BeOne Medicines logo
BeOne Medicines

Cancer has no borders. Neither do we.

Director CDx Development

DirectorDirectorFull TimeRemoteLeadTeam 10,001+Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$176.6K - $236.6K / year

Seniority

Lead

Postgraduate Degree5 yrs expEnglish

Job Description

• 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.

Job 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

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