Medical Director

ABOUT US

XBiotech 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 OVERVIEW

We 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 RESPONSIBILITIES

Clinical Development & Multi-Program Medical Oversight

• Provide medical oversight and strategic input for clinical trials across multiple therapeutic areas including oncology, rheumatology and infectious diseases
• Collaborate with cross-functional teams to design clinical development plans and study protocols for diverse indications
• Serve as medical monitor for clinical trials, ensuring patient safety and data integrity across programs
• Coordinate with therapeutic area consultants and advisors to ensure clinical and scientific expertise for each program
• Review and interpret clinical data across different therapeutic areas to guide development decisions and regulatory strategies
• Contribute to regulatory submissions including INDs, and responses to health authority queries

Expert Network & KOL Management

• Build and manage a network of therapeutic area experts, clinical consultants, and scientific advisors
• Establish relationships with key opinion leaders (KOLs) across multiple therapeutic areas
• Coordinate scientific advisory boards and leverage external expertise for study design and data interpretation
• Identify and engage consultants for specific therapeutic area needs as programs advance
• Synthesize input from multiple experts to make informed medical and strategic decisions

Medical Affairs Leadership

• Build and lead medical affairs capabilities as the company scales
• Create scientific communication materials including publications, presentations, and medical education content
• Establish relationships with key opinion leaders (KOLs) and scientific advisory boards
• Oversee investigator-initiated studies

Cross-Functional Collaboration & Leadership

• Partner with regulatory affairs to ensure scientific rigor in submissions across therapeutic areas
• Work closely with clinical operations to ensure trial execution aligns with medical objectives
• Prioritize resources and balance competing demands across multiple programs

External Engagement & Representation

• Represent the company at scientific conferences and medical meetings across relevant therapeutic areas
• Present clinical data to investigators, healthcare professionals, and scientific audiences
• Engage with patient advocacy groups to understand unmet medical needs
• Participate in scientific discussions with regulators

QUALIFICATIONS

Required:

• MD, or equivalent medical degree with active medical license
• Minimum 5-7 years of clinical medicine and/or pharmaceutical industry experience in an early stage pharma/biotech company
• Strong understanding of biologics development, including regulatory pathways and CMC considerations
• Demonstrated experience in clinical trial design, execution, and medical monitoring across multiple programs
• Proven ability to work effectively with external consultants and leverage therapeutic area expertise
• Experience coordinating scientific advisory boards and managing expert networks
• Deep knowledge of drug development lifecycle from IND through commercialization
• Experience with FDA and international regulatory agencies
• Excellent scientific writing and communication skills with ability to synthesize complex information
• Strong organizational skills and ability to prioritize across multiple concurrent projects
• Proven ability to work effectively in a fast-paced, resource-constrained entrepreneurial environment
• Comfort with ambiguity and ability to make sound decisions with incomplete information

Preferred:

• Board certification in internal medicine, oncology, immunology, or another relevant therapeutic specialty
• Prior experience in startup or emerging biotech companies, particularly with limited resources
• Experience managing clinical programs across 2-3 therapeutic areas simultaneously
• Track record of publications in peer-reviewed journals across different therapeutic areas
• Previous medical affairs or medical leadership experience
• Experience working with CROs and external clinical development partners

COMPETENCIES

• Strategic thinking with ability to balance scientific rigor across diverse programs
• Exceptional analytical and problem-solving skills
• Strong leadership presence and ability to influence without authority, especially when working with external experts
• Intellectual curiosity and willingness to learn across therapeutic areas
• Excellent judgment in knowing when to seek deep therapeutic area expertise versus leveraging generalist knowledge
• Adaptability and resilience in a dynamic startup environment with evolving priorities
• Highly collaborative mindset with excellent interpersonal and relationship-building skills
• Efficient time management and ability to context-switch between different programs
• High ethical standards and unwavering commitment to patient safety
• Comfort operating independently while building networks of support and expertise

WHAT MAKES THIS ROLE UNIQUE

This 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.

TRAVEL

Approximately 20-30% travel expected eventually for conferences, investigator meetings, advisory boards, and site visits across therapeutic areas

COMPENSATION

Competitive 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.