Director, Clinical Systems and Processes

About the role

Ascendis Pharma, a global biopharmaceutical company focused on Endocrinology, Rare Disease and Oncology, is hiring a Director of Clinical Systems and Processes in Princeton. The role supports the Clinical Development team and works closely with partner functions to ensure robust, compliant, efficient and fit-for-purpose processes.

Key responsibilities

• Maintain an overview of Clinical Development systems and processes and monitor them to identify changes needed to SOPs, coordinating document updates and initiating new documents
• Analyze how systems and processes interface across the molecule lifecycle (document templates, data collection, review, delivery, analysis and reporting, vendor management)
• Serve as Super User for Veeva and illuminate, and as TMF Ambassador for Clinical Development
• Liaise with IT on behalf of Clinical Development and act as its representative for quality assurance
• Provide expert advice on identifying, managing and mitigating risk in clinical trials and development strategy
• Promote quality-by-design and coordinate inspection readiness, including maintaining the eTMF
• Partner with SMEs to mitigate risks, help prepare responses to audit and inspection findings, and support deviations, investigations, root cause analyses, CAPAs and change controls
• Catalogue and analyse audit, inspection and quality event data, and act as Clinical Development SME on MER
• Stay current on GCP, industry trends and regulatory guidelines, promote GxP best practices, and provide guidance on interpreting regulations
• Optimize training, coordinate SOP training, arrange event-related training, and act as Cornerstone Learning Administrator

Required profile

• Bachelor's degree required; advanced clinical or science degree (PhD, PharmD, MSN, MPH) preferred
• 10+ years of industry experience in a related role
• Experience with global GCP regulations, quality systems management, SOPs and training programs, and regulatory inspections
• Risk-based judgment, ability to handle multiple projects and communicate effectively with cross-functional colleagues
• Willingness to travel about 10-15% domestically and internationally

Required skills

• Proficiency in Veeva and Cornerstone is desirable
• Knowledge of GCP and GxP

What we offer

• Estimated salary of $210-225K per year, depending on experience, qualifications and location
• Discretionary annual bonus, stock-based long-term incentives and paid time off
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits, pet and legal insurance, EAP, HSA and flexible spending accounts