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Day One Biopharmaceuticals · 1 day ago

Director, Precision Medicine

United States

Full-time

Remote

Director/Executive

$215K/yr - $230K/yr

10+ years exp

Day One Biopharmaceuticals is focused on advancing first- or best-in-class medicines for childhood and adult diseases. They are seeking a scientific leader to develop and maintain precision medicine vision and strategy, providing expertise in clinical diagnostics across their portfolio of targeted therapeutics for cancer.

BiopharmaBiotechnologyHealth CarePharmaceutical

No H1B

Responsibilities

Develop and maintain precision medicine vision and strategy through cross-functional partnership with Leadership of Clinical Development, Translational Research, Regulatory Sciences, Clinical Pharmacology, and Commercial, as well as other Day One functions

Design and implement hypothesis-driven strategies to deliver evidence of target engagement, mechanisms of action/resistance, patient selection/CDx strategies and other clinically-relevant biomarker endpoints to advance the Day One pipeline

Provide technical, clinical and regulatory expertise in assay development and diagnostics (NGS, IHC, Immunoassays along with emerging biomarker technologies and platforms) across diverse stakeholders comprising leadership in Research and Development, Commercial, Regulatory Sciences, Medical Affairs, and Patient Advocacy, including but not limited to, training, education, and representation on behalf of our Translational and Precision Medicine-related events

Effectively partner with Precision Medicine leaders to execute on the development of clinical biomarkers, assay development through companion diagnostics to maximize patient access to Day One drugs

Manage external diagnostic partners, CROs, academic collaborators, and vendors to ensure high-quality biomarker and CDx deliverables

Leadership expertise in developing and maintaining precision medicine screening strategies across clinical programs, leveraging your extensive experience in testing report interpretation

Author and review Precision Medicine related publications as well as appropriate sections in clinical study / regulatory documents (i.e. INDs, IBs, trial protocols/ops manuals, ICFs, IRB responses, HA Briefing Books, CSRs, etc.)

Work closely with Business Development and Precision Medicine leaders to support candidate asset acquisition assessments through clinical biomarker and CDx considerations

Develop and implement comprehensive clinical biomarker strategy across clinical programs

Lead the strategic planning and execution of CDx development, including assay selection, analytical validation strategies, clinical validation plans, and alignment with regulatory and commercial partners

Help Day One remain a leader in oncology drug development across all ages

Engaging, inspiring, and successfully communicating with employees of any level in the organization

Understanding and embracing one of our highest values: that the most precious asset is our team

Proactively contributing to company-building and process evolution as we grow

Qualification

Precision Medicine StrategyClinical Biomarkers DevelopmentAssay DevelopmentOncology Drug DevelopmentDiagnostic Testing ExpertiseScientific CommunicationTeam LeadershipIntegrityTrustworthinessCreative Problem SolvingMentorship

Required

Bachelor's degree in biology, immunology, chemistry, pharmacology, biochemistry, or related discipline

10+ years' experience in commercial diagnostic testing and/or oncology drug discovery/development setting within the biopharmaceutical industry (biotech or large pharma)

A diverse background across assay, diagnostics, cancer biology, and drug development is required with relevant expertise in the interpretation of clinical molecular diagnostic testing reports

Understanding of clinical biomarkers and Companion Diagnostics development strategy and execution is strongly desired

Ability to interpret complex molecular and clinical datasets and translate insights into program strategy

Unwavering integrity and trustworthiness, embodying Day One's core values

Eloquent and passionate when talking about science and the potential to help patients

Keen scientific acumen and intellectual curiosity, good judgement, and the highest scientific integrity

Curious, creative with an ability to think outside of traditional drug development and corporate models

A team player and a mentor – someone who cares for their colleagues as people as well as contributors and collaborators, while delivering results

Inspires the confidence of others, and inspires others to fulfill their potential

The ability to elicit and synthesize information from a range of individuals and sources rapidly and clearly communicate findings across the organization