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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in oncology biomarker studies and translational clinical research, with a strong focus on clinical trial development and execution. Proven ability to lead cross-functional teams and communicate effectively with health authorities while driving biomarker strategy and implementation.
Highest-signal resume keywords
Ph.D. Or M.D.15 Years' Experience In Oncology Biomarker StudiesClinical Trial Development And ExecutionLeadership In Matrixed Team EnvironmentBiomarker Discovery And Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Translational ResearchBiomarker DevelopmentClinical OncologyCancer BiologyCancer ImmunologyStatistical AnalysisData CommunicationExperimental ResearchBioinformaticsDrug Development
Soft Skills
Strong Leadership SkillsStrong Communication SkillsAnalytical Skills
Tools & Technologies
BiostatisticsMolecular AssaysClinical Development PlatformsDiagnostics
Industry Keywords
End-To-End Drug DevelopmentHealth Authority EngagementsEU IVDRChina HGRACJapan PMDAOncology Drug DiscoveryCompanion Diagnostics
About the role
Key responsibilities & impact- Lead one of the company's Biomarker Centers of Excellence
- Supervise PhD-/MD-level scientists
- Develop and oversee end-to-end biomarker strategy for oncology therapeutic platforms from pre-FIH through Phase 3 and beyond
- Oversee cross-functional translational efforts on key oncology therapeutic platforms
- Oversee translational biomarker efforts across clinical product development teams and multiple indications
- Lead scientists embedded in oncology clinical development programs
- Formulate testable hypotheses and develop clinical biomarker and translational research strategies
- Align development-team strategy with broader portfolio strategy
- Identify scientific gaps and risks and develop mitigation plans
- Collaborate with experimental, bioinformatics, statistical, and clinical experts on statistical analysis plans, analysis reports, and data communication plans
- Participate in data analysis and interpretation
- Communicate study plans, updates, and outputs across functions
- Collaborate with development, discovery, informatics, diagnostics, modeling, biostatistics, and molecular assay teams to author biomarker plans and ensure implementation
- Evaluate novel technologies and platforms for clinical biomarker analysis
- Engage external key opinion leaders in hypothesis-driven collaborations
- Drive publication of biomarker and translational research
- Interface with translational and discovery laboratories on preclinical and translational projects
- Partner with clinical, BMx, and companion diagnostics teams to ensure efficient biomarker implementation
- Contribute to health authority engagements, registrational efforts, and post-marketing commitments
- Provide translational and biomarker expertise for due diligence teams
- Report to the head of the Translational Clinical Biomarker team
Requirements
What you’ll need- Ph.D., M.D., or M.D./Ph.D.
- Minimum of 15 years' experience in oncology biomarker studies and translational clinical research
- Extensive experience in clinical trial development and execution
- Clear strategic view on translational needs in clinical studies
- Experience with experimental and bioinformatic aspects of translational research and biomarker development
- Strong leadership skills in a matrixed team environment
- Proven track record in cross-functional, highly matrixed collaborative groups on drug discovery and/or clinical development
- Proven track record in biomedical research, scientific scholarship, and achievement
- In-depth understanding of end-to-end drug and BMx/diagnostic development
- Experience in biomarker discovery, biomarker and diagnostic development, and early or late drug development
- Strong scientific expertise in translational and biomarker work involving antibody-drug conjugates and T cell engagers
- Deep scientific knowledge of cancer biology and cancer immunology
- Strong working knowledge of clinical oncology
- Strong communication and analytical skills
- Experience communicating with health authorities
- Experience with EU IVDR, China HGRAC, Japan PMDA, and other global markets for BMx and translational analyses strongly preferred
- Prior direct management experience leading PhD-/MD-level scientists with a demonstrated passion for and track record of talent development
- Prior experience in oncology drug discovery strongly preferred
- Must be based in New Jersey, Pennsylvania, or Boston area locations listed for the role
- No visa sponsorship
- 25% travel required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement