Lead Clinical Development Director, Rare (Remote)

Title:

Lead Clinical Development Director, Rare (Remote)

Company:

Ipsen Pharma (SAS)

 

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:

As Global Clinical Development Lead, you will lead the clinical development of Potravitug within Ipsen’s Rare Disease (Nephrology) Therapeutic Area. Working in close partnership with the Global Asset Lead, you will own the Clinical Development Plan (CDP) and the clinical strategy within the Integrated Development Plan (IDP). This is a senior, highly visible role for an individual who wants to shape development programs from end-to-end, including registration and launch. You will report to the Vice President, Potravitug Global Asset Lead.

• Lead the design and delivery of the CDP and the clinical components of the IDP, aligned with the Target Product Profile (TPP).
• Interpret clinical trial results in the context of external data and the competitive landscape to make fit-for-purpose development recommendations.
• Serve as the clinical development representative in interactions with health authorities (e.g., FDA, EMA).
• Author or oversee key clinical documents, including synopses, protocols, the Investigator’s Brochure, clinical sections of regulatory submissions, and clinical study reports.
• Act as the clinical decision-maker for study teams, partnering with Clinical Operations and CRO partners to deliver high-quality studies on time and within budget.
• Provide medical oversight of ongoing clinical trials to ensure data integrity and sound interpretation, in line with ICH-GCP, applicable regulations and company SOPs.
• Build strong relationships with key opinion leaders and investigators, and represent Ipsen at investigator meetings, advisory boards and scientific congresses.
• Contribute to abstracts, publications and presentations arising from Ipsen-sponsored studies.
• 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 within the Therapeutic Area and contribute to competitive intelligence.

Knowledge & Experience (essential):

• • Medical Doctor (MD) or internationally equivalent medical degree (e.g., MBBS/MBChB).
  • Clinical training and experience in nephrology or transplant nephrology, or a closely related specialty (e.g., internal medicine or critical care) with substantial renal expertise.
  • 10+ years of combined clinical and drug development experience, including significant industry experience (pharma, biotech or CRO) leading renal clinical trials.
  • A proven track record in global late-stage clinical development, ideally including regulatory submissions and registration.
  • 3+ years of line-management experience; industry experience is preferred, but leadership gained in clinical or academic settings will be considered.
  • 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%
  • Knowledge & Experience (preferred):Board certification in nephrology, transplant nephrology, internal medicine or critical care.Experience in rare diseases.PhD and/or academic appointment (Assistant/Associate Professor or equivalent).A record of peer-reviewed publications in high-impact journals.Cross-functional exposure to Medical Affairs or Safety/Pharmacovigilance.Working knowledge of French could be advantageous. 

Location: Remote in Europe or East Coast US

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même