Vice President of Drug Safety

Vice President, Drug Safety

New Providence, NJ/Hybrid

Description

Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join us, you will join a group of talented people who share this mission.

What You’ll Do:

Position Overview

This person will be accountable for all of the activities and deliverables of the Drug Safety Department on a daily basis including providing operational and medical oversight of safety activities for all our 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. 

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 our 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

Requirements

·      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.