HEAD OF CLINICAL DEVELOPMENT

RESPONSIBILITIES

• Provide medical and scientific leadership for the design, execution, and analysis of Phase I and II clinical trials in oncology and CNS
• Lead the clinical strategy for development programs and ensure alignment with regulatory and commercial objectives.
• Serve as the medical representative on cross-functional project teams, contributing to study design, safety monitoring, protocol development, and data interpretation.
• Manage and mentor a small team (3–5 direct reports) including Clinical Research Associates, Clinical Trial Managers, and Regulatory Affairs personnel.
• Interact with external stakeholders including investigators, KOLs, CROs, and regulatory bodies.
• Review and sign-off on clinical documents including protocols, investigator brochures, and clinical study reports.
• Contribute to regulatory submissions (IND, CTA) and interact with health authorities as needed.
• Ensure compliance with GCP and all applicable regulatory requirements.

REQUIREMENTS

• Medical degree (MD) and valid license to practice, specialization in oncology, neurology, or psychiatry is a plus.
• Knowledge or tranings on ICH‑GCP application in clinical trials, Regulatory affairs (from trials to approval, EU/FDA/global pharmaceutical legislation, Compliance & ethics in pharmaceutical practice).
• 7–10 years of clinical research experience in pharma/biotech.
• Experience with small molecules and biologics.
• Strong background in oncology and/or CNS development.
• Hands‑on work with Phase I–II trials and IND/CTA submissions.
• Leadership skills and ability to manage small cross‑functional teams.
• Fluent English (Polish or other EU languages are an advantage).
• Quick and effective response to change.
• Strong strategic decision‑making.
• Continuous learning mindset.
• Creative problem‑solving and analytical thinking.
• High attention to detail and quality.
• Ability to present clear, well‑reasoned recommendations.
• Driver’s license