Grail

  • Menlo Park, CA, USA
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Clinical Laboratory Associate (CLA) is responsible for assisting the Clinical Laboratory Scientist and supporting the daily operations of the Clinical Laboratory.  CLA may serve as a team lead to the CLA team to coordinate tasks, divide workload, manage projects and review documents as assigned. The work requires excellent attention to detail, effective written and verbal communication skills, the ability to multitask, be flexible with tasks and schedules and ability to work independently in a team environment. You Will: Assist in analytical testing activities including specimen processing, quality control, and preparation and aliquoting of reagents according to the laboratory’s standard operating procedures.Operate and maintain laboratory instruments and equipment according to laboratory standard operating.Troubleshoot and problem solve instrument issues.Check, monitor and record temperature and perform root cause analysis of deviations and implement a resolution or initiates a service request as necessary.Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties.Assist with organizing and maintaining Clinical Laboratory records.Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.Perform and document routine preventive maintenance.Support on-time calibration of laboratory equipment is scheduled and performed.Assist with training of new laboratory personnel and training of new procedures with existing personnel.Report all concerns of test quality and/or safety to the Laboratory Manager or Safety Officer.Write and revise standard operating procedures, as needed.Participate in introduction of assay improvements, new assay configurations and validation.Participate and comply with Quality and applicable regulatory requirements.Participate in cross-functional teams responsible for securing CLIA certification, CAP accreditation, and state licensure for the GRAIL Clinical Laboratory, including compliance with all applicable standards and regulations.Communicate effectively with coworkers and non-laboratory personnel.Identify process improvement opportunities and report to laboratory management.Perform other laboratory duties as needed. Your Background Will Include: Bachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field preferred.Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed.Strong organizational skills and meticulous attention to detail.Able to integrate and apply feedback in a professional manner.Able to prioritize and drive to results with a high emphasis on quality.Ability to work as part of a team within a highly collaborative environment.Strong computer skills.Ability to proactively communicate consistently, clearly and honestly.Ability to prioritize tasks with a high emphasis on quality.Ability to participate in projects and complete assignments as expected.Flexibility of work schedule to meet the needs of GRAIL’s Clinical Laboratory. Physical Demands/Working Environment Hours and days may vary depending on operational needs.Standing or sitting for long periods of time may be necessary.May be exposed to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high speed centrifugation. Repetitive manual pipetting may be necessary.Some lifting (up to 25 pounds) may be necessary.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com Position Summary As R&D Laboratory Supervisor at GRAIL you will be responsible for the daily operations of the Research and Development laboratory spaces, adherence to good laboratory practice, enforcement of standards for laboratory safety, and maintenance of a safe work environment. You Will: Develop, coordinate, and ensure adherence to procedures for a large and varied group of lab users, for example, covering safety and hygiene of lab spaces, and booking/use of materials and equipmentEnsure/facilitate required equipment and process training for laboratory personnel, including new hire lab training and basic on-boardingMaintain cleanliness of the laboratory workspace, and ensure EHS PPE and Job Hazard assessments are followed by lab usersServe as a liaison between R&D and EHS, notify EHS Team of laboratory-related EHS issues and concerns including new processes and chemicals being introduced to the labWork with Equipment Engineering as needed to ensure lab equipment is operational and appropriately maintainedCoordinate with Supply Chain to ensure availability of general lab supplies and reagentsMaintain R&D inventory, order and track use of reagents and consumables that are not stocked by Supply ChainProduce general consumables for laboratory operation (buffers, solutions, etc.)Assist with the transfer of materials and information for internal and external collaborationsPerform daily laboratory maintenance procedures for selected equipmentProvide input for the procurement of new laboratory equipmentAssist in additional miscellaneous laboratory tasks as required Your Background Will Include: 2+ years of laboratory operation (lab supervisor/manager) experienceAttention to detail, safety, and good laboratory practiceGood organizational, communication and interpersonal skillsExperience with 5S or other lean manufacturing systemsExperience in BLS2 lab and handling of blood tubesExperience with nucleic acids QC instrumentation (Nanodrop, Bioanalyzer, Fragment Analyzer, qPCR, etc.)Experience with molecular biology techniques and familiarity with Next Generation Sequencing (pipetting, SPRI, PCR, qPCR, Illumina workflows, etc)General computer skills and proficiency in GSuite
