You will:

• Develop and apply statistical methods to assay monitoring and in operations support in the following areas:
• Modeling, analysis and visualization of data
• Analytical validation
• Statistical process control and assay monitoring
• Create and perform end-to-end analyses that include design, data gathering, processing, analysis, iteration with stakeholders, and presentation of results.

Your qualifications and background will include:

• MS or PhD in Bioinformatics, Computational Biology, Statistics, Biological Sciences, Cancer Biology, Genetics, Genomics, Computer Science, Physics, or similar field.
• MS with 3+ years of experience or PhD with 1+ years of experience in molecular diagnostics or pharmaceutical industry experience will be considered, experience performing benchwork preferred.
• Familiarity with regulatory standards, quality management systems, and medical device product development design control preferred.
• Strong knowledge of theoretical and applied statistics.
• Strong verbal, writing, and presentation skills.
• Ability to succeed and thrive in a rapid paced and cross-functional team environment.
• Experience programming in Python or R, experience with SQL, version control tools and reproducible research practices, Tableau is good to have.

You will:

• Provides broad Benefits subject matter expertise to support employeesMaintains benefits communication materials and keeps up the FAQs and reviews and answers all help desk tickets and escalates as needed. This support includes all health & welfare plans, time-off and Leave of Absence (absence management in Workday), retirement plans, life insurance for the US and UK and recognition.
• With the Benefits Managers direction, works with insurance carriers and the benefits broker to ensure benefits are administered correctly.
• Audits benefits enrollment data in Workday benefits, vendor and payroll systems to ensure data accuracy. Supports all reporting and benefit integrations in Workday by troubleshooting any data discrepancies. Assists with data conversion into Workday.
• Supports data and answers inquiries to benefits outsourcer, HR, Payroll, managers and employees regarding new hire enrollment, life events and other general benefit questions. Provides reports to various outsource vendors and ensures the data is accurate and timely.
• Administers the LOA process in Workday and with the outsource vendor and answers employee questions. Reports back to the Benefits Manager for utilization and vendor management of issues.
• Responsible for providing to payroll bi-weekly LOA, WC and 401k deferral payroll-related entries, payroll preparation, and various audit requests.
• Participates in testing Open Enrollment in Workday and supporting employees with Open Enrollment. Runs reports in Workday and provides final audits for all integrations.
• Maintain data integrity and system functionality of all benefits information to ensure accuracy and successful operations
• Ensure all leave of absences are processed smoothly and efficiently from an employee and vendor perspective.
• Accountable for ensuring the accuracy of all benefits enrollments and benefits-related data between HR systems, to provide vendors with accurate information.
• Optimize the performance of our benefits administration system, including gathering and analyzing data, documenting processes, and making recommendations for improvements.
• Responsible for performing benefits analysis, validations, and audits in HR benefits systems to ensure quality control and adherence to established procedures.
• Work closely with the Total Rewards team to complete benefits related projects, driving to a successful outcome.

Your background should include:

• Bachelors degree and 5+ years benefits experience ideally in a biotech, high-growth environment, multi-location experience
• Working knowledge of Workday benefits administration highly preferredCEBS, SHRM-CP or PHR certification desired
• Understanding of Federal and State regulatory laws with Payroll, Benefits, COBRA, HIPAA, FMLA, ADA and ERISA. 
• Capability to apply discretion and sound judgment in managing complex processes, decisions and handling sensitive information.
• Strong organizational skills and ability to manage competing priorities.
• Ability to work within compressed timeframes and embrace the sense of urgency, innovation and resourcefulness required in a fast-paced company.
• Can accomplish results and desired outcomes through formal and informal corporate structures.
• Exceptional client relationship and project management skills.
• Strong written and verbal communications skills. 
• Strong analytical skills - the ability to synthesize data and develop insights.
• Familiarity with Google Workspace and Microsoft Office software & documents

You will:

• Collaborate with functional leads to design and build Quality System processes to work with GRAILs existing systems and product pipelines.
• Design, develop, approve, and implement Software Development Lifecycle SOPs, work instructions, forms, reports, protocols, and documents associated with design control and Computer System Validations processes.
• Approve changes to process and new design activities.
• Provide QA support for Software Test from feasibility through transfer into commercialization.
• Perform and review/approve design control and risk management activities. 
• Work closely with research and development organizations to ensure potential product issues are identified and addressed in the design.
• Lead US and UK SW Quality teams ensuring procedural standardization and compliance.
• Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures and other medical device regulations.
• Lead assessment of hazard analyses, design risk assessments, use of risk assessments, system risk assessments, and process risk assessments.
• Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures.
• Represent the company as a Software Quality Assurance subject matter expert during internal and external regulatory inspections.
• Ensure software design control documentation and requirements are on complex technical problems, utilize quality engineering methods and provide innovative solutions.
• Monitor, track/trend all KPI and periodically provide a summary report to Senior management including participation in Quality Management Review meetings and Product Lifecycle meetings.
• Facilitate Design review activities, process capabilities, including validation in partnership with Engineering, Product/Program team, and Clinical Development team, etc.
• Provide coaching to QA, product development key stakeholders personnel on Quality Systems requirements and process improvement methodologies.

