04 set - Milano
EUSA Pharma
Job Purpose
We are looking for a Senior Manager Clinical Development Onco to:
- Provide comprehensive medical and scientific leadership to the design, set-up, execution and conduct of planned and ongoing clinical trials, from protocol development to study closure and Regulatory submission.
- Support program and portfolio goals; may participate in the preparation of the Clinical Development Plans, based on the strategy agreed with the cross-functional Team.
- Ensure that development strategies, trial designs, and execution plans are scientifically sound, operationally practical, and compliant with GCP standards and Regulatory expectations.
- Act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.
- Establish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with Patient Associations.
- Collaborate effectively with Clinical Pharmacology, Clinical Operations and Biostatistics to inform protocol design, amendments, and Regulatory interactions.
- Provide medical/clinical support to the Business Development Team.
Key Responsibilities
- Act as the medical expert to ensure that clinical trial designs, endpoints, and assessments are fit-for-purpose in rare disease settings, scientifically rigorous, and operationally feasible.
- Lead the clinical components of key clinical trial documents, including clinical trial protocols and amendments, Investigator's Brochures and updates, Informed Consent Forms, Medical Monitoring Plans, Safety Monitoring Plans, and statistical analysis plans.
- Act as Medical Monitor to ensure continuous evaluation of clinical and safety data; provide medical support to investigators and CROs.
- Maintain end-to-end medical oversight of trial execution in close partnership with internal functions and external stakeholders.
- Ensure that the necessary regulatory, safety and data evaluation requirements are met in conjunction
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