Clinical Pharmacology Modelling & Simulation
13 hours ago
Leeds
Job Title: Clinical Pharmacology Modelling & Simulation (CPMS) Location – Stevenage (remote working possible) Contract Length – 7 months Rate: - Up to £250 per day (PAYE) SUMMARY: The Biomarker Operations Team within Platform Sciences provides operational support for clinical pharmacology (including PK), biomarker project plans, translational research studies, and diagnostic (Dx) development. Roles in this group collaborate with various internal departments and external partners to progress Clinical Pharmacology Modelling & Simulation (CPMS), Biomarker and Diagnostic (Dx) activities across the Respiratory, Immunology, and Infectious Disease (RIID) and Oncology portfolios. Specifically, this role is for a CPMS Contract manager who will ensure internal stakeholder alignments, track project deliverables, identify and mitigate risks, and communicate with relevant stakeholders. Additionally, they will reconcile activities with contracting and finance operations and provide advice to the CPMS department and client groups. This will support decision-making with respect to outsourcing by developing detailed specifications, analyse proposals (for both service (activity) and cost provision), negotiate (both costs and content) and execute new and amended contracts that are robust, timely, and add significant opportunity for value generation to the business whilst minimising risk. KEY RESPONSIBILITIES: • Vendor and Contract Management: Managing vendor contracts, approving invoices, and ensuring compliance with policies and procedures. This also involves developing and negotiating clinical service provider contracts., • Demonstrate broad knowledge of biomarker and pharmacokinetic outsourcing with awareness of Dx technologies, and IVD development., • Financial Oversight: Tracking and updating project budgets, milestones, and payments., • Risk Management: Identifying and communicating risks related to timeline, budget, and scope to stakeholders in a timely and clear manner., • Collaboration and Communication: Working closely with internal teams and external partners to ensure project objectives are met. Regular communication of timelines, milestones, and goals to stakeholders is essential., • Stakeholder Management: Develop key stakeholder relationships liaise between and external suppliers to provide value-added customer service., • Compliance and Documentation: Ensuring compliance with policies and procedures, maintaining accurate records, and supporting regulatory submissions., • Bachelor’s degree in biological sciences or related discipline; advanced scientific degree a plus, • Minimum of 3-5 years of project or program management experience in the Dx, pharmaceutical, or biotech industry, clinical development, • Experience managing bioanalytical, clinical biomarker, and/or In Vitro Dx development programs, • Experience managing third party vendors, vendor contracts and budgets including approval of invoices, • Understanding of drug discovery and development, clinical trial design, and overall principles of clinical development, • Established expertise and hands-on experience with Word, Excel, PowerPoint, Outlook, SharePoint, remote meeting tools such as MS Teams, WebEx, etc. and a working understanding of innovative AI technologies (e.g., CoPilot, ChatGPT, GiGi, Jules, etc.) Preferred qualifications & skills: • Strategic thinking and ability to work effectively in a matrixed environment while managing multiple projects/competing initiatives simultaneously., • Excellent time management, organizational skills, and results focused., • Ability to establish trust, work with integrity, and motivate others to achieve project goals., • Highly effective communication and negotiation skills for various audiences, including technical and business stakeholders., • Financial analysis experience with a proven track record in budget management, contract financial analysis, and negotiation., • Strong negotiation, influencing, analytical, problem-solving, and facilitation skills within the pharmaceutical or CRO industry., • Knowledge of clinical pharmacology and the use of PK data to inform drug development programs., • Knowledge of electronic trial master file and filing of clinical trial documentation, • Experience in pharmaceutical development and companion Dx, including analytical and clinical validations and regulatory submissions., • Good understanding of CPMS analysis including non-compartmental analysis techniques would be an advantage.