The Opportunity
Relay Therapeutics is seeking a motivated and patient-centric VP who is looking to have a broad and tangible impact on pivotal precision medicine drug development in breast cancer. Reporting into the SVP, Head of Clinical Development, this role will provide medical leadership for our breast cancer therapeutic area, including driving forward late phase pivotal development for our first-in-class allosteric pan-mutant selective PI3Kα inhibitor, RLY-2608, in HR+ HER2- advanced breast cancer to registration. This role will also drive forward clinical strategy in breast cancer, including combination studies, other populations within breast cancer and potentially other assets in the therapeutic area.
Your Role:
- Drive forward the clinical strategy and study design and oversee execution of pivotal clinical development to registration of RLY-2608 in second line HR+ HER2- advanced breast cancer, in collaboration with clinical operations, clinical science, biostatistics, regulatory, medical affairs, disease-specific experts and Phase 3 investigators
- Collaborate with early clinical development, translational medicine, biology, pharmacology and new product planning to develop novel combinations with RLY-2608 for indication expansion in breast cancer, including earlier lines of therapy and other subtypes of breast cancer, as well as potential novel assets in breast cancer
- Lead authoring of clinical sections of key documents, including Investigator’s Brochures, CTAs for initiation of ex-US studies and responses to questions from regulatory authorities, IRBs, and ethics committees and Clinical Study Reports.
- 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 equivalent degree) with oncology experience, and preferably are an oncologist
- You have experience clinical and/or development experience in advanced breast cancer, preferably with existing relationships with global disease experts
- You know what successful small molecule development looks like and you bring 6+ years of industry experience in late-stage clinical development, preferably through registration
- You have experience developing targeted oncology products in molecularly selected patient populations.
- You have experience in design and execution of innovative late phase 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.
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!