Clinical Development Leadership Opportunity – Rare and Specialised Diseases

Medical Director / Senior Clinical Development Physician

Salary up to €135,000

Withers & Wagg are partnered with an ambitious European biopharmaceutical group that is dedicated to advancing therapies for patients with rare and complex diseases. With a lean, science-driven culture and an integrated model spanning discovery through to commercialisation, this organisation combines clinical excellence with a strong entrepreneurial spirit. Their flat structure and collaborative mindset enable rapid decision making and genuine scientific ownership—making it an ideal environment for leaders who want to make a tangible impact.

As part of their continued pipeline expansion, we are seeking an experienced clinical development physician to lead global development activities across multiple projects. This is a senior strategic role offering broad exposure across trial design, regulatory interactions, cross-functional collaboration, and business development support.

This is a fantastic opportunity to join a highly focused and agile company where your clinical and strategic insights will directly shape the future of development in high unmet-need areas. You will play a central role in ensuring scientific quality, team leadership, and successful delivery of development plans that make a real-world impact.

Key Responsibilities

• Team Leadership & Management:
• Provide strategic and operational leadership to the clinical development team, ensuring alignment with R&D objectives. Define priorities, allocate resources effectively, and maintain a high-performance environment through coaching, performance evaluation, and professional development of direct reports.
• Clinical Strategy & Trial Design:
• Lead the development of clinical strategies, including the authorship of clinical development plans, study synopses, protocols, and amendments. Ensure that trial designs are innovative, evidence-based, and aligned with regulatory expectations across multiple regions (EU and US).
• Regulatory Documentation & Interaction:
• Draft and review clinical documents for regulatory submissions, including briefing books, orphan designation requests, and eCTD modules. Represent clinical development in cross-functional preparation for interactions with regulatory authorities and scientific advisory boards.
• Medical Oversight & Safety:
• Provide ongoing medical oversight during trial execution, including medical/safety review of clinical data, expert input into the evaluation of SAEs, SUSARs, DSURs and PSURs, and collaboration with pharmacovigilance colleagues to ensure patient safety across studies.
• Cross-Functional Collaboration:
• Work closely with Clinical Operations on site identification, feasibility, and trial execution. Collaborate with functions including Biostatistics, Regulatory Affairs, Drug Safety, and Commercial to ensure scientific alignment across the entire development lifecycle.
• Scientific Communication & Data Presentation:
• Present study data to internal governance boards and external stakeholders, including participation in the authorship and review of peer-reviewed publications, abstracts, and presentations at key scientific meetings.
• Business Development & In-Licensing Support:
• Contribute to the evaluation of in-licensing opportunities within targeted therapeutic areas. Conduct literature reviews, assess external development programmes, and attend scientific conferences and congresses to stay informed on emerging science and market activity.

Candidate Requirements

• Medical Degree (MD) is essential
• At least 5 years of experience in global clinical development, with proven exposure to both US and EU regulatory environments
• Strong background in early-phase development, including Phase I and II trials and translational research
• Demonstrated experience in medical writing and authorship of regulatory documents
• Knowledge of Good Clinical Practice (GCP); active certification is preferred
• Fluent English communication skills (written and verbal)
• Proficiency with Microsoft 365 and Adobe tool