Kiniksapharmaceuticals
Executive Director, Clinical Pharmacology
Lexington, MA · Director
Sponsorship not specified$315k-$325kDetected 41 days ago
PharmacologyFDA RegulatoryScientific WritingLeadershipCommunicationRegulatory Affairs
About the role
- 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.
- Please contact us to request accommodation.
Responsibilities
- Lead the analysis, interpretation, and integration of PK and ADA data from rodent, non‑human primate (NHP), and clinical studies.
- Interpret non‑clinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy
- Support the design and interpretation of clinical PK/ADA sampling strategies, including timing and assay considerations and assess the impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety across clinical studies.
- Author and review clinical pharmacology-related sections of regulatory documents such as INDs, BLAs, Clinical study reports (CSRs), and Investigator's brochures
- Ability to mentor, develop, and scientifically guide team members
- 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.
Requirements
- 12+ years of progressive experience with demonstrated program leadership.
Skills
- Deep expertise in clinical and non‑clinical PK, ADA and immunogenicity risk assessment, exposure-response interpretation
- Strong understanding of biologic drug disposition, translational PK principles (rodent → NHP → human)
- Excellent scientific writing and data communication skills
- Demonstrated ability to influence program strategy through data‑driven insights
Compensation
- $315,000 - $325,000 USD
- 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.
Benefits
- Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
- decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
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