Overview of Position
Reporting to the VP of Clinical Operations, the Director, Site Management & Monitoring, is responsible for providing strategic, planning, oversight and delivery of the monitoring function throughout the lifecycle of the clinical development program. This role will work collaboratively and strategically with our cross-functional teams and external partners to ensure that all data deliverables generated by Taysha Gene Therapies are accurate, timely, consistent and executed with the highest Good Clinical Practice (GCP), patient safety and quality standards, in accordance with established contractual agreements, budgets and study timelines.
Essential Duties & Responsibilities
- Accountable to oversee and manage clinical monitoring for global development programs in accordance with industry clinical data standards; accountable for achieving final clinical data deliverables in accordance with clinical protocols and related operational plans
- Accountable to develop and/or oversee the risk-based monitoring strategy and workstream in collaboration with cross-functional team
- Identification and hiring of appropriate monitoring function resources to support multiple development programs in accordance with strategy, budget and timelines; develop, forecast and manage function budget
- Accountable to oversee and manage team of monitoring experts expected to attend multidisciplinary project teams providing specific expertise on timeline development and deliverables related to clinical monitoring
- Lead and/or assist in clinical data related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners
- Develop in consultation with cross-functional partners clinical monitoring related key performance indicators (KPIs) and key quality indicators (KQIs) to build into contractual agreements
- Establish company-wide standards for clinical monitoring activities; lead efforts to drive adoption of external innovations related to clinical monitoring to accelerate drug development, optimize risk-based quality management and enhance analytic capabilities enabling a proactive approach to ensure compliance with regulatory requirements
- Oversee and/or drive preparation and review of clinical monitoring related documentation including clinical protocols, monitoring plans, oversight plans, risk-based critical data identification, protocol deviation plans, etc.
- Accountable to oversee and/or lead investigator/site identification and selection including development of quality and performance standards to support data-driven decision-making, support start-up activities, support recruitment projections and recruitment/retention management, support ongoing site management activities
- Accountable to oversee and/or manage performance of external vendors responsible for clinical monitoring deliverables (e.g., monitoring resource identification/selection, on-site/remote monitoring, centralized monitoring, data collection, entry, cleaning, investigator/site compliance and issue management etc.); ensure quality completion of all clinical monitoring related deliverables
- Lead portfolio-level clinical monitoring related risk identification, management, and mitigation efforts and report progress to senior leadership
- May participate in due diligence team in evaluating potential in-licensing assets or other mergers / acquisition discussions
- Manages internal staffing and performance management, including hiring, training, coaching and performance reviews for clinical monitoring staff. Mentors and develops clinical operations staff.
- Respond to and participate in Quality Assurance audits and/or regulatory authority inspections
- Accountable for overall clinical monitoring performance of regulated clinical trials including inspection readiness; responsible to implement regular quality checks including results reporting to senior leadership
- Contribute to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations
- Bachelor's degree required, advanced degree highly desirable
- 8+ years’ clinical research or equivalent healthcare experience with progressive management experience in clinical monitoring space (minimum 4 years of direct clinical monitoring oversight experience)
- Experience in gene therapy, rare/orphan disease highly desirable
- Experience designing, standardizing and implementing monitoring strategies and standards for global development programs is required
- Experience in managing CROs performing monitoring activities is required; experience with establishing FSP is desired
- Experience with all aspects of clinical trial conduct (startup through close-out) is required
- Experience overseeing Investigator Initiated Trials highly desirable
- Prior demonstrated experience serving as a key leader to support organizational decision making and strategic planning required
- Understanding of drug development and program management from pre-IND through regulatory filing is essential
- Demonstrated excellence in complex project management and effective management of multiple projects/priorities
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
- Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired
- Previous involvement in the oversight and management of GCP regulatory inspections desired
- Ability and willingness to travel up to 10% of the time, as needed (domestic and international)
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
The level of this position will be based on the final candidate’s qualifications.