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com In this role, you will analyze some of the largest, richest biological datasets in the world to find biological signals and patterns and guide our assays, bioinformatic pipelines, and product strategies. Working closely with scientists, clinicians, and engineers, you will develop inference to investigate the biology of cell free nucleic acid  tumor biology and how that relates to classification performance. You will execute statistical analyses operating across GRAIL’s data sets, public data, and data from collaborators in academia and industry. Your analyses will result in exciting discoveries in cancer biology, impactful publications, and products for early detection of cancer. You Will: Modeling and analysis of large, complex genomics datasets using machine learning and statistical methods to generate biological insights. Perform end-to-end analysis that include data gathering, processing, analysis, iteration with stakeholders, and presentation of results.Interact cross-functionally with other teams including software, clinical, operations, research, product development, and external collaborators.Promulgate analyses that reinforce scientific rigor and quality and which maintain GRAIL’s statistical culture. Your Background Includes: Ph.D. in Bioinformatics, Computational Biology, Statistics, Biological Sciences, Cancer Biology, Genetics, Genomics, Computer Science, Physics, or equivalent preparation and experience.Proven track record of strong contributions demonstrated by highly cited publications, impactful tools, products, or data sets used by the scientific community, presentations at international conferences, and awards.Preferred, 3 years relevant experience in positions of increasing responsibility.Deep understanding of modern statistical and machine learning tools for analysis of genomics datasets. Demonstrated ability to apply these skills to uncover new biological insights from large genomics datasets.Demonstrated expertise in at least one programming language (R, Python, Go, C++), proficiency in Linux environment, version control tools, and reproducible research practices. Self-direction, willingness to both teach others and learn new techniques.Effective written and verbal communication skills.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Associate Director (AD) of Clinical Compliance - has overall responsibility for and oversight of the GCP Audit Program. This will include audit process development/maintenance, risk assessments, tracking, audit metrics and development of the annual audit plan.  This position will require the candidate to have a high level of knowledge and experience with the Good Clinical Practice (GCP) audit process, Internal / Investigator Site / Vendor audits, drug/device development regulations and standards, clinical operations and data management processes, and regulatory inspections.  A thorough understanding of the audit process, applicable regulations and standards, metrics development, interpretation and reporting, issue management and regulatory authority inspections.  It is important that this person have the ability to successfully, and independently, work across functions and incorporate broad viewpoints into the deliverables. You Will: Lead the GCP Audit Program – Internal, Investigator Site and Vendor auditsConduct and oversee GCP audits as requiredSupport Clinical Issue Management and follow upDevelopment, interpretation and reporting of audit metricsLead and support Inspection readiness and preparation activities Work with teams and stakeholders to address compliance concernsSupport Quality Management ReviewsAbility to participate in and/or lead departmental or interdepartmental strategic initiatives independentlyWork cross-functionally to create shared solutions Your Background Includes: 6+ years of relevant experience preferredBachelor’s degree or equivalent in the life sciences or related field required; advanced degree preferredExperience conducting all types of GCP audits, Computer System Validation (CSV) audit experience also desiredExperience overseeing GCP audit consultantsExperience developing and maintaining a GCP audit program and developing audit responses
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The AP Associate is a key contributor in the Finance organization who assists with the processing, accounting, reconciliations, analysis, and reporting related to AP operations. He/she is an accounting professional with experience in a fast-paced private or public company environment who has demonstrated experience supporting the accounting function to meet the needs of a changing and growing business. You Will: Enter invoices, properly coding them with the appropriate informationReview all invoices for required documentation and approval prior to paymentRespond to all vendor inquiries, reconciling all vendor statements, correcting any discrepanciesProcess expense reimbursements, ensuring spending is within Company policyAssist in month-end close, preparing journal entries and balance sheet reconciliationsMaintain vendor records, keeping information currentAssist in the preparation of 1099sApplying a thorough understanding of the Company’s business to all aspects of Accounts PayableAssist in maintaining regular contact and building solid working relationships with various groups to ensure a high level of customer serviceAssist on projects and ad hoc assignments as neededProtect the Company’s value by keeping all information confidential Your Background Should Ideally Include: 3+ years of AP/AR experienceCollege degreeExcellent professional written and verbal communication and interpersonal skills requiredAbility to prioritize assignments, deal with interruptions, and meet deadlines in a fast paced and growth oriented environmentExperience with the Google Suite of products (Sheets, Docs)Experience with NetsuiteProven teamwork and collaboration skillsExperience in Life Science industries strongly preferred
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The candidate must be able to operate in a fast-paced organization with high expectations on quality of deliverables. This is an excellent opportunity for an experienced leader seeking to join a high-performing mission-driven team.  