- Company Name
- Lexeo Therapeutics
- Job Title
- Manager/Senior Manager, Non-Clinical Operations
- Job Description
-
**Job Title:** Manager / Senior Manager, Non-Clinical Operations
**Role Summary:**
Lead and coordinate outsourced non-clinical animal studies for AAV‑based gene therapy programs, ensuring adherence to GLP/ICH, timelines, budgets, and regulatory reporting requirements. Act as the primary liaison between internal stakeholders and CROs, bioanalysis leads, and medical writing teams.
**Expectations:**
- Deliver robust study plans and SOWs that align with internal SOPs and regulatory frameworks.
- Maintain transparent communication of study status, issues, and milestones to cross‑functional teams.
- Ensure high‑quality, compliant non‑clinical data and documentation for pre‑IND/IND submissions.
**Key Responsibilities:**
- Draft, negotiate, and monitor SOWs and CRO contracts for small and large animal studies.
- Coordinate vendor meetings; capture minutes, track action items, and update internal teams.
- Work with bioanalysis leads to synchronize sample collection, tracking, and storage.
- Track study timelines, deliverables, budgets, and raise escalations for deviations.
- Collaborate with QA to verify GLP and ICH compliance throughout study execution.
- Compile and present key data findings to internal review groups.
- Partner with Medical Writing and external contractors to draft and review non‑clinical sections of regulatory documents (pre‑INDs, INDs).
- Interface with Clinical, CMC, Regulatory Affairs, and Finance/Accounting to ensure integrated project delivery.
**Required Skills:**
- 10+ years (BS), 8+ years (MS), or 4+ years (PhD) in life sciences, pharmacology, toxicology, or related fields.
- Minimum 2 years of experience with AAV gene‑therapy products.
- Proficient in GLP, ICH guidelines, and regulatory document preparation.
- Strong cross‑functional communication, project management, and decision‑making in ambiguous environments.
- Results‑focused with a demonstrated ability to execute tasks in a fast‑paced setting.
- Excellent multi‑tasking, independent work with tight deadlines, and proactive escalation skills.
**Required Education & Certifications:**
- Bachelor's (BS) in life sciences, pharmacology, biology, physiology, biochemistry, chemistry, or toxicology with ≥10 years experience;
- Master’s (MS) in related field with ≥8 years experience; or
- Ph.D. in related science with ≥4 years experience.