Companion Diagnostics: Project Leader will work collaboratively with the global cross-functional project teams and partner with R&D, Clinical Development, Biostatistics, Quality, Regulatory, Manufacturing, Commercial, Finance and Business Development. External partnerships include laboratories, collaborators, and manufacturers to support and progress diagnostic assay development at Predicine. To be successful in this role, you should be a business diplomat, strong collaborator, and effective communicator.
This is Full Time/Onsite: Hayward, CA
What you will get to do:
- Independently coordinate and lead global, cross-functional projects in a matrix organization with minimal guidance from the Program Manager. Some assignments may include projects of greater complexity involving global team’s communication.
- Demonstrate accountability and urgency to define, drive execution, and deliver expected results according to agreed project scope, requirements, cost, quality, and timelines.
- Establish yourself as the primary point-of-contact for key leaders and stakeholders across multiple business functions.
- Plan, analyze and track project activities and timeline to identify issues and minimize delays, raise as appropriate.
- Estimate and track project costs; proactively communicating deviations to relevant stakeholders.
- Apply appropriate risk management techniques to ensure timelines, business priorities and quality standards are met.
- Use standardized organizational tools, systems, and techniques for tracking project progress, maintain current project Gantt charts and task lists.
- Organize and lead team meetings with detailed agendas, clearly documenting meeting minutes, action items, issues, risks, and decisions.
- Drive project strategy decisions with Senior Leadership teams; demonstrating an ability to influence at multiple levels.
- Execute multiple projects simultaneously, some being complex, and successfully multi-task amongst several competing initiatives.
Qualifications/Skills/Relevant Experience:
- BA with MS/MBA and/or PHD in life sciences preferred or equivalent combination of education and experience.
- 8+ years project or program management experience in the diagnostic, medical device, pharmaceutical or biotech industry
- Experience with Next Generation Sequencing and/or Liquid Biopsy is preferred.
- Experience in clinical biomarker or In Vitro Diagnostic development.
- Experience in companion diagnostic development, analytical and clinical validations, and regulatory submissions a plus
- Experience in PMA submission is highly preferred.
- Experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001)
- Clear verbal and written communications for a wide variety of audiences
- PMP certification a plus
Salary Range $130,000 + Base Plus Annual Bonus Award.
Our Opportunity
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology.
What we offer
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Other benefits include stock allocation and 401k benefits, 1 month sabbatical after 5 years of service and an employee referral program. We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives. Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.
We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data
