Kiniksa is seeking a highly organized and execution-oriented Associate Director / Director, Pre-Clinical Program and Alliance Management to drive the operational planning, integration, and delivery of pre-clinical programs from candidate nomination through successful IND filing and acceptance. The role reports to the Group Vice President, Chief Business Officer.
This individual will serve as the central operational hub for one or more pre-clinical assets, coordinating cross-functional activities across research, CMC, nonclinical safety/toxicology, translational, regulatory, and program leadership, while also managing day-to-day interactions with external partners, CROs, and collaborators. The Associate Director / Director will be accountable for building and maintaining integrated program plans, anticipating critical path risks, and ensuring alignment of internal stakeholders and external alliance partners against shared IND-enabling milestones
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
Pre-Clinical Program Management & IND Enablement
- 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.
Alliance Management
- 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.
- Partner with Business Development, Legal, and Finance to track milestones, deliverables, and payments, and to support amendments, SOWs, and tech transfer plans.
Standout Skills for Impact
- Entrepreneurial mindset with a bias for action and ownership
- Thrives under pressure, consistently delivering against aggressive timelines
- Expert in balancing risk and acceleration to optimize program outcomes
- Drives pre-clinical programs forward to the clinic with speed and precision
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.
- Associate Director level: A minimum of 7+ years of biotech or pharmaceutical experience, including 3 + years directly supporting pre-clinical program management and IND-enabling activities. Director level: A minimum of 10+ years of biotech or pharmaceutical experience.
- 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.