Development Director Clinical and Regulatory Operations

4 days ago


Horsham, West Sussex, United Kingdom Cmed Group Ltd Full time
Job Overview

The Aixial Group is an International Contract Research Organization (CRO) with offices worldwide. We are currently seeking an experienced Director, Strategic Development and Delivery to join our Clinical and Regulatory Operations team. This role will be home-based in the UK or EU where we have the ability to hire.

Key Responsibilities
  • Provide clinical and therapeutic expertise during pre-sales and sales engagements
  • Nurture ongoing client relationships to gather meaningful intelligence regarding future projects and prospects
  • Oversight of programs and projects within the Clinical and Regulatory Operations or Full Services project portfolio
  • Represent Aixial Clinical and Regulatory Operations externally to current and prospective clients
  • Participate in capabilities presentations, bid defense meetings, and develop quality proposals
  • Support recruitment, supervision, and development of staff as well as ensure available resources are balanced with contracted obligations and corporate objectives
  • Lead strategic planning and implementation of process improvement in support of operational excellence aligned with project/program delivery, the clinical/regulatory operations business unit, and the CRO enterprise

Requirements
  • Bachelor's or master's degree in life sciences or equivalent industry experience
  • Minimum of 10 years global drug development experience with deep clinical research and operational strategy experience in the Pharmaceutical/Biotech and CRO industries
  • Knowledge of ICH GCP guidelines and industry standards of quality
  • Problem-solving capabilities with strong attention to detail
  • Relationship-building skills and strong interpersonal presence

Preferred Qualifications
  • Clinical research experience in numerous therapeutic areas
  • Proven project management experience within the Pharmaceutical/Biotech and CRO industry
  • Ability to prioritize multiple tasks and follow to completion with industry expertise
  • Strong motivational skills and understanding of customer service

Technical Skills
  • Demonstrated experience in relevant therapeutic disciplines
  • Demonstrated ability and experience in building client partnership
  • Experience in personnel, financial, and operational management
  • Demonstrated experience in relevant software (e.g. Microsoft Office)

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