Full-time - Hybrid Role - UK
IMC are currently supporting a UK head quartered client to hire a technical Clinical Development expert to join their fast-growing team. The role will be supporting Global Pharma & Biotech clients with Product Development & Regulatory services.
The Role
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.
• 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:
o Sales/marketing introductions
o Preparation of project proposals & educational materials
o 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)
Location & Reporting Structure
• 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 public holidays
• 5% employer pension contribution
• Private Healthcare
• Employee Assistance Programme
• Employee Ownership Trust Scheme
To be considered for this role you must have unrestricted Right to Work in the United Kingdom
To learn more about this opportunity, please contact Stuart Hunter on 07423 774 841 or email your CV to stuart.hunter@IMC-LifeSciences.co.uk
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