Medical Director, Integrated Evidence Generation

At Abivax, our purpose is simple: to improve patients' lives. As a global clinical-stage biotechnology company with headquarter in Paris and offices in the United States, we are advancing innovative therapies for people living with chronic inflammatory diseases.We are looking for talented, purpose-driven individuals who want their work to have a meaningful impact. Every day, we challenge ourselves to ask: "How did I make a patient's life better today?" If that question inspires and motivates you, we invite you to join our team.Position SummaryThe Medical Director, Integrated Evidence Generation will lead the development and execution of Abivax’s postmarketing clinical evidence program as the company prepares for commercialization. Reporting to the Senior Director, Scientific Strategy and Evidence Integration, this individual will be accountable for translating strategic evidence needs into a rigorous, feasible, and differentiated data generation plan for obefazimod.The role will lead Phase IIIb/IV initiatives to generate new real-world evidence—including observational studies, registries, and pragmatic studies —with particular attention to treatment persistence, durability, long-term safety, and outcomes in clinically relevant populations. The role will bridge Medical Affairs and Clinical Development, applying clinical development experience to study concepts, protocols, endpoints, analyses, interpretation, and scientific communication.The Medical Director will work in close partnership with Clinical Development, HEOR, Biostatistics, Epidemiology, Pharmacovigilance, Regulatory Affairs, Medical Communications, Market Access, and regional Medical Affairs teams. The successful candidate will combine clinical judgment, evidence-generation expertise, scientific credibility, and strong operational ownership in a fast-moving biotechnology environment.Key Responsibilities / Essential FunctionsEvidence strategy and planning. Own and maintain the integrated postmarketing evidence generation plan under the direction of the Medical Affairs Publications and Integrated Evidence Generation lead, ensuring alignment with the medical strategy, product profile, clinical development program, stakeholder evidence needs, and anticipated launch priorities.Clinical and real-world study leadership. Lead the design, evaluation, and execution of Phase IV, observational, registry, pragmatic, and database studies from concept through final reporting and publication.Clinical development partnership. Serve as the Medical Affairs clinical development bridge by contributing medical and scientific input to study concepts, synopses, protocols, eligibility criteria, endpoint selection, estimands, statistical analysis plans, safety monitoring approaches, and interpretation of results.Priority evidence questions. Develop research approaches that address long-term effectiveness and safety, durability of response, treatment persistence and discontinuation, adherence, sequencing, comparative effectiveness, healthcare resource use, patient-reported outcomes, and outcomes in important patient subgroups. Close partnership with HEOR initiatives, data sourcing and study design will be key.Study quality and scientific rigor. Ensure that study designs and analyses are scientifically defensible, clinically meaningful, operationally feasible, and appropriate for the intended scientific, regulatory, access, or medical audience. Identify and proactively address bias, confounding, missingness, and other methodological limitations.Cross-functional evidence governance. Lead cross-functional study teams and decision forums; establish clear objectives, decision points, roles, timelines, and dependencies. Present recommendations and tradeoffs to senior leadership in a concise and decision-oriented manner.External scientific partnerships. Identify and engage investigators, academic collaborators, research networks, data partners, and vendors. Build productive relationships with external experts while maintaining appropriate scientific independence, transparency, and compliance.Vendor and portfolio management. Lead vendor selection and oversight, including requests for proposal, scope and budget development, contracting support, performance management, risk mitigation, and delivery against quality, timeline, and financial commitments.Evidence dissemination. Partner with Publications and Medical Communications to develop publication strategies and ensure timely communication of evidence through congress abstracts, presentations, manuscripts, evidence dossiers, and internal scientific materials.Compliance and inspection readiness. Ensure that evidence-generation activities comply with applicable company policies, approved procedures, contractual obligations, privacy requirements, and relevant standards, including GCP, GPP, data transparency, and observational research guidance.Organizational capability. Help establish scalable evidence-generation processes, templates, standards, and tracking tools appropriate for a growing biotechnology company transitioning from clinical development to commercialization.Financial accountability. Develop