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Bristol Myers Squibb
Bristol Myers Squibb
H1B vizos rėmėjasKonsultavimasLogistikaSveikatos priežiūra
Bristol Myers Squibb yra pasaulinė biofarmacijos bendrovė, tirianti, kurianti ir tiekianti vaistus sunkioms ligoms gydyti. Jos veikla apima širdies ir kraujagyslių sveikatą, ląstelių terapiją, imunologiją ir onkologiją. Bendrovė telkia dideles tarptautines komandas ir bendradarbiauja su tyrėjais, sveikatos priežiūros paslaugų teikėjais bei kitais partneriais. Jos veiklos pagrindas – medicinos mokslo pažanga ir pacientų gydymo rezultatų gerinimas pasitelkiant novatoriškus gydymo būdus.
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Darbai įmonėje

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.

USJungtinės ValstijosCAKalifornijaNJNaujasis Džersis
173 217 $ – 230 888 $ / metai
Darbas vietojeVisas etatasVyresnysis specialistasPrivaloma Kalba: anglųDirektorius

Aprašymas

  • 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

Reikalavimai

  • 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%

Privalumai

  • 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

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