Associate Director/Director, Pre-Clinical Program & Alliance Management

About the role

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. This role reports to the Group Vice President, Chief Business Officer and serves 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.

This role is based in Lexington, MA and requires onsite presence five days per week.

Responsibilities

• 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.

Skills

• 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

• 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.

Pay

Pay Range: $191,000 - $242,000 USD