Laboratory Director Salary in Redwood City, CA

Associate Director, Clinical Data ManagementJob LocationsUS-CA-Redwood CityReq No.2020-6332CategoryBusiness AnalyticsTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Associate Director, Clinical Data Management is responsible for managing a team of Clinical Data Managers to support the effective collection and management of clinical study data used for reporting, analysis, and presentation. The functional team that this position leads is responsible for utilizing a variety of different data sources, electronic platforms, and environments to handle clinical data acquisition, data cleaning, data processing, data transfer, and data archival. This role is responsible for ensuring efficient and effective Clinical Data Management deliverables through compliance of established procedures and best practices. The Associate Director, Clinical Data Management performs hands-on data management in support of the collection, mining, and purveyance of clinical, pathology, laboratory, and genomic data in compliance with applicable regulatory requirements.Essential Duties and ResponsibilitiesAssess and recommend functional headcount requirements associated with recruiting and hiring decisions and onboard newly hired staff. Evaluate, update, and maintain job descriptions and associated job leveling in alignment with industry benchmarks, relevant salary surveys, and corporate policies and practices. Drive the definition and implementation of best practices and standardization to ensure the effective and efficient collection, maintenance and/or handling of laboratory, pathology, and clinical data for Exact Sciences’ studies. Provide key input to the definition and utilization of data management systems, tools, processes, and procedures to support successful study execution and results delivery. Provide hands-on data management support, as appropriate; including acting as a Lead Clinical Data Programmer/Analyst on the group’s most complex clinical studies and projects.Ensure the accurate, complete, and timely collection, validation, and delivery of laboratory, pathology, and clinical data, and related documentation of the highest quality and in accordance with business requirements, timelines, and appropriate budget control based on corporate priorities and objectives. Collaborate with functional areas across the company in the strategic evaluation and assessment of data management needs, solutions, and business development opportunities. Contribute to the ongoing development and improvement of department procedures by being primary author of highly complex process documents and by effectively and actively leading or contributing to complex process discussions.Work closely and effectively in a team-oriented environment with colleagues from Biostatistics, Non-clinical biostatistics, Clinical Operations, Medical, Pathology, Research and Development, and Program Management to ensure Data Management needs and status updates are addressed and well-communicated.Lead Data Management teams and cross-functional teams with well-defined objectives or interactively guides these teams to establish objectives.Provide support and coordinate with other functional areas regarding overall clinical study conduct and management; including protocol development, study start-up, study closeout, and data analysis.Manage staff; including, but not limited to, organize and prioritize work, write/conduct performance reviews, train/develop, and manage work performance.Communicate goals clearly to employees to ensure understanding and success in achieving them.Motivate and inspire employees to do their best work through coaching.Maintain morale and support employee engagement initiatives.Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability to lift up to 10 pounds for approximately 5% of a typical working day.Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.Ability and means to travel between Redwood City locations.Ability to travel to other Exact Sciences locations up to 4 times per year. Ability to travel 10% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor’s degree in Life Sciences, Computer Sciences, Scientific, or related field.12+ years of experience in Data Management or related field. 5+ years of experience leading or directing people and/or project teams.Proficient in Microsoft Office to include Excel macros and pivot tables and Word mail merge.Demonstrated ability to perform the Essential Duties of the position with or without accommodation.Preferred QualificationsMaster’s degree in Life Sciences, Computer Science, Scientific, or related field. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Customer Relations Specialist IJob LocationsUS-CA-Redwood CityReq No.2020-6735CategoryCustomer SupportTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Customer Relations Specialist I (CRS) provides a vital link between Exact Sciences customers, the external Exact Sciences sales force, and the internal commercial operations group.  The CRS will often be the first point of contact for all external parties who communicate with Exact Sciences directly via phone, email, regular mail, or other means.  There is likely to be a wide variety of questions and comments that come to the Company through these channels from a diverse group that may include healthcare professionals, cancer patients and their family members, media representatives, insurance company claims managers, and many others.  The impressions we create when we interact with those people who seek us out will play a significant role in establishing favorable perceptions of the Company. It is imperative that the CRS possess exemplary Customer Service Skills, have a demonstrated ability to work independently, and also function effectively as a member of the Exact Sciences team.  