Clinical Development Director; remote

Responsibilities

• 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 Pharm
  
  D).
• 5+ years of clinical research and/or drug development experience within the pharmaceutical industry, a CRO, or similar organization.
• Experience in designing and conducting Phase I-III clinical trials and providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA.
• Pediatric hepatology expertise preferred.

• 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.