Clinical Development Lead

3 weeks ago

London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time
Global Program Clinical Head: In-market Brands

Job ID: REQ-10010858

Location: United Kingdom

Summary

Designs and provides oversight of clinical research programs. Builds relationships with key opinion leaders and applies their input to enhance study design and protocols. Serves as medical/scientific consultant to marketing or research project teams and government regulatory agencies. Establishes the criterion essential for determining safety, efficacy, and medical utilities. Interprets results of Phase I-III investigations in preparation for new-drug or medical device application. May serve as safety expert for individual clinical projects. May be responsible for post-marketing studies.

May serve as the Clinical Development Representative on NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP).Where applicable, supporting Business Development & Licensing (BD&L) activities.Requirements:
  • MD, PhD, or PharmD degree required, specialization in a subspecialty preferred.
  • Minimum 10 years involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers.
  • Sophisticated knowledge of assigned therapeutic area preferred, with the capability to innovate in clinical development study designs that provide relevant evidence to decision-makers, and to interpret, discuss and present clinical trial or section program level data.
  • Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and regulatory/clinical development process.

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