The CRS will need to understand not only the technical aspects of the services that Exact Sciences offers, but must also possess the ability to communicate professionally and effectively with all individuals, including external customers and other internal personnel.Essential Duties and ResponsibilitiesAnswer in-coming calls from the customer service 800 hotline during business hours, and reply to phone messages left overnight when the phones are not staffed. Document all calls accordingly into CRM according to Customer Service Policy and Procedures.Provide assistance and information on all aspects of product knowledge, sample accessioning processes, and clinical information within their scope of expertise in accordance with official Standard operating procedures (SOPs) for customer service. Requests that can be addressed by scripted responses anticipated in the Knowledge Base should be handled in the manner prescribed.  Other questions should be handled with sensitivity, common sense, and referrals to others in the company as circumstances require.    Appropriately triage and direct callers to Medical Affairs, Patient Advocacy, Regulatory, Public Relations as needed. Respond to inquiries posted through our company website and document each inquiry appropriately in CRM.Forward calls to designated personnel with responsibility for official communication with external parties and log these calls into the system, set realistic expectations with callers regarding the timing of an official reply, and ensure the calls are received by the right person in a timely manner. Appropriately field calls for reimbursement and billing and direct them to the Billing Vendor (Quadax) for follow up and resolution.Provide inside sales support to the field sales staff: Regional Oncogenomic Liaisons (ROLs) Genomic National Account Reps (GNAMs), Regional Managers (RMs) and Director of Sales Operations when needed while providing the outside field staff with timely communication on their accounts, practices, and orders. Provide new physician outreach calls to all new accounts and ordering physicians regarding Oncotype Dx and our products.Maintain a productive operational relationship with the IT department for the operation of CRM system for CRS activities.Communicate initial and ongoing CRS needs to the IT group for modification of the CRM system on behalf of the CRS team.Support the Sample Accessioning staff with sample intake and accessioning in accordance with the SOPs.Perform daily quality control checks on all sample accessioning requisitions prior to report generation and work closely with the Clinical Laboratory Scientists (CLS) to ensure the highest level of quality is achieved in the handling or patient samples and requisitions.Participate in sales administration/operations activities as necessary; including shipment of promotional materials and other items to sales representatives, managing materials inventories, developing and producing sales reports, development of items for inclusion in the sales force reference guide, etc.Assist in building on existing customer base by providing the highest level of customer service and support.Ability to handle technically complex material and articulate technical concepts. Maturity and good judgment to understand when to exercise initiative and handle queries directly, and when to escalate queries to higher authority.Excellent team player.Highly effective in working with others but also capable of working independently as necessary. Ability to multi-task and strong to attention to detail.Highly effective at overcoming obstacles; tenacious and resilient. Flexibility to cross-train in other areas of the lab where qualifications and procedures allow.Willingness to adhere to strict procedures for database management and approved responses to selected queries.Highly effective at assimilation of large body of complex scientific material.Strong interpersonal and organizational skills.Excellent listening, oral, and written communication skills.Professional telephone manner.Strong customer service orientation and willingness to prioritize needs of those seeking information from the Company.Comfortable in working in a laboratory environment and able to handle specimens.Ease of working with internal and external groups in reinforcing policy, as well as accepting of suggestions for improvement.Superb follow-through skills and relationship management.Strong communicator with ability to maintain open communication with internal employees, managers, and customers as needed.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. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company’s Quality Management System policies and procedures. Regular and reliable attendance. Ability to work designated schedule.Ability to work nights and/or weekends.Ability to work overtime as needed. Flexibility with respect to working hours as some shifts will require early morning arrivals to handle calls from East Coast.Ability to lift up to 20 pounds for approximately 5% of a typical working day.Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 100% of a typical working day.QualificationsMinimum QualificationsHigh School Diploma or General Education Degree (GED).3+ years of customer service experience. Deep understanding of drivers of customer satisfaction and an overt willingness to be an internal champion for both the field sales team and health care providers. Basic scientific aptitude that will allow rapid learning of new technologies and clinical data associated with Exact Sciences services.Significant PC knowledge and Windows OS experience.Authorization to work in the United States without sponsorship. Demonstrated ability to perform the Essential Duties of the position with or without accommodation. No disqualifications for employment in the US lab industry as determined by the Federal Government.Preferred QualificationsBachelor’s Degree.3+ years of experience in healthcare, laboratory, or pharmaceutical industry.We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Senior Systems Engineer IIJob LocationsUS-CA-Redwood CityReq No.2020-6728CategoryClinical Lab OperationsTypeRegular Full-TimeSummary of Major ResponsibilitiesThe Mission of the Precision Oncology Business Unit of Exact Sciences is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics, both as in-vitro diagnostic (IVD) devices and as Laboratory Developed Tests (LDTs) conducted in our Redwood City Clinical Laboratory. Reporting to the Director of Systems Engineering, the Senior Device and Process Systems Engineer will provide technical expertise, vision, and leadership to drive continuous improvement of our state-of-the-art diagnostic tests for cancer patients. The Senior Device and Process Systems Engineer will lead projects to innovate, analyze, design, and implement improved business processes and laboratory workflows for diagnostic tests conducted in our Clinical Laboratory. Beginning with analysis of the business process requirements, these process design and integration efforts will encompass the generation and collection of requirements, design, and architecture, incorporation of applicable automation technologies, integration of multiple subsystems, and end-to-end testing.  