Beschreibung

As a Clinical Development Director in Neuroscience, you will lead the development of clinical strategies and regulatory documents while ensuring data quality and compliance. This role involves collaborating with various stakeholders and mentoring colleagues, making a significant impact on clinical trial success.

Anforderungen

• •Advanced degree in life sciences, healthcare, or clinically relevant degree
• •Background or experience in Neuroscience, Neurodegeneration, Neuromuscular, Gene Therapy, Rare diseases, Neuroinflammation or similar
• •Fluent oral and written English
• •At least 7 years of involvement in clinical research or drug development
• •Advanced knowledge of assigned therapeutic area
• •Demonstrated ability to establish strong scientific partnership with key stakeholders
• •Thorough knowledge of GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/clinical development process
• •At least 1 year of people management experience or management in a matrix environment
• •Excellent communication skills, written and oral
• •Excellent interpersonal skills
• •Excellent negotiation and conflict resolution skills
• •Budget Management, Clinical Research, Clinical Trials, Coaching, Cross-Functional Teams, Lifesciences, People Management, Risk Management, Risk Monitoring

Aufgaben

• •Support and lead delivery of clinical deliverables in assigned program sections
• •Develop clinical development strategies for assigned program sections
• •Review clinical data and ensure compliance with program-specific standards
• •Contribute to the development of Clinical Study Reports (CSRs) and publications
• •Lead the creation of regulatory documents like Investigator’s Brochures and safety updates
• •Conduct ongoing reviews of clinical trial data with medical monitors and experts
• •Collaborate with data management and statistics teams for data quality and analysis
• •Prepare for inspections and audits, including risk assessments and mock interviews
• •Author and review abstracts, presentations, and manuscripts for clinical accuracy
• •Support monitoring and safety data analysis for assigned clinical trial sections
• •Engage with external stakeholders such as regulatory authorities and advisory boards
• •Facilitate the transition of pre-PoC projects to Development Decision Point
• •Ensure career development and mentoring for clinical colleagues
• •Provide medical/scientific training to Novartis stakeholders
• •Lead global initiatives for process improvement and training
• •Serve as Clinical Scientific Lead for clinical trials, guiding all clinical aspects