Clinical Program Manager, LUNAR Program
- 505 Penobscot Dr, Redwood City, CA 94063, USA
We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.
The Clinical Program Manager will play an important role in supporting Clinical Development programs for the LUNAR program in alignment with Guardant Health’s mission. This individual will work closely with internal cross-functional teams and external collaborators to ensure clarity of strategy, to manage across projects/programs, and to facilitate communication across all parties. This position reports to the Director, Clinical Development.
TASKS AND RESPONSIBILITIES:
- Coordinates and drives clinical program development strategy and process activities within and across clinical programs
- Serves as functional manager for team members
- Identifies and resolves issues around scope/cost/schedule/quality changes across programs
- Interacts with Agency Regulators and lead BIMO Inspections for both Sponsor and is a resource to the clinical lab for Site-related Inspections
- Adapts program management processes across programs
- Identifies and helps resolve resource constraints and/or conflicts that affect multiple projects within and across program(s)
- Identifies and mitigates risk activities across programs
- Develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation
- Interacts with senior leadership and major stakeholders to establish strategic plans and objectives for programs and projects
- Coordinates activities between Clinical Development, Clinical Operations, R&D, Commercial Laboratory, Data Management, Clinical Technology, etc. to ensure the timely and compliant execution of clinical trials across programs
- Ensures all programs have timelines and project teams have clear goals, objectives, and milestones consistent with Guardant Health’s objectives and financial goals
- Participates in portfolio review and budget process
- Facilitates team level decision-making and escalates key decisions
- Ensures that effective collaboration and communication takes place across the organization
- Effectively communicates project/program strategy, status, critical path activity timing, resource requirements, and risks, both internally and tocollaborators, as appropriate
- Requires understanding and application of principles, practices and standards that govern the industry
- Manage and engage with study scientific advisory boards, and other thought leaders to innovate and refine clinical development strategies
- Bachelor’s degree or equivalent in the life sciences or related field required; advanced degree (Master’s or above) preferred. Additional coursework in clinical trial planning and execution strongly desired
- 10+ years’ functional experience with clinical trials and clinical development
- Experience with direct management of team members within a similar functional role
- Experience with leading teams in a matrix structure
- Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience can substitute in part for IVD experience
- Experience in FDA interactions, strategy, and BIMO Inspections
- Experience in clinical research and successful clinical trials conduct in genomics, diagnostics, oncology, or other applied medical fields
- Demonstrated ability to work independently with new, complex technologies and produce professional work products.
- Possess excellent organizational, record retention, time management, decision-making, customer service, communication, and interpersonal skills.
- Possess excellent analytical, thorough follow-through, planning, and implementation skills.
- Strong team player with demonstrated track record of success in cross-functional team environment and leadership roles.
- Strong work ethic and demonstrated ability to deliver assignments ontime.
- Thrive in a team-oriented and values-driven environment.
- Be flexible and embrace change.
- Have the ability to travel as required (up to 20%).