Director Clinical Affairs - Home Based Europe
- Employer
- Proclinical Staffing
- Location
- France, Île-de-France, Paris
- Salary
- Negotiable
- Start date
- 19 May 2023
- Closing date
- 2 Jun 2023
View more
- Discipline
- Clinical Research, Clinical Operations
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
I am partnered with a rapidly growing small medical device company who are looking for their first Director of Clinical Affairs. As the key leader in our clinical affairs group, you will play a crucial role in the development, execution, and success of a ground-breaking implantable device. This is a home-based position which will initially be a contract position with the option to go permanent. This is a long-term assignment.
Responsibilities:
- Strategic Leadership: Drive the overall clinical affairs strategy, aligning it with the company's objectives and vision. Develop and implement comprehensive clinical plans to support product development and regulatory approval.
- Clinical Research Oversight: Lead and manage all aspects of clinical studies, from study design and protocol development to site selection and patient recruitment. Ensure compliance with relevant regulations, including Good Clinical Practices (GCP) and International Organisation for Standardisation (ISO) standards.
- Regulatory Compliance: Collaborate with cross-functional teams to navigate regulatory requirements, including pre-market submissions and post-market surveillance. Maintain a deep understanding of FDA regulations, CE Marking, and other global regulatory frameworks.
- Key Stakeholder Engagement: Foster strong relationships with key opinion leaders, investigators, and regulatory authorities. Represent the company in meetings, conferences, and industry events, building a positive reputation and driving collaboration.
- Team Management: Recruit, mentor, and lead a high-performing clinical affairs team. Provide guidance, support, and professional development opportunities to ensure team success.
Requirements:
- Advanced degree in a relevant scientific field (Ph.D., M.D., or equivalent).
- Proven track record of success in clinical affairs, preferably within the medical device industry.
- Deep understanding of clinical study design, execution, and regulatory requirements.
- Extensive knowledge of FDA regulations, ISO standards, and other global regulatory frameworks.
- Strong leadership skills with the ability to inspire and motivate a team.
- Excellent communication, negotiation, and stakeholder management abilities.
If you are having difficulty in applying or if you have any questions, please contact Troy Neenan at +44 207 437 6824.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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