Director of Product Lifecycle ManagementBrisbane, 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.

We are seeking a highly motivated and experienced Product Life Cycle Management Executive to join our team at CareDx. The ideal candidate will help to oversee multiple new product launches of our Cell Therapy/ Bone Marrow Transplant pipeline testing products and help to shape CareDx's market entry into this new therapeutic area. This individual will also partner closely with the VP of Cell Therapy & Transplant, medical, R&D and business development colleagues to identify & commercialize new products aligned with CareDx's long term vision of being a leading molecular diagnostics company in cell therapy and transplant.

Key Responsibilities:

Product Strategy, Planning and Execution Leadership:

• Lead a cross-functional team to develop, prioritize and implement product life cycle management strategies that align with the company's goals and objectives as well as a robust design control process. Ensure that all the relevant functional expert opinions are included in each stage of the product development and commercialization process.
• Conduct market research and competitive analysis to identify opportunities for new products and enhancements to existing products.
• Lead cross-functional team to create robust business cases and resourcing plan for assessment and approval. Once approved, accountable for driving the cross-functional team to deliver against the business case and development/launch plan
• Collaborate with cross-functional teams to define product requirements, specifications, and timelines.
• Internally, be an influential voice of the customer/patient needs throughout the development process to ensure successful market adoption and meaningful clinical impact
• Externally, be an effective and respected ambassador of the company and our products to key stakeholders such as KOLs, patient advocates, societies, etc.

Product Development:

• Manage the high level product development process, ensuring that products are designed in alignment with customer and market needs, developed, and launched on time and within budget.
• Work closely with R&D, engineering, and manufacturing teams to ensure that products meet quality and regulatory standards.
• Manage the high level product testing and validation processes to ensure product performance and reliability.
• Ensure the evidence generation plan and all other development activities clearly support successful commercialization inclusive of regulatory approval, payer coverage, guideline inclusion and KOL advocacy and adoption.

Product Launch and Marketing:

• Collaborate with medical affairs, regulatory, managed care, supply chain to ensure all aspect of the product launch are well planned, effective and efficient in achieving pre-defined launch objectives
• Develop and execute product launch plans, including commercial readiness reviews that include product positioning, messaging and a detailed go to market promotional plan.
• Monitor product performance in the market and gather customer feedback to drive continuous improvement.

Product Maintenance and Support:

• Drive cross-functional team in ensuring robust post-launch product support, including customer service, technical support, and product updates.
• Manage product life cycle activities, including product enhancements, updates, and end-of-life planning.
• Ensure compliance with industry regulations and standards throughout the product life cycle.

Financial Management:

• Work with finance to develop and manage project budgets, forecasts, and financial performance metrics.
• Monitor product profitability and make product-related recommendations for cost optimization and revenue growth.
• Monitor and report on key performance indicators (KPIs) related to product life cycle management.

Qualifications:

• Master's or PhD degree in a relevant field (e.g., Business, Marketing, Life Sciences).
• 12+ years of experience with at least 5 years of experience in product life cycle management in the healthcare or diagnostics industry with successful product launches
• At least 2 years of experience in marketing of diagnostics or therapeutics to hematology oncologists. Marketing to cell therapy and/or bone marrow transplant specialists is a plus but not a requirement.
• Strong experience in hematology and understanding of the CAR-T therapy landscape
• Understanding of hematopoietic stem cell transplantation processes and relevant diagnostic technologies including molecular MRD is a plus
• Proven track record in managing cross-functional teams and launching successful diagnostic or therapeutic products.
• Strong understanding of CLIA product development processes, quality standards, and regulatory requirements is a plus
• Excellent project management skills with a focus on delivering results in a fast-paced environment. Solid communication, and leadership skills.
• Strong analytical and problem-solving skills; detail-oriented; sense of accountability
• Comfortable working in a fast-paced dynamic environment

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 for US Employees 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!
• Please refer to our page to view detailed benefits athttps://caredx.com/company/careers

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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