Key Accountabilities/Core Responsibilities: Support the strategic rationale and develop the business case for clinical evidence to support commercialization, reimbursement, and clinical use – define, business plan, target clinical use cases, and value proposition through partnerships with clinical development leadership and other cross-functional expertsAlign the evidence plans to the product goals and criteria for success Implement the evidence roadmap, ensuring the development of high-value healthcare products that meet GRAIL’s mission Represent the project to management and work cross-functionally to understand all technical and non-technical roadblocks and work with stakeholders to resolve them. Stakeholders include R&D, clinical, engineering, regulatory, business development, legal, marketing and senior leadership. Develop PRDs, strategy documents and presentationsLead teams to deliverables related to product and project goals Required Qualifications: Motivated by making the world a better place and a desire to contribute to GRAIL’s missionBachelor’s Degree or equivalent and MBA and/or advanced Life Sciences degree A minimum of 7-10 years of experience in product management in molecular diagnostics and oncology products or related work Understanding of next generation sequencing technology and cancer biology Proven ability to collaborate and work cross-functionally to drive results in a matrixed, fast-paced environment Detail-oriented in making sure all aspects of product use, performance, manufacturing and QC are well-understood Demonstrated track record of getting things done and growing responsibility over time Ability to effectively manage multiple competing priorities and negotiate scope, product features, and specifications across the organization Strong understanding of legal and regulatory environment in diagnostics and pharmaceutical industries.Strong interpersonal, organizational, analytical, communication and presentation skills Willing and able to travel as needed
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com Position Summary: As an Associate Director/Director IVD Product Development at GRAIL, you will join an exceptional and innovative product development team responsible for delivering commercial-scale NGS assays to serve impactful areas of unmet clinical need.  You will be responsible for driving new product introduction to completion by leading teams through the validation and regulatory submission phases of product development. Leveraging your technical expertise in NGS and regulatory strategy insights, you will help bring new technologies and product concepts through uncharted regulatory paths. The ideal candidate should have extensive experience developing and validating assays in LDT- and IVD-regulated environments, including successful interactions with the FDA. You Will: Lead IVD product development teams through planning, design & execution of technical validation activities for regulatory submissionsPerform & review complex analyses of study data sets to address verification/validation study objectives in collaboration with bioinformatics & biostatistics teamsReport project updates, data analyses & experimental conclusions at technical meetingsDrive study documentation in compliance with good laboratory practices & quality systems requirements to support regulatory filingsBuild out an IVD product development team through a combination of strategic hires & mentorship of existing team members Your Background Will Include: Ph.D in Molecular Biology, Biochemistry or related fields with 8+ years of industry experience requiredStrong track record of successful IVD product regulatory submissions is essentialHands-on, practical knowledge of requirements of working under design control requiredExperience launching LDT products in high volume clinical settings is highly desiredNext generation sequencing assay development desiredExperience managing mid-size technical teams, recruiting and developing talentExperience with statistical programming and software (e.g., R, JMP) is a plus.Strong verbal and written communication skills and willingness to collaborate cross-functionally in a fast paced and dynamic environment.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Director, Marketing will focus on market development and branding & promotions efforts for GRAIL’s multi-cancer product.  This individual should have significant experience leading the development of both unbranded and branded campaigns. You Will: Develop comprehensive strategic and tactical plans for market development and promotional efforts for GRAIL’s multi-cancer product that are aligned with the overall US commercial strategy Operate both at a strategic level, leading long-term planning, and at a tactical level, executing upon key deliverables on short timelines including copy/content development Be an expert in GRAIL’s clinical study designs, clinical data, technical platform, and test performance to drive the development of effective communications around a novel, complex product to multiple diverse stakeholder audiencesCollaborate closely with Medical Affairs, Clinical Development, Corporate Affairs, Legal, Regulatory, and other Commercial functions on all activities Closely manage timelines across all activities, and update and revise frequently based on shifting priorities and corporate milestones Contribute to development of overall commercial strategy Your Background Will Include: Bachelor’s Degree or equivalent; MBA is preferredA minimum of 15 years of experience in Marketing or related Commercial functions in healthcare companiesExperience developing and launching branded and unbranded campaignsExperience translating complex clinical data to promotional messaging Prior experience launching products Proven ability to collaborate and work cross-functionally to drive results in a matrixed, fast-paced environmentDemonstrated track record of getting things done and growing responsibility over timeAbility to effectively manage multiple competing prioritiesStrong interpersonal, organizational, analytical, communication and presentation skillsWilling and able to travel as needed
