OraGrowtH Scientific Data Review and Database Readiness

• Conduct scheduled, ongoing review of blinded patient-level clinical data and listings for completeness, consistency, trends and scientific plausibility, within approved access and blinding procedures.
• Identify missing or out-of-window assessments, inconsistent dates, unusual or implausible growth measurements, laboratory discrepancies, important protocol deviations, and other clinically meaningful data anomalies.
• Document scientific findings, raise and track scientific queries with Data Management and relevant functions, and follow them through to documented resolution; identify recurring patterns and recommend preventive actions.
• Escalate potential safety concerns, unblinding risks, and matters requiring medical judgment promptly to the Medical Director or designated medical lead; do not independently make medical or participant-care decisions.
• Contribute to ongoing data-cleaning priorities, review of critical data, interim readiness checkpoints and database lock preparedness throughout the study.

Screening, Protocol Support and Site Scientific Training

• Help sites understand approved inclusion/exclusion criteria, screening requirements, assessment schedules and documentation expectations; check screening information for completeness before sponsor medical review, without making final medical eligibility determinations.
• Track recurring screening delays, screen failures, and protocol questions; work with Clinical Operations and the medical lead to identify causes and implement appropriate corrective actions.
• Maintain a consistent, version-controlled log of protocol questions and approved scientific responses; route interpretations requiring medical judgment or formal protocol clarification to the medical lead.
• Provide targeted, approved scientific training on growth measurements, hormone biomarkers, and other critical assessments at investigator meetings, site initiation visits, or follow-up sessions; assess subsequent data and site performance to determine whether training and corrective actions are effective.

Clinical Trial Design, Scientific Documents and Reporting

• Own assigned scientific sections of protocols, amendments, endpoint definitions, schedules of activities and clinical development materials, incorporating site practicality and patient burden.
• Provide scientific review of data outputs, tables, listings and figures; contribute to Clinical Study Reports, results narratives, integrated summaries, investigator materials and regulatory briefing documents, ensuring traceability and consistency.
• Partner with Biostatistics on clinical interpretation of analyses and with Medical Writing on clear, accurate documentation; statistical methods, Statistical Analysis Plans and programming remain owned by Biostatistics.

Cardiometabolic Development and Other Work

• Provide a defined, leadership-approved contribution to cardiometabolic development, such as literature and evidence review, endpoint/biomarker evaluation, synopsis input and scientific feasibility assessment, with deliverables and capacity agreed against OraGrowtH needs.
• Support clinical diligence, portfolio analysis or special projects only after priority OraGrowtH responsibilities and agreed cardiometabolic deliverables are covered and leadership approves the allocation.

Functional Accountability and Boundaries

• Senior CRS: owns assigned scientific data review, issue follow-through, scientific document contributions, protocol-support tracking, and approved site scientific training.
• Medical Director / medical lead: retains sponsor medical guidance, safety interpretation, medical eligibility decisions requiring sponsor input, and medical escalation. Investigators retain responsibility for participant care and site medical decisions.
• Clinical Operations: owns trial operational delivery, site management, and CRO/vendor oversight. Data Management: owns EDC/database processes, technical query creation and closure workflows, and data-management controls.
• Biostatistics: owns statistical methodology, analysis plans and statistical outputs; the Senior CRS provides clinical and scientific interpretation and input.

REQUIRED QUALIFICATIONS

• Advanced degree in life sciences, pharmacy, clinical research, or related discipline (e.g., PharmD, PhD, NP, or relevant master’s degree).
• At least 7 years of relevant clinical research or clinical development experience, including direct sponsor or CRO clinical development responsibilities and independent ownership of scientific deliverables.
• Demonstrated hands-on review of patient-level clinical trial data and ability to recognize missing, inconsistent, or implausible data and follow issues through cross-functional resolution.
• Working experience with electronic data capture (EDC), clinical listings, query workflows, CRFs and clinical data review tools; ability to interpret SAPs and tables, listings and figures and assess clinical significance without assuming statistical ownership.
• Experience supporting protocol execution and site-facing scientific questions; strong written scientific communication, issue tracking, prioritization and collaboration across Clinical Operations, Data Management, Biostatistics and medical leadership.
• Working knowledge of GCP, applicable ICH guidance and clinical data integrity/privacy requirements.

PREFERRED QUALIFICATIONS

• Late-stage or global Phase 2/3 trial experience in a small biotech or virtual sponsor environment.
• Pediatric, endocrinology, growth endpoint, auxology or hormone biomarker experience; rare disease experience.
• Experience with CSR authorship, clinical/regulatory submissions, targeted site training, trend review and root-cause/corrective-action assessment.
• Advanced analytical skills using EDC review platforms, clinical data listings, Excel-based reconciliation/pivot analysis or visualization tools; ability to explain patterns, limitations and recommendations to technical and nontechnical audiences.

WORK ENVIRONMENT AND TRAVEL

WHAT YOU CAN EXPECT AS A LUMOSIAN

• Industry-competitive compensation
• Generous health and welfare benefits, including company-paid dental and vision benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
• Lumos covers 95 – 85% of medical premium
• Health Reimbursement Arrangement
• 8 weeks of fully paid parental leave for all new parents
• Gym or fitness class reimbursement
• 401(k) with 5% employer contribution
• Flexible work hours and location
• Generous PTO policy
• 11 paid holidays in the US
• Offices in Austin, TX and Ames, IA