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Lead Study Manager

2 months ago

Ada, Ohio, United States AmplifyBio Full time

Are you dedicated to enhancing the future of healthcare? AmplifyBio, a premier contract research organization, provides a comprehensive array of services in discovery R&D, preclinical evaluations, and therapeutic manufacturing.

About ASET West Jefferson: ASET is AmplifyBio's unit focused on safety, efficacy, and toxicology, specializing in preclinical evaluations for innovative therapies. They are in search of a Study Director.

The Study Director will manage the scientific components of non-clinical evaluations, collaborate with project teams, and ensure the execution of studies is timely and of high quality. Key responsibilities include acting as Study Director, offering expertise to project teams, creating proposals, drafting study protocols, overseeing studies within budget constraints, and engaging in continuous improvement initiatives.

Qualifications:

  • Bachelor's or Master's degree in life sciences
  • Experience in a regulated setting
  • Strong communication and time management abilities
  • Proficiency in writing regulatory documents
  • Capability to operate in a BSL2 environment
  • Immunization with FDA vaccines

Benefits of Working at AmplifyBio:

  • Competitive compensation package
  • Flexible PTO policy
  • Generous paid parental leave
  • Wellness programs
  • 401(k) matching and tuition reimbursement
  • Engaging work environment with opportunities for advancement
  • An opportunity to make a significant impact

At AmplifyBio, we emphasize excellence, proactive engagement, and the well-being of our team members.