What are the responsibilities and job description for the Senior Director Global Safety Leadership position at ADC Therapeutics?
Overview
At ADC Therapeutics, we are revolutionizing cancer treatment by developing innovative antibody-drug conjugates (ADCs). As a key member of our team, you will play a vital role in ensuring the safety and efficacy of our products. Our company is passionate about making a difference in patients' lives, and we are looking for talented individuals who share our vision.
About the Role
This position is responsible for overseeing all activities and deliverables of the Drug Safety Department on a daily basis. You will provide 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.
Key Responsibilities
Requirements
We are seeking a highly experienced professional with a strong background in drug safety and pharmacovigilance. 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.
At ADC Therapeutics, we are revolutionizing cancer treatment by developing innovative antibody-drug conjugates (ADCs). As a key member of our team, you will play a vital role in ensuring the safety and efficacy of our products. Our company is passionate about making a difference in patients' lives, and we are looking for talented individuals who share our vision.
About the Role
This position is responsible for overseeing all activities and deliverables of the Drug Safety Department on a daily basis. You will provide 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.
Key Responsibilities
- Oversee receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual cases.
- Review, interpret, and summarize aggregate safety data from all sources, determining their potential impact on planned and ongoing clinical programs and post-approval use.
- Serve as the senior safety advisor on relevant project/product core teams.
- Assess and update the safety profile of ADCT's compounds, including safety labeling updates in collaboration with regulatory affairs.
Requirements
We are seeking a highly experienced professional with a strong background in drug safety and pharmacovigilance. 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.
