strategy & AI Integration
- Define and execute comprehensive bioanalytical strategies for small molecules, large molecules, and complex modalities (ADCs) from discovery through preclinical development covering both non-GLP and GLP environments.
- Oversee the design, validation, and transfer of robust PK, PD, and immunogenicity (ADA) assays at external labs.
- Collaborate with AI/machine learning scientists to integrate bioanalytical data back into predictive models, helping to continuously improve our platform's accuracy.
- Lead biomarker assay strategies, utilizing both traditional approaches and AI-identified novel biomarkers to support preclinical proof-of-concept.
Global CRO Management & Logistics
- Select, qualify, and manage a high-performing network of global CRO partners, ensuring rigorous data quality, strict timelines, and budget alignment.
- Master complex global logistics, including international sample shipments, cold-chain management, import/export compliance, and stability tracking across borders to ensure data integrity.
- Serve as the primary technical point of contact for CROs, troubleshooting complex assay anomalies rapidly.
Cross-Functional Leadership and Regulatory Authoring
- Work seamlessly at the intersection of Drug Discovery, Translational Medicine, and Computational Biology to drive candidates into the clinic.
- Author and review high-quality regulatory documents, specifically bioanalytical sections of Investigational New Drug (IND) applications and Investigator Brochures (IBs).
- Represent the bioanalytical function in cross-functional project teams and during interactions with regulatory agencies (FDA, EMA, etc.).
Required expertise and experience
- Ph.D. in Biochemistry, Analytical Chemistry, Pharmacology, or a related scientific discipline with 5+ years of biotech/pharmaceutical industry experience; OR a B.S./M.S. with 8+ years of equivalent experience.
- Proven track record of leading bioanalytical strategies across multiple modalities (must include small molecules, biologics, and ADCs).
- Deep understanding of GLP and non-GLP preclinical study regulations, FDA/EMA bioanalytical method validation guidelines, and ICH guidelines.
- Technical & Logistical Expertise
- Extensive experience with diverse analytical platforms (e.g., LC-MS/MS, LBA, flow cytometry).
- Demonstrated success in biomarker assay development and validation.
- Expert knowledge of global sample shipping logistics, biosafety regulations, and maintaining chain-of-custody for precious preclinical samples.
- Experience writing bioanalytical sections for successful IND submissions.
Nice to have
- Experience of generating reagent in collaboration with drug design teams
- Experience of developing or using AI tools (LLM) to accelerate processes including reporting
Stack
- Posted
- Jul 9, 2026
- Last seen
- Jul 9, 2026
- First seen
- Jul 9, 2026
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