Distinguished Scientist, Companion Diagnostics
$210,400–$331,100 year
Hybrid · Boston, Massachusetts, United States or Rahway, New Jersey, United States
Job Summary
Lead and oversee CDx strategy and cross-functional DxDT teams to develop and implement diagnostic projects in oncology, supervising PhD-/MD-level staff and coordinating with external Dx partners. Drive CDx development through selection of assays/platforms, oversee regulatory documentation (pre-submissions, IDEs, PMAs, PSAs) and regulatory agency engagements, and collaborate with clinical, biomarker, regulatory, and commercial teams to meet program goals. Identify and assess novel technologies, guide pilot studies with Dx vendors, and ensure integration of DP efforts when applicable. Provide CDx expertise for due diligence, global trials, and regulatory submissions, while contributing to the strategic direction and governance of DxDT programs and partnering with global pharma teams to advance biomarker-enabled decision making in oncology.
Required Qualifications
- PhD required
- Minimum of 8 years of industry experience
- Extensive experience with biomarker platforms (e.g., NGS, IHC, PCR)
- Track record in CDx development and regulatory submissions
- Peer-reviewed publications or patents demonstrating diagnostic development expertise
- Ability to lead cross-functional teams and engage with global health authorities
- Strong communication and leadership skills
Desired Qualifications
- PhD required
- Experience leading cross-functional teams
- Biomarker development experience
- CDx regulatory submission experience
- Experience with NGS/IHC/PCR
- Oncology biomarker program leadership
- Strong written and verbal communication skills
- Leadership and strategic thinking abilities
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