Director Clinical Affairs
il y a 17 heures
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.
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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ClinicalOperations
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