Experteer Overview

In this role, you lead medical strategy and scientific oversight across oncology clinical trials from protocol to regulatory submission. You work with cross-functional teams to align development plans with strategy, ensure GCP compliance, and maintain strong relationships with investigators, KOLs, and patient groups. You drive trial design, safety monitoring, and regulatory interactions, shaping the portfolio and advancing the company’s oncology programs. This role offers meaningful impact through leading clinical development in rare disease settings and collaborating across global teams.

Massimizzi le sue possibilità di successo assicurandosi che il suo CV e le sue competenze corrispondano ai requisiti di questa posizione.
Benefits

- Serve as medical expert to ensure trial designs and endpoints are fit-for-purpose in rare disease settings
- Lead clinical documents (protocols, amendments, Investigator's Brochures, ICFs, safety and monitoring plans, statistical analysis plans)
- Act as Medical Monitor for ongoing evaluation of clinical and safety data and support investigators/CROs
- Provide end-to-end medical oversight of trial execution with internal and external stakeholders
- Coordinate regulatory, safety and data evaluation with Regulatory and Pharmacovigilance teams
- Be primary medical contact for study-related questions and regulatory responses
- Lead engagement with external experts, investigators, KOLs,



advisory boards, and patient groups
- Contribute to Regulatory interactions and clinical sections for submissions
- Support development plans in line with company strategy; assist Business Development and Licensing
- Maintain relationships with Clinical Operations to ensure study setup and management
- Identify high-quality investigators and study sites in collaboration with Clinical Operations
- Address safety issues with appropriate departments with Safety Leads
- Collaborate with Biostatistics/Data Management on data analysis and interpretation
- Work with Clinical Pharmacology to contextualize PK/PD data
- Assist in preparation of clinical study reports and study communication xysqume plans/publications
- Foster relationships with KOLs and medico-scientific community
- Support discussions on investigator-initiated trials relevant to company portfolio

Responsibilities

At least 3 yrs clinical experience (trial experience desirable)

At least 5 yrs in the pharmaceutical/biotech industry

At least 3 yrs in a clinical development role with direct medical monitor responsibility

Experience with Regulatory interactions and submissions

Experience within onco-haematology/immunology and rare diseases

Medical Doctor Degree

Board Certification in Oncology/Haematology/Immunology will be considered a plus

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📌 Senior Manager Clinical Development Onco (Milano)
🏢 Experteer Italy
📍 Milano