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About the Role
Lead the clinical development of Potravitug within Ipsen’s Rare Disease (Nephrology) Therapeutic Area. Own the Clinical Development Plan (CDP) and clinical strategy within the Integrated Development Plan (IDP). This senior role shapes development programs from end-to-end, including registration and launch.
Responsibilities
- Lead the design and delivery of the CDP and clinical components of the IDP, aligned with the Target Product Profile (TPP).
- Interpret clinical trial results and make development recommendations.
- Serve as the clinical development representative in interactions with health authorities.
- Author or oversee key clinical documents, including synopses, protocols, Investigator’s Brochure, clinical submission sections, and study reports.
- Act as the clinical decision-maker for study teams, partnering with Clinical Operations and CRO partners.
- Provide medical oversight of ongoing clinical trials.
- Build strong relationships with key opinion leaders and investigators.
- Represent Ipsen at investigator meetings, advisory boards, and scientific congresses.
- Contribute to abstracts, publications, and presentations.
- Work across a global matrix with Early Development, Clinical Pharmacology, Regulatory Affairs, Safety, Medical Affairs, and Commercial teams.
- Provide clinical development input to Business Development on in-licensing and partnering opportunities.
- Contribute to competitive intelligence.
Requirements
- Medical Doctor (MD) or internationally equivalent medical degree.
- Clinical training and experience in nephrology or transplant nephrology, or a closely related specialty with substantial renal expertise.
- 10+ years of combined clinical and drug development experience, including significant industry experience leading renal clinical trials.
- Proven track record in global late-stage clinical development, ideally including regulatory submissions and registration.
- 3+ years of line-management experience.
- Demonstrated ability to lead cross-functional teams and influence senior stakeholders without direct authority in a global matrix organization.
- Clear, confident communication with health authorities, external experts, and senior leaders.
- Fluent English, spoken and written.
- Willingness to travel domestically and internationally (up to 20%).
Skills
- Nephrology
- Transplant nephrology
- Internal medicine
- Critical care
- Renal clinical trials
- Global late-stage clinical development
- Regulatory submissions
- Line-management
- Cross-functional team leadership
- Stakeholder influence
- Health authority communication
- External expert communication
- Senior leader communication
- Rare diseases
- Medical Affairs
- Safety/Pharmacovigilance
- French language
Location
- Remote in Europe
- Remote in East Coast US
Work Type
- Remote
- Full-time
Experience Level
- 10+ years of combined clinical and drug development experience
- 3+ years of line-management experience
Education Level
- Medical Doctor (MD) or internationally equivalent medical degree
- Board certification in nephrology, transplant nephrology, internal medicine or critical care (preferred)
- PhD and/or academic appointment (preferred)
About the Company
- Ipsen is a mid-sized global biopharmaceutical company focused on transformative medicines in 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.
- Tackles areas of high unmet medical need through research and innovation.
- Passionate teams in more than 40 countries focused on what matters and endeavor every day to bring medicines to patients in 88 countries.
- Builds a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence, and impact.
- Empowers every individual to be their true selves, grow, and thrive alongside the company’s success.
- Journey towards sustainable growth, creating real impact on patients and society.
Equal Opportunity
- Committed to creating a workplace where everyone feels heard, valued, and supported.
- Values diverse perspectives and experiences, motivating commitment to inclusion and equal opportunity.
- Believes diverse thinking leads to more thoughtful decisions and innovative solutions.
- Strives to better understand the communities served.
- Provides support during the application process; information treated with care and does not impact application outcome.