Associate Director, Clinical Science

POSITION SUMMARY:

We are seeking an Associate Director, Clinical Science to architect trial strategies and protocol execution for our oncology biobanking studies and specimen repositories. 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 Neda Huseinovic, Senior Director of Clinical Science, you will lead the strategic alignment and tactical delivery of complex biobanking clinical protocols. Operating with an active builder mindset, this position co-develops clinical program strategy and drives collaborative execution across clinical operations, biostatistics, and translational data science teams, directly managing the clinical scientists embedded within the biobanking workstream.

PRIMARY RESPONSIBILITIES:

Trial Strategy and Protocol Architecture

• Design robust clinical study concepts, specifying overall design parameters, sample-size logic, schedules of assessments, trial objectives, clinical endpoints, and patient eligibility criteria
• Lead clinical development activities and protocol design for oncology biobanking studies and biospecimen repository portfolios
• Collaborate cross-functionally to author clinical study protocols, informed consent documents (ICFs), 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 across 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 biospecimen and clinical datasets, 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 to advance personalized oncology diagnostics
• Partner with Medical Directors and cross-departmental 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 supporting biobanking initiatives, taking explicit accountability for hiring, training, developing, and retaining 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, next-generation sequencing, and cell-free genomic testing variations
• Manage trial portfolios in absolute compliance with HIPAA, protected health information (PHI) privacy requirements, and corporate security guidelines
• Independently isolate trial execution bottlenecks and take full ownership to close operational gaps

QUALIFICATIONS:

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

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 complex 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