ADC Therapeutics · 22 hours ago
Vice President, Global Drug Safety
New Providence, NJ
Full-time
Hybrid
Director/Executive
7+ years expADC Therapeutics is a commercial, global leader in the field of antibody-drug conjugates dedicated to revolutionizing cancer treatment. The Vice President of Global Drug Safety will oversee all safety activities for medicinal products, ensuring compliance with regulatory requirements and managing risk strategies throughout the product lifecycle.
BiopharmaBiotechnologyMedicalTherapeutics
Responsibilities
Oversees receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual cases
Oversees the review, interpretation and summarization of aggregate safety data from all sources and determine their potential impact on planned and ongoing clinical programs and post approval use
Oversees signal management system including signal detection, evaluation and management
Serve as the senior safety advisor on relevant project /product core teams
Oversees assessment and update of the safety profile of ADCT’s compounds including safety labeling update in collaboration with regulatory affairs
Oversees safety data exchange with Partners
Collaborates with the clinical development and medical affairs team in the compilation of safety sections in documents such as but not limited to IBs, clinical trial reports, IND annual reports, ad-hoc materials for regulatory consultation, DSMB meetings and advisory board meetings, scientific publication, etc
Oversees PV quality system, and ensures adherence to SOPs, policies, regulations and laws as applicable
Provides quality oversight on safety service providers’ work including safety database hosting
Leads, guides and develops direct reports; sets performance standards and responsible for performance management
Demonstrates the ability to deal effectively and collaboratively with relevant cross-functional departments
Accountable for effective departmental resource planning and sound operational execution
Works closely with the Business Development department on safety data disclosure for partnering opportunities
Qualification
Required
MD required
7 years of clinical development experience including 4 years' direct involvement in drug safety/pharmacovigilance activities
In-depth knowledge of best drug safety/pharmacovigilance practices
Expert knowledge in generation of periodic reports and in providing safety input on Clinical Study Protocols, IBs and Study Reports for products in development intended for regulatory approval, DSUR, PADER and PBRER
Proficient in drug safety regulations domestically and preferably internationally including relevant GVP/GCP/ICH guidelines
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
Demonstrates excellent organizational and management skills
Effective communicator with strong verbal and written skills
Seen as a strong, influential leader and manager of employees
Creates strong morale and spirit on his/her team
Able to think creatively; develop and execute within a fast-paced environment
10% domestic travel
Company
ADC Therapeutics
ADC Therapeutics develops antibody drug conjugates and non-antibody drug conjugate products.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.02BKey Investors
TCG CrossoverRedmile GroupDeerfield
2025-10-13Post Ipo Equity· $60M
2025-06-12Post Ipo Equity· $100M
2024-05-06Post Ipo Equity· $105M
Leadership Team
Jose Carmona
Chief Financial Officer
Mohamed Zaki
Chief Medical Officer, SVP
Recent News
Canada NewsWire
2025-12-19
2025-12-11
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