BeOne Medicines

Director CDx Development

BeOne Medicines

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $176,600 - $236,600 per year

Job Level

Lead

About the role

  • Lead the development and execution of integrated CDx strategies across clinical development programs, ensuring alignment with overall drug development objectives and timelines.
  • Engage early with Translational Discovery and Research teams to understand predictive hypotheses and biomarker strategies for pipeline programs.
  • Partner with internal research teams and external vendors to develop predictive assays when suitable assays are not already available.
  • Define and advance CDx strategies through internal governance bodies, securing timely alignment and endorsement.
  • Collaborate cross-functionally to define Diagnostic Target Product Profiles and identify optimal diagnostic platforms and CDx partners.
  • Work closely with Regulatory Affairs to support the preparation and submission of regulatory documentation (e.g., IDEs, PMAs) and to interact with global health authorities as needed.
  • Oversee CDx development activities to ensure on-time delivery of diagnostic kits to support pharmaceutical registration and commercial launch.
  • Provide clear, proactive communication to cross-functional stakeholders on CDx program progress, risks, and mitigation strategies.
  • Monitor and interpret emerging industry trends, technology advancements, and evolving regulatory requirements related to IVDs and companion diagnostics.

Requirements

  • PhD with a minimum of 5+ years of industry experience in clinical biomarker testing and companion diagnostics development
  • Strong scientific and technical expertise in clinical development, biomarker strategies, and regulatory requirements for IVD and CDx products
  • Hands-on knowledge of diagnostic platforms such as NGS, IHC, FISH, and related technologies
  • Proven ability to lead complex, cross-functional programs to completion on time and within budget
  • Strong analytical and strategic thinking skills, with the ability to make data-driven decisions in ambiguous or complex situations and to think at a portfolio level
  • Demonstrated ability to influence and align stakeholders across development and commercial organizations without direct authority
  • Excellent communication skills, with the ability to convey complex scientific and strategic concepts clearly to both technical and non-technical audiences
  • Experience working effectively in a matrixed environment and leading cross-functional teams.
Benefits
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness
Applicant Tracking System Keywords

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

Hard Skills & Tools
clinical biomarker testingcompanion diagnostics developmentregulatory requirements for IVDregulatory requirements for CDx productsdiagnostic platformsNGSIHCFISHdata-driven decision makingcross-functional program management
Soft Skills
analytical thinkingstrategic thinkinginfluencing stakeholderscommunication skillsproactive communicationleadershipcollaborationproblem-solvingadaptabilityteam leadership
Certifications
PhD