Medical Development Director, Rare Disease

We are looking for a Medical Development Director in the Rare Diseases Therapeutic Area to join our Clinical Development team. 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 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 cross-functional 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 cross-functional, matrix environment with internal and external stakeholders.
  
  Advanced scientific degree (MD [or equivalent], PhD or PharmD).


• 7+ years of clinical research and/or drug development experience within the pharmaceutical industry, a CRO, or similar organization; experience in hepatology beneficial.


• Experience in designing and conducting Phase I-III clinical trials and providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA.


Key Technical Competencies Required


• Objective-driven, solution and results oriented, with a solid sense of urgency.


• Ability to thrive in a fast-paced 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.