Representing Lab Operations, the successful candidate will also be a key member on project teams developing new IVD devices and laboratory automations, ensuring their efficient and effective transfer into production, and will also contribute to ongoing improvements of existing commercialized processes and products.  It is critical that the candidate has strong expertise in medical device quality standards and regulations, including ISO13485, ISO14971, 21CFR Part 820, and experience in the operationalization of new diagnostic and/or medical devices. Demonstrated ability to effectively execute multiple projects simultaneously with Lean Methodology is required. Experience with business process analysis and design is required, ideally including experience with order to revenue processes.Essential Duties and ResponsibilitiesParticipate in or lead cross-functional process development teams to innovate, plan, develop, validate, and implement robust and scalable laboratory and business processes. Participate in new product development programs, operationalizing production processes including manufacturing, product distribution, and order to revenue workflows.Collaborate with internal Manufacturing, Supply Chain, R&D, and QA teams, and with  third party technology partners, contract IVD manufacturers and logistics partners as needed to create, scale, and validate supply chain, manufacturing, and distribution processes and infrastructure.Translate business needs and customer requirements into clear, well-vetted requirements, and conduct and guide requirement tracing, architecture design and other key Systems Engineering methodologies for new production processes.Incorporate business strategy into project scope, plan, and design that may involve multiple phased releases of the product or process.Provide leadership in incorporating risk management into project planning and execution, conducting, facilitating, and reviewing risk assessments required in development and revision of production processes. Systemize learning and best practices into practical procedures. Advise and present options, recommendations, and plans, and status to senior management on projects and associated issues and risks.Apply Robust Design / Design for Six Sigma principles to development of production processes.Lead complex problem solving in design and support of production processes and associated processing equipment.Provide expertise and leadership in Design of Experiments (DOE), failure analysis, root cause analysis, and associated statistical methods. Ability to assist and mentor junior Systems Engineer members. Ability to effectively lead and participate in multidisciplinary project teams, providing technical leadership and guidance to team members.Superb written and oral communication skills, and excellence in communicating and collaborating with colleagues, customers, and external collaborators from a wide variety of scientific, engineering, operational, and regulatory disciplines at many different levels. Deal with ambiguity and deliver simple engineering solutions to complex problems. Apply understanding of complex end-user applications, collecting and clearly documenting user needs. Ability to methodically break down complex applications into simpler elemental constituents and formulate clear and concise requirements to meet end user needs. Perform work with minimal direction, exercising sound judgement in defining technical objectives of assignments.Apply critical thinking skills to judiciously plan and prioritize project activities for maximum leverage and impact. Apply leadership skills to align colleagues and partners around a vision, a plan to achieve it, and the execution of this plan. Exhibit commitment to quality in the development, testing, and implementation of systems and processes to be used in diagnostic tests. Ability to integrate and apply feedback in a professional manner. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.Support and comply with the company’s Quality Management System policies and procedures.Regular and reliable attendance.Ability to work designated schedule.Ability to work nights and/or weekends, as needed.Use of computer, and or telephone for long periods of time may be necessary.Considerable periods of time may be spent concentrating and or analyzing data.Some lifting (greater than 25 pounds) may be necessary.May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.Ability and means to travel between Red Wood City locations.Ability to travel 10% of working time away from work location, may include overnight/weekend travel.QualificationsMinimum QualificationsBachelor’s degree in Engineering or related field; or High School Degree/General Education Diploma and 4 years of relevant experience in lieu of Bachelor’s degree.10 + years of IVD, laboratory automation, and/or medical device experience.Proficient familiarity with the principles and tools for Innovation Processes (i.e., TRIZ), Lean Design, Robust Design, Design for Six Sigma, Systems Engineering, DOE, VOC, and Design for Reliability, and related methodologies.Demonstrated ability to perform the Essential Duties of the position with or without accommodation.Authorization to work in the United States without sponsorship.Preferred QualificationsAdvanced Engineering degree. Experience with development of business workflows using enterprise software systems for clinical diagnostic applications.Experience in developing diagnostic test in a highly regulated environment (i.e., CLIA, FDA, ISO13485 etc.).Experience with requirements management tools (i.e., Jama, Aligned Elements, DOORS, etc.).Six Sigma Black Belt.Experience in project management.#LI-LA1We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.