Director, 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

Medical, dental, and vision

AD&D insurance

Short/long-term disability

Pet Insurance

Employee Assistance Program

Professional Development

HSA

Flexible Spending Accounts

Paid leave for new parents

Job summary

Ascendis Pharma, a global biopharmaceutical leader, seeks a Director of Systems, Quality, and Training to strengthen Clinical Development processes and ensure compliance with GxP standards. The role partners with IT and SMEs to drive quality, risk management, and training programs across global operations.

The incumbent will oversee SOP updates, TMF governance, and inspection readiness, while promoting a culture of quality and continuous improvement.

Qualifications

• Bachelor’s degree required. Advanced clinical/science degree preferred (e.g., PhD, PharmD, MSN, MPH)
• 10+ years of industry experience in related role
• Experience in global GCP regulations and quality systems management, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs
• Experience in regulatory inspections (preparation and follow up)
• Analysis and decision-making based on sound risk-based judgment
• Ability to handle multiple projects simultaneously and to prioritize tasks in a dynamic environment
• Ability to speak effectively and communicate directly with cross-functional colleagues in a positive/constructive and collaborative manner
• Possesses excellent communication skills, both verbal and written, and ability to write clearly and concisely
• Strong self-motivation, ability to work independently as well as in a team environment
• Proficient knowledge of Veeva and Cornerstone is desirable
• Ability and willingness to travel approximately 10-15% of the time, domestically and internationally

Responsibilities

• Maintains an overview of systems and processes relevant to Clinical Development, and how they interface with each other
• Continuously monitors existing systems and processes relevant to Clinical Development to determine the need for changes to SOPs; coordinates updates to documents and initiates new documents
• Analyzes and refines how systems and processes interface across the molecule lifecycle
• Promotes consistency and efficiency across teams and program
• Serves as a Super User for Veeva and illuminate on the Clinical Development team
• Acts as TMF Ambassador for Clinical Development
• Liaises with IT on behalf of Clinical Development
• Provides expert advice to identify, manage, and mitigate risk in clinical trials and development strategy
• Promotes quality-by-design from study conception to reporting
• Promotes a quality culture and coordinates inspection readiness activities
• Partners with SMEs to mitigate identified risks
• Collaborates with subject matter experts and senior management on responses to audit findings
• Coordinates and supports preparation, review, and finalization of deviations, investigations, root cause analyses, corrective/preventative actions, and change controls
• Catalogues, tracks, reviews, and analyzes audit data to identify trends and exposure
• Acts as Clinical Development SME on MER
• Stays current on GCP and regulatory guidelines and assesses impact to processes
• Partners cross-functionally to determine GxP best practices and drive improvements
• Provides guidance on interpretation and application of regulations to Clinical Development
• Optimizes training for Clinical Development based on team roles
• Ensures a feedback loop between outcomes and processes and training
• Directs training on SOPs to ensure regulatory compliance
• Arranges event-related training for audits/inspections
• Acts as Cornerstone Learning Administrator for Clinical Development
• Ensures training documentation

Skills

Program management

GxP knowledge

Regulatory inspections

Risk-based decision making

Cross-functional collaboration

Communication skills

Veeva proficiency

Cornerstone proficiency

Travel willingness

Quality systems

Education

Bachelor’s degree

Advanced clinical/science degree (PhD/ PharmD/ MSN/ MPH)

Tools

Veeva

Cornerstone

Job description

Ascendis Pharma, a global biopharmaceutical leader, seeks a Director of Systems, Quality, and Training to strengthen Clinical Development processes and ensure compliance with GxP standards. The role partners with IT and SMEs to drive quality, risk management, and training programs across global operations.

The incumbent will oversee SOP updates, TMF governance, and inspection readiness, while promoting a culture of quality and continuous improvement.