Head of Clinical Operations
Gefunden in: Talent DE 2A C2 - vor 2 Wochen
Join a pioneering rare disease biotech startup dedicated to transforming the landscape of healthcare. Our mission is to develop innovative therapies that address the unmet needs of patients suffering from rare diseases. With a dynamic team and a commitment to scientific excellence, we are poised to make a meaningful impact in the lives of patients. We are currently seeking a visionary Head of Clinical Operations to lead our clinical development efforts in Germany.
Responsibilities:
As the Head of Clinical Operations, you will be instrumental in shaping and executing our clinical strategy for rare disease therapeutics. Your key responsibilities will include:
- Leading and managing the clinical operations team, fostering a culture of excellence and innovation.
- Overseeing the planning, execution, and monitoring of clinical trials from inception to completion, ensuring adherence to timelines, quality standards, and regulatory requirements.
- Collaborating closely with cross-functional teams to drive clinical trial activities, including protocol development, site selection, patient recruitment, and data management.
- Establishing and maintaining relationships with clinical research organizations (CROs), vendors, and investigational sites to ensure efficient trial conduct.
- Developing and implementing standard operating procedures (SOPs) and best practices to optimize clinical operations processes.
- Providing strategic input into clinical trial design, budget planning, and resource allocation.
- Participating in regulatory interactions and submissions, ensuring compliance with applicable regulations and guidelines.
- Monitoring trial progress and proactively identifying and addressing risks and issues to mitigate potential delays.
- Representing the company at scientific meetings, conferences, and industry events.
Qualifications:
We are seeking candidates with the following qualifications and attributes:
- Advanced degree in life sciences or related field.
- Extensive experience in clinical operations leadership roles within the biotech or pharmaceutical industry, with a focus on rare diseases.
- Strong understanding of clinical trial methodology, regulations, and guidelines (e.g., ICH-GCP).
- Proven track record of successfully managing multiple clinical trials simultaneously, from early-phase to late-phase development.
- Excellent leadership, communication, and interpersonal skills, with the ability to inspire and motivate teams.
- Strategic mindset with the ability to drive innovative approaches to clinical development.
- Experience working in a startup or fast-paced environment is highly desirable.
- Fluency in German and English is required.
Benefits:
- Competitive salary and equity options.
- Comprehensive benefits package, including health insurance and retirement plans.
- Opportunities for professional growth and development in a dynamic startup environment.
- Flexible work arrangements and a supportive company culture.
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