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.
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.
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.
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.

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.
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.
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.
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., At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

3 contract Biotechnology / Life Sciences jobs in Hackney