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The People Business Partners (sometimes called HRBPs) at GRAIL are critical to achieving our mission to detect cancer early when it can be cured.  This team helps shape our collective leadership, our ability to do life saving work, and helps us connect with one another with authenticity and greatness.  At GRAIL, we rely on the strategic thinking of our People Team and its ability to advise and advance the business. GRAIL seeks a thought leader and disrupter that is also a thoughtful steward of organizational resources You Will: Consult and advise executive clients on strategic culture, business, and talent topics to advance the life-saving objectives of GRAIL.  Advance our collective leadership through disruptive and innovative people-partnering.Serve as both a thought leader and operational expert to enable the business to provide fantastic coaching, employee development, organizational development, succession planning, talent planning, and performance management at all levels.Provide employees with an empathetic and invested first-contact point to discuss and solve employee challenges such as total rewards, leaves of absence, employee development and career pathing, etc.Build and lead solutions and programs that are tailor and appropriate for the clients for their given stage of development and evolution; drive those programs in ways that stand-out and make meaningful impact for our people and mission.Collaborate closely with Talent Acquisition and Total Rewards to provide a seamless and integrated experience for potential and current employees and leaders.Manage employee relations issues for your clients as they arise addressing challenges with sensitivity, thoughtfulness, and care for compliance and legal considerations.Build a culture of growth and development among our teams by enabling all GRAILers to be leaders and to lend support for the growth process.Ensure data-driven insights and decisions are drawn and made in the business by partnering with the Total Rewards + Systems team to produce talent reporting and translate those data into meaningful storiesFacilitate strategic change, resilience, and adaptability as GRAIL grows and shifts. Your Background Will Include: 8+ years of People Operations or Human Resources experience with progressive scope and scale of responsibility; HRBP or generalist experience considered favorably as is diversity of experienceRelevant undergraduate degree or noteworthy experience combined with HR certifications; advanced degree in organizational behavior or business considered favorablyExperience building and implementing People Operations programs with measured successExperience partnering at the leadership levels as a trusted advisorFluency with and ability to coach on diversity, inclusion, equity and belongingExperience handling sensitive employee relations mattersExperience working with tech or life sciences preferred; experience working with technical and scientific experts highly preferredAbility to work adeptly with data analysis and systemsStrong competency with coaching with proven results in advancing the development of managers and leadersStrong knowledge of HR compliance, legislation, and best practiceExperience in a rapid growth or start-up organization (and the resulting requirement to wear multiple hats) viewed favorably
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com A People Ops Generalist (HR Generalist) at GRAIL is a key role that will inform and influence our culture.  At GRAIL, we rely on the strategic thinking of our People Team and its ability to advise and advance the business.  GRAIL seeks a trusted partner to serve as a People Ops Generalist that will advance our people practices and processes in order to achieve our critical mission. You Will: Provide project management for the People Team that is rooted in our strategy and mission, owning critical People initiatives and solutions.Analyze issues and opportunities across the Talent Lifecycle for client groups in order to build and deliver advisement, programs, and/or initiatives that improve our capabilities as an organization and advance our mission.Provide support and coaching to employees and managers on People policies and processes, people management, and career development, as some examples.Counsel and/or coach employees and managers regarding employee relations issues including performance management, facilitation of formal/informal investigations, and any resulting disciplinary actions.Assist managers in assessing and identifying resources to meet employee training needs.Support and enable effective compensation equity and planning processes for the assigned client group, in close collaboration with People Business Partners and Total Rewards.Elevate the People Team by providing thoughtful and strategic program management for large scale People initiatives and annual processes.Facilitate learning experience and challenging conversations with employees and managers alike in order to more thoroughly embed our values throughout the organization.Partner with People Business Partners and business leaders to oversee and provide guidance on activities that shape culture and drive employee engagement. Your Background Will Include: 5+ years of People Operations or Human Resources experience with progressive scope and scale of responsibility; generalist experience considered favorablyRelevant undergraduate degree or noteworthy experience combined with HR certifications; advanced degree in organizational behavior or business considered favorablyKnowledge and understanding of US labor and employment law, relevant compliance considerations, and experience overseeing employee relations issues.Demonstrated strong analytical skills and storytelling abilities deriving insights from data; Ability to work adeptly with data analysis and systemsAnalysis, problem solving, decision making, negotiating and influencing skills.Excellent interpersonal and communication skills to interface with all levels of the organization including employee relations, coaching, communications and presentations, etc.Energy for creating change and instincts towards actionAbility to balance multiple and sometimes competing priorities and projects with complex interdependenciesFluency with diversity, inclusion, equity and belongingExperience working with tech or life sciences preferred; experience working with technical and scientific experts highly preferredExperience in a rapid growth or start-up organization (and the resulting requirement to wear multiple hats) viewed favorably
