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Head of Clinical Leadership

2 months ago

Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full time
Job Opportunity

About the Role

We are seeking a highly skilled and experienced individual to join our team as a Head of Clinical and Principal Consultant. This is a key position that will play a critical role in the development and mentoring of staff, as well as providing high-quality regulatory technical advice and product development strategies for clients.

Key Responsibilities

  • Lead and manage the Clinical team, co-ordinate technical leadership and strategy with senior team members, and support the senior leadership team at Scendea to meet the company goals.
  • Provide strategic, technical, and regulatory advice/services to clients to facilitate the entry of Client's 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.
  • Provide innovative drug development plans, data gap analyses and international regulatory strategies from a clinical perspective for complex products within the changing regulatory environment.
  • Creates and delivers high-quality billable regulatory related documentation for clients, contributing to the technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
  • 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 any current and/or future projects, contracts, or new business opportunities.
  • Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
  • Line manage, train, and mentor members of the Scendea Operational team, including the Clinical Team development.
  • Develop 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.

Requirements

​

  • 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 (from early phase trials to marketing authorisation), 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.

Benefits

  • 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.
  • Employee Ownership Trust Scheme.
  • A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.
  • 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. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.

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. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. 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.

As a Scendea Employee

Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instill trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.

Eligibility & Conditions

Applicants must reside and be eligible to work in the UK without the requirement for sponsorship now or in the future.