Open Positions at Avalo

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.

Position Summary: Senior Manager / Associate Director, Biostatistics to provide strategic and operational statistical leadership across clinical development programs. This individual will serve as the lead biostatistician for one or more clinical development programs and will partner closely with Clinical Development, Medical Affairs, Data Management, Statistical Programming, Regulatory Affairs, and external partners to ensure the delivery of high-quality statistical strategy, analyses, and regulatory submissions.The successful candidate will contribute to study design, protocol development, analysis planning, interpretation of clinical data, regulatory interactions, and evidence generation activities that support development, registration, and lifecycle management of Avalo's programs. This role offers the opportunity to influence development strategy, advance innovative statistical methodologies, and contribute to regulatory and business decision-making across the organization. Essential Duties and Responsibilities: Statistical Leadership & Clinical Development Lead the biostatistics strategy for one or more clinical development programs and studies. Serve as the statistical representative on cross-functional study teams, Clinical Development Teams, and governance committees. Collaborate with Clinical Development and Medical teams to design clinical studies aligned with program objectives, regulatory expectations, and business needs. Provide strategic input into clinical development plans, including study design, endpoint selection, sample size determination, interim analyses, and decision criteria. Identify potential statistical, operational, or scientific challenges and proactively develop solutions. Evaluate and implement innovative statistical methodologies to enhance development strategies and study efficiency. Support quantitative decision-making, including benefit-risk assessments, probability of technical success analyses, and Go/No-Go evaluations. Study Design, Analysis & Reporting Author and/or review statistical sections of protocols, statistical analysis plans (SAPs), data review plans, and study reports. Develop and/or oversee analysis strategies, including tables, listings, and figures (TLFs), ensuring methodological rigor and regulatory compliance. Ensure timely delivery and quality of statistical analyses for interim reviews, final analyses, integrated summaries, and regulatory submissions. Interpret study results and effectively communicate findings to technical and non-technical audiences. Prepare and review abstracts, posters, manuscripts, presentations, and scientific publications. Regulatory & External Interactions Contribute to regulatory strategies and support global submissions. Represent Biostatistics during interactions with health authorities, including FDA, EMA, PMDA, and other regulatory agencies, as appropriate. Support responses to regulatory questions related to study design, analysis methodologies, and interpretation of results. Ensure statistical deliverables meet applicable ICH, FDA, EMA, and other global regulatory requirements. Medical Affairs, HEOR & Evidence Generation Provide statistical leadership for post-marketing studies, observational research, registry studies, real-world evidence initiatives, and outcomes research activities, as applicable. Support evidence generation strategies that address clinical, scientific, payer, and market access objectives. Collaborate with cross-functional partners to identify evidence gaps and develop analytical approaches to address unmet evidence needs. Contribute statistical expertise to publications, scientific communications, and evidence dissemination activities. Vendor Oversight & Operational Excellence Oversee CROs, functional service providers, and external statistical vendors to ensure high-quality deliverables and adherence to timelines. Collaborate with Statistical Programming and Data Management to ensure data quality and efficient execution of analyses. Support departmental initiatives focused on process improvement, innovation, quality standards, and inspection readiness. Contribute to the development and maintenance of statistical standards, procedures, and best practices. Required Education and Experience: Sr Manager: Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 4 years of pharmaceutical, biotechnology, or clinical research experience; or M.S. with a minimum of 6 years of experience Associate Director: Ph.D. in Biostatistics, Statistics, or a related quantitative discipline with a minimum of 6 years of relevant pharmaceutical industry experience; or M.S. with a minimum of 8 years of experience Demonstrated experience providing statistical leadership for clinical development programs and clinical trials. Strong knowledge of clinical trial methodology, study design, statistical analysis, and regulatory requirements. Experience supporting regulatory submissions and health authority interactions. Experience leading cross-functional teams and influencing development strategies. Expertise in statistical methods applicable to clinical development, including adaptive designs, longitudinal analyses, survival analyses, and integrated analyses. Experience overseeing CROs and external statistical vendors. Proficiency in SAS and/or R. Strong understanding of ICH, FDA, EMA, and other global regulatory guidance. Experience with real-world evidence, observational studies, HEOR, or post-marketing research is a plus. Experience in immunology, inflammation, autoimmune disease, or related therapeutic areas is preferred.  

Position Summary: Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for abdakibart (AVTX-009), the company's lead asset, as it advances into Phase 3, and potential registration The Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. The ideal candidate will bring a balanced mix of strategic and operational regulatory expertise. Essential Duties and Responsibilities: Design, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs. Serve as the Regulatory Affairs representative on cross-functional project teams and provide proactive, strategic guidance to advance program objectives. Evaluate evolving regulatory requirements, competitive developments, and emerging scientific trends, and assess potential impacts on development strategy. Identify regulatory risks, develop mitigation plans, and communicate recommendations to project teams and senior leadership. Contribute to regulatory development plans supporting advancement throughout development to commercialization. Collaborate with senior regulatory leadership on major strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA planning, and labeling activities. Lead the planning, preparation, review, and submission of regulatory documents throughout the product lifecycle. Provide hands-on leadership for a broad range of U.S. and global regulatory submissions, such as DSURs, protocol amendments, information amendments, INDs, CTAs, labeling, etc. Ensure submissions are scientifically accurate, strategically aligned, compliant, and delivered on schedule. Lead and coordinate routine regulatory submissions independently while supporting more complex registration activities under the guidance of senior regulatory leadership. Support preparation and maintenance of future NDA/BLA and ex-U.S. marketing application activities. Serve as a key point of contact with FDA and support interactions with ex-U.S. regulatory agencies. Lead preparation of regulatory briefing materials, meeting requests, information packages, and responses to agency inquiries. Participate in and support regulatory authority meetings, teleconferences, and written communications. Coordinate regulatory intelligence and ensure project teams remain informed of evolving agency expectations. Manage external regulatory consultants and CRO partners supporting global CTA submissions, maintenance activities, and health authority responses. Drive accountability and alignment across functions to meet aggressive development timelines. Additional Responsibilities Participate in departmental initiatives, task forces, and special projects. Support diligence activities and regulatory assessments as needed. Perform other duties as assigned. Required Education and Experience: Bachelor's degree in scientific discipline required. Advanced degree (MS, PharmD, PhD, or equivalent) preferred. 10–15 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry. Minimum of 5 years of experience within a small or emerging biotechnology company preferred. Demonstrated experience supporting late-stage clinical development programs. Experience supporting biologics development programs preferred. Proven experience authoring, reviewing, and managing a broad range of regulatory submissions, including INDs, CTAs, amendments, IND Safety Reports, DSURs, annual reports, and briefing packages. Experience interacting directly with FDA and supporting ex-U.S. regulatory activities. Experience managing CROs and external consultants supporting global regulatory submissions and agency responses. Experience supporting preparation for major regulatory milestones such as End-of-Phase 2 meetings, Phase 3 development programs, BLA preparation, and registration planning preferred. Knowledge, Skills & Competencies: Deep understanding of global drug development and regulatory requirements for biologics. Strong knowledge of FDA regulations and familiarity with EMA and other international regulatory frameworks. Ability to thrive in a fast-paced biotechnology environment while managing multiple priorities and deadlines. Experience working in a cross-functional team Working in a fast-paced environment to ensure timelines are consistently met Travel Less than 5% travel.