{"id":3234406,"url":"https://alion.io/job/genentech-director-cdx-clinical-platform-development","title":"Director, CDx & Clinical Platform Development","company":{"id":1757810,"name":"Genentech","domain":"gene.com","url":"https://alion.io/company/gene-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":82,"open_postings":31,"ghost_share":0,"stale_share":0.935,"repost_share":0,"time_to_fill_p50_days":21,"computed_at":"2026-10-31T05:58:55Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":189300,"max":351500,"currency":"USD","period":"year","gross":null,"usd_annual":351500},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Immunohistochemistry","optional":false},{"name":"IVDR","optional":false},{"name":"Next-Generation Sequencing","optional":false},{"name":"PCR","optional":false}],"status":"live","first_seen_at":"2026-09-02T00:00:00Z","employer_posted_date":"2026-09-02","last_verified_at":"2026-10-31T06:34:23Z","board_verified":true,"closed_at":null,"days_open":59,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":59},"description":"We advance science so that we all have more time with the people we love.\nAs a senior leader within Translational Medicine’s Scientific Operations, Diagnostics Development and Technology (TM-ODT) function, the Director of CDx and Clinical Platform Development is responsible for architecting the long-term vision and operational framework across three foundational pillars: Companion Diagnostic (CDx) Development, Clinical Platform Development, and Biomarker Policy Innovation. In this role, the leader ensures deep strategic alignment with key partner functions within Pharma - such as Biomarker Science, Clinical Science, Regulatory, Commercial, Medical Affairs, Policy, and Clinical and Biomarker Operations - as well as Diagnostic partners such as Roche Diagnostics and Foundation Medicine. By leveraging technical and scientific advancements to advance the therapeutic pipeline, this position ensures that Roche/GNE maintains its position at the global forefront of precision medicine and patient-focused translational research.\nThe Opportunity:\nAs an integral member of our dynamic team, you will be able to provide:\nStrategic Vision and Leadership Impact\nFormulate and implement an overarching diagnostic co-development strategy to expedite the progression of the Roche/Genentech therapeutic pipeline from early-stage development through to global regulatory approvals.\n\nDevelop and oversee key strategic partnerships with both internal and external diagnostic collaborators, ensuring clinical platform developments activities align with future clinical and scientific requirements.\n\nPromote an environment of scientific rigor and forward-looking strategy, developing a robust, top-tier team equipped to handle the intricacies of both standard (such as IHC, PCR, NGS) and emerging (such as advanced liquid biopsy, digital pathology, and multi-omic assays) diagnostic assay and clinical platform development.\n\nEnhance cross-functional alignment by acting as a primary interface connecting Translational Medicine (TM) with Roche Diagnostics and Foundation Medicine (FMI).\n\nCultivate and manage critical strategic alliances with internal and external regulatory and policy collaborators, ensuring the successful translation of biomarker innovations into future policy frameworks.\n\nCOMMUNICATION / INTERACTION\nCollaborates strategically with VPs/SVP of Translational Medicine, TM Disease Area Leaders (DALs), Translational Medicine Subteam Leaders (TMSTLs), gRED, PD, Regulatory, Commercial, Medical Affairs, Roche Diagnostics, Foundation Medicine, and external collaborators to guide molecule and above-molecule development strategies for CDx development, Clinical Platform development and Biomarker-based Regulatory Policy Innovation.\n\nMaintains a robust and collaborative partnership with the pRED CDx development group, as well as pRED’s biomarker and technology focused functions.\n\nConnects with external stakeholders, such as regulatory policy consortia, Health Authorities and TAEs in order to drive novel pathways for biomarker innovation at the portfolio and/or disease area level.\n\nLEADERSHIP / MANAGEMENT / SUPERVISION\nManage and mentor a team of 6-8 scientific professionals, assuming full accountability for talent acquisition, retention, and proactive succession planning.\n\nDefine unit priorities, operational blueprints, and internal budgets, ensuring efficient resource deployment across molecular programs and strategic campaigns.\n\nFoster an inclusive culture of scientific excellence, supporting team members in resolving matrixed challenges and optimizing complex priority workflows.\n\nTEAMWORK AND INTERACTION\nDrives a high-performing, collaborative team culture while actively encouraging cross-functional knowledge sharing and alignment.\n\nEstablishes robust, trust-driven alliances across multi-functional groups including Clinical Science, Commercial, Regulatory, Medical Affairs, Clinical Operations, Biomarker Operations, TM, Roche Diagnostics, and Foundation Medicine.\n\nCollaborates closely with leadership in gRED BOMs and PD BOMs (Biomarker Operations Managers) to bridge clinical platform and diagnostic development with operational execution seamlessly across both early and late-stage programs.\n\nNavigate enterprise boundaries to cultivate productive engagements with internal and external partners, exerting influence across all organizational levels.\n\nWho You Are\nBachelor of Science (BS) degree in life sciences, biomedical engineering, or a related bioscience field is required (advanced degree is preferred) with 12-15 years of professional experience within the biotech, pharma, or diagnostics sectors; 5+ years of experience in CDx or IVD development; 3+ years of people leadership experience overseeing scientific professionals in a matrixed corporate environment.\n\nDeep understanding of CDx, IVD, and clinical platform development, covering assay design, analytical/clinical validation, bridging approaches, and regulatory pathways such as FDA PMA/IDE, EMA IVDR, and China NMPA.\n\nExtensive familiarity with both established diagnostic and emerging clinical platforms, including IHC, PCR, NGS, liquid biopsy, digital pathology, multi-omic assays.\n\nThorough grasp of the drug development lifecycle, including clinical trial designs, endpoints, coupled with an understanding of how diagnostic approaches impact commercialization and drug development.\n\nKnowledge of external regulatory policy, including consortium leadership, public comment procedures, and Health Authority engagement methods.\n\nDemonstrated experience interacting with global Health Authorities (such as the FDA and EMA) on IVD/CDx regulatory issues.\n\nPreferred:\nPrior background in regulatory science, consortia leadership, or external policy influence.\n\nExperience regarding diagnostic product rollouts, market access trends, test reimbursement, and clinical guidelines.\n\nRelocation benefits are available for this posting.\nThe expected salary range for this position based on the primary location of California is $189,300 - $351,500 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.\nBenefits\nGenentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.\nIf you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.","description_format":"text","description_chars":6982,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["Biotechnology","Health Care","Molecular Diagnostics","Care Coordination & Population Health"],"lifecycle":[{"event":"open","at":"2026-10-25T10:25:27Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 188 · green card filings: 34","filings_12m":188,"filings_prev_12m":151,"green_card_filings_12m":34,"median_offered_wage_usd":150788,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":1}],"liveness":{"score":14,"band":"cold","label":"Long shot","p_open":1,"p_active":0.518,"p_room":0.28,"age_days":59,"expected_fill_days":21,"reasons":["conf:4","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":351500,"is_top_pay":true},"html_url":"https://alion.io/job/genentech-director-cdx-clinical-platform-development","json_url":"https://alion.io/job/genentech-director-cdx-clinical-platform-development.json","meta":{"generated_at":"2026-10-31T06:36:33Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9725,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1757810},"rest":"https://alion.io/mcp/rest/get_company?id=1757810"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenentech-director-cdx-clinical-platform-development"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fgenentech-director-cdx-clinical-platform-development"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fgenentech-director-cdx-clinical-platform-development"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/genentech-director-cdx-clinical-platform-development\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenentech-director-cdx-clinical-platform-development"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3234406}},{"tool":"search_jobs","arguments":{"company":"gene.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3234406},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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