Director of Clinical Systems, Quality & Training

Ascendis Pharma; Princeton (NJ); On-site; USD 210,000 - 225,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, and vision plans

Life and AD&D insurance

Disability benefits

Pet Insurance

Employee Assistance Program

Employee Discounts

Professional Development

Health Saving Account (HSA)

Flexible Spending Accounts

Job summary

Ascendis Pharma is seeking a Director of Systems, Quality, and Training to support the Clinical Development team. This role drives robust processes, ensures regulatory compliance, and partners with IT and SMEs to integrate quality into all study activities.

You will lead SOPs, training programs, and TMF responsibilities across global programs. The position requires a minimum of 10 years in related roles, experience with GCP regulations, and proficiency with Veeva and Cornerstone.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 10+ years of industry experience in related role.
• Experience with global GCP regulations and quality systems.
• Ability to manage multiple projects and prioritize in a dynamic environment.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Maintain overview of systems and processes for Clinical Development and interface with other functions.
• Monitor and update SOPs, document templates, data collection and reporting, and vendor management.
• Promote consistency and efficiency across teams and program.
• Serve as Super User for Veeva and Illumination on the Clinical Development team.
• Act as TMF Ambassador for Clinical Development.
• Liaise with IT on behalf of Clinical Development.
• Provide guidance on quality and risk management in trials.
• Oversee training optimization and Cornerstone admin duties.

Skills

Leadership

Risk management

Cross-functional collaboration

Communication

Education

Bachelor's degree in life sciences

Advanced clinical/science degree preferred

Tools

Veeva

Cornerstone

Job description

Ascendis Pharma is seeking a Director of Systems, Quality, and Training to support the Clinical Development team. This role drives robust processes, ensures regulatory compliance, and partners with IT and SMEs to integrate quality into all study activities.

You will lead SOPs, training programs, and TMF responsibilities across global programs. The position requires a minimum of 10 years in related roles, experience with GCP regulations, and proficiency with Veeva and Cornerstone.