Interim Senior Clinical Scientist

An Interim Senior Clinical Scientist is sought to provide temporary support in the Sponsor oversight of clinical data generation and reporting. Candidates will be a self-starter, able to drive collaboration across internal cross-functional teams and external service providers to ensure processes, plans and core study documents are robust and consistent, enabling communication of reliable data in accordance with development strategy.

Key Responsibilities:

• In collaboration with Clinical Operations, define processes for oversight of clinical data generation, and maintain a clinical data delivery plan that defines the timing and specification of outputs to serve strategic decision making, scientific publication and business development deliverables.

• Act as a Subject Matter Expert for clinical study protocol development, contributing to design elements, enabling delivery of key endpoints/Critical to Quality factors, conducting literature reviews and participating in discussions with key opinion leaders and other contributors as appropriate.

• Support the development of other key regulatory and operational documents including e.g. Statistical Analysis Plans, Investigators Brochures, Development Safety Update Reports, briefing documents.

• Execute key components of the medical communications plan, e.g. manuscripts, working cross-functionally to coordinate authoring, review and approval.

Experience, Skills & Knowledge

• A degree in a Life Sciences, Pharmacy or health-related field.

• A minimum of 10 years’ experience in an early-phase oncology clinical development role within biotech, pharma or CRO is essential.

• Solid understanding of clinical research methodologies, regulatory guidelines, and Good Clinical Practice.

• Familiarity with biostatistics and data analysis.

Personal Attributes

• Self-starter, able to work in an agile, hands-on environment

• Collaborative and a strong communicator

• Solution focused