Senior Director, Global Clinical Development - Remote

Overview

The Senior Director of Clinical Affairs at Sirtex Medical will lead the strategic planning and execution of clinical development plans, ensuring trials adhere to Good Clinical Practices and regulatory standards.

In Short

• Lead clinical development plans and regulatory submissions.
• Collaborate with various internal and external stakeholders.
• Ensure scientific rigor in clinical trial design and execution.
• Manage clinical operations and budget.
• Provide medical expertise and support to external groups.
• Oversee global implementation of clinical trials.
• Mentor clinical research personnel.
• Maintain compliance with regulatory requirements.
• Identify and mitigate project risks.
• Participate in due diligence activities.

Requirements

• 10+ years of clinical research experience.
• Advanced degree (MD, PhD, PharmD) required.
• Experience in interventional oncology and radiopharmaceuticals preferred.
• Excellent communication and project management skills.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.
• Experience in budget development and management.
• Prior experience with trials spanning all phases of development.
• Experience with FDA approval pathways.
• Strong leadership and team-building skills.
• Data management experience.

Benefits

• Competitive salary and bonus structure.
• Flexible work arrangements.
• Health insurance and paid time off.
• 401k matching program.
• Ongoing professional development opportunities.
• Inclusive and collaborative work culture.
• Challenging work with a global impact.
• Commitment to employee safety and excellence.
• Diversity and inclusion initiatives.
• Confidential handling of applicant information.