Sr Clinical Scientist
On-siteLondon, England, United Kingdom
Job Summary
Provide scientific direction for clinical study design and conduct across Phase I–III trials, leading protocol development, amendments, and Clinical Study Reports (CSRs). Conduct targeted literature searches to support endpoint selection and study strategy, while managing Investigator's Brochures and Master ICFs in alignment with regulatory and ethics requirements. Interpret clinical data to support internal review materials and IDMC charters, ensuring document accuracy through quality control and TMF filing. Collaborate with Medical Experts, Biostatisticians, and Regulatory Affairs to deliver integrated study outcomes and contribute to IND/CTA submissions. Contribute to departmental SOPs and writing guidelines to maintain alignment with operational and regulatory standards.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field
- 5–10 years of experience in clinical research or clinical development within the pharmaceutical, biotech, or CRO environment
- Hands-on experience contributing to clinical study design, conduct, and documentation (e.g., protocols, ICFs, IBs, CSRs)
- Experience working in cross-functional study teams, in close collaboration with Medical Experts and Biostatisticians
- Practical understanding of clinical data review and interpretation during study conduct
- Strong knowledge of ICH-GCP and clinical development regulations
- Solid understanding of the clinical development lifecycle and regulatory documentation requirements
- Experience with TMF requirements and document lifecycle management
- Strong scientific judgment and ability to critically evaluate clinical data and study designs
- Excellent written and verbal communication skills, with the ability to convey complex scientific concepts clearly
- High attention to detail, quality, and consistency in clinical documentation
- Ability to manage multiple deliverables in a matrixed, cross-functional environment
Desired Qualifications
- Advanced degree (Master's, PhD, or MD)
- Clinical or biomedical background relevant to drug development
- Experience overseeing or collaborating with Medical Writers and external vendors
- Familiarity with governance activities such as IDMC participation and interim data review
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