Associate Director, Clinical Operations
The Associate Director, Clinical Operations is accountable for the planning and execution of assigned development global clinical trials (includes First-In-Human, Phase 1b, and other signal-seeking Phase 1 trials) under the direction of the Director/Senior Director, Clinical Operations. The Associate Director is a member of one or more cross-functional Zai Project Teams (ZPTs). These complex programs focus on the rapid development of NMEs with limited clinical data, and as such, require the implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, including biomarkers and diagnostics. This is a developing leadership role that will increasingly demonstrate the ability to work independently, problem-solve, effectively collaborate, and innovate.
Major Responsibilities and Duties:
- Lead and coordinate a global cross-functional study team following the RACI framework through all study stages (start-up, conduct, close-out) to contribute to the accomplishment of studies outlined by the clinical development plan.
- Accountable for the overall operational delivery (e.g. country and site selection/start-up, site contracts, patient recruitment and retention, etc) of assigned clinical trials; ensuring that study-level deliverables are met according to timeline and budget requirements.
- Participates in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents such as informed consent forms (ICFs), protocols, site and country budget templates, EDC, IxRS, central/specialty lab, ECG, imaging, PRO specifications, drug supply, biomarker/sample management plans, TMF, and CSRs. Liaises with cross-functional team members including the ZPT members to solicit input.
- Drafts and implements study plans including; vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
- Ensures TMF creation and QC completion.
- Supports EDC, IxRS, and CTMS systems and data maintenance.
- Tracks budget, timelines, milestones, and critical study activities, identifies issues and proposes potential resolutions.
- Partners closely with medical in designing global clinical trial protocols and provides strategic operational input on protocol feasibility.
- Provides input to the study budget and manages assigned vendor budget(s); communicates variances in actual versus forecasted spend in vendor budgets and presents an action plan for resolution.
- Participates in the selection of vendors (participates in the Request for Proposal (RFP) process) on a global scale.
- Oversees delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
- Leads the Investigator Meeting preparation and execution with the support from cross-functional team members.
- Participates/serves as a subject matter expert for business and/or functional initiatives.
- Stays current on relevant therapeutic area knowledge and clinical research best practices.
- Ensures study adherence to ICH/GCP and company SOPs.
- Undergraduate degree in a scientific or health-related discipline.
- Minimum of 7+ years relevant clinical experience in the pharmaceutical industry, including 2 years in study management experience, or equivalent combination of education, training, and experience.
- Demonstrated ability in clinical study management processes and clinical/drug development.
- Highly effective verbal and written communication skills; effectively deliver key messages; aptitude to independently communicate with teams and stakeholders.
- Experience with effective vendor management.
- Demonstrates strategic thinking skills; manages risk (including risk identification and mitigation); identifies critical path/critical dependencies.
- Strong customer focus with investigators, functional peers, vendors, etc.
- Excellent planning and organizational skills.
- Ability to build trusting and collaborative relationships globally.
- Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
- Willingness to travel domestically and internationally and work across cultures.