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Bristol Myers Squibb
Bristol Myers Squibb
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Bristol Myers Squibb este o companie biofarmaceutică globală care cercetează, dezvoltă și furnizează medicamente pentru boli grave. Activitatea sa acoperă sănătatea cardiovasculară, terapia celulară, imunologia și oncologia, reunind echipe internaționale numeroase și colaborări cu cercetători, furnizori de servicii medicale și alți parteneri. Compania se concentrează pe promovarea științei medicale și îmbunătățirea rezultatelor pentru pacienți prin tratamente inovatoare.
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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.

USStatele Unite ale AmericiiCACaliforniaNJNew Jersey
173.217 $ – 230.888 $ / an
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăDirector

Descriere

  • 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

Cerințe

  • 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%

Beneficii

  • 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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