Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Director, Clinical Development leading medical guidance for rare liver diseases at Ipsen. Collaborating across teams to design and implement clinical trial protocols with regulatory compliance.
Responsibilities
- Provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases
- 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 to ensure adherence to ICH GCP, patient safety, and data integrity
- Provide medical expertise for interactions with regulatory authorities
Requirements
- Advanced scientific degree (MD [or equivalent], PhD or PharmD)
- 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
Benefits
- 401(k) with company contributions
- group medical, dental and vision coverage
- life and disability insurance
- short- and long-term disability insurance
- flexible spending accounts
- parental leave
- paid time off
- discretionary winter shutdown
- well-being allowance
- commuter benefits
Job title
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Degree requirement
Tech skills
Location requirements
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