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CareDx, Inc. · 2 days ago

Director of Product Lifecycle Management

Brisbane, CA

Full-time

Onsite

Director/Executive

$255K/yr - $294K/yr

12+ years exp

CareDx, Inc. is a leading precision medicine solutions company focused on providing high-value healthcare solutions for transplant patients and caregivers. The Director of Product Lifecycle Management will oversee new product launches in the Cell Therapy/Bone Marrow Transplant pipeline and collaborate with cross-functional teams to ensure the successful commercialization of new products.

BiotechnologyHealth CareHealth DiagnosticsInformation Technology

No H1B

Responsibilities

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

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

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

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

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

Qualification

Product Life Cycle ManagementMarket ResearchHematology KnowledgeCross-Functional Team LeadershipRegulatory ComplianceFinancial ManagementProject ManagementAnalytical SkillsCommunication SkillsProblem-Solving SkillsLeadership Skills

Required

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

Strong experience in hematology and understanding of the CAR-T therapy landscape

Proven track record in managing cross-functional teams and launching successful diagnostic or therapeutic products

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

Preferred

Marketing to cell therapy and/or bone marrow transplant specialists is a plus but not a requirement

Understanding of hematopoietic stem cell transplantation processes and relevant diagnostic technologies including molecular MRD is a plus

Strong understanding of CLIA product development processes, quality standards, and regulatory requirements is a plus

Benefits

Health and welfare benefits, including a gym reimbursement program

401(k) savings plan match

Employee Stock Purchase Plan

Pre-tax commuter benefits

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.

Company

CareDx, Inc.

CareDx, Inc., headquartered in South San Francisco, is a precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers.

Founded in 1998

Brisbane, California, USA

501-1000 employees