Associate Director, Clinical-Regulatory Methodology

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.

Responsibilities

• 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across pre-IND / Type B / Type C / conditional-approval correspondence (including stale, partially-satisfied, or superseded), and provenance completeness.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.
• 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.

Requirements

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 personally authored, reviewed, or materially revised regulated artifacts — protocols, briefing books, IND / NDA / BLA modules, 505(b)(2) responses, CSRs, MLR review packages, CMC regulatory responses, or commitment trackers — and can discuss concrete artifact-level failures with technical detail.

Build-side and practitioner-side experience. You have worked on product, technology, or methodology tooling for life sciences in addition to the practitioner side.

Systems-of-record adjacency. Experience at the intersection of clinical / regulatory content and Veeva Vault, CTMS, RIM, or comparable platforms; can define provenance handoffs across organizational boundaries.

Evaluation framework / acceptance criteria / QC design for automated systems in regulated environments — GxP CSV, RegTech, AI / ML validation, GAMP 5.

Cognitive task analysis (CDM, CTA) or human-factors approaches to expert workflows.

MLR or promotional review experience.

Time on the customer side — fractional CMO, small-biotech head of RA, VP / head of nonclinical or preclinical development, DABT-track regulatory toxicologist, or clinical-pharm consultant.

Qualifications

Nonclinical / preclinical depth — Module 2.4 / 2.6 authoring, GLP tox study oversight, NOAEL adjudication under 21 CFR 58, ICH S-series fluency, or NAM credibility work under FDAMA 2.0 and the FDA AI Credibility framework (Jan 2025 draft).

Hands-on experience with cross-artifact reconciliation — the person who tracked what a manufacturing change touched, who maintained a sponsor’s commitment register across an active IND, or who held the IB consistent with active protocols across an amendment cycle.

Evaluation framework / acceptance criteria / QC design for automated systems in regulated environments — GxP CSV, RegTech, AI / ML validation, GAMP 5.

Cognitive task analysis (CDM, CTA) or human-factors approaches to expert workflows.

MLR or promotional review experience.

Time on the customer side — fractional CMO, small-biotech head of RA, VP / head of nonclinical or preclinical development, DABT-track regulatory toxicologist, or clinical-pharm consultant.

Skills

Comfortable with JSON / CSV, object schemas, API payloads, issue trackers, and versioning.

Structured analytical thinking with measurement-science instincts. Decomposes a workflow into decision points, identifies where expertise is load-bearing, articulates the result for engineers and product.

Comfortable distinguishing construct, criterion, and content validity.

Structures data and product-spec literacy. Comfortable with JSON / CSV, object schemas, API payloads, issue trackers, and versioning.

Not expected to write production code!

Dynamic operator who thrives in startup pace. High agency, comfort with ambiguity, willingness to define your own scope and ship before the playbook exists. You would rather build it than wait for someone else to.

Benefits

Medical, Dental, Vision, and 401(k).

Pay

The compensation for this full-time position is between $165,000 - 230,000. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training.

Schedule

Start: July - August, 2026.