Head of Clinical Leadership

1 day ago

Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full time
Head of Clinical Opportunity

Scendea is seeking a highly skilled and experienced professional to lead our clinical team as a full-time Head of Clinical and Principal Consultant.

This is a hybrid position, affiliated to our Bishop's Stortford office, UK, with a requirement to work in the office a minimum of one day per month.

About the Role

The position reports into the Head of Product Development and regulatory consulting.

This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy.

Key Responsibilities
  1. Play a key role in the development and mentoring of staff
  2. Provide high-quality regulatory technical advice and product development strategies for clients
  3. Establish and maintain a high level of technical knowledge in product development and international regulatory affairs
  4. Provide innovative drug development plans, data gap analyses and international regulatory strategies from a clinical perspective for complex products within the changing regulatory environment
  5. Creates and delivers high-quality billable regulatory related documentation for clients
  6. Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections
  7. Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets
  8. Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities
  9. Develop systems and procedures to ensure a high level of quality in clinical services
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 five years management experience in consultancy, including leading and managing a team, and co-ordinating technical leadership and strategy.

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.

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.

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.

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.

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