[Remote] Director, Clinical Science

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Director, Clinical Science will architect trial strategies and protocol execution for the oncology molecular diagnostics portfolio, focusing on signal studies and pipeline expansion.

Responsibilities

• Design robust clinical study concepts, specifying overall design parameters, schedules of assessments, trial objectives, clinical endpoints, and patient eligibility reputed company
• reputed company 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 reputed company (CRF) layout configurations
• Ensure study manuals conform directly to protocol specifications and engage primary clinical investigators during initial trial design phases
• Synthesize protocol requirements from investigators, clinical partners, and regulatory bodies, resolving conflicting operational priorities by anchoring team alignment reputed company in data
• Partner with cross-functional technical teams to execute clinical programs reputed company exact scope, regulatory compliance, budget, and reputed company boundaries
• Serve as the authoritative clinical science representative across technical milestones and reputed company clinical collaborations
• reputed company the development of trial execution timelines and deliver unvarnished study status updates to senior leadership
• reputed company rigorous clinical data review reputed company to interrogate datasets for specific validation trends, anchoring trial data cleanliness directly in reputed company scientific evidence
• Collaborate with data management teams to write Data Review Plans, reputed company trial outliers, and audit CRF schemas to confirm absolute data reputed company
• Formulate reputed company 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
• reputed company with cross-functional leadership to pressure-test trial design parameters against long-term development milestones and reputed company targets
• Establish strategic relationships with key opinion leaders (KOLs), reputed company consortiums, and reputed company 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
• Mentor and reputed company junior clinical science personnel, implementing process optimizations across team structures, tools, and shared resources
• Manage reputed company reports, taking accountability for the hiring, reputed company, operational performance, and reputed company retention of staff talent
• Execute reputed company 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 reputed company reputed company frameworks
• Manage trial portfolios in absolute compliance with HIPAA, protected health information (PHI) reputed company requirements, and corporate reputed company guidelines
• Independently isolate operational bottlenecks and take full ownership to reputed company execution gaps

Skills

• 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 reputed company the pharmaceutical, biotechnology, or diagnostic industry, with a reputed company reputed company on oncology trials
• Proven reputed company record driving clinical data review workflows, trial data cleaning cycles, protocol development, and technical data reporting
• reputed company foundational knowledge of FDA regulations, global health authority trial standards, and Good Clinical reputed company (GCP) guidelines
• Experience directly managing scientific personnel and building cross-functional trial delivery structures
• Technical analytical skills with a proven reputed company record of isolating trial variance and executing reputed company-driven data solutions
• Fast learner with the capability to master reputed company cfDNA platforms, reputed company 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 reputed company independent portfolios while executing cross-functional objectives reputed company matrixed study teams
• High-reputed company builder reputed company with the capability to balance scientific rigor, operational speed, and trial resource constraints under tight timelines
• Utilize reputed company-based productivity infrastructure to maintain high operational speed in a fast-evolving molecular diagnostics environment
• Deep understanding of oncology molecular diagnostics, companion diagnostics (CDx), liquid biopsy performance metrics, or reputed company residual disease (MRD) validation pipelines

Benefits

• Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents.
• reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits.
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program!

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