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. 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 and support to GRAIL commercial projects to ensure all Project milestones and deliverables are met, and that activities are well executed and managed. Responsibilities include the day-to-day planning, coordinating and tracking of critical activities, as well as strategic oversight to the Programs from the Program Management perspective. The successful candidate will partner with Product Manager/Project Team Lead or Sub Team Leader to optimize team effectiveness and decision making, facilitate team building and communication. Creates and drives timelines to keep project(s) on schedule. Collaboration with Program Management Leadership and team to define program-related budget assumptions for annual operating plan. You Will: 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.Facilitate communication of sub-team issues & outcomes to the Core Team/Project team leadership.Use solid understanding of business and diagnostic market to serve as a key Business Partner for Project Leads to help establish priorities for each key project and identify risks and tradeoffs associated with various strategies.Manage the interfaces between functional areas and ensure effective handoff and communication between department functions to execute on important project milestones.Works 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   Effectively direct resources across projects to ensure maximum efficiency.Synthesize the strategy, options, risks and costs of each project, then create the broader picture for the team.Work fluidly on multiple projects at a time. Act as an integrator to identify opportunities and timelines to ensure consistency and harmony from project to project. Your Background should Include: 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 medical devices or business.Minimum 5 years’ experience in project management working on product development in diagnostics or life science industry.Experience with project management for commercial functions a plus. Oncology experience highly desirable. Ability to multitask as needed in a start-up environment.Demonstrated ability to develop, manage and lead cross-functional teams.Outstanding written and verbal communication skills.  Flexibility to changeEffective process and project management skills.Project Management Certification (PMP or equivalent) a plus.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com Grail is hiring a software quality engineer to assist us in the automated and manual testing of our LIMS and EDC software platforms. This role will be responsible for ensuring high quality product releases by developing comprehensive test plans, finding, tracking and resolving bugs. This will include working cross functionally with Grail’s software, lab operations and clinical teams. This individual will embed with our software engineering team and provide the foundation for a larger quality team in the future. You Will: Develop automated and manual test plans that will establish product quality standards for our development process.  Build and manage our automated testing library.Find and document bugs.Improve testing infrastructure with accountability and scalability in mind.Implement and execute test plans.Be a user advocate.Participate in the development of technical tools and documentation to expedite deployment, and improve customer experience. Your Background Should Include: BS degree in Computer Science, Information Systems or equivalent practical experience.3-20 years of experience testing enterprise software, preferably in the life science industry.Programming experience in JavaScript, Python, Go, PHP.Strong attention to detail and consistency.Outstanding written and verbal communications skills and the ability to adapt your message to the technical level of the audience.Ability to work well in a cross-functional and geographically dispersed team of engineers and scientists.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com POSITION SUMMARY The Senior Automation and Systems Engineer c oordinates, manages, implements and provides technical engineering support for a variety of process automation hardware, software applications, and laboratory instruments . The Automation and Systems Engineer will primarily interact with scientists, software developers and end users to  transfer and continuously improve to implement robust automated solutions into day-to-day laboratory operations. The ideal candidate will be experienced in liquid handling robotic platforms, software integration and supporting complex systems. TASKS AND RESPONSIBILITIES Configure, program and troubleshoot laboratory automated platformsOptimize existing automated processes to improve efficiency, throughput, robustness and qualityProvide support for existing equipment and coordinate vendor support as requiredSupport the installation, facility acceptance test and validation of the new and or revised equipment, automated systems to ensure quality compliance and user requirements.Author, execute and document test plans and Standard Operating Procedures (SOPs) for automated workflowsCoordinate with different cross functional team members and execute projects in a timely mannerRecommend and implement changes to ensure ongoing high-quality performance of laboratory equipmentMonitor and evaluate new and emerging technologies in laboratory automation systemsPerform other duties as assigned PREFERRED BACKGROUND B.S. or M.S. in molecular biology, chemistry, engineering or related disciplineMinimum 3-5 years hands on experience in integrated automated solutions and liquid handling platformsProficiency in both writing and optimizing scripts on automated liquid handling platforms (e.g., Hamilton, Tecan, Beckman, etc.,)Experience with writing and executing test protocolsWorking knowledge of clinical laboratory operations and activitiesAnalytical, creative thinker, ability to solve problemsEffective organizational and time management skillsHighly energetic and self-motivated. Able to work independently and as part of a teamExperience working in a clinically regulated environment is highly desirableExcellent written and communication skills
