Clinical Development Director
1 month ago
Division / Function: R&D Oncology Therapeutic Area
Manager: Vice president, Early Clinical Development Oncology
The Clinical Development Director, Early Clinical Development, is a key member of the Global Oncology team, responsible for the development of the Clinical Development Plan (CDP) and medical aspects of the Integrated Development Plan (IDP) of Ipsen's new products in oncology. This role is aligned with the Oncology Therapeutic Area strategy and collaborates with the global Asset Lead to ensure the successful development of new products.
Key Responsibilities:
- Develop and propose Clinical Development Plans (CDPs) and medical aspects of Integrated Development Plans (IDPs) for new products in oncology.
- Lead the Global Development Team for the Asset and work in partnership with other global asset functions to ensure the successful development of new products.
- Collaborate with Global Regulatory Affairs, Global Drug Safety, Global Medical Affairs, and Global Franchise Oncology to provide medical support for drug development programs.
- Deliver high-quality medical/scientific/strategic input and medical/scientific interpretation on specific product data to support the development business objectives for registration.
- Provide pivotal medical input to Ipsen's individual oncology drugs, including recently acquired assets, and support regional and/or global drug development.
- Ensure compliance with GCP, ethical, scientific, and medical guidelines and statutory principles throughout all clinical development activities.
- Work within complex medical situations under tight time constraints, prioritizing appropriately to deliver expected results.
- Participate in Business Development activities, including providing expert clinical evaluation of asset data and developing relevant Clinical Development Plans.
- Support in all medical, scientific, strategic, and clinical matters for Project Teams and drug development programs from lead compound identification to product registration and launch.
Requirements:
- Board-certification (board-equivalence) in Hematology and/or Medical Oncology or training in hematology and/or oncology is highly desirable.
- Minimum 5 years proven experience in oncology/hematology.
- Substantial scientific and academic experience (preferably with clinical trial experience); with state-of-the-art medical, scientific knowledge.
- Substantial experience in pharmaceutical drug development and, in industry context, track record of global clinical trials management.
- Previous experience directly and independently leading projects and/or a team of professionals.
- Previous experience on transversal projects (with other functions) and multiple therapeutic areas and stages of drug development, exhibiting the ability to influence others (above and beyond one's own function).
About Ipsen Biopharm Ltd:
Ipsen Biopharm Ltd is a leading biopharmaceutical company dedicated to improving patient outcomes through innovative treatments. Our team is passionate about delivering high-quality products and services that make a difference in people's lives.
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