Ph3Descrizione dell’offerta di lavoro /h3h3Job Purpose /h3pWe are looking for a Senior Manager Clinical Development Onco to: /pulliProvide 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. /liliSupport program and portfolio goals; may participate in the preparation of the Clinical Development Plans, based on the strategy agreed with the cross-functional Team. /liliEnsure that development strategies, trial designs, and execution plans are scientifically sound, operationally practical, and compliant with GCP standards and Regulatory expectations. /liliAct as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials. /liliEstablish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with Patient Associations. /liliCollaborate effectively with Clinical Pharmacology, Clinical Operations and Biostatistics to inform protocol design, amendments, and Regulatory interactions. /liliProvide medical/clinical support to the Business Development Team. /li /ulh3Key Responsibilities /h3ulliAct 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. /liliLead 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. /liliAct as Medical Monitor to ensure continuous evaluation of clinical and safety data; provide medical support to investigators and CROs. /liliMaintain end-to-end medical oversight of trial execution in close partnership with internal functions and external stakeholders. /liliEnsure that the necessary regulatory, safety and data evaluation requirements are met in conjunction with the Regulatory and Pharmacovigilance Departments.



/liliAct as primary contact for any study related medical/clinical questions and manage the preparation of responses to requests of Regulatory Authorities. /liliProvide scientific leadership during engagement with external experts and stakeholders, including investigators, key opinion leaders, advisory boards, and patient advocacy groups. /liliContribute to Regulatory interactions, including preparation of clinical sections and participation to meetings as a medical expert. /liliMay contribute to the preparation and the execution of clinical development plans in line with Company strategies and objectives. /liliSupport Business Development and Licensing activities. /liliMaintain close relationship/provide clinical and medical support to Clinical Operation Team to ensure smooth and effective study setup and management. /liliSupport Clinical Operations to identify high quality investigators and study sites for the conduct of clinical studies. /liliIn cooperation with the Safety Leads, ensure that any important safety issues are discussed and handled with appropriate departments. /liliWork closely with Biostatistics/Data Management team to ensure Data Analysis and interpretation of data. /liliCollaborate with Clinical Pharmacology to interpret and contextualize pharmacokinetic and pharmacodynamic data. /liliSupport preparation and finalistion of clinical study reports. /liliSupport preparation of study related communication plans/ publications. /liliEstablish and maintain excellent professional relationships between the company and Key Opinion Leaders (KOL) and the broader medico-scientific community.



/liliSupport discussions related to potential investigator-initiated trials and relevance to Company portfolio and objectives. /li /ulh3Required Education /h3ulliMedical Doctor Degree /liliBoard Certification in Oncology/Haematology/Immunology will be considered a plus /li /ulh3Required Skills and Experience /h3ulliAt least 3 yrs clinical experience (trial experience desirable) /liliAt least 5 yrs in the pharmaceutical/biotech industry /liliAt least 3 yrs in a clinical development role, with direct medical monitor responsibility for clinical trials /liliExperience with Regulatory interactions and submissions /liliExperience within onco-haematology/immunology therapeutic areas and with rare diseases /li /ulh3Technical Competencies /h3ulliKnowledge of clinical trial methodology, including trial set-up and conduct, protocol development, medical monitoring, review and interpretation of clinical data /liliSound knowledge of GCP /liliKnowledge of Regulatory frameworks /liliFamiliarity with fundamental clinical pharmacology and pharmacokinetic principles as applied to Oncology drug development (e.g., dose selection, exposure-safety relationships, and interpretation of PK outputs) /liliAbility to critically evaluate external assets and contribute to scientific and clinical due diligence for business development and portfolio expansion activities /liliAbility to interpret and communicate complex clinical and scientific data /liliAdvanced communication skills with ability to interact with internal and external stakeholders /liliAbility to manage multiple tasks and respond to rapidly changing priorities /li /ulh3Required Behaviours and Competencies /h3ulliStrong medical and scientific leadership, with the ability to influence and align diverse stakeholders /liliStrategic thinking combined with a hands-on, accountable approach to program delivery /liliHigh level of scientific integrity, decision-making rigour, and attention to detail /liliCollaborative mindset with the ability to operate effectively in a global matrix organization /li /ulh3Required Languages /h3pFluency in spoken and written English /p /p #J-18808-Ljbffr

📌 Senior manager clinical development onco (Spoleto)
🏢 EUSA Pharma
📍 Spoleto