**General Description:** The Diagnostics Lead (Director) in the Clinical Biomarker Sciences and Companion Diagnostics Development department is responsible for developing and executing end-to-end diagnostic strategies in alignment with clinical development timelines. The Diagnostics Lead will conceive and develop companion diagnostics (CDx) strategies, define Diagnostic Target Product Profiles (DxTPP), identify suitable assays and CDx partners, and obtain endorsements from governance bodies. Additionally, the role requires overseeing CDx development, ensuring timely delivery of CDx kits for pharmaceutical registration and launch, and staying updated with industry trends and regulatory requirements. **Essential Functions of the job:** + Develop end-to-end diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines. + Interact early with Translational Discovery and Research to understand the predictive hypotheses to be tested for specific programs. Collaborate with internal research capabilities or external vendors to develop a predictive assay if not already available. + Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies (e.g., DCT, DRC, BPRC etc.). + Work with a cross-functional team to define Diagnostic Target Product Profile (DxTPP) and identify suitable assays and CDx partners based on DxTPP. + Work with Regulatory Affairs to ensure that regulatory documents (e.g., IDEs, PMAs, etc.) are delivered and communicate with health authorities when required. + Oversee the CDx development and ensure timely delivery of a CDx kit for pharmaceutical registration and launch. + Communicate updates to, and seek feedback from, cross-functional stakeholders surrounding the progress of the CDx program. + Stay up to date with industry trends, technology advancements, and regulatory requirements for IVD and CDx. + Drive diagnostic product innovation and improvement through both in-house R&D efforts and in collaboration with IVD partners. **Supervisory Responsibilities:** + Participate in other training, supervisory and management activities as required by the company. **Computer Skills:** Microsoft Office, data analysis skills **Education Required:** + Ph.D./MD preferred with 5+ years of related experience. **Other Qualifications:** + 5+ years of industry experience in clinical biomarker testing and CDx development. + Deep understanding of scientific concepts, clinical development processes, clinical testing guidelines, and the regulatory requirements for IVD products and CDx. + Ability to identify key information and make data driven decisions. + Ability to use critical and strategical thinking to handle complex or ambiguous situations. + Ability to articulate facts, ideas, and strategies in all communication formats. + Ability to set and manage stakeholder expectations, ability to influence without authority. + Ability to work effectively in a matrixed environment, ability to manage cross-functional teams. **Travel:** up to 10% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.