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com POSITION SUMMARY The Senior Automation Engineer will join a team responsible for transitioning manual workflows and processes on to semi/fully automated robotics platforms as appropriate and provide ongoing support of these systems. The Automation Engineer will primarily interact with scientists, software developers and end users to bring automation technologies into day-to-day laboratory operations. The ideal candidate will be experienced in liquid handling robotic platforms and NGS assay workflows. You Will: Transition manual workflows onto automated liquid handlersConfigure, program and troubleshoot laboratory automated platformsOptimize existing automated processes to improve efficiency, throughput, robustness and qualityProvide support for existing equipment and coordinate vendor support as requiredAuthor, execute and document test plans and Standard Operating Procedures (SOPs) for automated workflowsCoordinate with different cross functional team members and execute projects in a timely mannerMonitor and evaluate new and emerging technologies in laboratory automation systemsPerform other duties as assigned Your Background Will Include: B.S. or M.S. in molecular biology, chemistry, engineering or related disciplineMinimum 3-5 years hands on experience in automation and liquid handlingProficiency in both writing and optimizing scripts on automated liquid handling platforms (e.g., Hamilton, Tecan, Beckman, etc.,)Experience with writing and executing test protocolsExperience with NGS methods is highly desirableAnalytical, creative thinker, ability to solve problemsEffective organizational and time management skillsHighly energetic and self-motivated. Able to work independently and as part of a teamExperience working in a clinically regulated environment is highly desirableExcellent written and communication skills
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Senior Quality Engineer will aide in the definition and implementation of the Quality Management System framework, focusing on CAPA, Nonconformance, and Deviation programs.  This role will support other Quality Management Systems (QMS) activities related to audits, supplier quality, design control, validation, and risk management as needed. You Will: Lead and manage overall programs for CAPAs, Nonconformances, and Deviations from initiation to closure.  Responsible for overseeing and providing Quality guidance for root cause investigation, containment actions, immediate correction, corrective/preventive action, and effectiveness check.  Monitor and ensure timely closure of investigations and corrective/preventive actions.Responsible for developing and maintaining policies and procedures for an effective and compliant CAPA, Nonconformance, and Deviation programs.Develop, prepare and maintain various QMS metrics and dashboards for management review and quality monitoring. Manage and lead the implementation and conversion to an electronic QMS.Assist with QMS activities, such as, supplier quality, audits (internal and external), complaints, batch record review, validation, design control, and risk management. Provide support as a Quality representative on product development teams focusing on assay, reagent, and automation development and guide teams through design control and validation.Review and approve documentation that is consistent with design control procedures and regulations.  Documentation may include but not limited to DHF documents such as product requirements, design and development plans, verification and validation plans and reports, design transfer documents and risk management plans and reports.  Provide training, guidance, and support to the company for QMS related policies and procedures.Independently determine and develop approach to solutions for moderate/complex problems.Other duties as assigned. Your Background Should Ideally Include: BA/BS (or equivalent industry experience) with 5+ years of experience in the life sciences industry, preferably in an FDA medical device/IVD regulated environment.  Strong working knowledge of FDA QSR/cGMP, ISO 13485 and ISO 14971 regulations.Must have good verbal, written, communication and organizational skills, and be able to work in a cross-functional team environment.Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgment in support of QMS activities.  Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  Ability to prioritize tasks and deliver assignments with high quality in a timely manner. 
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Senior Quality Specialist is responsible for supporting the development, implementation and maintenance of the internal audit program. This role will also support other Quality Management Systems (QMS) activities as needed. You Will: Responsible for creating annual internal audit schedules, developing internal audit plans and coordinating activities with cross-functional teams.Function as a lead auditor for internal audits and perform audits to ensure compliance to procedures and regulatory standards by examining and analyzing records, reports, procedures and related documentation; Provide recommendations for continuous improvement to strengthen the internal processes and structure.Responsible for documenting audit findings and monitoring corrective actions associated with the audit findings until closure. Responsible for developing and maintaining policies and procedures for an effective and compliant internal audit program. Develop, prepare and maintain various QMS metrics and dashboards for management review and quality monitoring.Manage and lead the implementation and conversion to an electronic QMS.Assist with QMS activities, such as CAPAs, non-conformance, deviations, supplier quality, complaints, process monitoring and improvement, and batch records review. Provide training, guidance, and support to the company for QMS related policies and procedures. Develop solutions to routine assigned activities of moderate scope and complexity.  Independently determine and develop approach to solutions for moderate/complex problems.  Provide continuous assessment and identify areas of improvement for the QMS.Lead process improvement projects of low/medium complexity.Other duties as assigned. Your Background Should Ideally Include: BA/BS (or equivalent industry experience) with 5+ years of experience in the life sciences industry, preferably in an FDA medical device/IVD regulated environment.Strong working knowledge of FDA QSR/cGMP and ISO 13485, ISO 14971 regulations.ISO 13485 lead auditor preferred.Must have good verbal, written, communication and organizational skills, and be able to work in a cross-functional team environment. Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgment in support of QMS activities.Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.  Ability to prioritize tasks and deliver assignments with high quality in a timely manner. 
