Executive Director, Drug Safety & Pharmacovigilance at International AIDS Vaccine Initiative (IAVI)

Key Responsibilities:

• Accountable for all medical safety aspects of clinical development and post market surveillance of medicinal products in the IAVI portfolio.
• Lead both medical safety and safety operations across clinical programs for IAVI from clinical development planning to completion of execution.
• Lead safety signal assessments and validate safety signals through partnership with clinical development representatives.
• Responsible for the oversight of vendor deliverables and metrics associated with safety & PV for clinical programs.
• Design and manage DSPV function, including establishing Policies, Standard Operating Procedures (SOPs) and their periodic review.
• Oversee operational support to study teams regarding DSPV activities (e.g., investigator safety training, processing of Serious Adverse Events (SAEs) per protocols, supporting safety assessments activities).
• Lead the process for selection of DSPV vendor(s); maintain oversight of vendor activities related to DSPV (e.g., review quality of Individual Case Safety Reports (ICSRs), monitor compliance with SMPs, Key Performance Indicators/metrics), escalates issues with vendor performance.
• Lead development and implementation of Safety Management Plans (SMPs) needed between IAVI and vendors (e.g., Contract Research Organization).
• Responsible for strategic oversight and overall responsibilities for safety reporting requirements for US, EU and other international territories, as required.
• Management, oversight, and mentorship of the PV team with strategic and tactical vision for future build and planning.
• Participate in health authorities’ interactions regarding safety risk management and inspections.
• Responsible for the establishment and execution of a Safety Governance model, oversight of Drug Safety Committees.
• Heading the strategy for safety regulatory communications, providing oversight of to support submission activities.
• Review of safety components of documents such as protocols, IBs, clinical study reports and publications, regulatory submissions, safety labeling including Core Safety Information, safety sections of label, Risk Management Plans, Integrated Safety Summary, in close partnership with relevant functions.
• Oversee, write or review of periodic or ad-hoc aggregate/safety reports.
• Oversight of case processing and medical review of SUSARs and CSR narratives review, and safety reports follow-up with site investigators, in collaboration with clinical development functions.
• Perform ongoing benefit-risk assessments in collaboration with Clinical Development.
• Ensure compliance with global safety requirements and inspection readiness, ensuring non-compliance events are investigated, remediated, and prevented.
• Collaborate with Quality regarding safety impact assessment of manufacturing issues.
• Develop and maintain Safety Data Exchange Agreements with partners.
• Participate in due diligence and potential in-licensing opportunities as needed.

Education and Work Experience:

• MD Required.
• Minimum of 10 years’ experience in clinical development and minimum of 5 years’ drug safety and pharmacovigilance is required.
• Experience with infectious diseases and/or vaccine development is required.
• Experience with DSPV specifically related to vaccine and monoclonal antibody studies, including those conducted in healthy volunteers is highly desirable.
• Global DSPV experience, including oversight of studies conducted in Africa, is highly desirable.

Qualifications and Skills:

• Experience in leading DSPV for clinical development and marketed medicines, vaccines experience preferred.
• Experience in building and leading teams, directly or matrixed, and leading projects.
• Experience in risk management strategies and signal detection strategies.
• Deep knowledge of global DSPV regulations and requirements.
• Experience overseeing safety/PV vendors.
• Experience with regulatory authority inspections.
• Ability to provide robust safety strategies at the highest level as well as perform detailed work to support Phase 1-3 programs, as well as commercial products.
• Strong business acumen and ability to collaborate with cross-functional partners to achieve enterprise goals.
• Effective written, verbal communication and interpersonal, relationship-building skills.
• Proven professional track record of strategic, organizational, and executional skills to support project planning across multiple activities, with the ability to anticipate and prioritize team workload on multiple ongoing projects.
• Organized, attention to detail, and able to meet timelines in a fast-paced environment.
• Able to work with a high level of autonomy and independence.
• Knowledge and understanding of regulatory requirements for product approval and compliance in US and Europe.