Principal Clinical Consultant, Career Growth, UK - Remote (Contract)

This might be the opportunity you've been waiting for! A leading regulatory consultancy company is seeking a skilled Principal Clinical Consultant to join its dynamic team in the UK. As a Principal Clinical Consultant, you'll get the chance to provide strategic, technical, and regulatory advice/services to clients in diverse therapeutic areas, all while playing a pivotal role in mentoring and developing staff.

The Role:

As a Principal Clinical Consultant, your responsibilities will include offering support and advice across various regulatory activities, providing innovative drug development plans, contributing to the authorship and review of regulatory documents, leading multi-jurisdiction programs, and representing clients in regulatory agency interactions with the client. You will also be responsible for achieving project goals are met within agreed timelines, maintaining oversight of project budgets, and fostering 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 (e.g., a life science focused MSc or preferably a PhD)
• 10-15 years of drug development experience, with at least five years in the area of biotechnology and regulatory affairs
• Clinical development experience across a range of therapeutic indications/disease areas
• Preference for candidates with significant experience in drug development covering Europe, UK, and the United States
• Proven ability in defining and delivering creative scientifically driven solutions to technical development and regulatory issues
• Preference for candidates who have direct experience in providing strategic regulatory planning for the delivery of industry development goals, up to marketing authorisation
• Experience in negotiation with multinational regulatory authorities including, as a minimum, European, UK and US authorities
• Proven ability to deliver education via scientific conference presentations in chosen field and training of subordinates
• Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables
• Exemplary verbal communication and presentation skills in English and another EU language is a plus
• Experience on the international level so understanding and connections in the relevant authorities like EMA, FDA, Health Canada, Japan, etc.
• Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally and attendance to the local office once per month
• The role includes some Line Management responsibility, you will report directly to Head of Clinical
• Broad experience in a lot of different clinical documentation( also RA related) like 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

Benefits:

• Competitive salary on the market reflecting your experience
• Generous bonus program which serves as an excellent reward system
• Coaching and mentoring to support your continuous development
• Excellent working environment driven by strong company values and a very high level of employee engagement across international organisation

Apply now and become part of this exciting journey!

Interested? Don't miss out on this exciting opportunity! Apply today and take your career to new heights. Send me a copy of your CV in Word format or share as this is a great opportunity for the right person! This is initially a 7 months contract position with the intention to make it permanent afterwards so please make sure it will suit you. Please share your CV if interested, Forward to Oksana at O.Kolesnichenko@nonstop-recruitment.com or via linked in.

The job market changes very quickly so do not forget to connect with me on Linked in, check other roles that I am hiring for at the moment and follow for any future relevant roles.

NonStop is dedicated to raising the standard of ethical recruitment and comprises a number of brands, each having their own niche sector focus.