An innovative life sciences organisation is seeking a Director, Clinical Rare Disease to provide senior clinical leadership across a portfolio of collaborative and funded programmes. This is a strategic role with responsibility for shaping clinical development strategy, driving high-quality programme delivery and ensuring key assets progress through clinical development in line with wider organisational priorities.
The Role
You will take strategic and operational leadership of the rare disease clinical portfolio, ensuring programmes are delivered to time, cost and quality while maintaining strong clinical, scientific and regulatory standards.
Key Responsibilities
- Develop and implement clinical development strategies across the rare disease portfolio in collaboration with internal teams.
- Chair Clinical Development Teams and provide senior clinical leadership across programmes.
- Oversee delivery of clinical programmes to agreed cost, quality and timelines.
- Lead major clinical programme decisions, including risk management, prioritisation and resolution of complex challenges.
- Evaluate new opportunities and make recommendations on asset selection, clinical viability and developability.
- Provide clinical input into regulatory authority and Health Technology Assessment interactions where required.
- Oversee clinical programme budgets, funding allocation and financial risks.
- Report programme progress, risks and milestones to senior leadership, executives and external partners.
- Develop and maintain clinical governance frameworks, SOPs and effective ways of working.
- Build and manage strategic collaborations and external partnerships.
- Lead, develop and inspire direct reports and cross-functional teams.
- Represent the organisation at senior external forums and act as a subject matter expert in clinical development.
- Sponsor new business cases and contribute to the wider clinical strategy.
Requirements:
- Extensive global clinical development experience across therapeutics, diagnostics, devices or other medical technologies.
- Proven experience developing and implementing clinical strategy.
- Experience in asset selection, programme prioritisation and clinical development decision-making.
- Experience with clinical trial regulatory submissions, such as INDs or CTAs.
- Experience supporting product approval submissions, such as NDA, MAA or BLA.
- Experience interacting with national and international regulatory authorities.
- Strong expertise within rare disease clinical development.
- In-depth understanding of clinical research regulations and requirements.
- Proven experience building high-performing, collaborative teams and managing direct reports.
- Strong strategic, communication and stakeholder-management skills.
- Experience managing clinical programme budgets and funding allocation.
- Ability to influence effectively within a matrix environment and build strong internal and external relationships.