Clinical Development Lead

13 hours ago


Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time
Overview:
GSK is a global biopharma company dedicated to uniting science, technology, and talent to combat diseases. We focus on infectious diseases, HIV, respiratory/immunology, and oncology. As a Clinical Development Lead, you will be responsible for driving effective clinical strategies for our oncology pipeline.

About the Role:
This leadership opportunity involves leading GSK's medium and long-term oncology development strategies. You will work closely with the Global Oncology Research and Development and Medical Affairs teams to ensure the highest quality capabilities and expertise in oncology clinical research. Your goal will be to optimize the launch of new products and patient use of available GSK medicines through leadership and collaboration.

Main Responsibilities:
  • Provide scientific input during protocol development, study conduct, and result interpretation consistent with objectives to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient-reported outcomes.
  • Author Clinical Study Proposals (CSPs), prepare and present studies at Protocol Review Boards (PRBs), incorporate suggested changes post-governance meetings.
  • Assume responsibility for medical review of clinical trial data, directly or via oversight of delegated medical review.
  • Review/moitor safety data in collaboration with the pharmacovigilance group for active clinical studies.
  • Participate in blinded reviews of data packages intended for Independent Data Monitoring Committees (IDMCs).
  • Lead a clinical matrix team, prioritizing patient safety during the study lifecycle, ensuring study objectives meet regulatory and reporting requirements.
  • Engage and influence a diverse scientific community, including internal and external experts, through collaborations.

Requirements:
We seek an experienced professional with a background in pharmaceutical/biotechnology industry or related clinical experience. Essential skills include data review/interpretation, study design, protocol authoring, amendments, IBs, clinical study proposals, informed consent, and study manuals preparation. Excellent leadership skills are required, along with clinical development plan management experience. A master's degree or higher is preferred, with advanced knowledge of clinical development across all phases (I-IV) and regulatory requirements for registration.

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