Clinical Development - Senior Director / Principal Level

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