Clinical Research Scientist
Lumos Pharma
Remote
United States
Laboratory Scientist
Clinical Research Scientist
Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients. We take a patient-centric approach and maintain inspection-readiness across our programs.
The Clinical Research Scientist plays a critical role in Clinical Development supporting clinical research programs including data collection and analysis, data management, and preparation of Clinical Study Reports (CSRs). This position is responsible for ensuring high-quality data is collected and managed in alignment with regulatory standards, and for contributing to the scientific analysis and interpretation of study results. The Clinical Research Scientist collaborates closely with cross-functional teams, including clinical operations, regulatory, biostatistics, and medical writing, to ensure successful and compliant execution of clinical trials. In addition, the Clinical Research Scientist will support leadership teams in special projects supporting business development. This role will also contribute to protocol synopses, clinical development plans, and evidence strategies that align endpoints with patient-relevant outcomes and regulatory expectations.
KEY RESPONSIBILITIES
Clinical Trial Design and Protocol Development
- 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.
Clinical Study Reports (CSRs)
- 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.
Study Oversight and Site Support
- 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.
Cross-Functional Collaboration
- 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.
Business Development and Special Projects
- Support diligence activities by preparing clinical summaries, competitor landscapes, and data room materials.
- Contribute to scenario planning and forecasting inputs that inform portfolio decisions.
Qualifications
- 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. Experience in a sponsor or biotech environment preferred; rare disease experience is a plus.
- 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.
Desired Skills
- 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.
WORK ENVIRONMENT
- This position is remote in the United States.
TRAVEL EXPECTATION
- Periodic travel to study sites, investigators, vendors, or team meetings is estimated at up to 15 percent.
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