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Scientific and Operational Specialist
2 months ago
The Alliance and Scientific Senior Specialist/Manager will be responsible for managing the relationship with and activities provided by third-party partners/vendors of the Translational Medicine department. Internally, they will work in a cross-functional setting, collaborating with multiple teams within the company, including clinical operations, clinical development, biometrics, etc. They will build strong working relationships both with internal stakeholders and our external third-party vendors. They will ensure alignment with company priorities, meet internal deadlines and clinical study requirements. They will contribute their scientific expertise during vendor selection, development and validation of new assays where required and ongoing vendor oversight. They will provide detailed oversight of vendor activities ensuring the delivery of high-quality services and data to support ongoing clinical trials.
Key Responsibilities- Collaborate with Clinical Study Teams: Be a key member of the clinical study team to understand and align testing needs with clinical, regulatory and commercial requirements.
- Author and Amend Clinical Study Documents: Contribute to authoring/amending clinical study documents.
- Liaise with Clinical Development and Clinical Operations Teams: Liaise with members of the Clinical Development and Clinical Operations teams to understand the requirements for sample collection and logistics.
- Identify Assay Development Needs: Identify potential assay development needs and the requirement for outsourcing.
- Vendor Selection and Onboarding: Investigate assessment availability and quality at third-party vendors, perform official vendor selection, due diligence and onboarding of new vendors.
- Contract Negotiations and Budget Planning: Contribute to contract negotiations, master service agreements, statements of work and analytical plan authoring. Provide budget plans, updates and efficient tracking of costings.
- Vendor Oversight and KPI Tracking: Provide day-to-day oversight of vendor activities, tracking KPIs and contributing to the creation and management of vendor oversight plans.
- Clinical Sample Assessment and Data Interpretation: Ensure the prompt and efficient assessment of clinical patient samples, identifying ways and means to optimise processes/workflows. Support the planning, on-time delivery and accurate interpretation of high-quality data to be used for publications and regulatory submissions.
- Cross-Functional Collaboration: Collaborate cross-functionally with multiple teams (procurement, product development, business development, R&D, regulatory, quality, global development) to establish new relationships/strengthen current working relationships and contribute to company-wide goals.
- Process Improvement and Implementation: Be the Alliance and Scientific Management (ASM) lead for outsourced activities for specific clinical studies within the Translational Medicine team. Identify, document and implement new processes within the team.
- Scientific Expertise and Quality Assurance: The post-holder will work with third-party laboratories who will generate data using our samples. You will contribute your scientific expertise to both ensure services are provided to a high-quality standard and the generation of bespoke assays are developed to our requirements.
- Office-Based Role: This role is primarily computer-based and would request the successful candidate to attend the Autolus Limited office at least once per week.
