Sr. Clinical Scientist

Avalo Therapeutics; Chesterbrook (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Avalo Therapeutics is a clinical stage biotechnology company focused on IL-1β pathway therapies for immune‑mediated inflammatory diseases. The Senior Clinical Scientist will lead clinical data review and cross-functional collaboration to support Phase II/III programs and regulatory submissions.

The role involves proactive data interpretation, trend identification, and communication of results to drive timely, high‑quality decisions across multiple departments including Clinical Operations, Data

Qualifications

• Advanced degree in life sciences, clinical research or related field.
• 6+ years in clinical development, clinical science, data management or related functions.
• Experience performing ongoing clinical data review in late phase studies.
• Experience with Phase II/III clinical trials and cross-functional collaboration.

Responsibilities

• Lead clinical data review activities to ensure data quality, integrity, and inspection readiness.
• Interpret efficacy, safety, PK/PD data to support decision-making.
• Collaborate with Clinical Operations, Data Management, Biometrics, Pharmacovigilance, Regulatory Affairs, and Medical Writing.
• Author and review protocols, CSRs, Investigator Brochures, regulatory submissions, abstracts, publications, and presentations.
• Support inspection and audit readiness activities.

Skills

Clinical data review

Cross-functional collaboration

Data analysis

Regulatory submissions

Biometrics

Education

Advanced degree (PharmD/PhD/MS/MPH)

Bachelor’s degree with significant relevant experience

Tools

EDC systems

Job description

At Avalo (ahh-vah’-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1β pathway, which is a central driver of the inflammatory process.

We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders. Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.

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

About Avalo Therapeutics

Avalo Therapeutics is a clinical stage biotechnology company dedicated to developing therapeutics targeting the IL-1β pathway for immune‑mediated inflammatory diseases. Avalo is advancing its lead anti-IL-1β monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1-4% of the population globally. Avalo is pursuing additional development opportunities in IL-1β driven indications. Avalo is also developing AVTX-010, a long-acting next‑generation anti-IL-1β mAb. For more information about Avalo, please visit www.avalotx.com.