Executive Director, Clinical Development Lead
Kiniksa Pharmaceuticals
August 21, 2026
On-site
Lexington, MA
Clinical Research and Development
Responsibilities:
- Serve as the clinical lead on cross-functional development program teams to develop and execute overall clinical development strategy for assigned programs, providing scientific/medical input into target product profiles, development plans, and lifecycle strategies.
- Lead clinical trial design and strategies, including development of study protocols, investigator brochures, and clinical study reports.
- Partner with Clinical Operations to execute clinical trials, including study execution, recruitment/enrollment, study-specific management plans/materials, and data management activities.
- Collaborate with Program Management, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs to ensure high-quality study/program execution.
- Ensure training for internal teams, investigators, site personnel, and external vendors; support data management (case report forms, review of protocol deviations, resolution of issues).
- Support medical monitors in evaluating safety data (safety report review, risk assessment/mitigation input, investigator interfacing).
- Prepare for and serve as medical representative for DMCs, SRCs, or similar safety review boards.
- Contribute to regulatory submissions (e.g., IND/CTAs), participate in health authority interactions (e.g., FDA/EMA), and engage with thought leaders/investigators.
- Provide clinical insights for business development, licensing, and due diligence; drive scientific excellence, innovation, and collaboration.
- Ensure activities comply with regulatory requirements, ICH/GCP guidance, and company standards.
Qualifications/Experience:
- MD, PhD, or PharmD in relevant life sciences.
- 8–12+ years clinical research/drug development experience in biotech/pharma.
- Experience leading clinical programs and interacting with regulatory authorities; successful IND/CTA submissions.
- Strong clinical trial design knowledge (endpoints, patient selection, statistical analyses, sponsor oversight, regulatory requirements); experience across multiple phases.
- Strategic thinking/decision-making, strong leadership and cross-functional collaboration.
- Excellent communication/presentation; ability to manage multiple priorities.
Standout Skills:
- Deep clinical trial design expertise; clear articulation of scientific concepts.
- Proven cross-functional leadership; credibility/influence with external stakeholders.
- Translates strategy into actionable plans with impact.
Location/Work Schedule:
- Lexington, MA; onsite five days per week.
Compensation:
- Pay range: $315,000–$370,000 USD.
- Serve as the clinical lead on cross-functional development program teams to develop and execute overall clinical development strategy for assigned programs, providing scientific/medical input into target product profiles, development plans, and lifecycle strategies.
- Lead clinical trial design and strategies, including development of study protocols, investigator brochures, and clinical study reports.
- Partner with Clinical Operations to execute clinical trials, including study execution, recruitment/enrollment, study-specific management plans/materials, and data management activities.
- Collaborate with Program Management, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs to ensure high-quality study/program execution.
- Ensure training for internal teams, investigators, site personnel, and external vendors; support data management (case report forms, review of protocol deviations, resolution of issues).
- Support medical monitors in evaluating safety data (safety report review, risk assessment/mitigation input, investigator interfacing).
- Prepare for and serve as medical representative for DMCs, SRCs, or similar safety review boards.
- Contribute to regulatory submissions (e.g., IND/CTAs), participate in health authority interactions (e.g., FDA/EMA), and engage with thought leaders/investigators.
- Provide clinical insights for business development, licensing, and due diligence; drive scientific excellence, innovation, and collaboration.
- Ensure activities comply with regulatory requirements, ICH/GCP guidance, and company standards.
Qualifications/Experience:
- MD, PhD, or PharmD in relevant life sciences.
- 8–12+ years clinical research/drug development experience in biotech/pharma.
- Experience leading clinical programs and interacting with regulatory authorities; successful IND/CTA submissions.
- Strong clinical trial design knowledge (endpoints, patient selection, statistical analyses, sponsor oversight, regulatory requirements); experience across multiple phases.
- Strategic thinking/decision-making, strong leadership and cross-functional collaboration.
- Excellent communication/presentation; ability to manage multiple priorities.
Standout Skills:
- Deep clinical trial design expertise; clear articulation of scientific concepts.
- Proven cross-functional leadership; credibility/influence with external stakeholders.
- Translates strategy into actionable plans with impact.
Location/Work Schedule:
- Lexington, MA; onsite five days per week.
Compensation:
- Pay range: $315,000–$370,000 USD.