Senior Manager Clinical Development Oncology

About the role

Recordati is seeking a Senior Manager Clinical Development Oncology to provide medical and scientific leadership across the full lifecycle of clinical trials, from protocol design to regulatory submission. The role will support program and portfolio goals, ensuring scientific rigor and compliance with GCP and regulatory expectations.

Key responsibilities

• Lead design, set‑up and execution of oncology clinical trials, ensuring protocols, endpoints and assessments are fit‑for‑purpose.
• Develop and maintain key trial documents including protocols, Investigator’s Brochures, Informed Consent Forms and statistical analysis plans.
• Act as Medical Monitor, overseeing safety data, providing medical support to investigators and CROs.
• Serve as primary medical contact for health authorities, IRBs/ECs and ensure regulatory and safety requirements are met.
• Build and sustain relationships with KOLs, patient associations and the scientific community.
• Collaborate with Clinical Pharmacology, Clinical Operations and Biostatistics to inform protocol design and regulatory interactions.
• Provide medical and clinical expertise to the Business Development team.

Required profile

• Extensive experience in clinical development within oncology, preferably in rare disease settings.
• Strong knowledge of GCP, regulatory guidelines and safety monitoring processes.
• Proven ability to lead cross‑functional teams and manage complex trial programs.
• Excellent communication skills with external stakeholders, including health authorities and KOLs.

Required skills

• Clinical trial design and execution
• Medical monitoring and safety oversight
• Regulatory submission preparation
• Stakeholder engagement with KOLs and patient groups

What we offer

• Opportunity to work for a global pharmaceutical leader with a strong commitment to patient health.
• Collaborative environment with multidisciplinary teams.
• Impactful role influencing the development of innovative oncology therapies.