Head of Clinical Development
3 days left
- Experience Level
Joshua Leggett is searching for an experienced Head of Clinical Development (VP/SVP) to work for a small/mid-sized international Pharma company. This company have a headcount of approx. 800 employees and have offices in the UK, Germany, and the US.
Being one of the most senior roles within the team, we’re looking for someone with solid experience and interest in early phase clinical development to help design and launch 3 brand-new Oncology Programmes.
This is an entirely home-based opportunity with the opportunity to work in their Cambridge, UK office if desired. This is an excellent opportunity to join a passionate team and work with the broader executive management, with opinions valued and heard.
- Providing medical rationale, discussion of disease and context of treatment for protocols, IBs, IMPD/IND, clinical study reports and other required and/or supportive documents
- Translating clinical research concepts of the new drug candidates into specific objectives to effectively achieve program goals.
- Lead the delivery of clinical development activities for a clinical stage program in the Oncology and Pain Unit and ensure consistency with clinical development strategy for regulatory approvals, reimbursable medicines, and successful lifecycle management.
- Lead multi-disciplinary clinical matrix team and major contributor to integrated clinical development strategy and Clinical Development Plans.
- Contribute to the medicine development strategy.
- Assures clinical studies are conducted effectively in partnership with Local Operating Company, alliance partners and Clinical Operations colleagues and CRO as appropriate.
- Lead clinical study teams in development and conduct of clinical studies.
- Writing CSRs (reviewing final TLGs, working with medical writer to draft, review & revise CSR document, participating in comment resolution meetings).
- Lead authoring of study protocols, CRF's and contribute to development of analytical plans through discussion with matrix team members.
- Engaging in protocol development, adjustments and end point planning.
- Medical Doctor
- Minimum 10 years working in Clinical Development.
- Must have previous Pharma or Biotech experience
- Extensive experience in Early Phase Development
- Experience in Oncology or Pain is highly desirable
- Must have demonstrated experience with major regulatory submissions (NDA, BLA, MAA)
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk.
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