Associate Clinical Development Medical Director
The Associate/Clinical Development Medical Director (CDMD) leads the planning and management of assigned RLI clinical programs to support RTL trials from a clinical development perspective. As CDMD, you will have oversight of assigned programs and drive execution of the plan.
About the Role
* 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.
* Contributing 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 diligence 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.