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Salary: USD 210,000 - 225,000 / annual
Ascendis Pharma, a global biopharmaceutical company advancing programs in Endocrinology Rare Disease and Oncology, seeks a Director of Systems and Quality to support the Clinical Development team. This role is central to ensuring robust, compliant, and efficient processes across the clinical development lifecycle.
You will maintain oversight of systems and processes relevant to Clinical Development, continuously monitoring for needed updates to Standard Operating Procedures (SOPs) and analyzing how systems interface across the molecule lifecycle (document templates, data collection/review/delivery, data analysis, vendor management). You'll serve as a Super User for Veeva and illuminate platforms, act as TMF Ambassador, and liaise with IT on behalf of Clinical Development.
As the Clinical Development representative for quality, you will provide expert advice on identifying, managing, and mitigating risk in clinical trials and development strategy. You'll promote quality-by-design from study conception through reporting, coordinate inspection readiness activities, maintain the eTMF, and partner with subject matter experts to mitigate risks. You'll also coordinate deviations, investigations, root cause analyses, corrective/preventative actions, and change controls. Additionally, you'll catalogue and analyze audit, inspection, and quality event data to identify trends, stay current on GCP and regulatory guidelines, and provide guidance on regulatory interpretation to Clinical Development.
You will optimize training for the Clinical Development team based on roles and timing, ensuring a feedback loop between outcomes and processes/systems. You'll partner to direct SOP training, arrange event-related training (audits, inspections, system implementations), act as Cornerstone Learning Administrator, and ensure appropriate training documentation.
This role requires 10-15% domestic and international travel.
REQUIREMENTS:
- Bachelor's degree required; advanced clinical/science degree preferred (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 development/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 prioritize in dynamic environment
- Excellent verbal and written communication skills; ability to write clearly and concisely
- Effective cross-functional collaboration in positive, constructive manner
- Strong self-motivation; ability to work independently and in team environment
- Proficient knowledge of Veeva and Cornerstone desirable
- Willingness to travel 10-15% domestically and internationally
