Global Medical Affairs Research Manager

4 days ago

New Bedford, Massachusetts, United States Lantheus Holdings, Inc. Full time

Job Summary

Lantheus Holdings, Inc. is seeking a highly skilled Global Medical Affairs Research Manager to join our team. In this role, you will be responsible for managing the Investigator Sponsored Trial program across the Lantheus Medical Imaging portfolio.

Key Responsibilities

  • Independently manage, track, and monitor the Global Investigator Sponsored Trial program across all Lantheus assets.
  • Ensure compliance with SOPs is documented for all processes within the assigned portfolio.
  • Interface with physicians and scientists for study conduct and regulatory compliance for investigator sponsored trials in a global environment.
  • Ensure IST study files meet GCP requirements, regulatory requirements, and accurately reflect the content and status of all ISTs.
  • Prepare new IST applications for review by Research Review Committee (RRC) for all pre-clinical and clinical IST protocols.
  • Interact with investigators, applicants, and site staff as needed to effectively review and implement IST proposals.
  • Interface with Pharmacovigilance function, external business partners, and distributors to promote strategic alignment and safety requirements for marketed products involved in the IST program.
  • Support the IST agreement (contract) process for all ISTs, in collaboration with medical, legal, and regulatory functions.
  • Support activities to drive adherence to timelines, program objectives, and monitoring plans.
  • Accountable for accuracy and timeliness of information in all databases and tracking systems.

Requirements

  • Bachelor's degree or equivalent in a scientific or health-related field required.
  • Advanced healthcare professional degree (e.g., PharmD, PhD, DO, or MD) or equivalent strongly preferred.
  • Knowledge of medical imaging field and diagnostics agents preferred.
  • Project management training or one or more years of experience.
  • Working knowledge of current ethical, GCP, and regulatory guidelines.
  • Minimum 3 years' experience in Investigator Sponsored Trials and/or Clinical Trial Operations, in post-marketed products.

About Lantheus Holdings, Inc.

Lantheus Holdings, Inc. is a leading provider of innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight, and follow disease. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

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