The Director of Systems, Quality, and Training supports the Clinical Development team and collaborates closely with our partner functions to ensure robust processes that are compliant, fit-for-purpose, efficient and make sense within the broader framework.
Key ResponsibilitiesMaintains 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 Standard Operating Procedures (SOPs); coordinates updates to existing documents and initiates new documents as appropriate
- Analyzes and refines how systems and processes interface with and feed into each other across the lifecycle of a molecule (eg document templates; data collection, review, and delivery; data analysis and reporting; managing vendors)
- 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 as appropriate on behalf of Clinical Development
Serves as the Clinical Development representative for ensuring
quality within our processes and strategies
- Provides expert advice to identify, manage, and mitigate risk in our clinical trials and our clinical development strategy
- Promotes quality-by-design from study conception and protocol design, study start-up, trial conduct, through reporting on study results
- Promotes a quality culture and coordinates inspection readiness activities (including maintaining the eTMF and other documentation) throughout the clinical trial process
- Partners with SMEs to mitigate identified risks
- Collaborates with subject matter experts and senior management to formulate responses to audit and inspection 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, inspection, and quality event data to identify trends and areas of exposure
- Acts as Clinical Development SME on MER (Monitoring of External Requirements)
- Stays current on GCP, industry trends, practices, and regulatory guidelines and assesses impact to processes and systems relevant to Clinical Development,
- Partners cross-functionally to determine GxP best practices and drive continuous improvements within processes and systems relevant to Clinical Development
- Provides guidance on interpretation and application of specified regulations to Clinical Development
Optimizes
training for Clinical Development based on the team's roles and in terms of timing of trainings
- Ensures a feedback loop between outcomes and our processes/systems and training
- Partners to direct training on SOPs to ensure compliance with regulatory requirements
- Arranges appropriate event-related training, e.g., for audits & inspections, system training for newly implemented/upgraded systems
- Acts as Cornerstone Learning Administrator for Clinical Development
- Ensures appropriate and adequate training documentation
Requirements- Bachelors 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
The estimated salary range for this position is $210-225K/year. Actual salary determination is dependent on a variety of factors, some of which include: experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.
Benefits- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of Pet Insurance and Legal Insurance
- Employee Assistance Program
- Employee Discounts
- Professional Development
- Health Saving Account (HSA)
- Flexible Spending Accounts
- Various incentive compensation plans
- Accident, Critical Illness, and Hospital Indemnity Insurance
- Mental Health resources
- Paid leave benefits for new parents
