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 Senior Director of Clinical Outsourcing, the Clinical Finance contractor, Clinical Outsourcing and Business Operations (COBO) is accountable for successful execution of clinical financials within the Development Operations department including, but not limited to, leading the monthly vendor accrual process, building and maintaining clinical trial budgets and forecasts, negotiating clinical trial budgets, managing and coordinating month end clinical trial financial reporting activities, supporting ad-hoc auditing requests and partnering with Denali colleagues, especially finance and accounting. Ability to negotiate CTA budgets is a plus.
- Provide input to clinical development plans including clinical trial financial modeling
- Partner with Clinical Project Teams to create enrollment assumptions, clinical study budgets and clinical study forecasts to ensure financial estimate/spend harmonize with project timelines
- Track clinical trial accruals and forecasts related to CRO and service provider spend. Highlight to senior management potential financial risks and fluctuations
- Manage or support monthly clinical trial reporting activities including study enrollment, work completed to date, current and estimated budget spend, study budget projections for new studies, etc.
- Ability to manage CTA budgets
- Manage or support Quarterly Variance Analysis process for clinical study vendor contracts. Ability to analyze budget and forecast variances
- General understanding of outsourcing (i.e. RFx process)
- 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
- Thorough knowledge of contracting and ability to negotiate business terms and conditions
- As needed, support Clinical Outsourcing activities
- Support clinical trial vendor financial-related matter/issues including invoice issues
- Help manage and oversee Development wide contractor and consulting budgets
- Ability to provide input to continuously improve financial and business operations processes
- BS or BA, MS, Ph.D, or PharmD.
- 4+ years in biotech/pharma clinical research industry; 3 years of clinical finance (business operations and management experience a plus)
- Strong understanding of clinical trial forecasting and budget modeling
- Strong understanding of the drug development process and the cross-functional responsibilities including: clinical trial design, study start-up and execution, site management, safety reporting, data management, and biometrics.
- Good understanding of strategic outsourcing and vendors within the clinical landscape
- Strong interpersonal, communication and presentation skills to be able to engage with all levels both within Denali Therapeutics and entities and with our CRO and clinical service providers.
- Forward-thinking and creative with high ethical standards.
- Ability to work in a fast-paced environment with drug development professionals.
- Strong problem-solving skills.
- Ability to lead and manage cross-functional initiatives from concept to completion.