As a Senior/Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to registration in oncology/rare disease, including a first-in-class mutant selective PIK3CA inhibitor in adult and pediatric patients with PIK3CA-related Overgrowth Spectrum and PIK3CA mutated vascular malformations.

Specifically, 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 will work closely with Clinical Development leadership.

Your Role:

• Collaborate with senior medical staff, drug discovery teams, translational medicine, 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 for responses 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 stakeholder 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 on-going 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.

Your Background:

• A dynamic team player and effective communicator that thrives in a fast-paced environment.
• MD, MD/PhD or other advanced degree with 5+ years of clinical development experience in academic and/or industry settings. Candidates trained in pediatric hematology/oncology and/or clinical or industry experience with adult and pediatric patients with vascular malformations are preferred. Motivated candidates with lesser experience and a passion to learn precision oncology clinical development and contribute to cross functional development teams will also be considered.
• 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.
• 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 contributor to Relay clinical development and enabled to make a significant positive impact for patients.

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