Sr. Clinical Scientist

Position Summary:

The Senior Clinical Scientist contributes to the execution of Avalo's clinical development programs in partnership with the Senior Medical Director and cross-functional study teams. This individual will support End-of-Phase II activities by providing scientific leadership in clinical trial execution, ongoing clinical data review, interpretation of emerging efficacy and safety data, communication of results, and preparation for Phase III development.

The Senior Clinical Scientist will lead clinical data review activities to ensure study integrity, proactively identify trends and potential issues, and collaborate across Clinical Operations, Data Management, Biometrics, Pharmacovigilance, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Medical Affairs, and Medical Writing to support timely, high-quality clinical decision-making, regulatory submissions, and study execution.

Essential Duties and Responsibilities:

Clinical Development & Scientific Leadership

• Support execution of clinical development strategy for Phase II and Phase III clinical programs.
• Contribute to End-of-Phase II planning, including FDA briefing documents, regulatory meeting preparation, Phase III protocol development, endpoint selection, and dose justification.
• Interpret emerging clinical efficacy, safety, PK/PD, biomarker, and exploratory endpoint data to support scientific and clinical decision-making.
• Monitor evolving scientific literature and competitive intelligence to inform clinical development strategy.

Clinical Data Review

• Lead ongoing clinical data review activities throughout study execution to ensure data quality, integrity, and inspection readiness.
• Review patient-level clinical data for completeness, consistency, protocol compliance, and medical relevance.
• Analyze efficacy, safety, biomarker, laboratory, imaging, pharmacokinetic, and external vendor data to identify trends and proactively resolve issues.
• Partner with Medical Monitoring on review of serious adverse events (SAEs), safety narratives, signal detection, and benefit-risk assessments.
• Review Tables, Figures, Listings (TFLs), clinical narratives, and study reports to support data interpretation.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Data Management, Biometrics, Pharmacovigilance, Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Medical Writing, and Medical Affairs throughout study execution.
• Collaborate with Data Management on CRF design, edit checks, data validation plans, database builds, data review specifications, and external data integration.
• Provide clinical input into study design, endpoint definitions, data collection strategies, and User Acceptance Testing (UAT) of EDC systems and clinical technologies.
• Participate in study team meetings, safety review meetings, dose-escalation committees, and data review meetings.

Clinical Documentation & Regulatory Support

• Author and review clinical development documents including protocols, Clinical Study Reports (CSRs), Investigator Brochures, regulatory submissions, abstracts, publications, and scientific presentations.
• Support inspection and audit readiness activities.
• Contribute to development of clinical data review processes, SOPs, work instructions, and best practices.
• Perform other duties as assigned.

Required Education and Experience:

• Advanced degree (PharmD, PhD, MS, MPH, or equivalent) in life sciences, clinical research, or related field preferred. Bachelor's degree with significant relevant experience may be considered.
• 6+ years of experience in clinical development, clinical science, data management, or related functions within biotechnology, pharmaceutical, or CRO environments.
• Demonstrated experience performing ongoing clinical data review in late phase clinical studies
• Demonstrated experience performing ongoing clinical data review, summarization and interpreting efficacy, safety, biomarker, and PK/PD data
• Experience supporting Phase II and/or Phase III clinical trials.
• Experience working closely with Clinical Operations, Data Management and Biometrics teams.

Preferred Qualifications

• Immunology experience is strongly preferred.
• Strong analytical and problem-solving skills with the ability to interpret complex clinical datasets.
• Understanding of external data sources, including laboratory, imaging, biomarker, and pharmacokinetic data.
• Ability to synthesize complex clinical data into actionable insights.
• Strong scientific curiosity and attention to detail.
• Excellent communication and presentation skills.
• Proven ability to work effectively in highly cross-functional teams.
• Comfortable operating in a fast-paced, evolving biotechnology environments