Senior Manager Clinical Development Onco

Eusa Pharma; Spoleto; In loco; EUR 150.000 - 190.000; Tempo pieno

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.

Conoscenze

Clinical development

Regulatory submissions

GCP compliance

Medical monitoring

Cross-functional leadership

Oncology experience

Formazione

Medical Doctor Degree

Board Certification in Oncology/Haematology/Immunology (plus)

Descrizione del lavoro

Descrizione dell’offerta di lavoro

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

Required Education

• Medical Doctor Degree
• Board Certification in Oncology/Haematology/Immunology will be considered a plus

Required Skills and Experience

• 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

Technical Competencies

• Knowledge of clinical trial methodology, including trial set-up and conduct, protocol development, medical monitoring, review and interpretation of clinical data
• Sound knowledge of GCP
• Knowledge of Regulatory frameworks
• Familiarity 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)
• Ability to critically evaluate external assets and contribute to scientific and clinical due diligence for business development and portfolio expansion activities
• Ability to interpret and communicate complex clinical and scientific data
• Advanced communication skills with ability to interact with internal and external stakeholders
• Ability to manage multiple tasks and respond to rapidly changing priorities

Required Behaviours and Competencies

• Strong medical and scientific leadership, with the ability to influence and align diverse stakeholders
• Strategic thinking combined with a hands-on, accountable approach to program delivery
• High level of scientific integrity, decision-making rigour, and attention to detail
• Collaborative mindset with the ability to operate effectively in a global matrix organization

Required Languages

Fluency in spoken and written English