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Job Overview
Location
Oregon, USA
Job Type
Full-time
Category
Operations
Date Posted
September 13, 2025
Full Job Description
š Description
- ā¢ Own end-to-end operational delivery of one or more global oncology clinical studies within the RayzeBio radiopharmaceutical portfolio, ensuring every trial starts, runs and closes on-time, on-budget and inspection-ready while meeting the highest scientific and regulatory standards.
- ā¢ Translate the clinical development plan into an executable operational strategy: map country and site selection criteria, forecast enrollment trajectories, build integrated cross-functional timelines, resource plans and risk registers that are re-visited and refined as programs evolve.
- ā¢ Direct, coach and inspire a matrixed study execution team (Clinical Operations, Data Management, Biostatistics, Drug Supply, Safety, Regulatory, Medical Affairs, CROs and specialty vendors) through all trial phasesāfeasibility, start-up, conduct, close-out and CSR/ICH E3 reportingāremoving roadblocks before they threaten milestones.
- ā¢ Serve as the single point of accountability for CRO and vendor oversight: negotiate scope, budget and KPIs; chair weekly operational reviews; approve monitoring plans, data management plans, SAPs, TMF indices and risk-based quality strategies; verify root-cause analyses and CAPA effectiveness; maintain a real-time compliance dashboard that keeps teams inspection-ready 365 days a year.
- ā¢ Anticipate and neutralize program-level risks (radiopharmaceutical supply chain, theranostic imaging windows, dosimetry complexity, DSMC requirements, geopolitical site disruption) by embedding mitigation tactics into protocol amendments, country deployment sequences and contingency budgets.
- ā¢ Author or critically review core study documentsāprotocols, ICFs, IMPD sections, IB updates, site manuals, pharmacy handbooksāto ensure operational feasibility, patient safety and alignment with FDA/EMA/PMDA guidance for radioligand therapies and companion diagnostics.
- ā¢ Drive transparent, data-driven governance: maintain integrated Master Plans in Microsoft Project & Smartsheets, publish weekly KPI scorecards (enrollment, data query aging, SAE reporting, protocol deviation trending, TMF QC status), and present to Executive Leadership the āsingle version of truthā that informs go/no-go investment decisions.
- ā¢ Champion a culture of diversity, equity and inclusion in trial conduct: partner with site feasibility leads to broaden access to underserved populations, reduce patient burden through decentralized visit solutions, and ensure language- and culture-appropriate materials are available at every participating site.
- ā¢ Mentor and elevate talent across the Clinical Operations network: conduct quarterly career conversations, share lessons learned from radiopharmaceutical programs, and sponsor continuous-improvement initiatives that raise the bar for speed, quality and patient centricity.
- ā¢ Represent BMS/RayzeBio externally at scientific symposia, investigator meetings and health-authority inspections, articulating the operational strategy that underpins breakthrough therapies for patients who have exhausted standard-of-care options.
šÆ Requirements
- ā¢ Bachelorās degree (life sciences, pharmacy, nursing or related field); advanced degree (MPH, MSc, PharmD, PhD, MBA) preferred.
- ā¢ Minimum 10 years of progressive clinical operations experience in pharma/biotech, including 5+ years leading global oncology trials; prior accountability for radiopharmaceutical, theranostic or companion-diagnostic programs highly desirable.
- ā¢ Demonstrated success managing Phase IāIII studies via CROs across North America, EU and Asia-Pacific with budgets >$30 M and site networks >50 locations.
- ā¢ Expert knowledge of ICH-GCP, FDA/EMA regulations, GRP/GDP for radioactive IMPs, 21 CFR Part 312, EU CTR and CTIS submission requirements.
- ā¢ Advanced proficiency in project-management tools (Microsoft Project, Smartsheets, JIRA) and clinical systems (CTMS, EDC, IRT, eTMF, Safety); PMP certification a plus.
šļø Benefits
- ā¢ Base salary $210,572ā$255,164 plus annual performance bonus and long-term equity awards; comprehensive medical, pharmacy, dental and vision coverage from day one.
- ā¢ 120 hours paid vacation, paid national & optional holidays, Global Shutdown between Christmas and New Yearās, summer-flex Fridays and two paid volunteer days annually.
- ā¢ 401(k) with 6% company match, tuition reimbursement up to $10k/year, adoption/surrogacy assistance up to $25k, fertility/infertility coverage and elder/pet-care subsidies.
- ā¢ Remote-by-design role with up to 20% business travel; $1,500 home-office stipulation, monthly internet allowance and access to Living Life Better well-being program & 24/7 EAP.
Skills & Technologies
š Remote
šµ Salary not specified
ā° Full Time
š“ Senior
š Product Manager
š«šØāš No degree required
ā” TypeScript
ā” AWS
ā” GCP
Remote
About Bristol-Myers Squibb Company
Bristol-Myers Squibb is a global biopharmaceutical company headquartered in New York City. It discovers, develops, manufactures and markets medicines for cancer, cardiovascular, immunologic, fibrotic and infectious diseases. Formed through the 1989 merger of Bristol-Myers and Squibb, the company has pioneered therapies such as Opdivo, Yervoy and Eliquis. Operating in more than 60 countries, it invests heavily in R&D and partnerships to advance precision oncology, cell therapy and immunotherapy. BMS acquired Celgene in 2019, expanding its oncology and hematology portfolio. The company is committed to sustainability, access to medicines and global health equity initiatives.
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