Clinical Development Physician, Gene Therapy Specialist
1 month ago
As a Clinical Development Physician, you will be responsible for designing and making recommendations in clinical development plans for gene therapy drugs, collaborating with medical leads and other stakeholders to ensure the safe and effective development of these treatments.
You will be responsible for reviewing and analyzing the eligibility of participants per inclusion/exclusion requirements of clinical trials, as well as reviewing all adverse events to look for trends or risks, and reviewing all serious adverse events (SAEs) with close collaboration with the study's Product Responsible Person (PRP).
You will also provide 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.
Additionally, you will ensure activities related to Severe Adverse Events (SAEs) are conducted in accordance with applicable SOP's and regulations, and consult with internal and external stakeholders in the development of clinical trial design and conduct, including drafting of protocols and amendments.
You will develop and/or review operational, medical monitoring, and safety plans for studies, lead and/or participate in scientific and medical training to other team members and external clients, investigators, and other site staff as it pertains to assigned studies, and generate safety-related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
You will also write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events, and provide 24/7 emergency coverage for safety-related matters.
RequirementsRequired 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.
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Markham, Ontario, Canada Astellas Pharma Inc. Full timeJob SummaryAs a Clinical Development Physician, Gene Therapy Specialist at Astellas Pharma Inc., you will play a crucial role in designing and implementing clinical development plans for gene therapy drugs. Your expertise in medical monitoring and pharmacovigilance will ensure the safe and effective development of these life-changing...
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Markham, Ontario, Canada Astellas Full timeAbout the RoleAstellas Pharma Inc. is a pharmaceutical company dedicated to developing innovative therapies for patients. We are seeking a Clinical Development Physician to join our team in Ontario, Canada.This is a remote work opportunity, and candidates interested in working from home are encouraged to apply.Key ResponsibilitiesCollaborate with medical...
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Markham, Ontario, Canada Astellas Full timeAbout the RoleAstellas Pharma Inc. is a pharmaceutical company dedicated to developing innovative therapies for patients. We are seeking a Clinical Development Physician to join our team in Ontario, Canada.This is a remote work opportunity, and candidates interested in working from home are encouraged to apply.Key ResponsibilitiesCollaborate with medical...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective medicines to patients and physicians worldwide. With a strong commitment to ethics and integrity, we strive to address unmet medical needs and improve the health of people globally.Job SummaryWe are seeking a highly skilled Clinical...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective medicines to patients and physicians worldwide. With a strong commitment to ethics and integrity, we strive to address unmet medical needs and improve the health of people globally.Job SummaryWe are seeking a highly skilled Clinical...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective medicines to patients and physicians worldwide. With a strong commitment to addressing unmet medical needs, we strive to improve the health of people around the globe.Job SummaryWe are seeking a highly skilled Clinical Development Physician...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective medicines to patients and physicians worldwide. With a strong commitment to addressing unmet medical needs, we strive to improve the health of people around the globe.Job SummaryWe are seeking a highly skilled Clinical Development Physician...
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Markham, Ontario, Canada Astellas Pharma Inc. Full timeJob SummaryWe are seeking a highly skilled Clinical Development Physician to join our team at Astellas Pharma Inc. in the field of Gene Therapy.ResponsibilitiesCollaborate with medical leads to design and recommend clinical development plans for gene therapy drugs, incorporating input from Medical and Clinical Operations colleagues and other contributing...
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Markham, Ontario, Canada Astellas Pharma Inc. Full timeJob SummaryWe are seeking a highly skilled Clinical Development Physician to join our team at Astellas Pharma Inc. in the field of Gene Therapy.ResponsibilitiesCollaborate with medical leads to design and recommend clinical development plans for gene therapy drugs, incorporating input from Medical and Clinical Operations colleagues and other contributing...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. Our mission is to address unmet medical needs and conduct business with ethics and integrity, improving the health of people worldwide.Job SummaryWe are seeking a highly skilled Clinical Development...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a global pharmaceutical company dedicated to delivering innovative and effective new medicines to patients and physicians. Our mission is to address unmet medical needs and conduct business with ethics and integrity, improving the health of people worldwide.Job SummaryWe are seeking a highly skilled Clinical Development...
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Markham, Ontario, Canada Astellas Full timeAbout AstellasAstellas Pharma Inc. is a pharmaceutical company dedicated to improving the health of people around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.Job SummaryWe are seeking a Clinical Development Physician to join our team in Ontario, Canada. As a key...
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