The Opportunity
Relay Therapeutics is seeking a motivated and patient-centric VP who is looking to have a broad and tangible impact on precision medicine drug development. Reporting into the SVP, Head of Clinical Development, this role will provide medical leadership for our adult and pediatric rare disease programs with our first-in-class small molecules developed via our proprietary protein-motion platform, Dynamo. This role will drive the clinical development strategy from IND to POC to approval, potentially advancing multiple assets across multiple therapeutic areas in rare disease.
Your Role:
- Lead collaboration with drug discovery teams, translational medicine, 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:
- You have earned an MD or MD/PhD with rare disease and preferably pediatric experience
- You know what successful small molecule development looks like and you bring 6+ years of industry experience in early clinical development. We will also consider other highly qualified applicants.
- Ideal applicants have demonstrated success in a fast-paced small biotechnology company setting.
- You have experience in design and execution of innovative clinical trials including design and development of clinical protocols and statistical analysis plans.
- You have outstanding interpersonal and communication skills both written and oral and ability to communicate complex information clearly and succinctly.
- You have excellent leadership skills and proven ability to effectively work in a cross-functional/matrix environment.
- You know how to work collaboratively with experts and leaders across Research, Pharmaceutical Development, Clinical, Regulatory and Strategy & Operations.
- You have an unwavering commitment to help patients who suffer from debilitating diseases.
**This role is based in Cambridge, MA**
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!
