Medical Director

XBiotech USA, Inc.; Austin (TX); On-site; USD 250,000 - 350,000; Full time

Benefits offered by this job

Health insurance

Equity package

Retirement plans

Job summary

XBiotech USA, Inc. seeks a Medical Director to lead medical strategy for a multi-therapeutic biologics portfolio in early development.

The role requires strong clinical leadership, scientific rigor, and the ability to coordinate with external experts and KOLs to inform development plans and regulatory submissions. You will oversee trial design, safety monitoring, investigator-initiated studies, and medical education content while building a scalable medical affairs function and external

Qualifications

• MD/DO with active medical license required.
• Board certification in internal medicine, oncology, immunology or related field preferred.
• Experience in startup or emerging biotech companies and coordinating across programs should be demonstrated.

Responsibilities

• Provide medical oversight and strategic input for clinical trials across multiple therapeutic areas.
• Design development plans and study protocols with cross-functional teams.
• Lead medical monitoring, safety data review, and regulatory submissions support.

Skills

Clinical leadership

Regulatory strategy

Medical monitoring

KOL management

Cross-functional collaboration

Scientific writing

External partnerships

Education

MD/DO with active medical license

Board certification: IM/Oncology/Immunology or related

Startup biotech experience

Job description

We are seeking a Medical Director with proven early-stage pharmaceutical/biotechexperience to provide medical leadership across our multi-therapeutic area biologicsportfolio. This role requires exceptional generalist capabilities combined withcollaborative leadership skills; someone who can effectively leverage externaltherapeutic area experts, key opinion leaders, and clinical consultants to ensure bothscientific rigor and operational agility. You will serve as a trusted medical voice internallyand externally, seamlessly bridging clinical development and medical affairs as weadvance our pipeline.

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

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.

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

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.