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Clinical Lead Vendor Oversight

Clinical Lead Vendor Oversight

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Who we are

At Blueberry Therapeutics, our vision is to introduce high value, innovative medicines to the world that will make a real difference to patients’ lives. We are continuing to grow and are looking for a full time Clinical Lead Vendor Oversight to join our successful team. If you have the skills listed below, enjoy working in a dynamic, exciting environment, and really want to have a positive impact on patients’ lives, then we’d love to hear from you.

 

Summary:

The Clinical Lead Vendor Oversight will ensure adequate scientific support for Company clinical development programmes, providing expert input into clinical studies, clinical strategy, implementation of the Clinical Development Plan, as well as participation in problem-solving initiatives within development projects.

He or she will work under limited supervision to develop solutions utilising creativity and ingenuity, represent the organisation as a prime contact for technical matters and manage responsibility under a no cost centre budget.

 

Tasks and Responsibilities:

• Set objectives, deliver results and implement policies and operational targets that have a direct impact on the work unit or operational outcome
• Develop clinical trial designs, protocols and the clinical aspects of the execution of clinical trials Phases I-IV
• Develop suitable clinical development plans (and clinical section of Drug Development Plans) to address the global development requirements of the Company
• Key member of the regulatory document preparation and review team
• Key contributor in the review and interpretation of clinical trials data and development of associated integrated analyses and label claims.
• Stay updated on competitors and changes in the relevant therapeutic areas as appropriate
• Represent Company at professional meetings and with regulatory authorities as required
• Interact with KOLs across the relevant therapeutic areas as appropriate.
• May lead agendas and presentations to Executive level meetings and support Advisory Board meetings as required
• Work closely with Finance team to ensure transparency of Clinical plans and ensure sensitivity to overall company budgets.
• May manage the activities of contractors and ensure that contractors, consultants and vendors complete assigned project work according to agreed timelines. This may include troubleshooting routine client inquiries.

 

Requirements:

  • Degree in relevant scientific subject e.g., biochemistry, pharmacology.
  • Minimum 10+ years’ industry experience in Clinical, Regulatory or Medical functional areas and at a Program level for some of that time
  • Up to date GCP training (within last 2 years)
  • Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments
  • Strong team player

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