The Opportunity
Relay Therapeutics is seeking a motivated and patient-centric Senior Medical Director for our PI3Kα inhibitor precision oncology programs that focus on highly novel, mutant-selective, allosteric PI3Kα inhibitors developed via our proprietary protein-motion platform, Dynamo. This role will drive the clinical development strategy from IND to POC to approval to advance multiple PI3Kα assets.
Your Role:
- Lead collaboration with drug discovery teams, translational oncology, clinical operations, Phase 1 investigators and disease-specific experts to design and oversee execution of early clinical development plans that definitively test key translational hypotheses for Relay Tx medicines and establish clinical proof-of-concept as soon as possible after entering human testing.
- Design and oversee execution of multi-layered clinical development strategies, in compliance with regulatory guidelines, that identify opportunities for breakthrough therapy designation and accelerated approval while identifying subsequent opportunities for label expansion in a science-driven manner.
- Lead authoring of clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of ex-US studies and responses to questions from regulatory authorities, IRBs, and ethics committees.
- Inform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities.
- Oversee drug safety and pharmacovigilance activities for ongoing trial(s).
- Rapidly integrate new insights derived from on-going Relay Tx or external clinical trials, translational science or basic science into Relay Tx development plans and clinical trial activities.
- Create compelling data presentations for external disclosures.
- Proactively manage communication and build strong collaborative relationships with key stakeholders both internally and externally, including interactions with academic experts, clinical trial investigators, and other clinical stakeholders.
- Ensure Relay Tx maintains the highest standards of compliance and ethical behavior in the design, conduct, interpretation and communication of clinical trials, clinical trial data, and clinical trial results.
Your Background:
- MD required and MD/PhD preferred
- 5+ years of industry experience preferred, but will consider other highly qualified applicants
- Experience developing targeted oncology products in molecularly selected patient populations is strongly preferred.
- Experience in design and execution of innovative precision medicine trials including design and development of the clinical protocol and statistical analysis plans.
- Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information clearly and succinctly.
- An unwavering commitment to help patients who suffer from debilitating diseases
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About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
