Head of Clinical Development US (VP)

OM36155_1717085591
  • £350000 - £450000 PER ANNUM
  • USA
  • Permanent

Head of Clinical Development (Early) US

Location: US - Remote

Report to: CEO

ID: OM36155

Company:

  • A clinical stage CAR-T biotech with a pioneering platform demonstrating unparalleled efficacy and safety results, having innovate found solutions to overcome host rejection and achieve long persistence.
  • Active support from top US leukemia and lymphoma KOLs from institutions incl. MDACC, MSK, Moffitt and Mayo
  • Potential to be the key figure in the first US drug approval of its kind in history

Position Summary:

  • This position will provide leadership and direction for our lymphoma focused CAR-T therapies as a priority.
  • As a key senior leader you will be expected to provide medical insight, expertise, and determine clinical development strategies and deliveries that leading to the approval and commercialization of company's products in US and globally.
  • Responsibility to grow the Clinical Development and Clinical Operations teams in the US.

Essential Roles & Responsibilities:

  • Lead clinical development strategies, make critical decisions on aspects from clinical research to development, medical to regulatory process.
  • Provide oversight, leadership, and direction for functions of Clinical, Medical, Safety & Pharmacovigilance, Data Management and Clinical Quality Management.
  • Oversee the implementation of quality management efforts designed to improve medical/clinical performance and ensure compliance with regulations and accreditation standards.
  • Build relationships with hospitals and physicians by providing medical perspectives and communicating the clinical value of company's pipeline.
  • Manage the CROs, provide professional supports and medical monitoring.

Professional Experiences & Qualifications:

Required

  • MD and Hematologist/Oncologist.
  • Experience at Senior Director level and above within Clinical Development.
  • 5+ years of pharmaceutical or biotechnology industry experience with specific focus on early phase clinical development for hemato-oncology.
  • Experience of whole life cycle management for the development of novel drug.
  • Knowledge of drug regulations in U.S. and experience in interactions with FDA.
  • Strong interpersonal communication skills to interact effectively with investigators, physicians, regulatory agencies, partners, consultants, and team members across functions.
  • Experience with clinical risk management and safety protocols.
  • Willing to travel frequently within US.

Desirable

  • Professional knowledge in cellular immunology preferred
  • Specific experience in Lymphoma CAR-T therapies
  • 2+ years of experience as a practicing hematologist in academia/hospital/clinic
  • Direct experience as a leader on BLA/NDA processes
  • Experience in Autoimmune diseases would be beneficial
  • Experiences with global health authorities is a plus
Oliver Morkel Associate Director / AVP

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