Vice President, Global Drug Safety
ADC Therapeutics SA, New Providence, NJ, United States
Description
Transforming Cancer Therapy Together
At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.
Why ADC Therapeutics? ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.
We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at adctherapeutics.com and LinkedIn.
What You’ll Do Position Overview
This position will be accountable for all of the activities and deliverables of the Drug Safety function including providing operational and medical oversight of safety activities for all ADCT’s medicinal products administered to humans and ensuring regulatory requirements are met. The incumbent will be the key driver of risk management strategies for all drugs in development and post approval and ensure establishment and maintenance of core safety information during each product’s lifecycle. The individual will supervise and mentor the Drug Safety Department staff and effectively collaborate with other department heads within Development, team leaders and other relevant functions. The incumbent will also provide quality oversight to safety service providers and oversee safety data exchanges with license partners.
This role reports to the Chief Medical Officer and is based out of the New Providence, NJ office with the ability to work a hybrid schedule. We are flexible with the individual being remote based and has the ability to come into our NJ office as needed.
Job 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
Who You Are
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
ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
#J-18808-Ljbffr
At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.
Why ADC Therapeutics? ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.
We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at adctherapeutics.com and LinkedIn.
What You’ll Do Position Overview
This position will be accountable for all of the activities and deliverables of the Drug Safety function including providing operational and medical oversight of safety activities for all ADCT’s medicinal products administered to humans and ensuring regulatory requirements are met. The incumbent will be the key driver of risk management strategies for all drugs in development and post approval and ensure establishment and maintenance of core safety information during each product’s lifecycle. The individual will supervise and mentor the Drug Safety Department staff and effectively collaborate with other department heads within Development, team leaders and other relevant functions. The incumbent will also provide quality oversight to safety service providers and oversee safety data exchanges with license partners.
This role reports to the Chief Medical Officer and is based out of the New Providence, NJ office with the ability to work a hybrid schedule. We are flexible with the individual being remote based and has the ability to come into our NJ office as needed.
Job 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
Who You Are
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
ADC Therapeutics is proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
#J-18808-Ljbffr