Executive Director, Companion Diagnostics & Clinical Biomarkers
Tango Therapeutics
7 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
We are seeking an Executive Director, Companion Diagnostics & Clinical Biomarkers to own the strategy and execution of companion diagnostics (CDx) and all clinical biomarker efforts across the oncology portfolio.
Responsibilities:
- Own CDx strategy and execution across all relevant programs
- Drive delivery of IHC- and NGS-based CDx to support pivotal studies and approvals
- Partner with Program Management to align therapeutic development timelines with CDx readiness
- Identify risks early and drive mitigation to avoid delays in clinical or regulatory timelines
- Integrate biomarkers into clinical trials to support eventual CDx claims, including:
- Patient selection strategies
- Operational execution across global study sites
- Partner with Regulatory Affairs to define and support CDx regulatory submission plans
- Ensure CDx development activities align with requirements for approval and labeling
- Contribute CDx expertise to regulatory interactions and documentation
- Lead selection, negotiation, and management oversight of diagnostic partners and vendors
- Serve as primary point of accountability for external clinical biomarker collaborations
- Drive performance, timelines, and deliverables across partners
- Partner with Clinical Development, Clinical Operations, Medical Affairs, Translational Sciences, Data Management, Quality & Compliance, and Regulatory Affairs
- Embed CDx strategy into clinical development plans and key decision-making forums
- Drive alignment across functions to support efficient program execution
- Ensure biomarker efforts focus on clinical utility and CDx enablement
Qualifications:
- PhD (or equivalent) and 15+ years of experience in biotechnology/pharmaceutical industry
- Significant precision oncology and companion diagnostics experience, including driving and executing regulatory strategy
- Demonstrated track record of owning and delivering CDx programs
- Deep understanding of CDx co-development with therapeutics
- Direct experience supporting/leading CDx through domestic and international regulatory approval (e.g., FDA PMA, CE mark, PMDA)
- Experience with both IHC and NGS-based diagnostics
- Proven ability to lead and manage external diagnostic partnerships
Execution Profile (desired capabilities):
- Operator with a track record of delivering complex, cross-functional programs
- Strong ownership mindset; accountable for decisions, timelines, budgets, and outcomes
- Experienced navigating drug–diagnostic co-development challenges
- Effective at driving alignment across internal teams and external partners
- Focused on practical execution and results
Responsibilities:
- Own CDx strategy and execution across all relevant programs
- Drive delivery of IHC- and NGS-based CDx to support pivotal studies and approvals
- Partner with Program Management to align therapeutic development timelines with CDx readiness
- Identify risks early and drive mitigation to avoid delays in clinical or regulatory timelines
- Integrate biomarkers into clinical trials to support eventual CDx claims, including:
- Patient selection strategies
- Operational execution across global study sites
- Partner with Regulatory Affairs to define and support CDx regulatory submission plans
- Ensure CDx development activities align with requirements for approval and labeling
- Contribute CDx expertise to regulatory interactions and documentation
- Lead selection, negotiation, and management oversight of diagnostic partners and vendors
- Serve as primary point of accountability for external clinical biomarker collaborations
- Drive performance, timelines, and deliverables across partners
- Partner with Clinical Development, Clinical Operations, Medical Affairs, Translational Sciences, Data Management, Quality & Compliance, and Regulatory Affairs
- Embed CDx strategy into clinical development plans and key decision-making forums
- Drive alignment across functions to support efficient program execution
- Ensure biomarker efforts focus on clinical utility and CDx enablement
Qualifications:
- PhD (or equivalent) and 15+ years of experience in biotechnology/pharmaceutical industry
- Significant precision oncology and companion diagnostics experience, including driving and executing regulatory strategy
- Demonstrated track record of owning and delivering CDx programs
- Deep understanding of CDx co-development with therapeutics
- Direct experience supporting/leading CDx through domestic and international regulatory approval (e.g., FDA PMA, CE mark, PMDA)
- Experience with both IHC and NGS-based diagnostics
- Proven ability to lead and manage external diagnostic partnerships
Execution Profile (desired capabilities):
- Operator with a track record of delivering complex, cross-functional programs
- Strong ownership mindset; accountable for decisions, timelines, budgets, and outcomes
- Experienced navigating drug–diagnostic co-development challenges
- Effective at driving alignment across internal teams and external partners
- Focused on practical execution and results