Your qualifications and background will include

• Minimum of a Bachelor of Science Degree in Engineering or scientific field with at least 12 years of software quality assurance and validation experience in the medical device or CDx (combination products) industry.
• 10 years of progressive people management experience.
• At least 10 years of direct managerial responsibility leading all aspects of Design Control and Validation for Software and/or Medical Devices
• Extensive experience and understanding of design, development, verification and validation processes.
• Exceptional working knowledge and understanding of Device and Combination products regulations (21CFR 820,  and ISO 13485 and IEC 62304), Risk Assessment (ISO 14971, ICHQ 9), ASTM standards and other ICH guidance.
• ASQ, CQE, CQA, black belt or other equivalent certification is preferred.

You will:

• Own the overall AP Process, applying a thorough understanding of the business
• Enter invoices, properly coding them with the appropriate information
• Review all invoices for required documentation and approval prior to payment
• Respond to all vendor inquiries, reconciling all vendor statements, correcting any discrepancies
• Process expense reimbursements, ensuring spending is within Company policy
• Assist in month-end close, preparing journal entries and balance sheet reconciliations
• Maintain vendor records, keeping information current
• Assist in the preparation of 1099s
• Assist in maintaining regular contact and building solid working relationships with various groups to ensure a high level of customer service
• Assist on projects and ad hoc assignments as needed

Your background should include:

• 5+ years of AP/AR experience, experience in life sciences a plus but not required
• Bachelors degree or an equivalent combination of education and experience.
• Experience with expense processing systems. Netsuite, Coupa, and Concur are nice to have
• Excellent verbal and written interpersonal communication, while maintaining collaborative and professional relationships in a teamwork based environment
• Exceptional organizational and planning skills and a meticulous attention to detail with proven project management abilities.
• Strong Logical and critical thinking skills
• Ability to effectively prioritize and multitask to meet deadlines, in a fast paced high growth environment 
• Experience with working with cloud based and collaborate tools such as Google Suite of products (Sheets, Docs)

Responsibilities

• Develop and implement effective strategies to ensure timely completion of projects and studies, utilizing efficient time management and coordination techniques.
• Establish and maintain functionally integrated project schedules.
• Utilize tracking tools for effective project management across functional areas.
• Schedule, organize, and drive project team meetings: prepare and distribute agendas/minutes, track action items, and escalate areas of risk.
• Facilitate communication of sub-team issues and outcomes to the Core Team/Project team leadership.
• Manage interfaces between functional areas and ensure effective handoff and communication between departments for project milestones.
• Prepare status reports, specific project updates, or scenarios with project/study leaders and/or subject matter experts SMEs.
• Adhere to design control best practices and generate expected documentation throughout product development.
• Manage document review processes to support functional activities and project deliverables.
• Collaborate with quality and regulatory functions to ensure operational planning and execution meet standards.
• Define project-related budget assumptions with project/study leaders and/or SMEs.

Required Skills

• BS/BA degree plus  5 years of related experience, or MS/MA  plus  3 years of related experience, or PhD  plus  0 years of related experience.
• Blend of project management experience and knowledge of the medical diagnostics industry.
• Combination of analytical, organizational, and interpersonal skills.
• Ability to prioritize and manage multiple projects and stakeholders.
• Strong communication and presentation skills.
• Proficiency in project management tools and tracking software.
• Knowledge of design control best practices.
• Ability to work cross-functionally and collaborate with teams.

Desired Skills

• Previous experience in Clinical Development, Clinical Operations, or Data Management.
• Experience with validation studies.
• Familiarity with Life Cycle and study team optimization.
• Robust negotiating skills.
• Ability to work effectively in a fast-paced, dynamic environment.
• Knowledge of regulatory requirements in the medical diagnostics industry.
• Understanding of budgeting and financial planning processes.

