Jobs at XBiotech USA

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.

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.

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.