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Clinical Development Physician, Gene Therapy

Clinical Development Physician, Gene Therapy

Astellas Pharma Inc.Markham, ON
30+ days ago
Salary
CAD161.9–CAD220 daily
Job description

Responsibilities

  • In collaboration with medical lead, responsible for designing and making recommendations in clinical development plan for their drugs, after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics. Clinical Operations, Commercial).
  • Be readily available to advise on assigned clinical trial(s) related medical questions or problems during the conduct of the trial.
  • Reviews and analyzes the eligibility of participants per inclusion / exclusion requirements of a clinical trial.
  • Reviews all adverse events to look for trends or risks, reviews all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting, with close collaboration with the study’s Product Responsible Person (PRP)
  • Provides review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and / or adverse events are identified and appropriate responses to such concerns are developed and executed.
  • Ensures activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP’s and regulations.
  • Consults with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols and amendments.
  • Develops and / or reviews operational, medical monitoring, and safety plans for studies.
  • Leads and / or participates in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies.
  • Generates safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
  • Writes and / or reviews Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
  • 24 / 7 emergency coverage for safety-related matters

Requirements

Required Qualifications

  • Medical qualification such as MD or equivalent with experience treating patients with a current or prior license to practice.
  • Required direct experience in medical monitoring and / or pharmacovigilance and / or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
  • Proficiency with ICH / GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, drug development, clinical trials, and clinical research.

    • Preferred Qualifications

  • Experience working in gene therapy drug development
  • Subspecialty training and practice in the fields of Neurology, Cardiology, Immunology, or similar subspecialty
  • Strong knowledge of Immunology

    • Benefits :

  • Medical, Dental and Vision Insurance
  • Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
  • RRSP
  • Company paid life insurance
  • Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
  • Long Term Incentive Plan for eligible positions
  • Referral bonus program