Beschreibung

In this role, you will lead the Clinical Operations team to design and execute clinical trials, ensuring efficient processes and compliance. Your day-to-day responsibilities will involve collaborating with various departments, managing resources, and driving patient recruitment to support the growing pipeline.

Anforderungen

• •Thorough knowledge of biopharmaceutical drug development
• •Excellent understanding of pharmaceutical business operations
• •Deep understanding of CRO processes
• •Big-picture executive mindset
• •Well-rounded personality with strong executive presence
• •Strategic networking skills
• •MSc/PhD or MD with significant experience in Clinical Operations
• •Strong leadership skills in biopharmaceutical industry
• •Therapeutic area knowledge in oncology clinical development
• •Track record of managing clinical operations
• •Solid track record with CROs
• •Deep understanding of clinical development
• •Experience defining and executing global R&D strategies
• •Demonstrated leadership in clinical operations
• •Experience leading clinical trials and managing vendors
• •Excellent knowledge of FDA, EMA & ICH/GCP regulations
• •Ability to work in a team environment
• •Entrepreneurial experience with drive and bias for action
• •Comfortable leading through others
• •Experience in a collaborative, matrix-based organisation
• •Ability to influence externally
• •Ability to operate with high independence
• •Excellent networking and leadership skills
• •Passionate, curious, entrepreneurial self-starter
• •Strategic and analytical mindset
• •Unquestionable integrity and high ethical standards

Aufgaben

• •Build a Clinical Operations organization for clinical trials
• •Contribute to clinical trial strategy and management
• •Manage operational and logistical tasks for clinical development
• •Coordinate internal and external resources for patient recruitment
• •Communicate with countries, CROs, and vendors about trial updates
• •Create and implement SOPs for clinical trials
• •Implement process improvements based on trial needs and feedback
• •Work with trial sites to expedite patient recruitment
• •Provide leadership and mentorship to the clinical operations team
• •Support team members in prioritizing work and solving trial issues
• •Provide regular updates and status reports to senior management
• •Monitor CRO performance according to functional metrics
• •Maintain a positive, results-oriented work environment
• •Ensure compliance with applicable regulations
• •Oversee regulatory processes and quality assurance for studies