Associate Director, Clinical-Regulatory Methodology

About the role

" Translate deep regulated-pharma expertise into AI that validates biopharma workflows. " ■ Company Overview Cheiron is an AI-native pharma platform. Our products are in market today, supporting biopharma knowledge workers across discovery, translational, nonclinical, clinical, and regulatory work. We are building a unique platform for native representation of biopharma workflows - one that can represent the entire process of drug development as connected, versioned objects rather than a stack of disconnected documents. We're hiring an Associate Director, Clinical-Regulatory Methodology to lead how regulated-pharma judgment becomes product behavior. This is the first dedicated Life Sciences hire - a role for someone who thrives in startup pace, owns a function from scratch, and would rather build the thing than wait for the org chart to catch up. ■ About the Role You will translate hands-on pharma expertise into the workflow specs, evaluation criteria, and acceptance contracts that turn Cheiron's AI products into something a buyer's regulatory team can sign off on - and define what state must persist (claims, evidence, commitments, dispositions) so the next workflow downstream can trust it. For each in-scope workflow - pre-IND nonclinical briefing book, Module 2.4 / 2.6 nonclinical summary authoring, NAM substitution defense under FDAMA 2.0, pre-IND protocol synopsis, 505(b)(2) response, CMC comparability, regulatory commitment closure, DSUR / Investigator's Brochure consistency, Pre-MLR review - you will decompose how the work actually gets done, define what a correct output looks like, write the test set that proves it, and articulate what the platform can and cannot claim externally. You will report to the Head of Life Sciences and partner with the CPO, the PM owning agent-workflow execution, BD, and the founding team. ■ What You'll Do Decompose workflows. Lead Critical Decision Method (CDM) interviews with nonclinical / tox leads, regulatory writers, RA, CMC, medical reviewers, and MLR reviewers to surface decision points, failure modes, and quality criteria as the work actually happens. Define the domain object model. Claims, evidence, regulatory commitments, NAM credibility artifacts, endpoints, limitations, unresolved discrepancies - as objects Engineering can build to and the product can reason over across artifacts and over time. Operationalize "correct" per workflow: regulatory-grammar conformance (ICH M11, eCTDv4, IDMP, SPIRIT 2025, ICH S-series and M3(R2) / M7 for nonclinical, agency-specific), cross-artifact consistency (Module 2.4 / 2.6 ↔ Module 3 ↔ Module 5 ↔ IB), commitment fulfillment across pre-IND / Type B / Type C / conditional-approval correspondence (including stale, partially-satisfied, or superseded), and provenance completeness. Build the three-tier evaluation harness - citation trustworthiness, reasoning correctness, and workflow fidelity against work-as-done. Design ground-truth corpora, severity taxonomies, LLM-as-judge governance, and adjudication rules. Write integration handoff contracts. Source-of-truth hierarchy per workflow; what the platform ingests from Veeva, commercial-content tooling, EDC, eTMF, and other partner systems; what it exports; the provenance envelope. Co-define scientific acceptance gates with Product on the rule-to-UX interface - defer-to-human triggers, unsafe-output taxonomies, traceability requirements. Produce BD-citable conformance metrics - version-locked, with declared denominator, sample frame, model and prompt versions, and confidence intervals. Run methodological acceptance review of pilot outputs against pre-specified regulatory-envelope criteria before client delivery. Manage a bench of subject-matter experts (CMC, MLR, biostatistics, specific therapeutic areas) for second-opinion adjudication on high-severity findings. Serve as the domain-credible lead in early client deployments - guiding sponsor teams through validation workflows in white-glove onboarding and pilots, executing core Cheiron workflows alongside the customer's regulatory and nonclinical leads, and translating program-state findings into regulatory decisions. Client-facing comfort is a practical expectation of the role. ■ What We're Looking For Nonclinical / preclinical pharmacology or toxicology with submission-level engagement - Module 2.4 / 2.6 authoring, GLP tox study oversight, NOAEL adjudication under 21 CFR 58, ICH S-series fluency, or IND-enabling package experience. The first workflow this hire will validate against is the preclinical / CRL-front corpus (PC-203 case, NOAEL adjudication, Module 2.6, GLP QAU audits, SEND, IND-enabling package). 7+ years of regulated pharma / biotech experience, hands-on in one or more of: regulatory affairs, clinical operations, medical writing, pharmacovigilance, clinical pharmacology, biostatistics, or quality in a GxP environment - in addition to the preclinical depth above. Hands-on artifact ownership. You have

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