Executive Director, Clinical R&D; Translational Medicine and Companion Diagnostics

Executive Director, Clinical R&D (Translational Medicine and Companion Diagnostics)

Jersey City, NJ

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Position

As Executive Director of Translational Medicine and Companion Diagnostics, you will play a vital role to lead our efforts in bridging preclinical discovery to clinical development and ensuring the successful integration of companion diagnostics, driving biomarker research strategies for our groundbreaking biotechnology solutions. Collaborating closely with cross-functional teams, you will lead the identification, validation, and interpretation of biomarkers, and implementation of companion diagnostic assays to support our innovative pipeline.

About You

The ideal candidate will be a strategic thinker with a strong scientific background, proven leadership skills, and a deep understanding of drug development and regulatory pathways and bring extensive expertise in biomarker research, validation, and interpretation, as well as experience in companion diagnostic development. Their strategic leadership, dedication to pioneering research, and commitment to technology integration make them the ideal choice for driving visionary strategies, collaborating effectively with diverse teams, and advancing biotechnology in a dynamic and interdisciplinary setting.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in our New Jersey office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth and collaboration.

What You’ll Do

• Collaborate with cross-functional teams to develop and implement a comprehensive translational medicine strategy aligned with the company's overall drug development goals.
• Provide strategic input into preclinical and clinical development plans, ensuring seamless translation of scientific findings.
• Identify and champion novel translational approaches and technologies to enhance drug development.
• Establish and maintain strong collaborations with internal research, clinical development, regulatory affairs, and commercial teams.
• Lead the identification, validation, and implementation of relevant biomarkers (pharmacodynamic, predictive, prognostic) to inform clinical trial design, patient selection, and drug response monitoring.
• Oversee the development and execution of biomarker plans within clinical protocols.
• Ensure the rigorous scientific validation and clinical utility of identified biomarkers.
• Foster partnerships with internal and external experts, harnessing diverse knowledge to advance biomarker research.
• Drive the incorporation of advanced technology platforms for biomarker discovery, optimizing analysis and assessment.
• Contribute to the scientific community through publications, presentations, and active engagement in knowledge-sharing.
• Lead the strategy and execution for the development and regulatory approval of companion diagnostic assays in collaboration with diagnostic partners.
• Oversee the selection and management of diagnostic development partners.
• Ensure the timely and successful integration of companion diagnostics into clinical trials and commercialization strategies.
• Maintain a thorough understanding of relevant regulatory guidelines for companion diagnostics (e.g., FDA, EMA).
• Ensure all translational medicine and companion diagnostic activities are conducted in compliance with relevant regulatory guidelines and ethical standards.
• Contribute to regulatory submissions, including INDs, NDAs/BLAs, and companion diagnostic premarket approvals/supplements.
• Interact with regulatory agencies on matters related…