Associate Director Project Management

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

This position will be responsible for providing Project Management expertise at the Research Triangle Park (RTP) site being built by GRAIL. He/She will work closely with the RTP site lead to enable the execution plans for establishing and then maintaining the CAP/CLIA lab and technology transfer. Responsibilities include the day-to-day planning and project management that enables effective and on time operations at RTP. The successful candidate will develop, execute and adjust timelines; identify, plan for, and appropriately raise risks and issues; communicate effectively with stakeholders across functions and leadership teams at both GRAIL sites; and facilitate decision making that impacts activities at RTP.

This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Collaborate cross-functionally across all site functions but primarily Clinical Laboratory, Research & Development, Regulatory, Quality and Senior Site Leadership to establish and enable the site to meet/exceed all applicable regulatory standards.
• Facilitate communication of issues & outcomes to the RTP Project team leadership or other dependent teams as appropriate.
• Manage the interfaces between functional areas and ensure effective handoff and communication between functions and sites to execute on important project milestones.
• Work with project Lead and/or SME to prepare status reports, specific project updates, or scenarios.
• Manage document review practice to support submission activities and other key project deliverables.
• Establish and maintain functionally integrated project schedules and other tracking tools to enable accurate project management across various functional areas.
• Schedule, organize, and drive project team meeting(s): prepare and distribute agendas/minutes; track action items, and escalate areas of concern to the appropriate management entity.

• Minimum of a BA/BS in a scientific discipline is required, while an advanced degree (PhD, MS, MBA, MD) is desirable in a discipline related to drug development, genomics, or business.
• The ideal candidate will have at least 10 years multidisciplinary experience in the biotech/pharmaceutical industry, with at least 5 years direct project management in drug development, genomics or the medical device space.
• Experience working under design control, establishing and maintaining a CLIA lab facility, including tracking of SCARs, CAPAs, OOS, deviations and change records.
• Excellent interpersonal skills, ability to develop important relationships with customers and key stakeholders, good conflict management skills.
• Proactive individual with strong leadership, facilitation, teamwork, and influence management/negotiation as well as excellent organizational skills.
• Proven ability to proactively identify risks and drive resolution of issues.
• Ability to work independently for decision-making and resolution of project obstacles and conflicts. Familiarity with developing budgets and forecasting.
• Ability to drive project plans and timelines (across multiple functional areas) is essential.
• Strong communication skills (in person and written word) and ability to interact seamlessly with a diverse group of individuals and levels.

Preferred:
• Understanding of CLIA/CAP, FDA regulatory processes and prior experience with regulatory filings with Device/Diagnostics.
• Participation in an executive steering committee for product development.
• Results and detail-oriented; self-motivated, ability to work with minimal supervision.
• Ability to perform and be adaptive in a fast-paced environment under tight deadlines.
• Demonstrated ability to develop, manage, and lead cross-functional teams.
• Proven success in goal setting, prioritization, and time management.
• Strong analytical and problem solving capabilities.
• Oncology experience.
• Project Management Certification ( PMP or equivalent.)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.