Executive Director, Clinical Pharmacology
Kiniksa Pharmaceuticals
August 23, 2026
On-site
Lexington, MA
Clinical Research and Development
Executive Director of Clinical Pharmacology
Key Responsibilities
- 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 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 design and interpretation of clinical PK/ADA sampling strategies (timing, assays) and assess impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety.
- Author and review clinical pharmacology sections of regulatory documents (INDs, BLAs, CSRs, Investigator’s brochures).
Qualifications and Experience
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related; MD or PharmD with relevant experience considered.
- 12+ years of progressive experience with program leadership; hands-on clinical/non-clinical PK interpretation; ADA/NAb immunogenicity assessment and impact analysis; biologic drug development (ideally cardiovascular, rare, and/or inflammatory diseases).
- Strategic thinker with strong scientific judgment.
- Effective cross-functional collaborator and communicator; comfortable in a matrixed biotech environment.
- Ability to mentor and scientifically guide team members.
Skills (Standout)
- Deep expertise in clinical/non-clinical PK, ADA/immunogenicity risk assessment, and exposure–response interpretation.
- Strong biologic drug disposition and translational PK knowledge (rodent → NHP → human).
- Excellent scientific writing and data communication.
Onsite requirement
- Lexington, MA office; onsite five days per week.
Pay Range
- $315,000 - $325,000 USD.
Key Responsibilities
- 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 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 design and interpretation of clinical PK/ADA sampling strategies (timing, assays) and assess impact of immunogenicity (ADA, NAb) on PK, efficacy, and safety.
- Author and review clinical pharmacology sections of regulatory documents (INDs, BLAs, CSRs, Investigator’s brochures).
Qualifications and Experience
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related; MD or PharmD with relevant experience considered.
- 12+ years of progressive experience with program leadership; hands-on clinical/non-clinical PK interpretation; ADA/NAb immunogenicity assessment and impact analysis; biologic drug development (ideally cardiovascular, rare, and/or inflammatory diseases).
- Strategic thinker with strong scientific judgment.
- Effective cross-functional collaborator and communicator; comfortable in a matrixed biotech environment.
- Ability to mentor and scientifically guide team members.
Skills (Standout)
- Deep expertise in clinical/non-clinical PK, ADA/immunogenicity risk assessment, and exposure–response interpretation.
- Strong biologic drug disposition and translational PK knowledge (rodent → NHP → human).
- Excellent scientific writing and data communication.
Onsite requirement
- Lexington, MA office; onsite five days per week.
Pay Range
- $315,000 - $325,000 USD.