Clinical Development Director (remote)

Title:

Clinical Development Director (remote)

Company:

Ipsen Biopharmaceuticals Inc.

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Main 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.

Knowledge, abilities & experience

• 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.

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.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.