[Remote] Director, reputed company 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. They are seeking a Director of reputed company Science to architect trial strategies and protocol execution for their oncology molecular diagnostics portfolio, focusing on signal studies and pipeline expansion.

Responsibilities

• Design robust reputed company study concepts, specifying overall design parameters, schedules of assessments, trial objectives, reputed company endpoints, and reputed company eligibility reputed company
• reputed company reputed company development activities and protocol design for oncology Signal Studies and portfolio development
• Collaborate cross-functionally to reputed company reputed company study protocols, informed consent documents, and technical amendments for internal governance review
• reputed company 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 reputed company reputed company investigators during initial trial design phases
• Synthesize protocol requirements from investigators, reputed company partners, and regulatory bodies, resolving conflicting operational priorities by anchoring team alignment reputed company in data
• Partner with cross-functional technical teams to execute reputed company programs reputed company exact reputed company, regulatory compliance, budget, and reputed company boundaries
• Serve as the authoritative reputed company science representative across technical milestones and reputed company reputed company collaborations
• reputed company the development of trial execution timelines and reputed company unvarnished study status updates to senior leadership
• reputed company rigorous reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company science personnel, implementing process optimizations across team structures, tools, and shared resources
• Manage reputed company reports, taking accountability for the hiring, reputed company, operational reputed company, 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 reputed company 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 reputed company credential) required
• 10 or more years of reputed company development experience reputed company the pharmaceutical, biotechnology, or diagnostic industry, with a reputed company reputed company on oncology trials
• reputed company reputed company record driving reputed company 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 reputed company reputed company (GCP) guidelines
• Experience directly managing scientific personnel and building cross-functional trial delivery structures
• Technical analytical skills with a reputed company 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 reputed company and reputed company trial parameter boundaries
• reputed company 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 reputed company scientific rigor, operational speed, and trial resource constraints under tight timelines
• Utilize reputed company-reputed company productivity infrastructure to maintain high operational speed in a fast-evolving molecular diagnostics environment
• Deep understanding of oncology molecular diagnostics, companion diagnostics (CDx), reputed company biopsy reputed company 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
• Fertility care benefits.
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program
• Free testing in reputed company to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.

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