Senior Principal Consultant (Medical) at BioTalent, part of The IN Group
BioTalent is partnering with a biotechnology client developing RNA-editing medicines for patients with rare and common diseases. We are recruiting a clinical scientist to support the design, execution and analysis of clinical trials and to work cross-functionally to ensure scientific integrity and operational excellence in company-sponsored trials.
Responsibilities
Clinical Trial Design & Protocol Development
- Assist in or lead the design of clinical study protocols and amendments
- Write or contribute to study-related documents (e.g., IB, informed consent forms, CRFs, recruitment materials)
Study Execution Support
- Provide scientific and clinical input during trial conduct
- Monitor data for consistency, completeness, and potential safety/efficacy signals
- Collaborate with CROs, sites, and internal teams to resolve study-related issues
- Build relationships with sites including PIs and clinical trial site staff, supporting their start up activities and patient recruitment activities
Data Analysis & Interpretation
- Review clinical trial data in collaboration with data management and biostatistics
- Interpret data in the context of the disease, target, and competitive landscape
- Contribute to clinical study reports and documentation for regulatory submissions
Cross-functional Collaboration
- Work closely with Clinical Operations, Medical Monitors, Pharmacovigilance, and Regulatory Affairs
- Participate in clinical development plan creation and updates
- Present study results and strategy to internal stakeholders and governance bodies
Regulatory & Safety Input
- Support preparation of INDs, NDAs, CTAs and other regulatory documents
- Provide input into safety review processes and risk-benefit assessments
Qualifications
- An advanced degree in life sciences or health discipline (PhD, Pharmacy degree, MD, or MS with relevant experience)
- 2–6+ years of industry experience in clinical development and/or clinical operations
- Strong knowledge of ICH GCP and clinical trial methodology
- Ability to critically evaluate scientific data and literature
- Strong communication skills (verbal and written)
- Ability to manage multiple priorities and collaborate across functions
- Experience in rare disease
- Familiarity with working with and supporting clinical trial sites for study start-up and recruitment
- Working knowledge of clinical trial site monitoring
- Ability to travel to clinical trial sites and build relationships with PIs and clinical trial site staff
Location & Travel
This is a remote position that will require travel to sites. A candidate based in Europe/UK is preferred.
Seniority level
Employment type
Job function
- Research
- Industries: Biotechnology Research and Pharmaceutical Manufacturing
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