Lead Clinical Development Director, Rare (Remote)

Ipsen; Paris; Remote; EUR 180,000 - 240,000; Full time

Job summary

Ipsen is seeking a Global Clinical Development Lead to oversee Potravitug development within Rare Disease (Nephrology). You will own the Clinical Development Plan and drive strategy across registration and launch, reporting to the Vice President.

In this senior role, you will lead cross-functional teams, interact with health authorities, and shape development programs from early design to regulatory submission, while traveling up to 20% globally as needed and ensuring rigorous data integrity and

Qualifications

• MD/MBBS or international equivalent is required.
• Board certification in nephrology or related field preferred.
• PhD and/or academic appointment are a plus.

Responsibilities

• Lead design and delivery of global clinical development plan for Potravitug.
• Interpret trial results and advise on development path.
• Represent Ipsen with health authorities (FDA/EMA).
• Author key clinical documents and regulatory submissions.
• Provide medical oversight of trials ensuring data integrity.
• Collaborate with cross-functional teams across regions.
• Support business development through in-licensing input.

Skills

Cross-functional leadership

Stakeholder influence

Medical communication

English fluency

Travel readiness

Education

MD/MBBS or international equivalent

Board certification in nephrology

PhD (optional)

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