Kiniksa is seeking an experienced Executive Director of Clinical Pharmacology to provide strategic and scientific leadership in the analysis and interpretation of non‑clinical and clinical pharmacokinetic (PK), pharmacodynamic (PD), and anti‑drug antibody (ADA) data across our portfolio. This role will play a critical part in informing dose selection, clinical trial design, and regulatory strategy for biologic therapies from pre-clinical development through IND and late‑stage development.
The successful candidate will work cross‑functionally with Nonclinical & Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, and CMC to ensure rigorous and integrated interpretation of PK and immunogenicity data to support clinical and regulatory decision‑making.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week
Key Responsibilities (including, but not limited to):
- Provide scientific leadership for clinical pharmacology strategy across programs, with emphasis on PK, ADA, and exposure-response relationships.
- Lead the analysis, interpretation, and integration of PK and ADA data from rodent, non‑human primate (NHP), and clinical studies.
- Guide dose selection and optimization strategies using nonclinical-clinical translation and clinical PK/ADA data.
- Interpret non‑clinical PK and immunogenicity data to support first-in-human starting dose and escalation strategy
- Serve as the clinical pharmacology subject‑matter expert on clinical study teams.
- 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
Standout Skills for Impact:
- Proven track record supporting IND‑enabling through late‑stage clinical development and experience contributing to or leading regulatory submissions and agency interactions
- 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
Qualifications and Experience:
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or a related discipline (MD or PharmD with relevant experience will also be considered)
- 12+ years of progressive experience with demonstrated program leadership. Strong hands‑on experience with clinical and non‑clinical PK data interpretation, Immunogenicity (ADA/NAb) assessment and impact analysis, Biologic drug development, ideally in cardiovascular, rare, and/or inflammatory diseases
- Strategic thinker with strong scientific judgment
- Effective cross‑functional collaborator and communicator
- Comfortable operating in a fast‑paced, matrixed biotech environment
- Ability to mentor, develop, and scientifically guide team members
- High level of accountability, independence, and integrity