Company Overview:
SRT Therapeutics is a fast-paced, operationally minded and science-driven biotech company focused on advancing innovative therapeutics for inflammatory bowel disease (IBD). Associate Director, Non-clinical OperationsSRT Therapeutics is seeking an Associate Director, Non-clinical Operations, to lead the outsourced non-clinical studies supporting our pipeline of biologics and small molecules for IBD. As SRT’s primary operational lead with CROs and consultants, this person will manage studies from RFP through final report, including non-GLP and GLP toxicology, safety pharmacology, genetic toxicology, in vitro safety, TK/bioanalytical, PK, and dose formulation analysis studies, ensuring delivery on time, on budget, and to GLP and quality standards, with early visibility into risks to program milestones. This role is ideal for someone who has managed CROs from the sponsor side or served as a study director or study monitor, and who combines technical fluency with the judgment and authority to hold external partners accountable. This is an individual-contributor role working closely with colleagues (FTE and consultant) in toxicology, DMPK, CMC, clinical, regulatory, and program and portfolio management.
Work Location:
Remote (U.S.), with travel to CRO sites and SRT headquarters as needed and flexibility for meetings with international partners across time zones.
Responsibilities: Study oversight, sourcing, and budgets
- Lead day-to-day oversight of outsourced non-clinical studies across programs as SRT’s operational contact for CROs, study directors, and consultants, including on-site or remote monitoring of critical study phases.
- Source studies and vendors: prepare RFPs, evaluate proposals, and negotiate contracts and change orders with Non-clinical Program Leads, Legal, and Finance; maintain a network of qualified CROs and specialty laboratories assessed for capability, capacity, quality, animal welfare, and regulatory or geopolitical risk.
- Manage non-clinical study budgets: forecast spend, reconcile invoices against milestones, and provide monthly accruals to Finance. Study planning and execution
- Coordinate preparation and approval of study plans and amendments, integrating input from Toxicology, Biology, Clinical, PK, and CMC.
- Maintain integrated timelines from method validation and test article release through in-life, data delivery, QA audit, reporting, and SEND datasets, linked to program milestones such as dose selection, Investigator’s Brochure updates, and regulatory submissions.
- Independently verify critical-path prerequisites (e.g., bioanalytical method validation, test article CoA/RoA, CRO resourcing) and escalate gaps before milestones are at risk.
- Oversee bioanalytical (TK, ADA) and dose formulation method development, validation, and lot bridging, and assess the impact of new lots, formulations, or study design changes.
- Run CRO governance (weekly study meetings, action tracking, escalation pathways, and status reporting) and plan contingencies, including securing CRO capacity for upcoming studies. Materials, data, and submissions
- Manage logistics for test articles, reagents, and study samples across CDMOs, CROs, and bioanalytical laboratories, including international shipments, import documentation, lot accountability, and sample chain of custody.
- Manage study data and report flow, including draft and final report reviews and pathology peer review, and compile and quality-check non-clinical content (reports, tabulated summaries, SEND) for INDs, CTAs, Investigator’s Brochures, and ethics submissions, coordinating CRO input to agency and ethics committee questions.
- Maintain inspection- and diligence-ready records, including final reports, SEND datasets, archives, and specimen retention. Quality, communication, and process
- In partnership with Quality Assurance, plan sponsor audits of CROs and studies and track deviations and audit findings to resolution.
- Communicate status, risks, and mitigations with the Head of Program and Portfolio Management and Non-clinical Program Leads, and establish outsourcing processes scaled to SRT’s stage.
Required Qualifications:- Bachelor’s degree in Life Sciences or a related discipline; M.S. or Ph.D. in Toxicology, Pharmacology, or a related field preferred.
- 8+ years of non-clinical drug development experience in biotech, pharma, or CRO settings, including 5+ years managing or monitoring GLP studies across large and small molecule programs.
- Demonstrated successful oversight of GLP toxicology studies, including non-human primate studies, and associated TK and bioanalytical work through final report.
- Direct experience delivering the non-clinical package for at least one IND or CTA, including Module 4 study reports and SEND datasets.
- Working knowledge of GLP (21 CFR Part 58, OECD); ICH S6(R1), M3(R2), S3A, S7A/S7B, S2(R1), S5(R3), and M10; FDA SEND requirements; animal welfare requirements (USDA, OLAW, AAALAC); and 3Rs approaches.
- Track record of CRO contracting, budget forecasting and accruals, and holding external partners accountable to deliverables.
- Proficiency with Microsoft Office, MS Project or Smartsheet, and AI-enabled tools for study tracking and document QC.
Preferred Qualifications:- Prior experience as a CRO study director, study monitor, or sponsor-side non-clinical study manager.
- Familiarity with ligand-binding (TK, ADA) and LC-MS/MS assays sufficient to evaluate method readiness, critical reagent supply, and data quality.
- Experience with complex biologics (species relevance, tissue cross-reactivity, cytokine release, immunogenicity) and with FDA initiatives to reduce animal testing, including NAMs.
- Experience with international CROs and CDMOs, including cross-border shipment of test articles and NHP samples (CITES, CDC permits), and with non-clinical content for ex-U.S. first-in-human ethics submissions.
- Experience in IBD or immunology programs. Leadership Profile
- Highly organized, with the ability to manage multiple concurrent studies across programs.
- Direct communicator who escalates early, asks probing questions, and constructively challenges external partners.
- Strong ownership and accountability; comfortable with ambiguity and the pace of a growth-stage biotech. Travel
- Approximately 10–15% domestic and international travel for vendor qualification, study initiation, and critical in-life activities
Salary Range: $144k - $220k