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Senior or Staff Assay Biostatistician provides statistical expertise and leadership in the development and validation of analytical assays. The Biostatistician partners with key internal stakeholders to design, analyze, and interpret pre-analytical and analytical studies in support of GRAIL’s product development. You Will: Provide statistical support to pre-analytical and analytical studies by contributing to experiment design, analysis, study reports, presentations, publications and regulatory filings. Have the ability to influence internal collaborators on issues of study design, statistical methods, interpretation of results.Provide statistical methods to support process monitoring, qualification of reagents and instruments, and the establishment of assay quality specifications.Demonstrate knowledge of the application of statistics to Genomics, experimental design and assay optimization. Your Background Should Include: 5+ years of experience in academia or industry. Molecular diagnostics or pharmaceutical industry experience preferred.MS with 3+ years of experience or PhD with 0+ years of experience will be considered at the Senior level.Strong knowledge of theoretical and applied statistics.Outstanding verbal, writing, and presentation skills with a strong ability to influence.Demonstrated success supporting the statistical portion of an NGS assay development program in industry preferred.Experience programming in SAS or R.Strong team player with demonstrated track record of success in a cross-functional team environment.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The Design Quality Engineer will aide in the definition and implementation of the Quality Management System framework, focusing on product development, design control, and risk management procedures. You Will: Represent Quality on product development teams focusing on assay, reagent, and automation development and guide teams through design control.Lead risk management activities on cross functional teams and ensure required deliverables are documented properly in design history files. Collaborate with product development and operations on the transfer of reagents and consumables to suppliers. Review and approve documentation that is consistent with design control procedures and regulations. Documentation may include but not limited to DHF documents such as product requirements, design and development plans, verification and validation plans and reports, design transfer documents, and risk management plans and reports. Lead and participate in activities to establish and maintain GRAIL’s product development, design control, risk management, and supplier management systems.  Maintain knowledge of the evolving regulatory landscape for LDTs and NGS-based tests.Perform other related duties and responsibilities as assigned. Your Background Will Include: Bachelor’s Degree in Engineering or related scientific discipline.5+ years in Quality and/or Development experience in product development, product transfer, verification, validation under Design Control in life sciences industry, preferably in a FDA regulated medical device/IVD environment.Previous Quality engineering experience and demonstrated use of Quality practices and methods.Strong working knowledge of FDA QSR/cGMP and ISO regulations.Strong team player with demonstrated track record of success in a cross-functional team environment.Ability to perform a variety of duties involving critical thinking, analysis, evaluation, and judgement in support of QMS activities.  Ability to influence and be the voice of Quality when working  with various groups in the organization.Manages change well. Adopts a continuous improvement orientation to the role.Excellent communication and interpersonal skills.
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com Grail is looking for software engineers who enjoy testing, automation, performance, build and release and developing high quality software. As a software engineer in test, you will be working on a broad range of software systems and projects. The focus on the role will be developing automation test frameworks and building developer tools. This role will be part of a cross-functional team developing software and automation solutions. You will work closely with devops, lab operations and clinical teams developing software, comprehensive test plans, finding, tracking and resolving bugs.   You Will: Develop automated test frameworks that will establish product quality standards for our development process.Improve and measure the performance and efficiency of Grail’s engineering infrastructure and software applications.Build and manage our automated testing library.Manage and improve continuous integration.Find and document bugs.Improve testing infrastructure with accountability and scalability in mind.Be a user advocate.Participate in the development of technical tools and documentation to expedite deployment, and improve customer experience. Your Background Should Include: Bachelor's degree in Computer Science, Electrical Engineering, Bioinformatics or similar technical field.3+ years of experience in software engineering building testing infrastructure.Fluency in general purpose programming languages such as Java, Javascript, Python, Go.Experience with MySQL or other relational databases.Experience with AWS technologies.Demonstrated experience with and track record of quickly learning new programming languages and technologies.Attention to detail and consistency.Outstanding written and verbal communication skills and the ability to adapt your message to the technical level of the audience.Ability to work well in a cross-functional team of engineers and scientists.Interest in human biology and genetics (many software engineers on our team had no prior experience in the life science industry.) 