Responsibilities:

• Build, manage and lead complex Security programs like Identity and Access Management, Secure SDLC / SecDevOps, Vulnerability Management, Key Management.
• Be accountable for roadmap delivery including adoption and success criteria as defined by you and program stakeholders.
• Leverage your technical SME and quickly build expertise in support of the Security programs youll own.
• Lead technical tracking activities and perform risk assessment to identify key priorities and dependencies.
• Succinctly communicate risks, expectations, and timelines to stakeholders and management.
• Partner with Product, Engineering, IT, Security teams and other cross-functional stakeholders, in the Software Development Lifecycle (SDLC) as part of product and feature launches.
• Improve on existing frameworks, processes and standardized templates related to various stages of security requirements and reviews.
• Contribute to the architecture, maintenance and development of security controls.
• Identify and creatively resolve complex technical and cross-functional issues and risks.
• Scale programs by leveraging technology and driving automation of operational processes.

Your Background Includes:

• 5+ years total experience as a TPM, engineering, product manager (technical domain), or related discipline.
• 5+ years of experience in security, risk management, compliance, information systems or other relevant fields.
• Design and iteratively improve procedures that solve problems in simple and scalable ways.
• Diverse and deep experience with delivering cross-functional projects with multiple dependencies and constraints.
• Ability to learn new tools and technologies quickly.
• Existing experience with BI tools like Looker, agile project management tools like Jira, low code/no code tools, querying languages like SQL, scripting languages like Python.
• Organized, detail oriented, self-driven, and comfortable handling situations that may depart existing paved roads.
• Excellent interpersonal skills and ability to establish trust with internal/external partners.
• Excellent ability to communicate with technical and non-technical stakeholders, and across hierarchy in order to drive alignment.
• Strong written and verbal communication skills with a track record of communicating at all levels involving both technical and non-technical teams/stakeholders.
• Comprehensive understanding of security domains, processes, risks and controls.
• Experience working in a high security and/or highly regulated industry.
• Certification in Program or Project Management.

RESPONSIBILITIES

• Lead end-to-end bioinformatics analysis including data gathering, processing, analysis, iteration with stakeholders and presentation of results.  
• Take ownership of the assigned project components by drafting the analysis plan, driving execution, ensuring high quality deliverables, and meeting the project timelines.   
• Build and maintain cross-functional relationships with research, clinical, regulatory, and business teams. Collaborate with the team effectively to ensure the implementation of rigorous bioinformatics methods and delivery of scientifically sound results. 
• Communicate results and incorporate feedback from Pharma partners and internal stakeholders.
• Apply state-of-the-art statistical methods and machine learning algorithms to generate interpretable, reliable results. Design and implement innovative methodologies and tools to enhance data analysis and interpretation, and remain up-to-date on the latest advancements in computational methods.
• Contribute to scientific publications, conference presentations, and internal knowledge sharing activities to disseminate research findings and promote scientific excellence within the organization.
• Mentor junior members of the team.

REQUIRED SKILLS

• B.S. or M.S. with 5+ years relevant experience, or Ph.D. with 2+ years relevant experience in bioinformatics, computational biology, or a related field, or equivalent preparation and experience. 
• Solid understanding of statistics and machine learning methods. 
• Expertise in R or Python is required.
• Clear, positive, and proactive communicator in verbal and written communications.
• Extensive experience in translational bioinformatics, including the analysis and interpretation of genomic, epigenomic, transcriptomic, or proteomic data.
• Familiar with NGS workflows.
• Knowledge of version control tools and reproducible research practices in a Linux environment.

DESIRED SKILLS

• Experience working in oncology, diagnostics, and/or pharma.

You Will

• Conduct and deliver enterprise customer analytics
• Document customer reporting requirements and create product requirement documents 
• Coordinate and execute long-term reporting and evaluation schedules and identify opportunities for growth
• Maintain databases and perform updates as necessary to ensure accuracy
• Regularly examine data reports to locate and resolve mistakes throughout
• Accurately analyze and collect data for various types of  reports
• Develop ROI models to support life insurance reporting 
• Support adhoc requests to support additional enterprise needs
• Support various departments, including marketing, customer success, and sales, in reaching their goals
• Develop enterprise customer insights models to support quarterly business reviews 
• Monitor data to identify changes in business trends

