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Clinical Development Physician, Ophthalmology
4 months ago
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently searching for a Clinical Development Physician, Ophthalmology.
Description
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
