Sr Clinical Scientist

Sr Clinical Scientist

Galderma

London, United Kingdom

Key Responsibilities

Clinical Development, Study Design & Conduct

• Provide scientific input to ensure clinical development activities are aligned with regulatory guidance, scientific rationale, and the evolving competitive landscape.
• Conduct and/or oversee targeted literature searches to support clinical development strategy, study design decisions, endpoint selection, and interpretation of emerging data.
• Lead the development of clinical study designs (Phase I–III, as applicable), in alignment with the overall development strategy.
• Manage the development of study protocols, protocol amendments, and clinical study reports (CSRs), ensuring scientific accuracy and consistency.
• Ensure that study endpoints, eligibility criteria, and assessments are clinically meaningful and scientifically appropriate, in collaboration with relevant subject matter experts.
• Provide scientific direction and oversight to contractor Medical Writers involved in the development of clinical and regulatory documents.
• Lead the development of the Master ICF and review country‑ and site‑specific ICFs to ensure alignment with the master and local regulatory and ethics requirements.
• Perform QC to ensure document consistency, accuracy, and formatting.
• Act as a key point of contact during study execution, providing protocol‑related guidance and clarification to Clinical Operations and study teams.
• Ensure appropriate filing of authored clinical documents in the TMF in accordance with company procedures.
• Work closely with Medical Experts, Biostatisticians, Clinical Operations, Safety, Regulatory Affairs, and other stakeholders to ensure integrated study delivery.

Data Interpretation & Scientific Contribution

• Review and interpret clinical data and analyses in collaboration with the Study Team.
• Support the preparation of internal data review materials, e.g. IDMC charters and presentations.

Regulatory & Clinical Documentation

• Contribute to, and where appropriate author, clinical sections of regulatory documents, including IND/CTA submissions, Investigator’s Brochures (IBs), CSRs, briefing documents, and responses to health authority questions.
• Manage the annual update of the Investigator’s Brochure (IB) in collaboration with cross‑functional stakeholders.

SOP & Template Development

• Contribute to the development and maintenance of departmental SOPs, clinical document templates (e.g., protocol, IB, CSR), and writing guidelines, ensuring alignment with operational needs and regulatory requirements.

Skills & Qualifications

Education

• Bachelor’s degree in Life Sciences, Engineering, or a related field required; advanced degree (Master’s, PhD, or MD) preferred.
• Clinical or biomedical background relevant to drug development preferred.

Experience

• Typically, 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.
• Experience overseeing or collaborating with Medical Writers and external vendors preferred.

Technical & Regulatory Skills

• 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.
• Familiarity with governance activities such as IDMC participation and interim data review is an advantage.

Core Competencies

• 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.
• Proactive, collaborative, and solution‑oriented mindset.