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 medicinal products administered to humans and ensuring regulatory requirements are met.
- Drive risk management strategies for drugs in development and post-approval; ensure establishment and maintenance of core safety information across the product lifecycle.
- Supervise and mentor Drug Safety Department staff; collaborate with Development department heads, team leaders, and relevant functions.
- Provide quality oversight to safety service providers; oversee safety data exchanges with license partners.
Job Responsibilities
- Oversee receipt, processing, review, reporting, follow-up of adverse events and medical assessment of individual cases.
- Oversee review/interpretation/summarization of aggregate safety data; assess 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 safety profile assessment/updates, including safety labeling updates in collaboration with regulatory affairs.
- Oversee safety data exchange with partners.
- Collaborate with clinical development and medical affairs on safety sections for documents (e.g., IBs, clinical trial reports, IND annual reports, regulatory consultation materials, DSMB/advisory board materials, scientific publications).
- Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws.
- Provide quality oversight of safety service providers (including safety database hosting).
- Lead/guides/develops direct reports; set performance standards and manage performance.
- Manage cross-functional collaboration and departmental resource planning; ensure sound operational execution.
- Work with Business Development on safety data disclosure for partnering opportunities.
Requirements
- MD required.
- 7 years of clinical development experience, including 4 years directly in drug safety/pharmacovigilance.
- In-depth knowledge of best drug safety/pharmacovigilance practices.
- Expert knowledge of periodic report generation and safety input for Clinical Study Protocols, IBs, Study Reports, DSUR, PADER, and PBRER.
- Proficient in domestic drug safety regulations; preferably international; knowledge of GVP/GCP/ICH guidelines.
- Technical knowledge of drug safety databases, MedDRA, and WHO Drug coding.
- Experience with vendor oversight and management.
- Clinical and analytical knowledge in relevant therapeutic areas.
- Excellent organizational/management skills; strong verbal and written communication.
- Influential leadership and 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 medicinal products administered to humans and ensuring regulatory requirements are met.
- Drive risk management strategies for drugs in development and post-approval; ensure establishment and maintenance of core safety information across the product lifecycle.
- Supervise and mentor Drug Safety Department staff; collaborate with Development department heads, team leaders, and relevant functions.
- Provide quality oversight to safety service providers; oversee safety data exchanges with license partners.
Job Responsibilities
- Oversee receipt, processing, review, reporting, follow-up of adverse events and medical assessment of individual cases.
- Oversee review/interpretation/summarization of aggregate safety data; assess 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 safety profile assessment/updates, including safety labeling updates in collaboration with regulatory affairs.
- Oversee safety data exchange with partners.
- Collaborate with clinical development and medical affairs on safety sections for documents (e.g., IBs, clinical trial reports, IND annual reports, regulatory consultation materials, DSMB/advisory board materials, scientific publications).
- Oversee PV quality system and ensure adherence to SOPs, policies, regulations, and laws.
- Provide quality oversight of safety service providers (including safety database hosting).
- Lead/guides/develops direct reports; set performance standards and manage performance.
- Manage cross-functional collaboration and departmental resource planning; ensure sound operational execution.
- Work with Business Development on safety data disclosure for partnering opportunities.
Requirements
- MD required.
- 7 years of clinical development experience, including 4 years directly in drug safety/pharmacovigilance.
- In-depth knowledge of best drug safety/pharmacovigilance practices.
- Expert knowledge of periodic report generation and safety input for Clinical Study Protocols, IBs, Study Reports, DSUR, PADER, and PBRER.
- Proficient in domestic drug safety regulations; preferably international; knowledge of GVP/GCP/ICH guidelines.
- Technical knowledge of drug safety databases, MedDRA, and WHO Drug coding.
- Experience with vendor oversight and management.
- Clinical and analytical knowledge in relevant therapeutic areas.
- Excellent organizational/management skills; strong verbal and written communication.
- Influential leadership and employee management; builds team morale.
- Creative, able to develop and execute in a fast-paced environment.
- 10% domestic travel.