Head of Clinical Operations & Principal Consultant

The Role

Scendea is seeking a highly motivated individual to join our global team as a full-time Head of Clinical Operations & Principal Consultant. This is a hybrid position, affiliated to either our UK, Netherlands, US, or Australia office, with a requirement to work in the office a minimum of one day per month. The position reports to the Head of Product Development & Regulatory Consulting.

This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.

Role Requirements

• Lead and manage the Clinical team, co-ordinate technical leadership, and engage with Principal Medical Consultants on strategy.

• Provide strategic, technical, and regulatory advice/services 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.

• Create and deliver high-quality billable regulatory related documentation for clients, contributing to the technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs 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 providing technical leadership.

• Support the development of systems and procedures to ensure a high level of quality and the appropriate tools in place to support clinical services and the achievement of utilisation targets.

• Be an active participant of the senior leadership team to support achieving the company goals.

Skills and Experience

• A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD).

• A minimum of ten years of drug development experience.

• A minimum of ten years of regulatory experience, working with either FDA, MHRA, EMA or TGA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.

• Clinical development experience across a wide range of therapeutic indications/disease areas, with direct experience preferred in providing strategic regulatory planning from early-stage clinical development up 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’ holiday/vacation plus discretionary additional days for birthday and work anniversary and public holidays.

• Employer pension contribution/ compensation in line with country specific legislation.

• Provision of / compensation of 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.

The Company

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 instil 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 either the UK/Netherlands/US/Australia without the requirement for sponsorship now or in the future. Closing date for applications is Monday 19th May 2025 and candidates will be notified of the outcome of their application no later than Friday 23rd May 2025.