Medical Director
Position Overview
We are seeking an experienced Medical Director to provide medical leadership across a diverse, multi-therapeutic biologics portfolio. This is a hands-on, non-executive Medical Director role focused on supporting clinical development, clinical trials, medical monitoring, regulatory activities, and medical strategy across multiple therapeutic programs.
Key Responsibilities
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 develop clinical development plans and study protocols.
Serve as Medical Monitor for clinical trials, ensuring patient safety and data integrity.
Review and interpret clinical data to support development decisions and regulatory strategies.
Coordinate with therapeutic area consultants and advisors to ensure appropriate clinical and scientific expertise.
Contribute to regulatory submissions, including INDs and responses to health authority queries.
Expert Network & KOL Management
Build and maintain relationships with therapeutic area experts, clinical consultants, scientific advisors, and KOLs.
Coordinate scientific advisory boards and leverage external expertise for study design and data interpretation.
Identify and engage external consultants based on evolving therapeutic area needs.
Synthesize input from multiple experts to support medical and strategic decision-making.
Medical Affairs & Scientific Communications
Support medical affairs activities as the organization continues to grow.
Develop scientific communication materials, including publications, presentations, and medical education content.
Support relationships with KOLs and scientific advisory boards.
Oversee investigator-initiated studies.
Cross-Functional Collaboration
Partner with Regulatory Affairs to support scientifically rigorous regulatory submissions.
Work closely with Clinical Operations to ensure clinical trial execution aligns with medical objectives.
Collaborate with CROs and external clinical development partners.
Prioritize activities and balance competing demands across multiple development programs.
External Engagement
Represent the organization at scientific conferences and medical meetings.
Present clinical data to investigators, healthcare professionals, and scientific audiences.
Engage with patient advocacy groups and external stakeholders.
Participate in scientific discussions with regulatory agencies.
Required Qualifications
US MD degree required.
Active medical license required.
Minimum of 5-7 years of clinical medicine and/or pharmaceutical/biotechnology industry experience, preferably with significant clinical development exposure.
Strong experience in clinical development and clinical trial activities.
Demonstrated experience with clinical trial design, protocol development, execution, and medical monitoring.
Strong understanding of biologics development, including regulatory pathways and drug development processes.
Experience with INDs, regulatory submissions, and interactions with the FDA and/or other regulatory agencies.
Experience working with CROs, Clinical Operations, Regulatory Affairs, external consultants, and scientific advisors.
Able to work effectively across multiple therapeutic areas and development programs.
Excellent scientific writing, communication, analytical, and organizational skills.
Able to work effectively in a fast-paced and dynamic environment.
Preferred Qualifications
Experience with biologics or antibody therapeutics.
Board certification in Internal Medicine, Oncology, Immunology, or another relevant therapeutic specialty.
Prior experience in an early-stage or emerging biotechnology company.
Experience managing clinical programs across multiple therapeutic areas.
Previous Medical Affairs or medical leadership experience.
Experience with KOL engagement and scientific advisory boards.
Track record of publications in peer-reviewed journals.
Work Schedule & Location
This is a full-time position. On-site in Austin, Texas, 5 days per week. Candidates must be willing and able to work from the Austin location on a full-time basis. Travel approximately 20-30% travel may be required for scientific conferences, investigator meetings, advisory boards, and site visits.
Compensation & Benefits
Base Salary: $220,000-$260,000 per year, depending on experience and qualifications. Comprehensive benefits package, including medical insurance and retirement benefits.