Beschreibung

In this pivotal role, you will lead the clinical development strategy for a key asset, guiding a dedicated team while ensuring alignment with regulatory and commercial goals. Your work will focus on innovative planning and evidence generation to maximize the asset's potential.

Anforderungen

• •MD or PhD with profound experience in Medicine, preferably Gastroenterology, Hepatology, Endocrinology or Internal Medicine
• •Long-term experience in Clinical Drug Development in pharma industry and/or academia, preferably in an international role
• •Several years of experience in a leadership role in a matrix environment
• •Advanced knowledge in lifecycle stages of medicinal product, including pre-launch/launch/post-launch activities and dynamics
• •In-depth regulatory expertise with prior successful interactions with regulatory agencies like FDA and EMA
• •Excellent leadership communication, negotiation, and influencing skills; ability to act with grace and resilience under pressure; excellent presentation, training, and facilitation skills

Aufgaben

• •Design and execute a data-driven clinical development plan
• •Align the development plan with the asset's target product profile and corporate objectives
• •Provide strategic direction and scientific leadership to the clinical team
• •Drive excellence and innovation in clinical development
• •Develop and continuously update a high-quality clinical development plan post-PoC
• •Contribute to the asset strategy, including the Target Product Profile and Asset Narrative
• •Steer clinical development strategy through insight generation and evidence interpretation
• •Ensure alignment of clinical development with regulatory, access, and commercial goals
• •Lead and manage a team of Clinical Program Leaders, Study Physicians, and Scientific Project Coordinators