Clinical Development Director
Ipsen
full-time
Posted on:
Location Type: Remote
Location: Massachusetts • United States
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Job Level
Tech Stack
About the role
- 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.
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
- Join a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial protocolsclinical researchdrug developmentPhase I clinical trialsPhase II clinical trialsPhase III clinical trialsregulatory submissionsINDCTANDA
Soft skills
leadershipcollaborationrelationship buildingcommunicationteamworkinterpersonal skillscross-functional collaborationcollegialitystakeholder engagementscientific rigor
Certifications
MDPhDPharmD