ph3Job Purpose /h3 pWe are looking for a Senior Manager Clinical Development Onco to: /p ul liProvide 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. /li liSupport program and portfolio goals; may participate in the preparation of the Clinical Development Plans, based on the strategy agreed with the cross-functional Team. /li liEnsure that development strategies, trial designs, and execution plans are scientifically sound, operationally practical, and compliant with GCP standards and Regulatory expectations. /li liAct as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials. /li liEstablish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with Patient Associations. /li liCollaborate effectively with Clinical Pharmacology, Clinical Operations and Biostatistics to inform protocol design, amendments, and Regulatory interactions. /li liProvide medical/clinical support to the Business Development Team. /li /ul h3Key Responsibilities /h3 ul liAct 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. /li liLead 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. /li liAct as Medical Monitor to ensure continuous evaluation of clinical and safety data; provide medical support to investigators and CROs. /li liMaintain end-to-end medical oversight of trial execution in close partnership with internal functions and external stakeholders. /li liEnsure that the necessary regulatory, safety and data evaluation requirements are met in conjunction with the Regulatory and Pharmacovigilance Departments.



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



/li /ul h3Required Education /h3 ul liMedical Doctor Degree /li liBoard Certification in Oncology/Haematology/Immunology will be considered a plus /li /ul h3Required Skills and Experience /h3 ul liAt least 3 yrs clinical experience (trial experience desirable) /li liAt least 5 yrs in the pharmaceutical/biotech industry /li liAt least 3 yrs in a clinical development role, with direct medical monitor responsibility for clinical trials /li liExperience with Regulatory interactions and submissions /li liExperience within onco-haematology/immunology therapeutic areas and with rare diseases /li /ul h3Technical Competencies /h3 ul liKnowledge of clinical trial methodology, including trial set-up and conduct, protocol development, medical monitoring, review and interpretation of clinical data /li liSound knowledge of GCP /li liKnowledge of Regulatory frameworks /li liFamiliarity 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) /li liAbility to critically evaluate external assets and contribute to scientific and clinical due diligence for business development and portfolio expansion activities /li liAbility to interpret and communicate complex clinical and scientific data /li liAdvanced communication skills with ability to interact with internal and external stakeholders /li liAbility to manage multiple tasks and respond to rapidly changing priorities /li /ul h3Required Behaviours and Competencies /h3 ul liStrong medical and scientific leadership, with the ability to influence and align diverse stakeholders /li liStrategic thinking combined with a hands‑on, accountable approach to program delivery /li liHigh level of scientific integrity, decision‑making rigour, and attention to detail /li liCollaborative mindset with the ability to operate effectively in a global matrix organization /li /ul h3Required Languages /h3 ul liFluency in spoken and written English /li /ul /p #J-18808-Ljbffr

📌 Senior Manager Clinical Development Onco (Milano)
🏢 EUSA Pharma
📍 Milano