Medical Director

Role Summary

Medical Director at Relay Tx to advance our clinical pipeline from IND to proof of concept to registration. You will collaborate with senior medical staff to drive 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 role as Relay Tx continues to introduce product candidates into the clinic. You will provide clinical leadership to R&D teams and work closely with Development leadership. Location: Remote.

Responsibilities

• Collaborate with senior medical staff, drug discovery teams, translational oncology, clinical operations, clinical investigators and disease-specific experts to design and execute 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.
• Write clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs for initiation of ex-US studies, and work with senior medical staff to respond to questions from regulatory authorities, IRBs, and ethics committees.
• Provide expert medical review, assessment, and interpretation of clinical data and prepare results for presentation to internal clinical development leadership and external stakeholders including regulatory authorities.
• Manage drug safety and pharmacovigilance activities for ongoing trial(s).
• Attend and support clinical site initiation visits.
• Rapidly integrate new insights derived from ongoing Relay Tx or external clinical trials, translational science or basic science into Relay Tx development plans and clinical trial activities.
• 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.
• 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.

Qualifications

• A dynamic team player and effective communicator that thrives in a fast-paced environment.
• Experience working with solid tumors; breast oncology preferred.
• MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in academic and/or industry settings with work in oncology.
• Exposure to design and execution of clinical trials; protocol development and design, development of case report forms, and statistical analysis plans.
• Exposure to 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.