Strategic Clinical Affairs Director
hace 3 días
Key Responsibilities:
Develop and execute a comprehensive clinical affairs strategy for the EMEA region that aligns with the organization's global objectives.
Lead and mentor a team responsible for professional education programs, ensuring high-quality training and development opportunities for healthcare professionals.
Oversee the planning and execution of Investigator-Sponsored Research (ISR) and collaborative trials, ensuring compliance with regulatory standards and ethical guidelines.
Foster strong relationships with EMEA RM leadership, divisional clinical leadership, and key stakeholders to facilitate collaboration and support cross-functional initiatives.
Drive the creation and dissemination of clinical evidence to support product positioning and market access strategies.
Monitor and analyze industry trends, clinical data, and competitive landscape to inform strategic decisions and identify opportunities for growth.
Ensure adherence to Good Clinical Practice (GCP) and other relevant guidelines to maintain the highest standards of clinical research integrity and patient safety.
Qualifications:
Advanced degree in a relevant scientific or medical field.
Extensive experience in clinical affairs, preferably within the medical device or pharmaceutical industry, or experience of directing research within an academic environment.
Demonstrated leadership in building and managing professional education programs and clinical trials.
Strong understanding of the regulatory environment and GCP guidelines in the EMEA region.
Excellent communication, negotiation, and interpersonal skills, with the ability to engage effectively with diverse teams and stakeholders.
Fluent in English, with proficiency in additional EMEA languages being an advantage.
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