Bristol Myers Squibb
Bristol Myers Squibb
Bristol Myers Squibb — ауыр ауруларға арналған дәрі-дәрмектерді зерттейтін, әзірлейтін және ұсынатын жаһандық биофармацевтикалық компания. Оның қызметі жүрек-қантамыр денсаулығы, жасушалық терапия, иммунология және онкология бағыттарын қамтиды. Компания әлемнің түкпір-түкпіріндегі ауқымды командаларды зерттеушілермен, денсаулық сақтау мамандарымен және басқа серіктестермен ынтымақтастырады. Компанияның негізгі мақсаты — инновациялық емдеу әдістері арқылы медицина ғылымын дамыту және пациенттердің ем нәтижелерін жақсарту.

Associate Director of Clinical Science – San Diego Onsite

Associate Director leading clinical science activities for RayzeBio radiopharmaceutical programs in oncology. The role covers protocol development, clinical data review, trial execution support, and regulatory submissions.

Сипаттама

  • Support clinical development of RayzeBio radiopharmaceuticals for oncology indications
  • Partner with clinical development teams on activities across ongoing trial programs
  • Support functional-area work during program implementation and clinical study start-up, execution, and close-out
  • Contribute to clinical data analysis and reporting, with potential involvement in NDA and MAA filings
  • Develop or oversee study concept synopses and clinical protocols
  • Participate in scientific and procedural reviews of study designs
  • Prepare protocols, amendments, study manual sections, Investigator meeting materials, and related documents under guidance and supervision
  • Help design, develop, and review CRFs, Data Management Manuals, and Data Analysis Plans
  • Review data generated during ongoing clinical studies
  • Organize and oversee Data Review Committee meetings, including preparation of slides and meeting materials
  • Respond to Investigator questions on scientific and procedural matters with MD supervision
  • Prepare or review data listings, summary tables, study results, manuscripts, and scientific presentations
  • Assist with INDs, regulatory documents, IND annual reports and DSURs, Investigator Brochures, and NDA and MAA submissions
  • Advance functional-area priorities and implement solutions to moderately complex clinical-study challenges
  • Coordinate teams and provide direction when needed
  • Lead at least two components of departmental strategic initiatives as required
  • Advise colleagues on decisions and the resolution of moderately complex problems
  • Use AI tools to improve productivity and work quality

Талаптар

  • A PharmD or PhD is preferred
  • At least 6 years of relevant drug development experience with an MS degree
  • At least 8 years of relevant drug development experience with a BS degree in Biological Sciences, healthcare, or a related field
  • At least 5 years of clinical research or clinical pharmacology experience in a biotechnology or pharmaceutical company or contract research organization
  • Ability to learn new information quickly
  • Flexibility and adaptability when priorities change or projects shift
  • Proficiency with Microsoft Office, including Excel and PowerPoint
  • Experience using job-related applications such as SpotFire
  • Knowledge of FDA, EMA, and ICH regulations and guidelines
  • Ability to collaborate effectively across functions and organizational levels
  • Strong verbal, written, and interpersonal communication skills
  • Ability to enter a new therapeutic area and summarize published scientific information
  • Willingness to travel up to 20%

Артықшылықтар

  • Eligibility for discretionary cash and stock incentive opportunities
  • Wellbeing support programs
  • Retirement and financial protection benefits
  • Medical, dental, vision, life, and disability insurance options
  • Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees
  • 11 paid company holidays
  • 160 hours of annual paid vacation for eligible new hires
  • Three optional holidays
  • Paid sick leave
  • Up to two paid volunteer days each year
  • Flexible summer hours
  • Medical, personal, parental, caregiver, bereavement, and military leaves of absence
  • Annual Global Shutdown from Christmas Day through New Year's Day
  • Reasonable workplace accommodations and adjustments with ongoing support
  • Up to 20% travel requirement

Ұқсас жұмыс орындары

Thermo Fisher Scientific

Clinical Research Associate (CRA) – Israel

Thermo Fisher Scientific

Monitor clinical trial sites across Israel for Thermo Fisher Scientific’s PPD services, supporting protocol compliance, data quality, documentation, and audit readiness.

Ашу
Syneos Health

Principal Biostatistician – India (Remote)

Syneos Health

Join Syneos Health’s Clinical Solutions team as a Principal Biostatistician, supporting life sciences and clinical development services. Use biostatistical and drug development expertise to help customers advance drug development and commercialization.

Ашу
ICON plc

Senior Clinical Data Manager, Data Standards

ICON plc

Lead clinical data standards, quality, and governance for ICON’s sponsor-dedicated trials. Improve global processes and coordinate delivery across teams.

Ашу
IQVIA

Clinical Research Associate, Sponsor Dedicated

IQVIA

Monitor clinical trial sites and support protocol compliance, patient recruitment, and study documentation for IQVIA. Coordinate with site staff and project teams to help trials meet quality standards and milestones.

Ашу
Regeneron

Clinical Study Specialist at Regeneron

Regeneron

Support Regeneron clinical trial teams by coordinating study data, sites, reporting, and close-out activities. Help keep studies on track from site activation through completion.

Ашу
Thermo Fisher Scientific

Remote Biostatistician II in Spain

Thermo Fisher Scientific

Lead clinical trial analyses, statistical programming, and analysis plan development at Thermo Fisher Scientific. Mentor junior statisticians and coordinate work with sponsors, programmers, and data managers.

Ашу
University of Miami

Clinical Research Coordinator I

University of Miami

Support clinical studies across the University of Miami’s academic health system. Coordinate participant screening, study data, regulatory records, and protocol compliance.

Ашу
CTI Clinical Trial and Consulting Services

Senior Clinical Research Associate

CTI Clinical Trial and Consulting Services

Monitor clinical trial sites for CTI, a global clinical research CRO, and oversee site visits, regulatory records, investigational products, and study deliverables. Coordinate site management and study activities with investigators, sponsors, clients, and internal teams.

Ашу
MSK

Clinical Research Coordinator – New York, NY (Hybrid)

MSK

Support cancer research at Memorial Sloan Kettering Cancer Center by collecting clinical data and assisting with patient-facing studies. Maintain accurate research records and coordinate study protocols with research and care teams.

Ашу
Emory University

Clinical Research Coordinator III, Infectious Diseases — Emory University

Emory University

Lead infectious disease clinical trials and research projects at Emory University’s Grady Hospital. Coordinate study data, participant recruitment, regulatory compliance, sponsor communications, and staff guidance.

Ашу