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Head of Clinical Leadership

2 months ago

Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full time
Job Title: Head of Clinical

About the Role

Scendea is seeking a highly skilled and experienced professional to join our team as a Head of Clinical. This is a key leadership position that will play a critical role in the development and delivery of our clinical services.

Key Responsibilities

  • Provide strategic, technical, and regulatory advice to clients to facilitate the entry of their compounds into clinical trials and assist in the activities required for successful international marketing approvals.
  • Establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
  • Develop and deliver innovative drug development plans, data gap analyses, and international regulatory strategies 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 the technical authorship and review of development regulatory documents.
  • Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
  • Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.
  • Lead meetings with internal and external stakeholders on matters related to current and future projects, contracts, or new business opportunities.

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 five years management experience in consultancy, including leading and managing a team, and co-ordinating technical leadership and strategy.
  • 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.
  • Exemplary organisational and time management skills with a high level of attention to detail, and the proven ability to work both proactively and autonomously.
  • High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.
  • Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.

What We Offer

  • A competitive salary.
  • Generous bonus program, which rewards success.
  • 26 days' vacation plus discretionary additional days for birthday and work anniversary and public holidays.
  • 5% employer pension contribution.
  • Private Healthcare insurance.
  • Access to Employee Assistance Programme.
  • Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.

About Scendea

Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.