Senior Director, Clinical Scientist

How you’ll make an impact:
- Contribute to creation, design, and execution of clinical development strategy in collaboration with Biometrics, Regulatory, Clinical Operations, and external advisors.
- Provide scientific leadership for clinical trial design and protocol development; ensure operational feasibility, data quality, and participant/site engagement.
- Ensure patient safety and data accuracy/integrity via medical and clinical data reviews, protocol adherence monitoring, and protocol deviation management.
- Support timely, high-quality study delivery and successful execution of clinical programs.
- Lead or contribute to Investigator’s Brochures and safety updates; serve as subject matter expert for regulatory submissions and interactions with regulatory authorities.
- Improve/innovate clinical development practices and maintain consistency across studies.
- Engage KOLs, academic collaborators, and external experts; mentor and grow high-performing teams.
- Stay current on disease biology/therapeutic practices/MECHANISMS of action; support conference/publication/presentation materials.

Skills and experience you’ll bring:
- Required: Bachelor’s degree. Preferred: advanced degree in life sciences or healthcare (PhD/MD/PharmD/MSc or equivalent) and significant late-stage drug development experience (highly desirable).
- 10+ years in clinical trial planning, startup, execution, reporting, and publishing (biotech/pharma); immunology/inflammation experience is a plus.
- Expertise in protocol development, study reports, Investigator’s Brochure (IB) authoring, and regulatory submissions.
- Strong knowledge of GCP, ICH, FDA standards, and GCP Quality practices.
- Analytical/organized, strong critical thinking; can manage multiple priorities under tight deadlines.
- Excellent communication and cross-functional influencing/leadership.

Compensation:
- Anticipated base salary: $235,000–$330,000; eligibility for annual bonus, equity participation, and comprehensive benefits.