Senior Clinical Outsourcing Manager (Remote Eligible)

Denali Therapeutics•South San Francisco, CA

11d•$155,000 - $202,000•Remote

About The Position

Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases. This role directs and coordinates all clinical outsourcing needs, including vendor identification and selection, RFP processes, negotiating SOW and budgets, managing outsourcing budgets, performance metrics, and vendor oversight. The position partners with Finance to provide screening information, track work completed, manage current and estimated budget spend, and forecast study budgets for new studies.

Requirements

Typically requires a bachelor’s degree in life sciences, business, or a related field.
Typically requires 7+ years of experience in the biotech or pharmaceutical industry.
Significant experience in clinical outsourcing, vendor management, and contract negotiations.
Demonstrated expertise managing outsourcing strategies and vendor relationships across multiple phases of clinical development.
Strong understanding of clinical trial operations, drug development processes, and cross-functional clinical development activities.
Experience negotiating complex contracts, scopes of work, budgets, and change orders with CROs and clinical service providers.
Strong analytical, financial, communication, and stakeholder management skills with the ability to influence cross-functional teams and external partners.

Nice To Haves

Advanced scientific or business degree preferred.
Experience with clinical financial management activities including budgeting, accruals, forecasting, and vendor performance metrics preferred.

Responsibilities

Lead vendor identification, evaluation, and selection activities for clinical development programs, including CROs and specialty service providers.
Develop and manage Requests for Information (RFIs), Requests for Proposals (RFPs), bid analyses, and vendor recommendation materials.
Lead contract, scope of work, and budget negotiations with clinical vendors to achieve operational, financial, and timeline objectives.
Manage vendor governance activities including performance reviews, issue escalation, scorecard metrics, and continuous improvement initiatives.
Partner cross-functionally with Clinical Operations, Finance, Legal, and Procurement to align outsourcing strategies with program and organizational priorities.
Evaluate vendor capabilities, operational risks, and pricing structures to support informed business decisions and effective resource planning.
Facilitate bid defense meetings, governance reviews, and supplier business reviews with internal stakeholders and external partners.
Oversee contract administration activities including change orders, purchase order management, reconciliation activities, and vendor payment tracking.
Support audit readiness activities and participate in internal and external audit processes related to vendor oversight and contracting practices.
Oversee CRO negotiation of site level budgets and CTAs.
Contribute to the development and enhancement of outsourcing processes, standards, templates, and operational best practices.