Vice President, Drug Safety and Pharmacovigilance

IDRX is a clinical-stage biopharmaceutical company dedicated to transforming cancer care with intelligently designed precision therapies. IDRX aims to address the limitations of today's precision cancer medicines with highly potent and selective targeted therapies to stop key tumor escape mechanisms and prolong response to therapy. IDRX's lead program is IDRX-42, designed to inhibit key genetic drivers and drug-resistant mutations of KIT in gastrointestinal stromal tumor (GIST). Founded in 2021, IDRX's leadership team has extensive experience in drug development and collectively has been involved in the discovery, development, and commercialization of more than 10 approved drugs.

Title: Vice President, Drug Safety and Pharmacovigilance

Reports to: Chief Medical Officer

About the roleThe Head of Drug Safety and Pharmacovigilance will be responsible for establishing and leading the company's drug safety and pharmacovigilance strategy. This person will be accountable for all of the activities and deliverables for drug safety and pharmacovigilance, including providing operational and medical oversight of safety activities and ensuring regulatory requirements are met. This individual will play a pivotal role in ensuring the safety and driving the risk management strategies of IDRx's therapies from pre-clinical development through commercialization. The successful candidate will have extensive experience in drug safety, experience in the oncology therapeutic area and will be responsible for building and leading a high-performing drug safety team.

Responsibilities

• Lead the development and execution of the company's drug safety and pharmacovigilance strategy, ensuring alignment with regulatory requirements and corporate objectives.
• Oversee all aspects of safety signal detection, evaluation, and risk mitigation strategies for all products in the clinical pipeline.
• Oversee receipt, processing, review, reporting, follow-up of adverse events and company medical assessment of individual cases
• Oversee 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.
• Build and lead a pharmacovigilance and drug safety team to meet the expanding needs of the organization, fostering a collaborative and high-performance culture.
• Provide quality oversight to safety service providers
• Ensure that the company is in compliance with all applicable global safety regulations, including FDA, EMA, and other relevant regulatory agencies.
• Work closely with cross-functional teams, including Clinical Development and Regulatory Affairs to ensure patient safety is embedded throughout the product lifecycle.
• Develop, implement, and maintain risk management plans, safety monitoring plans, and safety data exchange agreements for clinical programs and marketed products.
• Provide pharmacovigilance expertise to clinical development teams, contributing to the design, conduct, and oversight of clinical trials with a focus on patient safety.
• Collaborate with the clinical development and regulatory teams in the compilation of safety sections in documents such as but not limited to IBs, clinical study reports, IND annual reports, ad-hoc materials for regulatory consultation, NDAs, DSMB meetings and advisory board meetings, scientific publication, etc.
• Serve as the primary point of contact for pharmacovigilance interactions with regulatory authorities and external partners.

Requirements

• MD + at least 7 years of experience in pharmacovigilance and drug safety roles in the biotech or pharmaceutical industry
• Experience in oncology therapeutic area
• Strong understanding of global safety regulations, including FDA, EMA, and ICH guidelines.
• Experience managing drug safety across clinical development, marketing authorization, and post-marketing stages
• Excellent leadership, communication, and problem-solving skills
• Ability to work collaboratively with cross-functional teams and senior leaders
• Strong analytical skills with the ability to interpret complex data and make data-driven safety decisions