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 scientific personnel and building cross-functional trial delivery structures
KNOWLEDGE, SKILLS, AND ABILITIES: - Technical analytical skills with a proven track record of isolating trial variance and executing target-driven data solutions
- Fast learner with the capability to master complex cfDNA platforms, bioinformatics workflows, and molecular assays rapidly
- Precise written and verbal communication styles with strict attention to raw data detail and clinical trial parameter boundaries
- Proven capability to drive independent portfolios while executing cross-functional objectives within matrixed study teams
- High-growth builder mindset with the capability to balance scientific rigor, operational speed, and trial resource constraints under tight timelines
- Utilize cloud-based productivity infrastructure to maintain high operational speed in a fast-evolving molecular diagnostics environment
Physical Demands and Work Environment- Modern office or home office environment with reliable, secure internet access infrastructure
- Standard requirements for computer operation, telephone communications, and continuous review of scientific data files
- Flexibility to engage with clinical collaborators and study teams across international, global time zones
- Ability to engage in work-related international and domestic travel up to 25% to manage site performance and support conference execution
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$192,600-$240,800 USD
