Head of Clinical Leadership

3 weeks ago

Hertfordshire, United Kingdom Leaman Life Sciences Full time
Head of Clinical Opportunity

We are seeking a highly motivated and experienced Head of Clinical to join our team at Leaman Life Sciences. As a key member of our regulatory consultancy, you will play a crucial role in developing and mentoring staff, providing high-quality regulatory technical advice, and driving product development strategies for our clients.

Key Responsibilities
  • Lead and manage the Clinical team, coordinating technical leadership and strategy with senior team members, and supporting the senior leadership team to meet company goals.
  • Provide strong strategic, technical, and regulatory advice and services to facilitate the entry of clients' compounds into clinical trials and assist in activities required for successful international marketing approvals.
  • Develop innovative drug development plans, international regulatory strategies, and data gap analyses from a clinical perspective for complex products within the changing regulatory environment.
  • Create and deliver high-quality billable regulatory related documentation for clients, contributing to technical authorship and review of development regulatory documents.
  • Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your area of expertise.
  • Support Business Development in sales/marketing introductions and generate additional business from current clients.
  • Line management, training, and mentorship of members of the Operational team, including Clinical Team development.
Requirements
  • A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent.
  • A minimum of ten years of clinical drug development experience.
  • A minimum of five years management experience in consultancy, including leading and managing a team, and coordinating technical leadership and strategy.
  • A minimum of ten years of experience with either FDA, MHRA, and/or EMA, including negotiation. Regulatory experience may include time within a National Competent Authority.
  • Direct experience preferred in providing technical clinical advice across all phases of clinical development, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
  • Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.
What We Offer

This role requires a minimum of one day a month in the offices in Hertfordshire, and a willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.

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