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Job Description
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