Associate Director of Clinical Development Onco

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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