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

Eikon Therapeutics•Jersey City, NJ

44d•Hybrid

About The Position

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. Ab out 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.

Requirements

MD or DO degree with 10+ years of experience in biomarker research, validation, and interpretation within drug development.
Demonstrated experience in leading the development and regulatory approval of companion diagnostic assays.
Strong understanding of clinical trial design, statistical principles, and regulatory requirements for drug and diagnostic development.
Exceptional analytical and problem-solving skills, capable of uncovering valuable insights from complex data sets.
Strategic thinking and problem-solving abilities with a results-oriented approach.
Experience building and leading high-performing teams.
Ability to thrive in a dynamic, fast-paced, and interdisciplinary biotech environment.

Responsibilities

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 to translational medicine and companion diagnostics.
Build, mentor, and lead a high-performing team of translational scientists and companion diagnostic experts.

Benefits

401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $304,000 to $332,500 depending on skills, competency, and the market demand for your expertise.

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