Medical Director / Senior Medical Director, Clinical Development
We are seeking an experienced physician to join our Clinical Development organization as a Medical Director specializing in gastroenterology. This individual will provide medical and scientific leadership across the development of novel therapies for gastrointestinal diseases.
About the Role
The Medical Director will play a central role in clinical strategy, study design and execution, medical monitoring, data interpretation, and regulatory activities. The successful candidate will combine strong clinical expertise in gastroenterology with the ability to work effectively across clinical operations, regulatory, biostatistics, pharmacovigilance, translational medicine, and other functions.
Responsibilities
- Provide medical and scientific leadership for clinical development programs in gastrointestinal diseases.
- Contribute to clinical development plans, product strategy, and indication-selection decisions.
- Lead or support the design of clinical protocols, including study objectives, endpoints, eligibility criteria, and safety-monitoring plans.
- Serve as the medical monitor for clinical studies, providing guidance on eligibility, safety events, protocol deviations, and other medical questions.
- Review and interpret emerging safety, efficacy, pharmacokinetic, and biomarker data.
- Partner with Clinical Operations to support study start-up, enrollment, execution, and closeout.
- Build and maintain relationships with investigators, key opinion leaders, research sites, and external development partners.
- Prepare and present clinical data to internal leadership, investigators, regulatory authorities, and external audiences.
- Contribute to regulatory documents and interactions, including IND submissions, briefing materials, annual reports, and responses to health authority questions.
- Support the preparation of investigator brochures, clinical study reports, publications, and scientific presentations.
- Collaborate with Drug Safety to evaluate adverse events and maintain an appropriate understanding of each program’s benefit-risk profile.
- Provide clinical input into business development, due diligence, and lifecycle-management activities when required.
Qualifications
- MD, DO, or equivalent medical degree.
- Board certification or board eligibility in gastroenterology strongly preferred.
- Active or previously active medical license in the United States preferred.
- Clinical experience treating patients with gastrointestinal diseases.
- At least two years of pharmaceutical, biotechnology, or relevant clinical research experience preferred.
- Experience supporting Phase 1, Phase 2, or Phase 3 clinical trials.
- Hands-on medical-monitoring experience strongly preferred.
- Knowledge of clinical trial design, Good Clinical Practice, and FDA regulatory requirements.
- Experience in one or more relevant indications, such as inflammatory bowel disease, eosinophilic gastrointestinal disease, celiac disease, liver disease, or other immune-mediated gastrointestinal conditions, is preferred.
- Strong written and verbal communication skills.
- Ability to evaluate complex clinical data and communicate clear medical recommendations.
- Comfortable working in a collaborative, fast-paced, and evolving environment.
- Willingness to work from the Seattle office on a hybrid schedule and travel periodically for investigator meetings, conferences, and study activities.
Preferred Skills
- Experience leading or making significant contributions to a clinical development program.
- Experience interacting directly with the FDA or other global health authorities.
- Familiarity with biologics, small molecules, or other novel therapeutic modalities.
- Established relationships within the gastroenterology clinical and scientific community.