Day One Biopharmaceuticals

Director, Precision Medicine

Day One Biopharmaceuticals

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $215,000 - $230,000 per year

Job Level

Lead

About the role

  • 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

Requirements

  • Bachelor’s degree (PhD or MD/PhD preferred) 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, and understanding of clinical biomarkers and Companion Diagnostics development strategy and execution is strongly desired
  • Pediatric oncology and/or rare disease experiences are highly desirable,
  • 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.
Benefits
  • Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
assay developmentdiagnosticsNGSIHCimmunoassaysbiomarker technologiesclinical biomarker strategyanalytical validationclinical validationinterpretation of clinical molecular diagnostic testing reports
Soft skills
leadershipcommunicationteam playermentorshipintegrityscientific acumenintellectual curiositycreativityjudgmentinspiration
Certifications
PhDMD/PhD