Vice President, Global Drug Safety
ADC Therapeutics
10 hours ago
Remote friendly (New Providence, NJ)
United States
Operations
Position Overview
- Accountable for all activities and deliverables of the Drug Safety function, providing operational and medical oversight of safety activities for all ADCT medicinal products administered to humans and ensuring regulatory requirements are met.
- Key driver of risk management strategies for drugs in development and post-approval; establishes and maintains core safety information during each product’s lifecycle.
- Supervises and mentors Drug Safety Department staff; collaborates with Development department heads, team leaders, and relevant functions.
- Provides quality oversight to safety service providers and oversees safety data exchanges with license partners.
Job Responsibilities
- Oversee receipt, processing, review, reporting, and follow-up of adverse events and medical assessment of individual cases.
- Oversee review, interpretation, and summarization of aggregate safety data; determine potential impact on clinical programs and post-approval use.
- Oversee signal management (detection, evaluation, and management).
- Serve as senior safety advisor on relevant project/product core teams.
- Oversee assessment and updates of compound safety profiles, including safety labeling updates in collaboration with regulatory affairs.
- Oversee safety data exchange with partners.
- Collaborate to compile safety sections for IBs, clinical trial reports, IND annual reports, regulatory materials, DSMB/advisory board materials, and scientific publications.
- Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws.
- Provide quality oversight on safety service providers’ work, including safety database hosting.
- Lead, guide, and develop direct reports; set performance standards and manage performance.
- Support cross-functional collaboration, resource planning, and operational execution.
- Partner with Business Development on safety data disclosure for partnering opportunities.
Requirements
- MD required.
- 7 years clinical development experience, including 4 years directly involved in drug safety/pharmacovigilance.
- In-depth knowledge of best drug safety/pharmacovigilance practices.
- Expert knowledge in generation of periodic reports and safety input for Clinical Study Protocols, IBs, Study Reports, DSUR, PADER, and PBRER.
- Proficient in drug safety regulations (domestic; preferably international) including GVP/GCP/ICH.
- Technical knowledge of commercial drug safety databases, MedDRA, and WHO Drug coding.
- Experience with vendor oversight and management.
- Clinical and analytical knowledge in relevant therapeutic areas.
- Excellent organizational and management skills; strong verbal and written communication.
- Strong, influential leadership/employee management; builds team morale.
- Creative, able to develop and execute in a fast-paced environment.
- 10% domestic travel.
- Accountable for all activities and deliverables of the Drug Safety function, providing operational and medical oversight of safety activities for all ADCT medicinal products administered to humans and ensuring regulatory requirements are met.
- Key driver of risk management strategies for drugs in development and post-approval; establishes and maintains core safety information during each product’s lifecycle.
- Supervises and mentors Drug Safety Department staff; collaborates with Development department heads, team leaders, and relevant functions.
- Provides quality oversight to safety service providers and oversees safety data exchanges with license partners.
Job Responsibilities
- Oversee receipt, processing, review, reporting, and follow-up of adverse events and medical assessment of individual cases.
- Oversee review, interpretation, and summarization of aggregate safety data; determine potential impact on clinical programs and post-approval use.
- Oversee signal management (detection, evaluation, and management).
- Serve as senior safety advisor on relevant project/product core teams.
- Oversee assessment and updates of compound safety profiles, including safety labeling updates in collaboration with regulatory affairs.
- Oversee safety data exchange with partners.
- Collaborate to compile safety sections for IBs, clinical trial reports, IND annual reports, regulatory materials, DSMB/advisory board materials, and scientific publications.
- Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws.
- Provide quality oversight on safety service providers’ work, including safety database hosting.
- Lead, guide, and develop direct reports; set performance standards and manage performance.
- Support cross-functional collaboration, resource planning, and operational execution.
- Partner with Business Development on safety data disclosure for partnering opportunities.
Requirements
- MD required.
- 7 years clinical development experience, including 4 years directly involved in drug safety/pharmacovigilance.
- In-depth knowledge of best drug safety/pharmacovigilance practices.
- Expert knowledge in generation of periodic reports and safety input for Clinical Study Protocols, IBs, Study Reports, DSUR, PADER, and PBRER.
- Proficient in drug safety regulations (domestic; preferably international) including GVP/GCP/ICH.
- Technical knowledge of commercial drug safety databases, MedDRA, and WHO Drug coding.
- Experience with vendor oversight and management.
- Clinical and analytical knowledge in relevant therapeutic areas.
- Excellent organizational and management skills; strong verbal and written communication.
- Strong, influential leadership/employee management; builds team morale.
- Creative, able to develop and execute in a fast-paced environment.
- 10% domestic travel.