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

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 191,000 - 242,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA is seeking an Associate Director/Director, Pre-Clinical Program and Alliance Management to drive integrated planning from candidate nomination through IND filing. You will coordinate cross-functional teams across CMC, nonclinical safety/toxicology, translational sciences, regulatory, and external partners.

Based in our Lexington office, this role reports to the Group VP, Chief Business Officer and requires onsite work five days per week.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Pharmacology, Chemistry or related field; advanced degree preferred.
• 7+ years biotech/pharma experience; 3+ years in pre-clinical program management/IND-enabling activities; Director level 10+ years.
• Experience contributing to IND filings with cross-functional inputs (CMC, nonclinical, pharmacology, regulatory).
• Prior alliance management with external partners, CROs or academic collaborators is preferred.
• Strong proficiency with Microsoft Office and willingness to adopt AI-driven tools.

Responsibilities

• Build and drive integrated cross-functional program plans, timelines, and budgets from candidate selection through IND filing.
• Lead governance meetings, define goals, and ensure timely action on decisions.
• Maintain line of sight to FDA IND data package requirements and cross-functional alignment.
• Coordinate IND-enabling activities and prepare for FDA interactions (pre‑IND, Type B/C meetings).
• Identify risks and communicate status to senior leadership with concise updates.
• Serve as central hub for external partners and manage alliance governance structures.

Skills

Entrepreneurial mindset

Bias for action

Organizational excellence

Strong communication

Education

Bachelor's degree in a relevant scientific discipline

Advanced degree (M.S./Ph.D./Pharm.D.)

Tools

Microsoft Office

AI tools readiness

Job description

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

Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

Kiniksaisseekinga highly organized and execution-orientedAssociateDirector / 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 totheGroup Vice President, Chief Business Officer.

This individual will serve as the central operational hub for one or more pre‑clinical assets, coordinatingcross-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. TheAssociate Director / Directorwill be accountable for building andmaintainingintegrated 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 candidateselectionthrough 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 andtimelyissueresolution.
• 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.) aplus.
• 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.

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$191,000 - $242,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

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