and manage study budgets and forecasts, identify resource needs, and recommend portfolio choices that maximize scientific and business value.Qualifications Initial Education, Training and/or Types of Certifications RequiredMD or DO strongly preferred; board certification or advanced clinical training in gastroenterology, internal medicine, or a related specialty is highly desirable.Candidates with a PharmD, PhD, DrPH, or other relevant advanced scientific or health-professional degree may be considered if they bring substantial, directly relevant clinical development and postmarketing evidence-generation experience.Formal training in clinical research, epidemiology, outcomes research, biostatistics, or real-world evidence methodology is desirable.Professional Experience LevelTypically 7 or more years of relevant experience in the biopharmaceutical industry, academia, clinical research, or a related setting; level may be adjusted based on the depth and relevance of experience.At least 3 to 5 years of direct experience leading Phase IV, observational, registry, pragmatic, or secondary database studies, with demonstrated responsibility for both scientific design and operational delivery.Meaningful clinical development experience is strongly preferred, including hands-on contributions to interventional study design, protocol development, endpoint strategy, safety evaluation, data review, and interpretation of clinical trial results.Experience supporting a product through late-stage development, launch preparation, or the post-approval setting is strongly preferred.Experience in inflammatory bowel disease, gastroenterology, immunology, or another chronic specialty-care therapeutic area is preferred.Demonstrated success leading complex, global, cross-functional programs and external research partnerships in a matrixed organization.Experience managing external vendors, study budgets, contracts, timelines, and competing portfolio priorities.Technical SkillsExpertise in clinical study design and applied real-world evidence methods, including cohort definition, endpoint selection, comparator strategy, confounding control, sensitivity analyses, and interpretation of observational data.Strong medical and scientific judgment, with the ability to integrate clinical trial evidence, natural history, treatment patterns, patient experience, and healthcare data into a coherent evidence strategy.Working knowledge of biostatistics and epidemiology sufficient to critically review protocols, analysis plans, tables, figures, and study reports and to partner effectively with quantitative experts.Knowledge of relevant standards and guidance for interventional and noninterventional research, including GCP, GPP, data transparency, privacy, and scientific publication practices.Excellent written and verbal communication skills, including the ability to translate complex evidence into clear recommendations for clinical, scientific, and executive audiences.Strong project, portfolio, budget, and vendor-management capabilities; comfortable establishing structure and driving execution in an evolving organization.Proficiency with standard business and scientific applications. Familiarity with evidence-planning platforms, literature databases, data visualization, or analytics tools is desirable.Leadership SkillsEnterprise and patient focus. Connects evidence choices to meaningful clinical questions, stakeholder needs, launch initiatives, and the long-term value of the asset.Ownership and execution. Takes accountability from strategy through delivery; anticipates risks, resolves ambiguity, and follows through on commitments.Influence without authority. Builds alignment across functions through credibility, sound judgment, transparency, and respect for differing perspectives.Agility. Thrives in a small, fast-paced biotechnology environment; can move between strategic planning and hands-on execution as priorities evolve.Decision quality. Frames options and tradeoffs clearly and makes timely recommendations using the best available information.Scientific integrity. Maintains high standards for rigor, balance, data transparency, and appropriate communication of uncertainty and limitations.Collaboration and development. Creates an inclusive, solutions-oriented working environment; gives clear feedback, shares expertise, and strengthens the capabilities of internal and external team members.Executive communication. Communicates with clarity and appropriate brevity, tailoring detail and recommendations to the needs of senior leaders, technical experts, and external stakeholders.This job description is intended to describe the general responsibilities and qualifications for this position and is not an exhaustive list of all duties. Responsibilities may change based on business needs, and Abivax reserves the right to modify this job description at any time.Reasonable accommodation will be provided to qualified individuals with disabilities to enable them to perform the essential functions of the position.Abivax is an Equal Opportunity Employer and makes all employment decisions without regard to any characteristic protected by applicable federal, state, or local law.