Lead Clinical Development Director, Rare

🕒 September 30

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Director

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 21%

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Ipsen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ipsen is a global biopharmaceutical group that focuses on improving patient lives through innovative medicines in the areas of oncology, rare diseases, and neuroscience. With a commitment to addressing high unmet medical needs, Ipsen leverages its expertise and resources to develop new therapies and collaborations, accelerating the path from scientific innovation to patient care. The company strives to make a significant impact in the lives of patients suffering from serious conditions such as cancer, rare diseases, and neurological disorders.

📋 Description

• Lead the clinical development of Potravitug within Ipsen’s Rare Disease (Nephrology) Therapeutic Area • Own the Clinical Development Plan and clinical strategy within the Integrated Development Plan • Lead the design and delivery of the Clinical Development Plan and clinical components of the Integrated Development Plan, aligned with the Target Product Profile • Interpret clinical trial results alongside external data and the competitive landscape to make development recommendations • Represent clinical development in interactions with health authorities, including FDA and EMA • Author or oversee clinical documents, including synopses, protocols, Investigator’s Brochure, regulatory submission sections and clinical study reports • Act as clinical decision-maker for study teams and partner with Clinical Operations and CROs to deliver studies on time and within budget • Provide medical oversight of clinical trials to ensure data integrity and sound interpretation in line with ICH-GCP, regulations and company SOPs • Build relationships with key opinion leaders and investigators; represent Ipsen at investigator meetings, advisory boards and scientific congresses • Contribute to abstracts, publications and presentations 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 and contribute to competitive intelligence • Report to the Vice President, Potravitug Global Asset Lead

🎯 Requirements

• 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 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 • 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%) • Board certification in nephrology, transplant nephrology, internal medicine or critical care (preferred) • Experience in rare diseases (preferred) • PhD and/or academic appointment (preferred) • Record of peer-reviewed publications in high-impact journals (preferred) • Cross-functional exposure to Medical Affairs or Safety/Pharmacovigilance (preferred) • Working knowledge of French could be advantageous

🏖️ Benefits

• Willingness to travel domestically and internationally (up to 20%) • Remote work arrangement in Europe or the East Coast US