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.
About the role:
Reporting to the CEO, this newly created position will play a critical role in the direction of the company by serving as the program lead for IDRX-42 as it moves into pivotal-stage testing, driving cross-functional collaboration and coordination, and developing and implementing an integrated plan for the development of the molecule.
Responsibilities:
- Partner with stakeholders to articulate a comprehensive program strategy for IDRX-42.
- Develop, own and maintain the integrated development plan for IDRX-42, including objectives, go/no go decisions, milestones, deliverables, risks and mitigations, and program investment requirements to successfully advance the program through development to global regulatory approvals.
- Provide direction and leadership to the cross-functional IDRX-42 program team, including integrated oversight of functional activities, data review based on key milestones, budget, and planning.
- Ensure that CMC, clinical, non-clinical and regulatory strategies and plans are aligned with the overall program strategy.
- Identify and manage interconnectivities across program.
- Proactively identify program challenges and risks, develop mitigations, and navigate team through technical and program issues as they arise.
- Ensure well-documented and cohesive set of decisions and timelines.
- Exert influence on program direction and needs with key stakeholders and senior leadership.
- Build trust across company, specifically with program stakeholders and leadership.
- Serve as key advisor to senior leadership on organizational matters, including team and functional structure, responsibilities and collaboration.
- Model excellence in open communication and transparency across the program and organization.
Requirements:
- Advanced degree in life sciences or medicine (MD or PhD) and/or an MBA AND 15+ years experience in R&D in a biotech or pharmaceutical setting
- Prior experience leading a clinical-stage program
- Strong communication skills, with demonstrated ability to engage and influence team members at all levels
- Experience working with diverse areas of subject matter expertise spanning CMC, research and clinical development/operations
- Experience identifying and leveraging relevant data and information to develop well-conceived and executable timelines
- Meaningful prior experience working with small molecule development highly preferred
- Experience working in oncology, specifically solid tumors, highly preferred
- Experience developing and submitting an NDA highly preferred
