Associate Director of Clinical Development Onco

Associate Director of Clinical Development Onco

Recordati

Milan, Italy

Job Purpose

The purpose of the new position is to:

• Participate in the preparation of the Onco portfolio Clinical Development Plans, based on the strategy agreed with the cross-functional team, and lead consistently the key projects;
• Establish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with patient’s associations;
• Provide medical/clinical support to the Clinical Operation Team in the setup, conduct and finalisation of planned and ongoing trials/clinical development plans;
• Act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.

Key Responsibilities

• Maintain engagement across the global landscape with all potential investigators to identify appropriate clinical trial programs and supervise investigator-initiated trials to data portfolio;
• Contribute to the preparation and the execution of clinical development plans and study protocols, in line with Company strategies and objectives;
• Act as primary contact for any study related medical/clinical questions and manage the preparation of responses to clinical related FDA, EMA and other regulatory authorities’ requests;
• Prepare and/or supervise the preparation of all clinical documents necessary to study setup, in accordance to current regulations and laws;
• Review and recommend amendments to the study protocols, Investigator Brochure and Informed Consent Forms to ensure study feasibility;
• Ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the Regulatory and Pharmacovigilance Departments;
• Maintain close relationship/provide clinical and medical support to Clinical Operation Team to ensure smooth and effective study setup and management;
• Participate in internal and external clinical meetings, including committee to assess/approve support to investigator-initiated trials, investigators meetings and Advisory Boards, related to assigned clinical studies;
• Support to Clin 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 Stats/DM team to ensure Data Analysis and interpretation of data;
• Prepare and finalise clinical study reports;
• Prepare the 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.

Required Education

• Medical Doctor Degree with current medical licensure;
• Board Certification in Oncology will be considered a plus.

Required Skills and Experience

Experience:

• At least 3 yrs clinical experience with clinical investigator track record;
• At least 5 yrs in the pharmaceutical/biotech industry;
• At least 3 yrs in a clinical development role;
• Experience within onco-hematology/rare diseases.

Required skills:

• Knowledge of GCP, regulatory interactions, clinical trial methodologies;
• Experience in clinical trial set-up and conduct, including protocol development, review and publication of clinical data, contribution to clinical sections of regulatory documents;
• 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 Languages:

• Fluency in spoken and written English.

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