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: This individual will serve as the commercial architect for Avalo's first potential product launch. The successful candidate will be responsible for developing and executing global and U.S. launch readiness plans, shaping brand strategy, generating deep customer insights, building commercial capabilities, and partnering cross-functionally to maximize the value of the HS franchise. This highly visible leadership role requires a strategic thinker who can operate effectively in a fast-paced biotechnology environment while balancing long-term commercial vision with hands-on execution. The individual will work closely with Clinical Development, Medical Affairs, Market Access, Regulatory Affairs, Investor Relations, Business Development, and external partners to position Avalo for a successful commercialization and growth trajectory. Essential Duties and Responsibilities: Commercial Strategy & Brand Leadership Advance and lead the overall commercial strategy for abdakibart, Avalo’s lead drug candidate, in Hidradenitis Suppurativa (HS). Build the brand vision, positioning, messaging, value proposition, and lifecycle strategy Direct market assessment, forecasting, competitive intelligence, and commercial planning activities. Translate clinical and scientific data into differentiated customer-focused strategies. Identify market opportunities, risks, and competitive dynamics to inform business decisions. Serve as the commercial lead on cross-functional program teams. Manage external agency partners. Launch Excellence Build and execute comprehensive cross-functional launch readiness plans. Establish launch milestones, KPIs, governance structures, and performance tracking mechanisms. Lead pre-launch customer engagement and market shaping initiatives. Ensure organizational readiness across marketing, sales, market access, patient services, and operations. Develop launch scenarios and contingency plans to support evolving clinical and regulatory timelines. Customer Insights & Market Development Generate actionable insights from healthcare providers, patients, payers, advocacy groups, and key opinion leaders. Develop customer segmentation and targeting strategies. Establish strong relationships with external experts, advocacy organizations and HS stakeholders. Market Access & Value Strategy Partner closely with Market Access to develop payer, reimbursement, and value communication strategies. Support pricing, contracting, and access planning efforts. Ensure commercial strategies are aligned with payer expectations and patient access objectives. Cross-Functional Leadership Collaborate closely with Clinical Development and operations, HEOR, Medical Affairs, Regulatory Affairs, , Manufacturing, and Supply Chain to ensure commercial perspectives are integrated throughout development. Partner with Medical Affairs to optimize scientific communication plans and publication strategies. Support investor and board communications regarding the commercial opportunity for abdakibart in HS and launch readiness plans Represent commercial perspectives in governance and strategic planning discussion Required Education and Experience: Bachelor's degree required; advanced degree (MBA, MPH, PharmD, MS, or PhD) preferred. 12+ years of biotechnology, pharmaceutical, or healthcare industry experience. 5+ years leading launch planning, launch excellence, commercial operations, new product planning, or strategic program management. Demonstrated success leading at least one major pharmaceutical or biotechnology product launch. Experience coordinating complex, cross-functional initiatives in a matrixed environment. Experience in dermatology and/or immunology/inflammation specialty products, preferred. Preferred Qualifications Experience launching biologics or specialty therapies. Understanding of HS, dermatology, immunology, or inflammatory disease markets. Experience within emerging biotechnology companies and first-launch organizations. Familiarity with global launch planning and commercialization frameworks.