Clinical Development Physician, Gene Therapy

2 months ago

Markham, Canada Astellas Full time

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas

 

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

 

This position is based in Ontario, Canada. Remote work from Ontario in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

 

Purpose and Scope:

The primary objective for the Development Physician is to provide input into the design and conduct of clinical trials, review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assess and interpret safety data, and contribute to investigator, site staff and clinical study team training.

 

Job 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

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