Non-Sponsored Study and Grant Lead

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients.

The Non-Sponsored Study and Grant Lead is a unique role that manages all Non-Sponsored Studies (NSS), including Investigator-Initiated Trials (IITs, a.k.a. Investigator-Sponsored or Externally Sponsored Studies), as well as various types of Research Collaborations, and Grants. The role serves as a central point of contact for investigators and study teams at academic medical institutions and coordinates the cross-functional work of internal functions incl. Medical Affairs, Legal, Compliance, and Finance.

Responsibilities

• Lead the proposal intake process, maintain the submission portal, and serve as central point of contact for external inquiries
• Organize the review process and chair the review committee
• Maintain review status trackers, document decisions and communicate with investigators and research coordinators.
• Project-manage post-approval activities incl. budget finalization and contract execution
• Create and maintain central progress tracker of all approved proposals
• Work with each site to create a workflow for ordering tests, kits, and receiving results.
• Track achievement of milestones that trigger payments and, working with Finance, forecast future milestone payment schedules of individual trials as well as allocated overall budget
• Forecast kit use for each approved study
• Prepare and present periodic executive updates
• Continually assess processes/workflows, systems and documentation, identify areas for improvement and implement agreed changes

Qualifications

• Minimum of 8 years' applicable experience either in industry or in medical academia required
• MD, PhD, PharmD or Master's in a relevant medical/biological field required
• Experience in clinical diagnostics preferred
• Experience in solid organ transplantation and/or cell transplantation preferred
• Experience in clinical trial design, GCP, and clinical operations matters preferred

Other requirements

• Proficiency in MS Office tools, incl. Excel, Word and PowerPoint
• Strong organizational skills, ability to multitask, project-manage self and others
• Comfortable working in a matrixed, cross-functional environment
• Excellent communication skills with external parties, cross-functional teams and executives
• Location remote, hybrid or at HQ in Brisbane, CA, with occasional domestic travel (<10%)

Additional Details:

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits including a gym reimbursement program
• 401(k) savings plan match
• Employee Stock Purchase Plan
• Pre-tax commuter benefits
• And more!

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it's an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer and participates in the E-Verify program.

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For HR administration purposes, the job title is Clinical Research Lead.

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