Associate Clinical Development Medical Director
About the Role
Major accountabilities:
Your responsibilities as a Nuclear Medicine expert will include:
• Providing clinical leadership and strategic medical input for all clinical results in the assigned project or section of a clinical program
• Leading development of RLI related clinical sections of trial and program level regulatory documents
• Driving execution of the program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable
• Supporting (Senior) Global Program Clinical Head (GPCH) in ensuring overall safety of the molecule for the assigned section, and may act as a core member of the Safety Management Team (SMT), supporting overall program safety reporting in collaboration with Patient Safety colleagues
• Supporting the Clinical Development Head (CDH) by providing medical input into Clinical Development Plan (CDP), Integrated Development Plan (IDP) and Clinical Trial Protocol (CTP) reviews, and contributing to/driving development of disease clinical standards for new disease areas
• As a Nuclear Medicine physician specialist, supporting the (Sr.) GPCH or CDH in interactions with external and internal partners and decision boards
• Contribute to the publication strategy of RLI/RLT compounds from the scientific standpoint
• May work with BR (Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed.
Role Requirements :
• Nuclear medicine Physician/Medical Doctor
• Sophisticated knowledge and clinical training in oncology PET; Clinical practice experience ≥ 5 years preferred.
• Experience in Clinical Trials with a PET component
• Experience with Radioligand therapy
• A consistent track record to interpret, discuss and present data relating to clinical trial(s) with a Nuclear Medicine component
• Demonstrated ability to establish effective scientific partnerships with key partners
• Solid understanding of GCP, clinical trial design, statistics, regulatory and clinical development processes
Role Requirements
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