Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
Reporting to the Associate Director of Clinical Outsourcing and Business Operations (COBO), the Manager, Clinical Outsourcing and Business Operations is accountable for successful execution of outsourcing and business operations processes within the development operations group including, but not limited to, strategic outsourcing, vendor management and contract and budget negotiation.
Manages the identification and selection process of clinical vendors such as CROs, imaging, data management, IRT, home health, central labs, biostatistics, etc.
Generates Requests for Information (RFI) and Requests for Proposals (RFP) and budget grids
Coordinates bid defenses and proposal review meetings and provides analysis to project teams
Manages operational aspects of clinical contracts and change orders, including active negotiation of scopes of work, payment terms and budgets
Ensures quality oversight of vendors by:
Partners with suppliers and internal staff to identify, manage, escalate and resolve issues related to supplier performance;
Measures supplier performance utilizing Scorecard/Metric activities; and communicating feedback to the supplier, encourage adaptation on best practices across supplier types and development of continuous process improvements/ maintenance;
Facilitates and executes supplier governance meetings and operating reviews;
Develops effective partnerships with suppliers and internal staff.
Support Quarterly Variance Analysis process for clinical study vendor contracts
Participate in the preparation and presentation of internal reports to management and other various business end users
Support Purchase Order management and contract/account reconciliation
Support quarterly external auditor reviewers and annual audits
Manage Clinical Business Operations procedures
BS or BA, MS, Ph.D, or PharmD.
4+ years in biotech/pharma clinical research industry; 2-3 years’ clinical outsourcing and business operations experience – Must have good knowledge of the clinical vendor landscape.
Expert in outsourcing and contracting best practices for all phases of clinical research with an understanding of the drug development process and the cross-functional responsibilities including clinical trial design, study start-up and execution
In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating SOW terms, and growing and fostering long-term, healthy strategic relationships
Strong interpersonal, communication and presentation skills to be able to engage with all levels both within Denali Therapeutics and entities within our CRO and clinical service providers.
Forward-thinking and creative with high ethical standards.
Understanding of clinical financials a plus (i.e. budgeting, accruals and forecasting)
Ability to work in a fast-paced environment with drug development professionals.