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Ipsen · 19 hours ago

Clinical Development Director (remote)

United States

Full-time

Remote

Lead/Staff, Director/Executive

5+ years exp

Ipsen Biopharmaceuticals Inc. is a mid-sized global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience. The Clinical Development Director will provide medical expertise and leadership in the design and implementation of clinical development strategies, ensuring compliance with regulatory requirements and fostering collaboration across teams.

BiotechnologyPharmaceuticalProduct Research

H1B Sponsor Likely

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

Qualification

Clinical trial designRegulatory submissionsClinical research experienceAdvanced scientific degreePediatric hepatology expertiseInterpersonal communicationTeam leadershipCollaboration skillsProblem-solving

Required

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

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

Preferred

Pediatric hepatology expertise preferred

Company

Ipsen

Glassdoor3.7

Ipsen is a global specialty-driven biopharmaceutical company focused on innovation and specialty care.

Founded in 1929

Boulogne-billancourt, Ile-de-France, FRA

5001-10000 employees

http://www.ipsen.com

H1B Sponsorship

Ipsen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2020 (1)