Senior Director Clinical Data Management #2593

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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
The Senior Director of Clinical Data Management (CDM) manages a group of data managers to provide expertise and leadership to the planning and execution of clinical data management activities in GRAIL studies across the whole product portfolio. The Senior Director of CDM will be responsible for developing and implementing a strategic vision for the CDM team and overseeing all CDM activities. 

You will:

• Operate as an expert strategic and thought leader for clinical data management processes and infrastructure to inform and accelerate GRAIL product development.
• Develop and lead a highly functional and scalable CDM organization, including formulating CDM strategy, operations, infrastructure, and processes.
• Develop corporate and/or organizational policies and authorize their implementation, and ensure compliance with SOPs, GCP, ICH guidelines, and other established guidelines of national and international regulatory authorities.I
• Interact internally and externally with executive level management requiring negotiation of difficult mattersInfluence policy and decision making bodies both internally and externally
• Play a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people
• Works on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
• Provides data management leadership in support of clinical trials and RWE studies.
• Development of strategy and implementation of innovative methods to capture regulatory-grade real-world data, ensuring integrity throughout the data lifecycle (e.g. acquisition, system integration, de-identification, transformation, mapping, natural language processing, technology enabled abstraction, etc.).
• Ensure that budgets, schedules, and performance requirements are established and met.
• Create formal networks with key decision makers and serve as external spokesperson for the organization Assist clinical data management audit and address audit findings 

Your qualifications and background will include:

• 15+ years of experience in academia or industry with demonstrated experience and knowledge in data management with at least 5 years of managerial experience. Molecular diagnostics or pharmaceutical industry experience preferred.
• Bachelors degree required; advanced degree preferred. Additional coursework in management, real-world evidence generation, life sciences, public health, or related fields is strongly desired.
• Extensive experience in both team and project management, including demonstrated experience in overseeing CROs and third-party vendors, and experiences in managing and mentoring direct reports. The experiences of successfully building a CDM team and overseeing multiple clinical trials and RWE studies is strongly preferred.
• Deep knowledge of clinical trials and medical device and/or drug development processes. Experience working on study start up, database locks, analysis timepoints and study closeout.
• Solid understanding of regulatory requirements and information governance frameworks (e.g. ICH, GCP, HIPAA. GDPR).Outstanding verbal, writing, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.
• Experience working on studies under the purview of the FDA and MHRA is a plus.
• Experience managing data for real-world evidence programs, registries, or other post-marketing studies is preferred, and experience working on studies involving integration with Electronic Medical Records (EMRs) or other electronic data sources is strongly preferred.
• Prior experience with software systems development and integration, EDC programming/configuration, or APIs is a plus.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.