2601 Operations Director jobs in MA
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Team Lead, Associate Director, Global Regulatory Affairs CMC

Genmab

South Grafton, MA

OnsiteUrgently Hiring

  • Master of Science in pharmacy, engineering or equivalent
  • Proficiency in English communication (verbal and written)
  • Experience with lifecycle management
  • A track record in moving therapeutic products through various stages of development
  • Experience with leadership
  • Minimum of 10 years of industry experience within RA CMC, with a strong understanding of compliance and biologics
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Associate Director, Biostatistics

Genmab

South Grafton, MA

RemoteUrgently HiringEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

  • Experience in statistical analysis, modelling and simulation and adaptive trial designs
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
  • Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
  • Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Master's or PhD in a statistical discipline
  • Experience directing multiple complex projects/studies in a technical capacity
  • 8+ years of experience in relevant technical area
  • Experience with the relevant regulatory requirements for biostatistics processes and SOPs
  • Proven performance in earlier role/comparable role
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Director, Business Development

SAAB

Quincy, MA

US Work Authorized

Bachelor's Degree

Within 15 miles of Quincy, MA

Requires TravelUrgently HiringEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

  • Knowledge of the US government budget process to skillfully navigate detailed defense budgets
  • Minimum of 15+ years relevant experience in Aerospace and Defense environment, in Program Management, Business Capture, Business Development, Marketing and Sales, or Military
  • Capable of obtaining a Secret level clearance
  • Advanced knowledge of the capture/business strategy and/or the Subsea/Seabed warfare stakeholder environment
  • Demonstrated track record leading large scale aerospace and/or defense business capture efforts
  • BS Degree in business or related engineering discipline
  • 10+ years of directly or indirectly leading organizations
  • Knowledge of the DoD acquisition process, and government procurement policies and procedures
  • Must be a U.S. citizen
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