Director, Translational Medicine

Company Overview

Accent Therapeutics is a biopharmaceutical company based in Lexington, MA that is focused on developing first in class and best in class small molecule Inhibitors of RNA modifying enzymes (RMEs) and adjacent pathways to primarily treat cancer. Founded in 2017, named as one of Fortune's Top Ten Workplaces in Healthcare and Biopharma in 2020, and one of Fierce Biotech's Fierce15 in 2020, Accent is building a highly collaborative team of experienced high-caliber drug developers to develop life-changing therapies for patients.

Position Summary

Accent is seeking a Director who will lead the Translational Medicine Team to support Accent's clinical portfolio in clinical development. This individual will apply deep knowledge of cancer biology and clinical assays to design and execute scientifically rigorous strategies to enable clinical development. This individual will be responsible for integration and execution of translational oncology objectives into oncology clinical protocols in cooperation with discovery scientists, clinical study directors, clinical operations, and other members of the program team. The successful candidate will use internal resources and CRO capabilities, as well as collaborate with cross-functional teams. This position reports to the Chief Scientific Officer and will also contribute to overall Research and Development strategy as part of the Translational Research and Translational Medicine Leadership Team.

Responsibilities

• Develop translational analysis strategies and lead their seamless integration into clinical study designs
• Oversee the implementation of the translational analysis plan and deliver high-quality data packages to inform key clinical and regulatory decisions, including dose and schedule selection, patient selection strategies, indication prioritization, and companion diagnostic development
• Build and manage effective working relationship with clinical operations, clinical sciences, translational sciences, regulatory and other key stakeholders
• Oversee the development and implementation of fit-for-purpose clinical biomarker assays for patient selection, pharmacokinetics and pharmacodynamic assessments
• Participate in selection of and management of partner CRO laboratories hosting clinical biomarker assays
• Authorship of biomarker-relevant sections of clinical study-related documents including INDs, clinical protocols, informed consent forms, Investigational Brochures and Lab Manuals
• Collaborate with clinical operations to ensure biomarker clinical trial sample management and timely biomarker data generation
• Collaborate with Translational Biology to define and execute research plans to investigate potential indication expansion opportunities for both single agent and combination strategies
• Support development and execution of future potential CDx strategies
• Effectively communicate biomarker data packages to internal and external audiences

Qualifications and Skills

• PhD in Biology, or a closely related field plus at least 10 years of industry experience or the equivalent expertise
• Experience managing and mentoring multiple direct reports
• In-depth understanding of the operational aspects of clinical trial execution and sample management, with a proven track record of establishing efficient and effective processes
• Deep expertise and knowledge of molecular mechanism of tumorigenesis and familiarity with biomarker discovery, assay development and implementation
• Evidence of expertise in one or more of the following techniques required: Flow cytometry, QPCR, immunohistochemistry, RNA or DNA NGS based techniques or ELISA
• Experience and expertise in managing external outsourced laboratories required
• Demonstrated track record driving collaborative approaches in drug discovery and development with internal as well as external partners
• Familiarity with and experience of working in a GCP environment preferred
• Ability to prioritize, present in an organized and concise manner, manage time efficiently, and implement creative solutions to meet program needs