Open Positions at Avalo

Position Summary: Reporting to the Executive Director of Clinical Development Operations (or delegate), the Clinical Trial Manager (CTM) plays a key role in the planning, execution, and delivery of clinical trials. This role supports studies in alignment with Avalo Therapeutics’ SOPs, ICH/GCP guidelines, and applicable regulatory requirements, while maintaining high standards for quality, timelines, and budget. The CTM collaborates closely with cross-functional partners and vendors to support efficient, patient-focused study execution. Main Responsibilities: Support and/or lead key aspects of clinical trial operations, including vendor management, site start-up, and monitoring activities Contribute to the development, review, and maintenance of study documents (e.g., protocols, amendments, informed consent forms, monitoring plans, study manuals, eCRFs, IVRS/IWR systems) Foster clear, respectful, and proactive communication between internal teams and external partners, ensuring alignment on study goals and expectations Identify, communicate, and help resolve study-related risks and issues in a timely and thoughtful manner Support the development, management, and negotiation of clinical site budgets Track and support site activation progress, partnering with CROs and internal stakeholders to address barriers and improve timelines Review vendor invoices and help monitor for trends or scope changes Contribute to monitoring oversight activities, including review of trip reports and monitoring plans Support site identification, feasibility assessments, and site selection processes Participate in cross-functional project teams and contribute to collaborative decision-making Build and maintain strong, respectful relationships with vendors, CROs, and clinical sites Support planning and execution of Investigator Meetings and training activities Contribute to risk assessment and development of mitigation strategies Assist with clinical supplies planning, including forecasting and accountability support Ensure accurate and timely filing of study documentation in CTMS and/or eTMF systems Support audit and inspection readiness activities Ensure compliance with clinical trial registry requirements and applicable SOPs Education & Experience: Bachelor’s degree in a relevant field or equivalent combination of education and experience Approximately 5+ years of experience in clinical research or clinical operations within biotech, biopharma, or related environments Strong organizational and time management skills, with the ability to manage multiple priorities Effective communication skills, with the ability to clearly convey information across diverse teams and stakeholders Experience contributing to or managing study documentation Proactive problem-solving skills and ability to adapt in a dynamic environment Working knowledge of ICH/GCP and applicable regulatory guidelines Experience working with vendors and cross-functional teams Ability to build collaborative, inclusive, and respectful working relationships Familiarity with clinical systems such as EDC, IVRS/IWR, CTMS, and Microsoft Office tools Commitment to integrity, professionalism, and patient-centered clinical research Travel Requirement: Up to 25% Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office. 

Position Summary: We are seeking a highly motivated and detail-oriented Senior Manager, Quality Assurance (QA) to lead and manage our electronic Quality Management System (eQMS). This role is critical to ensuring compliance with internal procedures and global regulatory requirements. The ideal candidate will have demonstrated experience in eQMS administration, document control, training metrics, and computer system validation (CSV), and will thrive in a fast-paced, hybrid biotech environment.  Essential Duties and Responsibilities: Veeva QMS Administration: Serve as the system owner and administrator for Veeva QMS. Ensure system configuration aligns with company needs and regulatory expectations. Manage user access, workflows, and periodic system updates. Document Control & Compliance: Oversee document lifecycle management including creation, revision, approval, and archival. Support staff in following SOPs and Work Instructions during document revisions. Provide guidance and hands-on assistance with document drafting and formatting. Training & Metrics: Monitor and report training compliance metrics to the team and management. Track periodic review schedules and ensure timely completion. Identify trends and areas for improvement in training effectiveness. Audit & Inspection Readiness: Assist in planning and execution of internal audits. Support external audits and inspections by providing documentation and system access. Maintain audit trail and metrics within the QMS. Regulatory Intelligence: Stay current with international GxP regulations and guidance (FDA, EMA, ICH, etc.). Interpret regulatory changes and assess impact on QA systems and processes. Computer System Validation (CSV): Lead or support CSV activities for QA-related systems (authorship and/or review of CSV documents). Ensure validation documentation is complete, accurate, and audit-ready. Education & Experience: Bachelor’s degree in Life Sciences, Engineering, or related field. Minimum 7 years of experience in QA within the biotech or pharmaceutical industry. Proven experience managing electronic QMS platforms, preferably Veeva. Strong understanding of GxP regulations and CSV principles. Excellent organizational, communication, and interpersonal skills. Ability to work independently in a hybrid team environment. Additional Skills, Knowledge, and/or Attributes: Experience in a small or startup biotech environment.  Familiarity with remote collaboration tools and virtual team dynamics. Knowledge of data analytics tools for tracking QA metrics. Location: This position is based in Chesterbrook, PA and offers a flexible hybrid work model with a minimum of 2 days/week in the office. 

