Nephrology Clinical Development Executive

Clinical Dynamix, Inc.; Jersey City (NJ); On-site; USD 250,000 - 370,000; Full time

Job summary

Clinical Dynamix, Inc. seeks a physician with senior clinical development leadership to guide strategy, protocols, and medical oversight across clinical programs.

You will supervise medical monitoring, pharmacovigilance, safety signal analysis, and regulatory interactions to advance first-in-human through proof-of-concept studies. You will collaborate with cross-functional teams to ensure GCP compliance, risk management, and scientific integrity while supporting regulatory submissions and

Qualifications

• MD degree required; Board eligibility with certification preferred.
• 8+ years in clinical research and drug development in industry.
• Experience in global clinical development, esp. EU and USA.
• Designing successful clinical studies in complex diseases; managing patient variation.
• Thorough knowledge of GCP, trial design, statistics, and regulatory/pharmacovigilance processes.

Responsibilities

• Provide clinical leadership and medical review for deliverables and regulatory documents.
• Lead the clinical program section in partnership with Clinical Operations and regional teams.
• Serve as Medical Lead for Clinical Trial Teams and represent the section in meetings.
• Ensure compliance with GCP, SOPs, and regulatory requirements; own cost forecasting for the clinical work package.
• Oversee safety surveillance, adverse event recording, and pharmacovigilance activities.
• Develop KOL engagement strategies and manage scientific advisory activities.

Skills

MD degree

Leadership

Clinical development

GCP familiarity

Pharmacovigilance

Regulatory strategy

Education

MD degree

Board-certified (preferred)

Job description

Clinical Dynamix, Inc. seeks a physician with senior clinical development leadership to guide strategy, protocols, and medical oversight across clinical programs.

You will supervise medical monitoring, pharmacovigilance, safety signal analysis, and regulatory interactions to advance first-in-human through proof-of-concept studies. You will collaborate with cross-functional teams to ensure GCP compliance, risk management, and scientific integrity while supporting regulatory submissions and