At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way – it’s about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions.
Our Values:
- We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
- We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
- We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
- We Care Deeply: We embrace our differences, do the right thing, and encourage each other
The Project Manager will lead cross-functional teams in the development and commercialization of diagnostic products. This individual will be accountable for the successful delivery of complex projects to ensure business objectives are met and accomplished on time, within budget, and meet operational standards. The ideal candidate brings a deep understanding of product development under ISO13485, global regulatory pathways (e.g., EU IVDR, US FDA, etc.), and lifecycle management, along with strong leadership and communication skills to influence and guide teams in a fast-paced, regulated environment.
Key Responsibilities:
- Lead project management of diagnostic development programs, from feasibility through development, verification/validation, regulatory submission, and commercialization.
- Drive cross-functional core teams (e.g., R&D, QA/RA, Clinical Affairs, Manufacturing, Supply Chain, Commercial) to achieve program milestones on time, within scope, and on budget.
- Serve as a leader for assigned programs/projects with a high level of comfort in leading others including senior level personnel.
- Develop and maintain integrated project plans, timelines, risk registers, and mitigation strategies in alignment with the Product Development Process (PDP).
- Partner closely with regulatory and quality teams to align project activities with global regulatory pathways and regulations (e.g., IVDR, US FDA 510k, PMA, etc.) and quality management system requirements (e.g., ISO 13485, MDSAP, US FDA 21 CFR 820).
- Drive the team for the creation, review, and approvals of QMS documentation to support stage gate exists
- Prepare and present project status, risks, and strategic recommendations to governance committees and executive leadership.
- Foster a culture of accountability, collaboration, and continuous improvement across teams and stakeholders.
- Contribute to the development of PMO processes and tools.
- Identify, raise, and address issues or risks that arise as needed.
- Identify individual project resource requirements and portfolio capacity needed. Work with functional leads to identify and assign individual project responsibilities.
- Report regularly on project status, milestones, and KPIs to senior leadership.
- Contribute to the design and implementation of project management framework and tools.
- Foster a culture of continuous improvement and innovation within the project management team and broader organization.
- Work with business leaders and PMO leadership to align product / program roadmaps to goals, portfolio priorities, budgets, and resource plans.
- Other duties as assigned.
- Minimum of 5+ years of project management experience within the IVD, diagnostics, or medical device industry.
- Bachelor’s or master’s degree in life sciences, biotechnology, engineering, business, or related field preferred.
- Strong working knowledge of IVD design development processes, including clinical validation, regulatory pathways (e.g., CE/IVDR, ISO 13485, 510(k), PMA), and quality systems.
- Proficiency in project management methodologies and tools. Smartsheet knowledge and experience is preferred.
- Excellent communication, collaboration, and leadership skills with the ability to influence at all levels of the organization
- Ability to effectively lead people and drive results through cross-functional engagement/alignment.
- Experience working with cross-functional teams, including Product Development, clinical, regulatory, operations, and commercial departments.
- PMP or equivalent certification preferred.
- You are comfortable with ambiguity
LI-Remote
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives, and restricted stock units. Veracyte is a multi-state employer, and this salary range may not reflect positions that work in other states.
What We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We offer competitive compensation and benefits, and are committed to fostering an inclusive workforce, where diverse backgrounds are represented, engaged, and empowered to drive innovative ideas and decisions. We are thrilled to be recognized as a 2024 Certified™ Great Place to Work® in both the US and Israel - a testament to our dynamic, inclusive, and inspiring workplace where passion meets purpose.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on X (Formerly Twitter).
Veracyte, Inc. is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability status. Veracyte participates in E-Verify in the United States. View our CCPA Disclosure Notice.
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