Distinguished Scientist, Companion Diagnostics

Job DescriptionThe Distinguished Scientist/ Executive Director within Companion Diagnostics (CDx) Development, will lead one of our company's Diagnostic Development Teams (DxDTs), supervising PhD-/MD-level employees, developing and overseeing CDx strategy development, alignment and execution for specific projects, including associated digital pathology (DP) projects when applicable. Position reports to Associate Vice President, Companion Diagnostics (CDx).Primary Responsibilities:Lead cross-functional DxDT including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy, development and implementation of CDx projects – and associated DP when relevant – for a portfolio of various assets/biomarkers, mainly in the therapeutic area of OncologySupervise PhD-/MD-level employees leading and executing diagnostic projects within CDx subteams and coordinating the work conducted with our external Dx partners, including associated DP efforts when neededPartner with internal stakeholders (e.g. clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies to address those needsContribute to the selection of appropriate assays, platforms and Dx partners for the execution of biomarker strategies, including overseeing possible design/execution of pilot studies with Dx vendorsIdentify and assess novel technologies/platforms with potential for CDx applicationOversee team preparation of Dx-related regulatory documents including, for example, pre-submissions, briefing books, IDEs, IVDR PSAs, PMAs, and participation in meetings with global regulatory agencies to provide CDx expertiseOversee team members performing operational tasks required to execute assigned projects as needed, e.g. ordering samples, QC of incoming clinical trial biomarker results, assay/data transfer troubleshooting, etc.Serve as a subject matter expert within our company, collaborating with project teams, biomarkers, clinical operations, regulatory affairs, medical affairs and commercial on the implementation of global CDx assay strategies in global clinical trialsOversee internal project-level senior management and governance interactions relevant to CDxOversee DxDT input into preclinical and early-stage oncology programsProvide CDx expertise/assessment for due diligence teamsEducation Minimum Requirements: PhDRequired Experience and Skills:Minimum of 8 years of experience in industry settingExtensive experience with one or more major biomarker platforms (i.e. NGS, IHC, PCR)Knowledge of the discovery, development and application of biomarkers in support of decision making for drug development and as CDxDemonstrated track record in the development and approval of CDxDemonstrated expertise in diagnostic development as evident by peer review publication record, patents, and/or productsDemonstrated experience in developing and implementing strategic approaches across functional groups and in conjunction with global pharma teams Demonstrated experience in working with clinical teams to support design, implementation and analysis of clinical trials incorporating key biomarkers in order to yield data that can support CDx development and regulatory submissionsFamiliarity with requirements for EU IVDR, China HGRAC, Japan PMDA, and other global markets for CDx development/registrationProven decision-making and planning skillsHigh level of verbal and written communication skills including presentation capabilities to senior executivesPreferred Experience and Skills:Experience in both pharma and Dx settingsDeep technical knowledge in an area of focus such as circulating tumor DNA (ctDNA), immunohistochemistry/ pathology, digital pathology, etc.Experience directly interfacing in meetings and written documents with global health authoritiesRequired Skills: Analytical Thinking, Assay, Bioanalytical Techniques, Biomarker Development, Clinical Trials, Communication, Companion Diagnostics (CDx), Drug Development, Innovation, Leadership, Scientific Leadership, Strategic ForesightPreferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$210,400.00 - $331,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geo