IMC are currently supporting a UK head quartered client to hire a technical Clinical Development expert to join their fast-growing team. The company Support Global Pharma & Biotech clients with Product Development & Regulatory services. Their international team offers strategic and operational support in the fields of Non-Clinical/Toxicology, CMC, Clinical/Medical and Regulatory.
You will be a technical Clinical Strategy expert joining the team on a full-time basis as a Principal Consultant (Senior Manager / Director / VP of Reg / Head of Department equivalent). The position requires that you have established experience in working independently and leading technical discussions on a range of clinical development topics in compliance with current regulatory requirements. You will be competent in direct hands-on clinical writing and review of documents for regulatory submissions.
This is an excellent opportunity to progress your career at a growing global 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.
- Provide strategic, technical, and regulatory advice/services to clients in clinical development of human medicinal products, across a wide range of therapeutic indications & activities
- Provide innovative drug development plans, data gap analysis and international regulatory strategies from a Clinical perspective for complex products within the changing regulatory environment
- Support company Business Development activities including:
- Sales/marketing introductions
- Preparation of project proposals & educational materials
- Review written estimates & quotations for accuracy
- Contribute to technical authorship and review of development regulatory documents, focusing on FDA, EMA & MHRA activities
- Provide technical leadership to other members of the consultancy team, including other Principal and Senior Consultants
- Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections
- Ensure delivery of project goals within agreed timelines and project budgets
- Identify and generate additional business opportunities from current Clients through exceeding expectations relating to the quality, delivery time and cost of services
- Educate clients on current regulatory trends and expectations
- Establish and maintain a high level of technical knowledge in product development and international regulatory affairs
- Challenge the regulatory boundaries from a technical and scientific standpoint
- Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities
- Provide strategic input/support to company Directors and the company’s growth plan
- Line manage individual contributors, and in doing so, provide ongoing coaching, mentoring and companywide training (when required)
- The role will be affiliated to their UK office
- The role will be flexible, working from home with a minimum of one office-based day per month
- The selected candidate will report directly to the Head of Clinical
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)
- At least fifteen years of drug development experience, with at least five years in 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
- A professional manner and presentable appearance for meeting customers/clients
- Ability to work in a proactive and autonomous manner as well as leading a global team, to ensure high-quality of deliverables
- Ability to balance competing priorities and complete work within a set timeframe
- Exemplary organisational skills with a high level of attention to detail
- Exemplary verbal communication and presentation skills in English
- High level of computer literacy and competency in MS Office programs
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the Netherlands, Europe, UK or internationally.
Salary & Benefits Include
- A Competitive Salary
- Company Bonus Scheme
- 26 Days Holiday Plus additional days for Birthday & Work Anniversary & all UK public holidays
- 5% employer pension contribution
- Private Healthcare
- Employee Assistance Programme
- Employee Ownership Trust Scheme
