Executive Director, Clinical Pharmacology
Kiniksa Pharmaceuticals
9 days ago
On-site
Lexington, MA
Clinical Research and Development
Key Responsibilities:
- Provide scientific leadership for clinical pharmacology strategy (PK, ADA, exposure–response).
- Lead 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.
- Serve as clinical pharmacology subject-matter expert on clinical study teams.
- Support design and interpretation of clinical PK/ADA sampling strategies (timing, assay considerations), assessing the 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).
Education:
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field (MD or PharmD with relevant experience also considered).
Experience/Qualifications:
- 12+ years progressive experience with program leadership; hands-on clinical/non-clinical PK interpretation; ADA/NAb assessment and impact analysis; biologic drug development (ideally cardiovascular, rare, and/or inflammatory diseases).
- IND-enabling to late-stage experience; contributed to or led regulatory submissions and agency interactions.
- Deep expertise in PK, ADA/immunogenicity risk assessment, and exposure–response interpretation; translational PK principles (rodent → NHP → human).
- Excellent scientific writing and data communication; ability to influence strategy with data-driven insights.
Leadership/Behavioral Competencies:
- Strategic thinking and scientific judgment; cross-functional collaboration; matrixed environment comfort; ability to mentor; accountability, independence, integrity.
Onsite requirement:
- Based in Lexington, MA; onsite five days per week.
- Provide scientific leadership for clinical pharmacology strategy (PK, ADA, exposure–response).
- Lead 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.
- Serve as clinical pharmacology subject-matter expert on clinical study teams.
- Support design and interpretation of clinical PK/ADA sampling strategies (timing, assay considerations), assessing the 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).
Education:
- PhD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related field (MD or PharmD with relevant experience also considered).
Experience/Qualifications:
- 12+ years progressive experience with program leadership; hands-on clinical/non-clinical PK interpretation; ADA/NAb assessment and impact analysis; biologic drug development (ideally cardiovascular, rare, and/or inflammatory diseases).
- IND-enabling to late-stage experience; contributed to or led regulatory submissions and agency interactions.
- Deep expertise in PK, ADA/immunogenicity risk assessment, and exposure–response interpretation; translational PK principles (rodent → NHP → human).
- Excellent scientific writing and data communication; ability to influence strategy with data-driven insights.
Leadership/Behavioral Competencies:
- Strategic thinking and scientific judgment; cross-functional collaboration; matrixed environment comfort; ability to mentor; accountability, independence, integrity.
Onsite requirement:
- Based in Lexington, MA; onsite five days per week.