Medical Director
ABOUT USXBiotech USA Inc. is fully integrated biopharmaceutical company developing a diversified portfolio of biologics across multiple therapeutic areas. We are advancing several assets from early clinical development through commercialization, with a mission to transform patient outcomes through groundbreaking science. From pre-clinical models to clinical trial execution, from discovery to manufacturing, all activities are under one roof. XBiotech is focused on developing antibody therapeutics targeting the major medical needs of inflammatory diseases, cancer and infectious diseases.XBiotech’s drug Research & Development center is headquartered in Austin, Texas. Our Austin facility incorporates all critical operations including discovery, research and development, drug testing, product formulation as well as clinical-regulatory affairs. Our excellent facilities allow us to effectively implement and fully develop any program we adopt. We are working to change the future of medicine.POSITION OVERVIEWWe are seeking a Medical Director with proven early-stage pharmaceutical/biotech experience to provide medical leadership across our multi-therapeutic area biologics portfolio. This role requires exceptional generalist capabilities combined with collaborative leadership skills; someone who can effectively leverage external therapeutic area experts, key opinion leaders, and clinical consultants to ensure both scientific rigor and operational agility. You will serve as a trusted medical voice internally and externally, seamlessly bridging clinical development and medical affairs as we advance our pipeline.KEY RESPONSIBILITIESClinical Development & Multi-Program Medical OversightProvide medical oversight and strategic input for clinical trials across multiple therapeutic areas including oncology, rheumatology and infectious diseasesCollaborate with cross-functional teams to design clinical development plans and study protocols for diverse indicationsServe as medical monitor for clinical trials, ensuring patient safety and data integrity across programsCoordinate with therapeutic area consultants and advisors to ensure clinical and scientific expertise for each programReview and interpret clinical data across different therapeutic areas to guide development decisions and regulatory strategiesContribute to regulatory submissions including INDs, and responses to health authority queriesExpert Network & KOL ManagementBuild and manage a network of therapeutic area experts, clinical consultants, and scientific advisorsEstablish relationships with key opinion leaders (KOLs) across multiple therapeutic areasCoordinate scientific advisory boards and leverage external expertise for study design and data interpretationIdentify and engage consultants for specific therapeutic area needs as programs advanceSynthesize input from multiple experts to make informed medical and strategic decisionsMedical Affairs LeadershipBuild and lead medical affairs capabilities as the company scalesCreate scientific communication materials including publications, presentations, and medical education contentEstablish relationships with key opinion leaders (KOLs) and scientific advisory boardsOversee investigator-initiated studies Cross-Functional Collaboration & LeadershipPartner with regulatory affairs to ensure scientific rigor in submissions across therapeutic areasWork closely with clinical operations to ensure trial execution aligns with medical objectivesPrioritize resources and balance competing demands across multiple programsExternal Engagement & RepresentationRepresent the company at scientific conferences and medical meetings across relevant therapeutic areasPresent clinical data to investigators, healthcare professionals, and scientific audiencesEngage with patient advocacy groups to understand unmet medical needsParticipate in scientific discussions with regulatorsQUALIFICATIONSRequired:MD, or equivalent medical degree with active medical licenseMinimum 5-7 years of clinical medicine and/or pharmaceutical industry experience in an early stage pharma/biotech companyStrong understanding of biologics development, including regulatory pathways and CMC considerationsDemonstrated experience in clinical trial design, execution, and medical monitoring across multiple programsProven ability to work effectively with external consultants and leverage therapeutic area expertiseExperience coordinating scientific advisory boards and managing expert networksDeep knowledge of drug development lifecycle from IND through commercializationExperience with FDA and international regulatory agenciesExcellent scientific writing and communication skills with ability to synthesize complex informationStrong organizational skills and ability to prioritize across multiple concurrent projectsProven ability to work effectively in a fast-paced, resource-constrained entrepreneurial environmentComfort with ambiguity and ability to make sound decisions with incomplete informationPreferred:Board certification in internal medicine, oncology, immunology, or another relevant therapeutic specialtyPrior experience in startup or emerging biotech companies, particularly with limited resourcesExperience managing clinical programs across 2-3 therapeutic areas simultaneouslyTrack record of publications in peer-reviewed journals across different therapeutic areasPrevious medical affairs or medical leadership experienceExperience working with CROs and external clinical development partnersCOMPETENCIESStrategic thinking with ability to balance scientific rigor across diverse programsExceptional analytical and problem-solving skills Strong leadership presence and ability to influence without authority, especially when working with external expertsIntellectual curiosity and willingness to learn across therapeutic areasExcellent judgment in knowing when to seek deep therapeutic area expertise versus leveraging generalist knowledgeAdaptability and resilience in a dynamic startup environment with evolving prioritiesHighly collaborative mindset with excellent interpersonal and relationship-building skillsEfficient time management and ability to context-switch between different programsHigh ethical standards and unwavering commitment to patient safetyComfort operating independently while building networks of support and expertiseWHAT MAKES THIS ROLE UNIQUEThis position offers a unique opportunity to shape medical strategy across a diverse portfolio while building a best-in-class network of therapeutic area experts. You'll have the autonomy to structure collaborations and expert engagement in ways that maximize scientific quality while optimizing resources. The ideal candidate thrives on variety, enjoys the intellectual challenge of working across disciplines, and excels at orchestrating diverse expertise to drive programs forward.TRAVELApproximately 20-30% travel expected eventually for conferences, investigator meetings, advisory boards, and site visits across therapeutic areasCOMPENSATIONCompetitive salary and equity package commensurate with experience, plus comprehensive benefits including health insurance, and retirement plans.XBiotech USA Inc. is an equal opportunity employer committed to diversity and inclusion in the workplace.