Director, Clinical Science

About this role

POSITION SUMMARY:

We are seeking a Director, Clinical Science to architect trial strategies and protocol execution for our oncology molecular diagnostics portfolio, with a dedicated focus on signal Studies and pipeline expansion. This clinical leadership role shapes the data validation pipeline for our cell-free DNA (cfDNA) technology, transforming population scale genomic profiles into standard-of-care screening benchmarks. Reporting directly to the Senior Director of Clinical Science, you will lead the strategic alignment and tactical delivery of early and late-stage oncology diagnostics protocols. Operating with an active builder mindset, this position co-develops clinical program strategy and drives collaborative execution across clinical development, clinical operations, biostatistics, and translational data science teams.

PRIMARY RESPONSIBILITIES:

Trial Strategy and Protocol Architecture

• Design robust clinical study concepts, specifying overall design parameters, schedules of assessments, trial objectives, clinical endpoints, and patient eligibility criteria

• Lead clinical development activities and protocol design for oncology Signal Studies and portfolio development

• Collaborate cross-functionally to author clinical study protocols, informed consent documents, and technical amendments for internal governance review

• Deliver technical protocol validation training to internal teams and contract research organizations (CROs), and guide case report form (CRF) layout configurations

• Ensure study manuals conform directly to protocol specifications and engage primary clinical investigators during initial trial design phases

Data Interrogation and Cross-Functional Alignment

• Synthesize protocol requirements from investigators, clinical partners, and regulatory bodies, resolving conflicting operational priorities by anchoring team alignment strictly in data

• Partner with cross-functional technical teams to execute clinical programs within exact scope, regulatory compliance, budget, and timeline boundaries

• Serve as the authoritative clinical science representative across technical milestones and external clinical collaborations

• Lead the development of trial execution timelines and deliver unvarnished study status updates to senior leadership

• Lead rigorous clinical data review loops to interrogate datasets for specific validation trends, anchoring trial data cleanliness directly in empirical scientific evidence

• Collaborate with data management teams to write Data Review Plans, track trial outliers, and audit CRF schemas to confirm absolute data fidelity

Scientific Stakeholder Management

• Formulate structured advisory boards, steering committees, and investigator meetings, including the production and delivery of technical evidence presentations

• Advance corporate clinical research pipelines by evaluating both sponsored protocols and investigator-initiated study designs

• Align with cross-functional leadership to pressure-test trial design parameters against long-term development milestones and commercial targets

• Establish strategic relationships with key opinion leaders (KOLs), academic consortiums, and active trial enrollment sites

• Partner with Medical Directors and cross-functional project leads to translate raw trial evidence into technical data sheets, abstracts, and peer-reviewed manuscripts

People and Operations Leadership

• Mentor and develop junior clinical science personnel, implementing process optimizations across team structures, tools, and shared resources

• Manage direct reports, taking accountability for the hiring, onboarding, operational performance, and professional retention of staff talent

• Execute structured competitive intelligence assessments to map the oncology diagnostics landscape and evaluate emerging industry methodologies

• Maintain deep clinical competency across relevant therapeutic domains, oncology biomarkers, and next-generation sequencing frameworks

• Manage trial portfolios in absolute compliance with HIPAA, protected health information (PHI) privacy requirements, and corporate security guidelines

• Independently isolate operational bottlenecks and take full ownership to close execution gaps

QUALIFICATIONS:

• Advanced degree in Life Sciences (MD, PhD, PharmD, MS, RN, or equivalent scientific or clinical credential) required

• 10 or more years of clinical development experience within the pharmaceutical, biotechnology, or diagnostic industry, with a direct focus on oncology trials

• Deep understanding of oncology molecular diagnostics, companion diagnostics (CDx), liquid biopsy performance metrics, or minimal residual disease (MRD) validation pipelines preferred

• Proven track record driving clinical data review workflows, trial data cleaning cycles, protocol development, and technical data reporting

• Sound foundational knowledge of FDA regulations, global health authority trial standards, and Good Clinical Practice (GCP)…