As a Senior Medical Director at Relay Tx, you will advance our clinical pipeline from IND to proof of concept to registration. Specifically, you will lead development of the clinical strategy, clinical trial design, and execution. Working cross-functionally with clinical project management, regulatory affairs, clinical operations, biostatistics, data management and medical writing, you will play a key leadership role as Relay Tx continues to introduce product candidates into the clinic. You will provide clinical leadership to R&D teams and will report to our Chief Medical Officer.
- 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.
- Write 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.
- Lead regular teleconferences with academic clinical investigators.
- Inform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authorities.
- Manage 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.
- Collaborate with research leadership and drug discovery teams to shape the Relay Tx drug discovery portfolio.
- 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.
- A dynamic team player and effective communicator that thrives in a fast-paced small biotech environment.
- MD, MD/PhD or other advanced degree with 5+ years of experience in oncology clinical development experience in academic and/or industry settings. Development of targeted oncology products in molecularly selected patient populations is strongly preferred.
- Experience in design and executing clinical trials; protocol development and design, development of case report forms, and statistical analysis plans.
- Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trials.
- Excellent written and oral communication skills.
- The successful applicant will thrive in the Relay Tx corporate culture where the core values are relentless, fearless, craftsmanship, candor, and humanity. You will be a key clinical leader enabled to make a significant positive impact for patients.
We believe in building balanced teams and a place where our people can be their best self every day. We encourage people from underrepresented backgrounds to apply.
Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
At Relay Tx, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line.
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.