Distinguished Scientist, Companion Diagnostics

$210K - $331K

Position Overview The 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 Oncology. Supervise PhD-/MD-level employees leading and executing diagnostic projects within CDx subteams and coordinating the work conducted with external Dx partners, including associated DP efforts when needed. Partner with internal stakeholders (clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies to address those needs. Contribute 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 vendors. Identify and assess novel technologies/platforms with potential for CDx application. Oversee team preparation of Dx-related regulatory documents (pre‑submissions, briefing books, IDEs, IVDR PSAs, PMAs, and participation in meetings with global regulatory agencies). Oversee 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 the 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 trials. Oversee internal project‑level senior management and governance interactions relevant to CDx. Oversee DxDT input into preclinical and early‑stage oncology programs. Required Experience and Skills Minimum of 8 years of experience in industry setting. Extensive experience with one or more major biomarker platforms (NGS, IHC, PCR). Knowledge of the discovery, development and application of biomarkers in support of decision making for drug development and as CDx. Demonstrated track record in the development and approval of CDx. Demonstrated expertise in diagnostic development as evidenced by peer‑review publication record, patents, and/or products. Experience developing and implementing strategic approaches across functional groups and in conjunction with global pharma teams. Experience working with clinical teams to support design, implementation and analysis of clinical trials incorporating key biomarkers to yield data that can support CDx development and regulatory submissions. Familiarity with requirements for EU IVDR, China HGRAC, Japan PMDA, and other global markets for CDx development/registration. Proven decision‑making and planning skills. High level of verbal and written communication skills including presentation capabilities to senior executives. Preferred Experience and Skills Experience in both pharma and Dx settings. Deep technical knowledge in an area such as circulating tumor DNA (ctDNA), immunohistochemistry/pathology, digital pathology, etc. Experience directly interfacing in meetings and written documents with global health authorities. Required Skills Analytical Thinking, Assay, Bioanalytical Techniques, Biomarker Development, Clinical Trials, Communication, Companion Diagnostics (CDx), Drug Development, Innovation, Leadership, Scientific Leadership, Strategic Foresight. Benefits The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity 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. 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: Location and Eligibility San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Other Information Job Posting End Date: 07/01/2026. #J-18808-Ljbffr Dormont Manufacturing Co