Director Clinical Affairs
Job Description
Position : Director of Clinical Affairs
Role Overview :
The Director of Clinical Affairs is responsible for driving the strategic direction and execution of the organization's clinical research initiatives, ensuring adherence to international standards and regulatory guidelines.
This role involves global leadership across clinical operations, partnering with data management, regulatory teams, clinical research professionals, and other stakeholders.
Key responsibilities include designing and overseeing clinical studies, managing clinical documentation, engaging with opinion leaders and site staff, and contributing to scientific publications to advance the organization's clinical objectives.
Required Qualifications :
- Advanced degree in a relevant clinical, medical, or biomedical discipline.
- 5-10 years of experience managing clinical trials, preferably in the medical device sector with an emphasis on cardiovascular studies.
- A minimum of 5 years leading cross-functional project teams.
- In-depth knowledge of FDA and EU regulatory frameworks, GCP, and ICH standards.
- Strong leadership and communication skills, fluency in English (German proficiency is an advantage).
- Proven ability to manage complex, international clinical programs independently.
Primary Responsibilities :
- Establish and execute clinical affairs strategies aligned with regulatory and business objectives.
- Foster relationships with key opinion leaders and physicians, overseeing Clinical Affairs investments and initiatives.
- Direct clinical trials across various regions, ensuring compliance with applicable regulations and ethical standards.
- Manage budgets, contractual agreements, and clinical data dissemination.
- Oversee individual trials, focusing on GCP adherence and patient safety.
- Collaborate on risk management activities and contribute to regulatory submissions and clinical strategies.
Work Environment :
- Regular travel and occasional extended working hours to accommodate global teams.
- Engagement in a dynamic, multicultural environment with participation in international conferences and clinical site visits.
Career Development :
This role provides opportunities for advancement within the senior leadership structure, paving the way for potential executive-level positions within the organization.
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