Senior Manager, Clinical Outsourcing (Remote Eligible)

Denali Therapeutics • South San Francisco, CA

3d • Remote

About The Position

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients. We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients. The Senior Manager Clinical Outsourcing is accountable for successful execution of outsourcing processes within the development operations group including but not limited to strategic outsourcing, vendor management and contract and budget negotiations. Specific CTA budget negotiation experience is preferred.

Requirements

• BS or BA required; MS, Ph.D, or PharmD. a plus
• 5+ years in the biotech/pharma clinical research industry, with 2+ years of clinical outsourcing and business operations experience required; must possess a strong knowledge of the clinical vendor landscape.
• Expertise 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, site management, safety reporting, data management, and biometrics
• 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 and with our CRO and clinical service providers.

Nice To Haves

• Understanding of clinical financials a plus (i.e. budgeting, accruals and forecasting)

Responsibilities

• Manages the identification and selection process of clinical vendors such as CROs, central labs, Imaging, data management, 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 scope of work, payment terms and budgets
• Ensures quality oversight of vendors by: Partnering with suppliers and internal staff to identify, manage, escalate and resolve issues related to supplier performance; Measuring 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; Facilitating and executing supplier governance meetings and operating reviews; Developing effective partnerships with suppliers and internal staff.
• Possesses a thorough understanding of vendor contracts, contract types and the ability to negotiate budgets
• Participates in the preparation and presentation of internal reports to management and other various business end users
• Supports Purchase Order management and contract/account reconciliation
• Supports quarterly external auditor reviewers and annual audits
• Manages Clinical Consultant agreements

Benefits

• Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.
• Learn more at https://www.denalitherapeutics.com/careers

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level