What are the responsibilities and job description for the Director of Drug Safety and Regulatory Affairs position at ADC Therapeutics?
Company Overview
ADC Therapeutics is a global leader in the field of antibody-drug conjugates (ADCs), with a pipeline of innovative therapies aimed at transforming cancer treatment. Our team is passionate about making a difference in patients' lives, and we are committed to delivering exceptional results. With a strong focus on research and development, we are constantly pushing the boundaries of what is possible in oncology. We are seeking an experienced Director of Drug Safety and Regulatory Affairs to join our team and contribute to our mission.
About the Role
This position is responsible for providing operational and medical oversight of safety activities for all ADCT's medicinal products administered to humans, ensuring regulatory requirements are met. Additionally, you will be the key driver of risk management strategies for all drugs in development and post-approval, establishing and maintaining core safety information during each product's lifecycle. You will also oversee the receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual cases.
Requirements
We are seeking a highly experienced professional with a strong background in drug safety and regulatory affairs. The ideal candidate will have a MD degree and at least 7 years of clinical development experience, including 4 years of direct involvement in drug safety/pharmacovigilance activities. In-depth knowledge of best drug safety/pharmacovigilance practices, expert knowledge in generation of periodic reports, and proficiency in drug safety regulations domestically and internationally are essential.
ADC Therapeutics is a global leader in the field of antibody-drug conjugates (ADCs), with a pipeline of innovative therapies aimed at transforming cancer treatment. Our team is passionate about making a difference in patients' lives, and we are committed to delivering exceptional results. With a strong focus on research and development, we are constantly pushing the boundaries of what is possible in oncology. We are seeking an experienced Director of Drug Safety and Regulatory Affairs to join our team and contribute to our mission.
About the Role
This position is responsible for providing operational and medical oversight of safety activities for all ADCT's medicinal products administered to humans, ensuring regulatory requirements are met. Additionally, you will be the key driver of risk management strategies for all drugs in development and post-approval, establishing and maintaining core safety information during each product's lifecycle. You will also oversee the receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual cases.
Requirements
We are seeking a highly experienced professional with a strong background in drug safety and regulatory affairs. The ideal candidate will have a MD degree and at least 7 years of clinical development experience, including 4 years of direct involvement in drug safety/pharmacovigilance activities. In-depth knowledge of best drug safety/pharmacovigilance practices, expert knowledge in generation of periodic reports, and proficiency in drug safety regulations domestically and internationally are essential.
