Senior Manager, Pre-Clinical Program and Alliance Management

Responsibilities

• Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing and acceptance, with clear critical path, dependencies, and decision points across CMC, nonclinical safety/toxicology, translational, and regulatory workstreams.
• Partner with program leadership to define goals, governance cadence, and decision frameworks; run core team and governance meetings and ensure timely follow-through on actions.
• Maintain line of sight to FDA IND data package requirements; track module completion and ensure cross-functional alignment on content, quality, and timing.
• Partner with Regulatory Affairs and functional leads to execute IND-enabling activities (GLP toxicology, safety pharmacology, CMC, analytical methods, translational readiness) and to prepare for and follow up from FDA interactions (e.g., pre-IND, Type B/C meetings).
• Proactively identify and mitigate program risks; communicate status, milestones, and resource needs to senior leadership through concise, executive-ready updates.
• Drive operational excellence and continuous improvement, including evaluation and adoption of emerging AI and digital tools to enhance program execution.
• Serve as the day-to-day operational point of contact for external partners (collaborators, licensors, academic groups, CROs), ensuring clear communication and timely issue resolution.
• Manage governance structures under collaboration, license, and services agreements (e.g., JSCs, working groups) and ensure adherence to contractual obligations and deliverables.
• Persistently track milestones, deliverables, and payments, and support amendments, SOWs, and tech transfer plans with Business Development, Legal, and Finance.

Qualifications and Experience

• Bachelor's degree in relevant scientific discipline (e.g., Biology, Biochemistry, Pharmacology, Chemistry); advanced degree (M.S., Ph.D., Pharm.D.) a plus.
• 8+ years of biotech or pharmaceutical experience, including 3+ years directly supporting pre-clinical program management and IND-enabling activities.
• Demonstrated contribution to the successful preparation, filing, and acceptance of one or more INDs, with clear examples of driving programs from candidate nomination through IND-ready status.
• Working knowledge of FDA IND data package requirements and the cross-functional inputs (CMC, nonclinical safety/toxicology, pharmacology, clinical pharmacology) required for a high-quality submission.
• Prior alliance management experience preferred, including direct interaction with external collaborators, CROs, or academic partners under collaboration, license, or services agreements.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Project / equivalent); willingness and curiosity to learn and implement emerging AI tools to drive efficiency.
• Strong organizational, communication, and interpersonal skills, with the ability to influence without authority across a matrixed organization and engage credibly with internal leadership and external partners.