Associate Director/Director, Pre-Clinical Program & Alliance Management
Kiniksa Pharmaceuticals
August 10, 2026
On-site
Lexington, MA
Clinical Research and Development
Responsibilities:
- Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing and acceptance, including critical path, dependencies, and decision points across CMC, nonclinical safety/toxicology, translational, and regulatory workstreams.
- Partner with program leadership on goals, governance cadence, and decision frameworks; run core team/governance meetings and ensure timely follow-through.
- Maintain line of sight to FDA IND data package requirements; track module completion and ensure cross-functional alignment on content, quality, and timing.
- Execute IND-enabling activities (GLP toxicology, safety pharmacology, CMC, analytical methods, translational readiness) and support/prep and follow up on FDA interactions (e.g., pre-IND, Type B/C meetings).
- Identify and mitigate program risks; communicate status, milestones, and resource needs to senior leadership.
- Drive operational excellence and continuous improvement, including evaluation/adoption of emerging AI and digital tools.
Alliance Management:
- Serve as 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/services agreements and ensure contractual deliverables are met.
- Partner with Business Development, Legal, and Finance to track milestones/deliverables/payments and support amendments, SOWs, and tech transfer plans.
Standout Skills:
- Entrepreneurial mindset with bias for action and ownership; thrive under pressure.
- Balance risk and acceleration; drive pre-clinical programs to the clinic.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline; M.S./Ph.D./Pharm.D. a plus.
- Associate Director: 7+ years biotech/pharma experience including 3+ years pre-clinical program management/IND-enabling. Director: 10+ years.
- Demonstrated contribution to preparation, filing, and acceptance of one or more INDs.
- Working knowledge of FDA IND data package requirements and cross-functional inputs.
- Alliance management experience preferred.
- Proficient in Microsoft Office; willingness to learn/employ emerging AI tools.
- Strong organizational, communication, and interpersonal skills; ability to influence in a matrix.
Pay Range: $191,000 - $242,000 USD
Application instructions: Not provided.
- Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing and acceptance, including critical path, dependencies, and decision points across CMC, nonclinical safety/toxicology, translational, and regulatory workstreams.
- Partner with program leadership on goals, governance cadence, and decision frameworks; run core team/governance meetings and ensure timely follow-through.
- Maintain line of sight to FDA IND data package requirements; track module completion and ensure cross-functional alignment on content, quality, and timing.
- Execute IND-enabling activities (GLP toxicology, safety pharmacology, CMC, analytical methods, translational readiness) and support/prep and follow up on FDA interactions (e.g., pre-IND, Type B/C meetings).
- Identify and mitigate program risks; communicate status, milestones, and resource needs to senior leadership.
- Drive operational excellence and continuous improvement, including evaluation/adoption of emerging AI and digital tools.
Alliance Management:
- Serve as 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/services agreements and ensure contractual deliverables are met.
- Partner with Business Development, Legal, and Finance to track milestones/deliverables/payments and support amendments, SOWs, and tech transfer plans.
Standout Skills:
- Entrepreneurial mindset with bias for action and ownership; thrive under pressure.
- Balance risk and acceleration; drive pre-clinical programs to the clinic.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline; M.S./Ph.D./Pharm.D. a plus.
- Associate Director: 7+ years biotech/pharma experience including 3+ years pre-clinical program management/IND-enabling. Director: 10+ years.
- Demonstrated contribution to preparation, filing, and acceptance of one or more INDs.
- Working knowledge of FDA IND data package requirements and cross-functional inputs.
- Alliance management experience preferred.
- Proficient in Microsoft Office; willingness to learn/employ emerging AI tools.
- Strong organizational, communication, and interpersonal skills; ability to influence in a matrix.
Pay Range: $191,000 - $242,000 USD
Application instructions: Not provided.