Clinical Development Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership of studies from start to finish as the clinical lead, overseeing everything from protocol development to start-up and enrollment.

• Compose protocols and the clinical components of regulatory documents, while making study-level design choices and presenting recommendations on endpoints, population, and go/no-go decisions to the Global Program Head.

• Collaborate with Clinical Operations to ensure CROs, sites, and vendors adhere to timelines, enrollment goals, budget constraints, and data quality standards.

• Evaluate blinded safety, pharmacokinetic, and operational data alongside the medical monitor and respond to findings accordingly.

• Demonstrate flexibility in decision-making across various therapeutic indications.

• Undertake studies in additional indications as required by pipeline demands.

• Incorporate AI tools into daily tasks to enhance work processes and share best practices with the team.

• Foster relationships with investigators, sites, and key opinion leaders (KOLs).

• Integrate the patient perspective into critical decision-making processes.

• Report directly to the SVP of Clinical Development and work closely with Global Program Heads, Clinical Operations, and medical monitors.

⛳️ Requirements

• Possession of an advanced degree (MD, DO, PhD, PharmD, or equivalent).

• Practical experience in clinical development: served as the primary author of written protocols and led at least one study from protocol development to database lock.

• Generally, 8+ years of experience for a clinical scientist or 3+ years in the industry post-clinical training for a physician.

• Clinical or trial experience in inflammatory bowel disease, preferably involving endoscopic endpoints and central reading (preferred but not mandatory).

• Experience in an additional therapeutic area.

• Data-driven decision-making skills using clinical, safety, and operational data.

• Willingness or capability to use AI for drafting, reviewing, and analyzing work, with an understanding of its potential limitations.

• A collaborative, straightforward, high-agency, and patient-first mindset.

🏝️ Benefits

• Medical, dental, and vision insurance covered at 90%.

• 401(k) plan with company matching contributions.

• Flexible paid time off (PTO).

• Company-wide weeklong recharge break.

• Adoption assistance.