Director, Clinical Science

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) guidelines

Experience directly managing scientif…