Headquartered in South San Francisco, CA, 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.
Associate Director/Director, New Product Development
CareDx is seeking a highly motivated Associate Director/Director New Product Development (NPD) to lead the strategy and planning for new testing services development and life-cycle management. Reporting to the VP Program Management, the role will be responsible for providing strategic guidance to cross-functional teams developing new products and upgrading existing products (lifecycle management).
- Gather deep understanding of current and anticipated future market needs by interacting with customers (KOLs, regular providers, nurses, administrators, etc.), medical societies, patients, patient advocacy/support groups and other stakeholders
- Develop subject matter expertise by attending scientific conferences, keeping up to date on pertinent scientific literature and monitoring competitor activities/offerings
- Build and maintain repository of competitor tactics/tools/messages (e.g., test requisition forms, test result forms, web portals, webinars, marketing materials, etc.)
- Distill learning's into actionable insights and translate findings into user requirements, product performance specifications and other goals (e.g., timing of launch and versions)
- Create and maintain long-term product/program strategies encompassing different versions, geographies, business models and regulatory classifications
- Develop good working knowledge of Market Access, Reimbursement, and Regulatory matters to enable close partnership with experts from these internal functions
- Work hand-in-hand with the project leader and project manager of assigned project teams to ensure teams have the latest market insight and are working towards the right deliverables. Ensure user/product requirements used for design control process documents and measured under PMO reflect latest market insights
- Create information materials and present updates to senior management. Aid in the generation of presentations to Board of Directors, investors and general public
- BA/BS/MS in life sciences or a pertinent technical discipline
- 8+ years of relevant work experience in a diagnostics/medical device/biotech company
- Comfortable interacting with stakeholders at all levels and influencing without authority
- Comfortable developing specifications for novel diagnostic products with minimal customer input
- Strong analytical and problem-solving skills, organization skills and attention to detail
- Strong interpersonal and negotiation skills, written and verbal communication skills
- Ability to adapt and respond quickly to change in a dynamic, high-growth environment
- 25% travel involved to scientific conferences and other important events
- Advanced degree (MD, PhD) in a pertinent discipline
- Experience working in regulated environments, e.g., FDA, CLIA, CAP and ISO 13485
- Familiarity with CLIA, In-Vitro Diagnostic (IVD), Lab-developed Test (LDT) and CE marking
- Understanding of artificial intelligence, health informatics, key health information technology platforms (EMR/HER) and patient-facing tools (apps, portals, etc.)
- Experience with transplantation would be helpful
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 participate in E-Verify program.
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