Clinical Development Lead, CRM

JobtailorRemote

Stellenbeschreibung:

Responsibilities

Hold full strategic and operational accountability for the clinical development of the asset
Responsible for designing and executing a forward-looking, data-driven clinical development plan
Provide strategic direction and scientific leadership to a dedicated team of Clinical Program Leaders
Drive excellence and innovation in clinical development
Empowered to drive strategic recommendations and operational decisions for Senior Management endorsement and governance committees
Accountable for the development and continuous update of a consistent high quality clinical development plan
Key contributor to the asset strategy including Target Product Profile (TPP), Asset Narrative, and ASSAY value proposition
Steer the clinical development strategy through insight generation, evidence interpretation, and enterprise-level decision-making
Ensure clinical development is scientifically rigorous and strategically aligned with regulatory, access, and commercial goals

Requirements

MD or PhD with profound experience in Medicine, preferably Gastroenterology, Hepatology, Endocrinology or Internal Medicine
Clinical or Pharma experience in the US is a plus
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 the lifecycle stages of medicinal product, including pre-launch/launch/post-launch activities and dynamics
In-depth regulatory expertise with prior successful interactions with various regulatory agencies like FDA and EMA
Excellent leadership communication (oral and written) as well as negotiation and influencing skills
Ability to act with grace and resilience under pressure as well as excellent presentation, training and facilitation skills

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