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Medical Development Director, Rare Disease
Il y a 3 mois
The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases.
Main responsibilities / job expectations
Main Responsibilities
Main Tasks
Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%)
- Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives.
- Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements.
- Provide study leadership and collaborate with crossfunctional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication).
- Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor.
- Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies.
- Build and maintain strong relationships with clinical investigators and thought leaders.
- Effectively fosters productive and collegial working relationships in a crossfunctional, matrix environment with internal and external stakeholders.
Knowledge, abilities & experience
- Advanced scientific degree (MD).
- 7+ years of clinical research and/or drug development experience within the pharmaceutical industry, experience in gastroenterology or hepatology is beneficial.
- Experience in designing and conducting Phase I-III clinical trials. Providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA is beneficial.
- Experience of working with translational science is beneficial
Key Technical Competencies Required
- Objectivedriven, solution and results oriented, with a solid sense of urgency.
- Ability to thrive in a fastpaced and dynamic environment.
- Excellent verbal, written, and interpersonal communication skills.
- Ability to lead teams with diverse backgrounds to deliver results.
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Ipsen
