Associate Clinical Development Medical Director

Associate Clinical Development Medical Director

Job ID REQ-

Ireland

Summary

The Associate/Clinical Development Medical Director (CDMD) is responsible for leading the planning and management of the assigned RLI clinical program(s) to support the RTL trials from an end-to-end clinical development perspective. As CDMD, you will have oversight of assigned programs and drive execution of the plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

About the Role Major accountabilities:

1. Providing clinical leadership and strategic medical input for all clinical results in the assigned project or section of a clinical program.
2. Leading development of RLI related clinical sections of trial and program level regulatory documents.
3. 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.
4. 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.
5. 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.
6. As a Nuclear Medicine physician specialist, supporting the (Sr.) GPCH or CDH in interactions with external and internal partners and decision boards.
7. Contributing to the publication strategy of RLI/RLT compounds from the scientific standpoint.
8. 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:

1. Nuclear medicine Physician/Medical Doctor.
2. Sophisticated knowledge and clinical training in oncology PET; Clinical practice experience 5 years preferred.
3. Experience in Clinical Trials with a PET component.
4. Experience with Radioligand therapy.
5. A consistent track record to interpret, discuss and present data relating to clinical trial(s) with a Nuclear Medicine component.
6. Demonstrated ability to establish effective scientific partnerships with key partners.
7. Solid understanding of GCP, clinical trial design, statistics, regulatory and clinical development processes.

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