Senior Director, Clinical Sciences

📋 Description

• Provide scientific support for ongoing clinical development activities.
• Collaborate with R&D, program management, clinical ops, biostatistics, and data management.
• Drive key development activities for clinical studies and CDP execution.
• Author or review trial documents: protocols, CRFs, informed consent, deviations.
• Contribute to regulatory documents: CSRs, Investigator’s Brochures, INDs/CTAs.
• Interact with external advisors, investigators, and internal teams to execute the plan.

🎯 Requirements

• Advanced degree (PhD, PharmD, or Master’s in science/medical field).
• PhD/PharmD with 5+ years CRO/clinical research, or Master’s with 10+ yrs.
• Knowledge of Phase 1-3 drug development.
• Clinical trial implementation and sponsor/site interactions.
• Strong GCP, ICH, FDA, EMEA knowledge.
• Excellent attention to detail and strong collaboration/communication.

🎁 Benefits

• Remote work opportunities within the United States.
• Travel to Cambridge, MA several times per year.
• Private, reliable remote work setup and internet access.