Associate Director, Clinical Science
$174,700–$218,400 year
Remote · United States or US
Job Summary
Associate Director, Clinical Science to architect trial strategies and protocol execution for oncology biobanking studies and cfDNA technology; lead cross-functional teams across clinical operations, biostatistics, and translational data science; design robust study concepts, specify design parameters, sample-size logic, schedules, endpoints, and eligibility; author clinical study protocols, informed consent documents, and amendments; validate protocols and CRF layouts; ensure data fidelity and regulatory compliance; mentor junior staff and manage biobanking initiatives; apply expertise in oncology diagnostics, cfDNA platforms, and data review workflows to drive clinical program delivery.
Required Qualifications
- Advanced degree in Life Sciences (PhD, MD, PharmD, MS, RN, or equivalent scientific or clinical credential) required
- 8+ years of clinical development experience within the pharmaceutical, biotechnology, or diagnostic industry, with a dedicated focus on oncology trials
- Deep understanding of oncology molecular diagnostics, companion diagnostics (CDx), liquid biopsy performance metrics, minimal residual disease (MRD) validation pipelines, or biospecimen repository frameworks
- Proven track record driving clinical data review workflows, trial data cleaning cycles, protocol development, randomized controlled trials (RCTs), and technical data reporting
- Foundational knowledge of FDA regulations, In Vitro Diagnostics (IVD) standards, global health authority trial benchmarks, and Good Clinical Practice (GCP) guidelines
- Documented experience directly managing scientific staff and building matrixed trial delivery structures
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