Grail Menlo Park, CA, USA
Nov 13, 2019
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 located in Menlo Park, California. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com The MSL - West will encompass the following states: Washington, Oregon, California, Nevada, and Hawaii. The primary responsibility of the MSL is to engage, educate, and support national and local key opinion leaders (KOLs) and health plan influencers with the most current clinical, scientific, and health economic materials supporting the clinical value and appropriate utilization of GRAIL’s product(s). This is completed through direct education of KOLs with slides, abstracts and publications relevant to GRAIL’s products and services, responding to unsolicited questions, participating in the development and creation of educational slides to be deployed in focused events, training speakers/educators, and identifying opportunities for collaboration on relevant research projects and other projects of mutual interest.   In this field-based position, the MSL will develop and execute an effective Territory Management Plan within the US (reach and frequency of interactions with thought leaders within their regions). Within GRAIL, the MSL will provide medical support to a range of functions including Medical Affairs, Clinical Development, Clinical Operations, and the Commercial organization.  The MSL will partner with the commercial field team to provide necessary and appropriate medical resources across the U.S.  This position will ensure that all interactions and activities in the territories adhere to corporate and healthcare compliance guidance, including those related to clinical trials, scientific interactions with internal and external groups, and responses to unsolicited requests for medical/scientific information. You Will: Identify, develop and/or maintain strong, collaborative working relationships with key academic and community physicians, other key physician influencers, and KOL champions (key decision makers in health systems, medical groups, healthcare provider offices, advocacy organizations, and national/regional professional societies) to promote understanding and adoption of GRAIL’s productsMaintain clinical, scientific, and technical expertise related to GRAIL’s productsParticipate in local, regional, and national meetings in support of all scientific and medical objectivesSummarize and communicate complex medical messages and position them in the best possible manner to enable clear and concise understanding by both external audiences and partners within GRAILCritically review and educate key personnel on relevant new publications and research findingsAssist the Medical Director(s) and Director of MSLs in agenda planning and meeting facilitation of Scientific Advisory Board(s), conducting Speaker Trainings, and External Payor Reviews as neededProvide monthly activity reports to summarize field activities and field medical intelligence (including that of competitor products and new products in development) that would advise internal programs and strategies, along with tracking key performance indicatorsEngage in continuous learning, actively attend and participate in upskilling training programs, utilize appropriate resources to stay current with the scientific literature (e.g., conducting regular literature searches and library research), participating in various internal and external clinical and scientific education programs, meetings, presentations and other forums that provide in-depth clinical and operational expertise and insights regarding GRAILs products, overall therapeutic area(s), as well as business related topics relevant to the therapeutic area(s)Fluent in the value-based scientific information associated with GRAILs products from the perspective of payers or others making population-based care decisionsFunction as the primary clinical resource to the Sales & Marketing team with participation in sales force training, medical updates, scientific presentations, journal clubs, teleconferences, and meetings as requestedSupport investigator sponsored trials Your Background Will Include: Advanced scientific degree (MD, PharmD, PhD or equivalent degree), experience in oncology, genomics, diagnostics, cfDNA-based applications, or similar applied medical fields strongly preferredMinimum of 3-5 years of industry experience in a diagnostics or pharmaceutical Medical Affairs settingPrior experience as an MSL in the introduction of a novel new clinical product is highly desiredAdvanced knowledge of the biotechnology, diagnostics and pharmaceutical industryAbility to apply advanced knowledge of GRAIL’s product specificationsAbility to work independently and remotely while maintaining a strong teamwork ethicFlexible to changes in an ever changing dynamic environmentMulti-dimensional in abilities to work on simultaneous tasks in a high-paced environmentExceptional problem-solving skills, good attention to detail, time management skills Learning mindset, open to training and becoming an expert across customer typesExcellent communication and presentation skills; exhibits professional maturity, confidence, and competence. Sound conflict resolution skills; proven ability to effectively and quickly achieve conflict resolution with affected parties. Outstanding oral presentation skills.Highly developed written skills, the ability to produce documents for dissemination both inside and outside the organization for presentations, technical briefs Ability to elicit and answer clinical questions in groups ranging from individuals to larger didactic roundtables and meetingsAbility to address high-level experts in the scientific field at company-sponsored events and scientific conferencesExtensive travel required up to 3-4 days per week to meet with KOLs, attend physician education talks and conferences, including specialty society scientific meetings (will require some weekend work). Travel is estimated to be approximately 60%.