Preclinical Project Manager (CRO Operations)

Position Overview We are looking for a scientifically adept Project Manager to oversee the planning, execution, and delivery of our outsourced preclinical programs. You will serve as the primary link between our internal R&D and external Contract Research Organizations (CROs), specifically coordinating wet lab activities and in vivo preclinical models. Your mission is to ensure data integrity, maintain timelines, and manage budgets as we move candidates toward IND-enabling studies. Key Responsibilities CRO Oversight & Vendor Management: Identify, vet, and manage CRO partners. Lead the Request for Proposal (RFP) process and negotiate work orders to ensure optimal study design and pricing. Study Coordination: Oversee the lifecycle of wet lab and preclinical studies (PK/PD, toxicology, efficacy models), ensuring all milestones are met according to the project plan. Protocol & Data Review: Critically review study protocols, amendments, and final reports. Ensure scientific rigor and compliance with internal standards and GLP requirements. Strategic Planning: Maintain integrated project timelines and budgets using tools like SmartSheet or MS Project. Communication Hub: Lead regular technical meetings with CROs, summarize data for internal stakeholders, and escalate risks to leadership. Qualifications Education: Bachelor’s or Master’s degree in Biology, Pharmacology, or a related field. A PhD is a plus given the technical nature of wet lab coordination. Experience: 3–7 years in preclinical drug development. Direct experience managing CROs or working within a CRO is highly preferred. Technical Expertise: Strong background in in vivo preclinical models and wet lab techniques. Familiarity with GLP regulations and the IND submission process. Soft Skills: Proven ability to manage multiple high-stakes timelines and navigate complex vendor relationships.