Your Background Should Include

• BS/BA + 5-8 years of experience and 3+ years of experience working as a technical analyst at a digital health, healthcare, wellness, benefits or SaaS company 
• Deep understanding of healthcare and how it works with employer groups and the US healthcare system
• Analytical skills that allow for the development of data-driven reports
• Demonstrated ability to manage time and prioritize projects to meet deadlines
• Ability to use SQL, Tableau, Microsoft Excel, and BI software (looker, Qlikview, Domo) to create pivot tables, graphs and charts
• Strong written and verbal communication skills to effectively relate data to coworkers
• Excellent critical thinking skills to help solve business problems and make decisions
• Tendency to pay close attention to small details that could impact results
• General knowledge of business operations, objectives, strategies, process and information flow
• A process-focused approach, with strong problem-solving skills and keen attention to detail
• Ability to analyze existing tools and databases and provide software solution recommendations.
• Demonstrated experience in handling large data sets and relational databases.
• Understanding of addressing and metadata standards.
• High-level written and verbal communication skills.
• Ability to translate business requirements into non-technical, lay terms.
• Experience working closely with benefits managers and administrators
• Strong interpersonal, relationship-building and listening skills, with a natural, effective consultative style
• Self-starter, curious, and proactive problem solver
• Flexibility and agility to work cross-functionally in a fast-paced environment
• A strong results focus, with a passion for finding smarter, better ways to achieve goals
• The ability to influence change and bring enthusiasm and excitement to the workplace

Responsibilities

• Create and drive timelines to keep project(s) and studies on schedule.
• Utilize tracking tools for effective project management across functional areas.
• Schedule and organize project team meetings, prepare agendas/minutes, track action items, and escalate risks.
• Facilitate communication of sub-team issues and outcomes to the Core Team/Project team leadership.
• Manage interfaces between functional areas and ensure effective handoff and communication for project milestones.
• Prepare status reports, project updates, and scenarios in collaboration with project/study leaders and SMEs.
• Adhere to design control best practices and generate expected documentation throughout product development.
• Manage document review processes to support functional activities and other key project deliverables.
• Engage with quality and regulatory functions to ensure operational planning and execution meet standards.
• Collaborate with project/study leaders and SMEs to define project-related budget assumptions.

Required Skills

• BS/BA degree + 2 years of related experience, or MS + 0 years of related experience.
• Analytical, organizational, and interpersonal skills.
• Project management experience.
• Knowledge of the medical diagnostics industry.
• Ability to prioritize information.

You will:

• Work closely with the Chief Commercial Officer (CCO) to optimize the people, processes, and infrastructure required to build and scale a world-class commercial strategy team and commercial function 
• Develop and refine the annual commercial strategy in alignment with the corporate planning process
• Lead key operational and commercial initiatives that drive long-term growth and profitability for the company, responsible for the future pipeline development
• Define strategy and lead execution of above market profitable sales growth
• Responsible for delegating and reviewing market target research and assessing the areas that a company should focus on for further development
• Research & analysis: oversight of the market intelligence team which enables GRAIL leadership to access critical insights and understand a rapidly evolving market landscape, industry, company situation, and the dynamics that inform commercial strategic decision making.
• Strategic skills: The VP of Commercial Strategy  should have considerable and proven strategic planning skills from years of experience in business management, marketing or a similar field. You will need to understand how to plan business strategies and how to measure the success of such also should have demonstrated success in executing on strategic plans in prior roles.
• Leadership & Management: You should have deep experience leading in roles that require a high degree of cross-functional collaboration. The position requires strong management and leadership skills to hire, develop and retain top talent

• 15+ years of experience both in a commercial leadership role, managing a large team in a matrixed organization, and focusing on strategy in a fast-paced, dynamic company
• Extensive product launch experience
• Deep marketing expertise
• Experience working across the entire lifecycle of products, from early pipeline through to launched products
• Experience in the diagnostic and pharma/biotech space is a must, ideally at both large and small companies
• Oncology experience and specific experience working on companion diagnostics is highly preferred
• Expertise working cross-functionally to effectively partner with Research, Development, Medical Affairs and other functions
• Demonstrated knowledge of strategy, management, sales, finance and leadership, with experience and understanding of the unique challenges in the healthcare industry 
• Experience driving significant growth 
• Deep understanding of the quickly-evolving digital and social media environments
• Strong business acumen and exceptional analytic skills with the ability to provide innovative solutions to complex problems, and to meet customer-driven business objectives
• Proven experience building and developing teams and selecting/hiring third-party talent 
• Excellent written, verbal, and presentation skills with ability to listen, solve problems, maintain flexibility and meet deadlines 
• Inherent aptitude to be organized, detail-oriented, motivated, and well-suited to a high-touch, quick paced environment 
• Strong work ethic, personal integrity, and passion for the work and mission of the organization