Kiniksapharmaceuticals

Kiniksapharmaceuticals

Executive Director, Clinical Development Lead

Lexington, MA · Director

Sponsorship not specified$315k-$370kDetected 22 days ago
GCPBusiness DevelopmentClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationCollaborationBiostatisticsRegulatory 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.
  • The ideal candidate is a strategic thinker with a hands-on understanding of the operational complexities of drug development and is eager to bring therapies to patients with a sense of urgency.

Responsibilities

  • Lead the development of clinical trial design and strategies based on the scientific rationale and development and program objectives, including development of study protocols, investigator brochures, and clinical study reports.
  • Partner closely with Clinical Operations to execute on clinical trials, including study execution, recruitment and enrollment, development of study specific management plans and materials, and data management activities.
  • Ensure internal study teams, investigators and site personnel, and external vendors are trained on clinical trial design and rationale, and provide support for data management activities, including development of case report forms, review of protocol deviations, and resolution issues.
  • Provide clinical insights to support business development, licensing, and due diligence activities.
  • Drive a culture of scientific excellence, innovation, and collaboration.
  • Deep clinical experience in clinical trial design and ability to clearly articulate scientific concepts.
  • Strong ability to build credibility and influence external stakeholders, including scientific and thought leaders.
  • Translates strategy into effective, actionable plans and delivers with impact.
  • Ability to manage multiple priorities in a fast-paced environment.

Requirements

  • Minimum 8-12+ years of experience in clinical research and drug development within biotech/pharma
  • Strong understanding of clinical trial design, including endpoint development, patient selection criteria, statistical analyses, sponsor oversight responsibilities, and regulatory requirements.
  • Experience across multiple phases of development

Skills

  • Proven cross-functional leadership driving alignment and results.
  • Excellent presentation and communication skills across diverse audiences.

Compensation

  • $315,000 - $370,000 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

  • Collaborate with Program Management, Clinical Operations, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs to ensure high-quality study and program execution.
  • Support medical monitors in evaluating safety data, including review of safety reports, contribution to risk assessment and mitigation plans, and interfacing with investigators as applicable.
  • Lead preparation for and serve as medical representative for Data Monitoring Committees (DMCs), Safety Review Committees (SRC), or similar safety data review boards.
  • Contribute to development of regulatory submissions (e.g., IND/CTAs), participate in health authority agency interactions (e.g., FDA/EMA), and engage with thought leaders and investigators.
  • 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.

Equal opportunity

  • Please contact us to request accommodation.

Visa & Work Authorization

  • derstanding of clinical trial design, including endpoint development, patient selection criteria, statistical analyses, sponsor oversight responsibilities, and regulatory requirements
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