Freelance Contract
Hybrid: 3 Days On Site In London or Edinburgh
Core Responsibilities
- Develop and implement clinical strategy in collaboration with key internal stakeholders and cross-functional teams
- Accountable for the successful delivery of clinical programmes within agreed timelines, budgets, and quality standards
- Provide strategic input into, and participate in, key interactions with regulatory authorities, HTA bodies, and other stakeholders to support programme delivery
- Evaluate opportunities and provide recommendations regarding clinical collaborations within rare disease and/or rare oncology, including assessments of scientific viability and development potential
- Oversee programme budgets and ensure timely escalation of forecast variances or changes outside agreed tolerances
- Lead reporting and communication of programme progress against corporate objectives to senior leadership, executive stakeholders, and external partners
- Build, lead, and develop teams, including direct line management responsibilities and leadership across cross-functional teams
- Act as programme lead across selected programmes and strategic projects where required
- Represent the client organisation across senior-level forums, partnerships, and external collaborations, acting as a subject matter expert within the clinical function
- Support clinical due diligence activities as required
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Requirements / Experience
- 15+ years of relevant experience within clinical development.
- BSc in Life Sciences required; PhD or MD preferred.
- Extensive global clinical development experience across pharmaceutical, biotechnology, academic, diagnostics, devices, or related medical technology environment
- Demonstrated experience in asset selection and programme prioritisation.
- Strong experience supporting IND/CTA submissions and NDA/MAA/BLA regulatory pathway
- Experience interacting with national and international regulatory authorities
- Experience with HTA processes and reimbursement strategies
- Strong therapeutic expertise within rare disease and/or rare oncolog
- Deep understanding of clinical research regulations and governance
- Professional qualifications in clinical research and/or clinical project management are advantageous
- Proven ability to build, lead, and develop team
- Previous line management experience required
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