At a Glance
- Tasks: Lead renal clinical development programs from strategy to execution, ensuring safety and regulatory compliance.
- Company: Join a leading biopharmaceutical company focused on innovative renal therapies.
- Benefits: Attractive salary, comprehensive health benefits, flexible working options, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and patient outcomes.
- Why this job: Make a significant impact in renal medicine while collaborating with top experts in the field.
- Qualifications: Extensive experience in clinical development and strong leadership skills required.
The predicted salary is between 80000 - 100000 £ per year.
Responsibilities
- Lead the end-to-end strategy and execution of assigned renal clinical development program(s) across the full Research, Development and Commercial (RDC) continuum; from early development through pivotal/registrational phases.
- Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program.
- Lead development of clinical sections of trial and program level regulatory documents.
- Drive execution of the assigned clinical program and/or clinical trial in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, where applicable.
- Support (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.
- Support 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 contribute to/driving development of disease clinical standards for new disease areas.
- As a medical expert, support the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
- May work with Biomedical Research/ Translational Medical Sciences (BR) to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) and with Business Development.
We think you need these skills to ace Senior Clinical Development Medical Director – Renal
Clinical Development Strategy
Regulatory Document Development
Clinical Trial Execution
Safety Management
Medical Expertise
Stakeholder Engagement
Clinical Development Plan (CDP) Review
