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 CMO, the Director/Senior Director, Clinical Pharmacology serves as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary development team for IDRx’s lead program and is responsible for providing subject matter expertise and/or managing external vendors/consultants for all clinical pharmacology & pharmacometrics matters relating to assigned clinical projects.
Responsibilities
- The Director/Senior Director of Clinical Pharmacology serves as Clinical Pharmacology Lead on core drug development team(s)
- The successful candidate will lead clinical pharmacology strategy, planning, and delivery for clinical studies, consistent with the target product profile, program goals and regulatory strategy
- In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label
- Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models.
- Accountable for clinical pharmacology deliverables to development team and clinical studies, providing both technical and strategic input to development team and management
- Oversee all relevant PK, PK/PD and exposure-response analyses to optimize clinical study dose, dosing regimen and design
- Lead clinical pharmacology profiling to support clinical dosing algorithm (e.g. food effect, drug-drug interaction & special populations)
- Collaborate with clinical study team to optimize trial design, execute clinical studies and contribute to relevant sections of clinical study protocols
- Explore exposure-response relationships for safety and efficacy using preclinical, translational and clinical data to support dose/dosing regimen selection for clinical evaluation
- Ensure high-quality and timely delivery of relevant sections of regulatory documents for global health authority submissions
- Represent clinical pharmacology as subject matter expert on cross-functional project teams and global health authority interactions
- Contribute to the design and oversight of toxicokinetic aspects for GLP toxicology studies
- Establish and maintain productive relationships with key internal business partners, consultants, and CROs
- Manage external consultants and vendors
Requirements
- PhD or PharmD in clinical pharmacology, pharmacometrics, or related discipline with at least 8-10 years of experience in the pharmaceutical and/or biotech industry, with proven track record in leading clinical pharmacology efforts for program(s) in late-stage drug development
- Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
- Excellent communication and leadership skills
- Ability to work effectively in a fast-paced, cross-functional environment
- Innovative mindset and enthusiasm for leveraging technology in drug development
