Beschreibung

In this role, you will lead the clinical science strategy for late-stage development, collaborating closely with teams to ensure effective execution of clinical plans while independently managing key relationships and overseeing data.

Anforderungen

• •Bachelor’s degree in life sciences
• •Advanced Clinical/Science Degree preferred
• •Extensive academic or industry experience in late stage clinical development
• •Strong knowledge of GCP, ICH, FDA, EMA guidelines
• •In-depth knowledge of cross-functional teams in drug development
• •Proven track record in a fast-paced, matrix environment
• •Experience with Study Management Team (SMT)
• •Experience as co-lead with various stakeholders
• •Experience leading and mentoring others
• •Experience solving unique or unpredictable problems
• •Ability to partner across diverse regions and cultures
• •Strong verbal communication and influencing skills

Aufgaben

• •Oversee Medical Data Review Plan execution
• •Manage database lock and data interpretation
• •Ensure effective execution of the Clinical Development Plan
• •Develop trial and protocol strategy within the broader CDP
• •Ensure appropriate data is reflected in protocols, ICFs, and CSR
• •Establish clinical science strategy for CTA/EC submissions
• •Prepare briefing packs and responses to health authority questions
• •Collaborate with filing team and stakeholders on CDP context
• •Act independently with investigators and oversee investigator meetings
• •Contribute to Therapeutic Area Expert interactions for clinical program optimization
• •Manage relationships with external partnerships and institutions