Medical Director-Sr Medical Director, Clinical Development
Seattle, WA · Biotech/Pharmaceutical
Medical Director / Senior Medical Director, Clinical Development Seattle, WA | United States
Our client is a fast-growing and dynamic organization seeking a Medical Director / Sr Medical Director to join its Clinical Development team. The Medical Director / Sr Medical Director will play a key role at all stages of clinical development. The successful candidate will have oversight for planning and execution of clinical trials and be involved in the exploration of novel indications.
The role will provide clinical leadership to cross-functional project teams on development strategies, clinical study outlines and protocols. Compilation and interpretation of study results and interfacing with multiple cross-functional areas including clinical operations, safety, medical and scientific communications, commercial (marketing, sales, managed markets), regulatory, product manufacturing and supply will be key responsibilities, as well as communication and interpretation with external partners, clinical investigators and Key Opinion Leaders.
Company Overview Our Client is an innovative biotechnology company focused on discovering, developing, and commercializing small-molecule and biologic therapeutics centered on immune-mediated disorders, hematologic conditions, oncology, and neurobehavioral diseases.
Our Client's lead lectin pathway inhibitor has just been approved by the FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients ages two years and older, with a planned U.S.
launch in January 2026. The European Launch is in the works. Our Client has also entered license agreement negotiations with Novo Nordisk for an additional inhibitor which will provide a significant strategic partnership and cash infusion. Our Client continues to have a strong financial outlook.
Key Role Responsibilities
Develop and refine clinical development strategies across multiple therapeutic programs
Serve as Clinical Lead on cross-functional project teams
Translate strategy into detailed clinical study outlines and protocols
Provide ongoing medical monitoring for clinical trials (eligibility, safety surveillance, toxicity management)
Collaborate closely with global investigators and research sites
Contribute to preparation and review of regulatory submissions, including INDs, safety reports, investigator brochures, and development plans
Participate in regulatory interactions and represent the clinical program before health authorities
Engage external key opinion leaders to explore novel indications and development pathways
Ensure compliance with regulatory requirements and Good Clinical Practice standards
Lead data review, analysis, and interpretation for internal and external stakeholders
Contribute to scientific publications and presentations
Serve as an internal clinical and scientific resource across research, translational science, safety, regulatory, and program management functions
Support evaluation of business development opportunities
Provide scientific/medical review support as needed
Education and Experience
MD required; hematology specialization and clinical experience preferred
Significant biotechnology or pharmaceutical industry experience
Strong strategic thinking and systems-based problem-solving capabilities
Excellent written and verbal communication skills
Demonstrated leadership and cross-functional collaboration experience
Ability to operate effectively in a fast-paced, evolving environment
Behavioral Competencies
Strategic mindset with strong prioritization skills
Ability to influence and collaborate across functions and senior leadership
High level of integrity and professional credibility
Strong interpersonal and conflict resolution skills
Supervisory responsibilities may include hiring, coaching, performance management, and team development
Compensation & Benefits Our Client offers a competitive total rewards package, including base salary commensurate with experience, annual incentive eligibility, equity participation, comprehensive health benefits, retirement plan with company match, paid time off, and holidays.