Senior Oncology Clinical Development Lead

Eusa Pharma

Spoleto

In loco

EUR 150.000 - 190.000

Tempo pieno

5 giorni fa

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Descrizione del lavoro

Eusa Pharma is seeking a Senior Manager Clinical Development Onco in Spoleto, Italy. You will provide medical leadership across trial design, execution and regulatory submissions, serving as the clinical expert for oncology programs.

You will collaborate with Clinical Pharmacology, Operations and Biostatistics to drive study success and ensure GCP compliance. The role requires deep oncology experience, strong leadership, and the ability to manage multiple trials within a global matrix

Competenze

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 for clinical trials.
Experience with Regulatory interactions and submissions.
Experience within onco-haematology/immunology therapeutic areas and with rare diseases.

Mansioni

Act as the medical expert to ensure trial designs are scientifically rigorous and feasible.
Lead the clinical components of key trial documents, including protocols, Investigator’s Brochures, updates, Informed Consent Forms, Medical 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 regulatory, safety and data evaluation requirements are met with Regulatory and Pharmacovigilance.
Act as primary contact for study-related medical questions and prepare responses to Regulatory Authorities.
Provide scientific leadership during engagement with external experts and stakeholders, including investigators and KOLs.
Contribute to regulatory interactions, including clinical sections and meetings as a medical expert.
May contribute to preparation and execution of clinical development plans in line with company objectives.
Support Business Development and Licensing activities.
Maintain close relationship with Clinical Operation Team for study setup and management.
Support Clinical Operations to identify high quality investigators and sites.
In cooperation with Safety Leads, ensure safety issues are addressed with appropriate departments.
Work with Biostatistics/Data Management to interpret results.
Collaborate with Clinical Pharmacology to contextualize PK/PD data.
Support preparation and finalisation of clinical study reports and related publications.
Establish relationships with KOLs and medico-scientific community.
Support discussions on investigator-initiated trials relevant to portfolio.