Clinical Development Director
New
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EnvedaClinical development
Remote, United StatesFull-TimeDirector
Salary225,000 - 250,000 USD per year
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Job Details
- Experience
- Typically 8+ years for a clinical scientist, or 3+ years in industry after clinical training for a physician.
- Required Skills
- Artificial Intelligence
Requirements
- Hold an advanced degree (MD, DO, PhD, PharmD, or equivalent).
- Have hands-on clinical development experience.
- Have written protocols as a primary author.
- Have led at least one study from protocol to database lock.
- Clinical scientists typically have 8+ years of experience, or physicians have 3+ years in industry after clinical training.
- Have experience in a second therapeutic area.
- Inflammatory bowel disease clinical or trial experience is preferred, ideally including endoscopic endpoints and central reading.
- Demonstrate data-driven judgment using clinical, safety, and operational data to make decisions.
- Be willing to learn or experienced in using AI to draft, check, and interrogate work, with awareness of its limitations.
Responsibilities
- Lead assigned studies from protocol through start-up and enrollment.
- Write protocols and clinical sections of regulatory documents.
- Make study-level design decisions and recommend endpoint, population, and go/no-go options to the Global Program Head.
- Work with Clinical Operations to manage CROs, sites, and vendors against timelines, enrollment, budget, and data-quality expectations.
- Review blinded safety, PK, and operational data with the medical monitor and act on findings.
- Take on studies in additional indications as pipeline needs require.
- Use AI in daily work and share effective approaches with the team.
- Build relationships with investigators, sites, and KOLs.
- Bring the patient's perspective into consequential decisions.
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