Head of Clinical
5 days ago
I am working with my client, who have a superb opportunity for a highly motivated Head of Clinical and Principal Consultant to their to join their extremely successful and rapidly growing Regulatory Consultancy
If you are looking to grow your career, playing a key role within the team, developing and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for their clients, this could be just the role for you
Key Requirements
- Lead and manage the Clinical team, co-ordinating both technical leadership and strategy with key senior team members, and supporting the senior leadership team to meet the company goals.
- Experience providing strong strategic, technical, and regulatory advice and services to facilitate the entry of Client’s compounds into clinical trials and assisting in the activities required for successful international marketing approvals.
- Providing innovative drug development plans, international regulatory strategies and data gap analyses from a clinical perspective for complex products within the changing regulatory environment.
- The ability to establish and maintain a high level of technical knowledge in product development and international regulatory affairs.
- Create and deliver high-quality, billable regulatory related documentation, contributing to the technical authorship and review of a full range of development regulatory documents according to area of expertise.
- Lead multi-jurisdiction programs of work and deliver consulting services within your respective 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 the Clinical Team development. Developing systems and procedures to ensure a high level of quality in clinical services and to ensure that the appropriate tools are in place to support the achievement of utilisation targets.
Skills and Experience
- A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD).
- 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 co-ordinating 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.
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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