Clinical Development Physician, Gene Therapy Specialist
1 month ago
We are seeking a highly skilled Clinical Development Physician to join our team at Astellas Pharma Inc. in the field of Gene Therapy.
Responsibilities- Collaborate 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 line functions.
- Provide medical expertise and guidance on assigned clinical trials, addressing questions and problems that arise during the conduct of the trial.
- Review and analyze participant eligibility for clinical trials, ensuring adherence to inclusion/exclusion requirements.
- Identify trends and risks in adverse events, reviewing serious adverse events (SAEs) and collaborating with the study's Product Responsible Person (PRP) on regulatory reporting.
- Ensure the safety of clinical trials by reviewing study protocols and providing ongoing medical oversight, identifying safety concerns and developing responses.
- Develop and review operational, medical monitoring, and safety plans for studies, ensuring compliance with SOPs and regulations.
- Consult with internal and external stakeholders on clinical trial design and conduct, including drafting protocols and amendments.
- Lead and participate in scientific and medical training for team members, external clients, investigators, and site staff.
- Generate safety-related documents, such as medical monitoring reports and safety databases, to ensure accurate and complete reporting of SAEs.
- Write and review safety narratives, investigator letters, and other safety documentation for site-reported safety events.
- Medical qualification, such as MD or equivalent, with experience treating patients and a current or prior license to practice.
- Direct experience in medical monitoring and/or pharmacovigilance and/or drug safety in a CRO, pharmaceutical, or clinical trial environment.
- Proficiency in ICH/GCP guidelines and other applicable regulatory rules and guidelines, as well as medical terminology, drug development, clinical trials, and clinical research.
- Experience working in gene therapy drug development.
- Subspecialty training and practice in Neurology, Cardiology, Immunology, or similar subspecialty.
- Strong knowledge of Immunology.
- Medical, Dental, and Vision Insurance.
- Generous Paid Time Off options, including Vacation, Sick time, and national holidays.
- 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 timeResponsibilitiesAs 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...
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Markham, Ontario, Canada Astellas Pharma Inc. Full timeResponsibilitiesAs 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...
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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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