Position Summary: The Medical Director will provide medical support and input to Avalo’s clinical development programs from early-stage trials through to regulatory approval, ensuring alignment with the company’s strategic objectives. The Medical Director will be responsible for collaborating with clinical operations, regulatory, translational medicine/biomarkers, clinical pharmacology, CMC, and quality assurance functions; liaising with clinical investigators and site personnel; and establishing and building relationships with key external experts. The position requires a leader with experience working with CROs and vendors and interfacing with investigator sites to ensure operational efficiency and effective execution of trials within a complex, fast-paced environment. Essential Duties and Responsibilities: Provide medical leadership and oversight for assigned clinical program(s). Contribute to early clinical development strategy, including dose selection and clinical trial design, safety monitoring, biomarker strategy, and proof-of-mechanism approaches. Support the design, review, and execution of clinical protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory documents in compliance with clinical development plans, GCP, and good medical practice. Serve as Medical Monitor for ongoing clinical studies, including review of eligibility criteria, safety data, adverse events, protocol deviations, and dose escalation decisions. Collaborate closely with Clinical Operations, Translational Medicine, Biometrics, Regulatory Affairs, Pharmacovigilance, CROs, and external vendors to support high-quality study execution. Provide medical writing support in preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling. Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials, and develop and implement risk management strategies. Participate in Safety Review Committees, data review discussions, and cross-functional development activities. Analyze, interpret and communicate emerging clinical, PK/PD, biomarker, and safety data to internal and external stakeholders. Support regulatory interactions, including IND submissions, briefing documents, and responses to health authority inquiries. Develop and maintain relationships with investigators, key opinion leaders (KOLs), advisory boards, and scientific experts. Present clinical and scientific findings internally and externally, including investigator meetings and scientific conferences. Maintain awareness of scientific advancements, emerging therapies, and competitive developments within rheumatology, immunology, and inflammatory diseases. Ensure studies are conducted in compliance with ICH-GCP guidelines, company SOPs, and applicable regulatory requirements. Required Education and Experience: MD or equivalent medical degree required. Background or therapeutic experience in Rheumatology, Immunology, Autoimmune Disease, or related inflammatory conditions. Minimum of 5+ years of biotechnology, pharmaceutical, academic medicine, clinical research, or related clinical development experience. Direct clinical experience supporting or leading late-stage (phase 2/3) drug development clinical studies required. Experience with or exposure to the development of biologic therapies is desirable. Previous regulatory submission experience a plus (e.g., NDA, BLA, etc.) Strong understanding of early clinical development, dose escalation methodologies, safety monitoring, and translational medicine principles. Experience reviewing and interpreting clinical safety, efficacy, PK/PD, and biomarker data. Preferred Qualifications Clinical training, board certification, or board eligibility in Rheumatology or related specialty preferred. Experience with biologics, monoclonal antibodies, or immune-mediated inflammatory diseases. Prior Medical Monitoring experience is strongly preferred. Experience supporting IND submissions and early regulatory interactions preferred. Experience working within small or emerging biotechnology companies preferred.