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Lumos Pharma · 1 month ago

Clinical Research Scientist

United States

Full-time

Remote

Mid Level

3+ years exp

Lumos Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases. The Clinical Research Scientist plays a critical role in supporting clinical research programs, ensuring high-quality data collection and analysis, and collaborating with cross-functional teams to execute compliant clinical trials.

BiopharmaBiotechnologyClinical TrialsHealth CarePharmaceutical

Responsibilities

Contribute to the development of clinical trial protocols, focusing on data collection strategies and study endpoints. Draft or own selected protocol sections such as objectives, endpoints, schedule of activities, and statistical considerations

Collaborate with cross-functional teams to ensure study design aligns with regulatory and scientific objectives. Ensure that the selection of study endpoints aligns with the underlying disease biology, uses validated clinical outcome assessments, and supports the biomarker strategy. Include evaluation of study practicality and participant burden in the overall design

Support the development of CSRs by providing accurate and comprehensive data summaries and collaborating with medical writing teams. Author results text and appendices where appropriate, ensuring traceability from SAP to TLFs

Work closely with biostatistics and medical writing to ensure that CSRs are scientifically sound, well-documented, and align with ICH guidelines. Contribute to integrated summaries where needed and prepare responses to authority questions

Review CSRs for accuracy, completeness, and consistency, contributing to the interpretation of study findings and scientific conclusions. Ensure clarity and patient relevance in the interpretation of outcomes

Provide scientific oversight for study sites, assisting in protocol adherence and data collection procedures. Serve as protocol expert during SIVs and investigator meetings

Support site training and monitoring efforts, ensuring that all study personnel know data collection and reporting requirements. Partner with CRAs to resolve systematic issues and implement corrective and preventive actions

Act as a scientific and clinical disease state and data expert within project teams, contributing insights for protocol amendments, study reports, and regulatory submissions. Engage with key opinion leaders and advisory boards to refine endpoints and study design considerations

Collaborate with clinical operations, and regulatory affairs to ensure data accuracy and consistency across all study documents. Support preparation of briefing documents, Investigational New Drug (IND) or Clinical Trial Application (CTA) amendments, and responses to questions from regulatory authorities

Support diligence activities by preparing clinical summaries, competitor landscapes, and data room materials

Contribute to scenario planning and forecasting inputs that inform portfolio decisions

Qualification

Clinical trial designClinical Practice (GCP)Statistical Analysis Plans (SAPs)Clinical Study Reports (CSRs)Data collection managementRegulatory requirementsAnalytical skillsEndocrinology experienceCross-functional collaborationOrganizational skillsAttention to detailCommunication skillsProject management

Required

Advanced degree in life sciences, pharmacy, or a related field (e.g., PharmD, PhD, NP, or master's in clinical research)

3+ years of experience in clinical research or a related field

Proficient in tools to evaluate and present data including Word, Excel and PowerPoint

Solid understanding of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidance, including E6 Revision 3 and E9, as well as familiarity with Title 21 of the Code of Federal Regulations (CFR) Part 11 and General Data Protection Regulation (GDPR) requirements for clinical data

Ability to interpret Statistical Analysis Plans (SAPs) and tables, listings, and figures (TLF) templates, and work effectively with statisticians and programmers

Preferred

Experience in a sponsor or biotech environment preferred; rare disease experience is a plus

Strong knowledge of data collection and management practices. Demonstrated CRF design and edit check specification experience

Familiarity with Clinical Study Report (CSR) templates, guidelines, and regulatory requirements

Strong analytical and organizational skills, attention to detail and commitment to data integrity. Comfort communicating complex results to technical and non-technical audiences

Ability to work collaboratively across multiple functions and manage complex projects

Prior experience in endocrinology. Experience with pediatric populations, growth endpoints, or hormone biomarker strategies is a plus

Benefits

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