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About the Role

Lead, manage, and coordinate the operational strategy, risk management, and overall execution of global clinical trials from study start-up to close out in accordance with ICH-GCP and applicable local regulations. Collaborate with cross-functional stakeholders to ensure deliverables are met in terms of quality, compliance, budget, and timing.

Responsibilities

• Lead and coordinate a cross-functional study team to ensure the clinical trial progresses as planned.
• Accountable for the overall operational strategy and delivery of assigned clinical trials, ensuring study-level deliverables are met according to timeline, budget, and quality requirements.
• Participate in developing and finalizing cross-functional activities to ensure delivery of critical clinical trial documents.
• Draft and implement study plans including vendor oversight, risk, quality, safety, communication, trial monitoring, and TMF.
• Ensure TMF creation and QC completion.
• Support EDC, IxRS, and CTMS systems and data maintenance.
• Track budget, timelines, milestones, and critical study activities, identifying issues and proposing potential resolutions.
• Accountable for the study budget and manage assigned vendor budget(s), communicating variances and presenting an action plan for resolution.
• Drive the selection of vendors on a global scale.
• Oversee delegated outsourced activities to ensure CRO and vendor delivery against the contracted scope of work.
• Lead the Investigator Meeting preparation and execution with support from cross-functional team members.
• Stay current on relevant therapeutic area knowledge and clinical research best practices.
• Ensure study adherence to ICH/GCP and company SOPs.

Requirements

• Undergraduate degree in a scientific or health-related discipline.
• Minimum of 8 years relevant experience, with at least 5 years in clinical experience in the pharmaceutical industry, including 3 years in study management or an equivalent combination of education, training, and experience.
• Ability to work across several time zones.
• Prior people management experience.
• Demonstrated ability in clinical study management processes and clinical/drug development.
• Highly effective verbal and written communication skills; ability to independently communicate with teams and stakeholders.
• Ability to effectively lead projects and persuade and influence peers; ability to build trusting and collaborative relationships globally.
• Experience with effective vendor management.
• Strong customer focus with investigators, functional peers, vendors, etc.
• Excellent planning and organizational skills.
• Working knowledge of international regulatory and ICH Good Clinical Practice guidelines.
• Maintains the highest standards of integrity and ethics.

Skills

• Clinical trial management
• Operational strategy
• Risk management
• ICH-GCP
• Cross-functional collaboration
• Budget management
• Timeline management
• Vendor management
• Project management
• Communication skills
• Organizational skills

Location

• South San Francisco, CA

Work Type

• Full-time

Experience Level

• Senior
• 8+ years relevant experience
• 5+ years clinical experience
• 3+ years study management experience

Education Level

• Undergraduate degree in a scientific or health-related discipline

Salary/Compensations

• $177K - $229K/year

Benefits

• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical benefits
• Financial benefits
• 401(k) eligibility
• Various paid time off benefits (vacation, sick time, parental leave)

About the Company

• Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.
• Founded in 2014, Zai Lab has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
• Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
• The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities, creating a portfolio of potential best-in-class and/or first-in-class therapies.
• Zai Lab has four products on the market in China.
• Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed a secondary listing on the Hong Kong Stock Exchange in September 2020, becoming dual-primary listed on both exchanges in 2022.
• As of January 2022, the Company has a global team of approximately 2000 employees.
• Zai Lab is proud of the gender diversity of its company and its promotion of women in biotech, having achieved gender base pay equity at all levels.
• The company is committed to the health of patients and the planet, with its environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life,” integrated within its business.

Equal Opportunity

• All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.