Location:

Remote with at least 50% travel to the Guangzhou office

Position Summary:

The Director, Clinical Operations will independently oversee multiple clinical trials within and between Clinical Development programs. This includes China-only studies as well as overseeing China and potentially other Asian regions for global clinical trials. This position will lead cross-functional teams and vendors to ensure Angitia clinical trials are executed efficiently, on time, within budget and in compliance with SOPs, applicable regulations, and ICH/GCP guidelines.

In addition, this position will be responsible for line management of Clinical Operations staff in China, including recruitment, retention, professional development, and performance management.

This position will report to the VP, Head of Global Clinical Operations, with a dotted line to the VP, Head of China Clinical Development.

Responsibilities and Duties:

Oversee Clinical Operations within China and Liaise with the Head of Global Clinical Operations as well as Head of China Clinical Development to manage clinical trials in China within and across molecule programs.
Maintain constant, clear communication with the Head of Global Clinical Operations and the Head of China Clinical Development to report all issues, study status, etc. in a timely manner so they are included in decision making process as needed.
In the event of China participation in a global clinical trial the Clinical Operations Director-China will partner with the Global Clinical Operations lead to ensure consistency across regions.
Provide guidance and oversight of the China Study Management Team(s) (SMT) to ensure that objectives of the Clinical Development Plan (CDP) are met
Oversee the identification, selection, on-boarding and management of study vendors in China including CROs, central /specialty labs, and imaging vendors following all applicable Global SOPs.
Provide study-specific training and direction/oversight to CROs, labs and vendors to ensure delivery against scope of work and key performance indicators
Lead the China team to develop, manage and communicate program timelines, budget, resources, clinical activities and priorities.
Oversee and partner with external and internal stakeholders to ensure clinical trial data, from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’.
Contribute expertise and guidance on clinical operations aspects of study design and development of clinical trial protocols.
Contribute to clinical deliverables by providing clinical operations strategies and updates (e.g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs.)
Review and approve study management plans (e.g. vendor oversight, TMF oversight, risk management, quality management, and monitoring). Ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations.
Oversee implementation of clinical systems including CTMS, TMF, EDC, IxRS, and sample management for clinical trials.
Manage program budget; ensure accurate and timely review of invoices and payments, monthly accruals and forecast budget variances.
Provide operational expertise and strategic input into the CDP for assigned studies
Contribute to the development of clinical operations SOPs.
Develop and oversee study quality metrics for clinical trials including collaboration with QA on study risk assessment and mitigation and CAPA management.
Collaborate closely with GCP Quality to ensure Quality Leads and study teams/QC are collaborating on inspection readiness.
Participate in and guide China Clinical Operations staff through Agency inspections and audits.
Provide leadership and mentoring to build a successful China team, including recruitment of candidates, performance management and development of team/staff line management.
May require up to 25% travel.

Qualifications:

BS/BA (or equivalent) in a relevant scientific discipline; advanced degree desirable
7+ years of clinical trial management experience (sponsor experience required)
At least 3/5 years people management, leadership and mentoring experience
Strong knowledge of China regulations, ICH Guidelines, and GCP governing the conduct of clinical studies required; familiarity with FDA and EMA Regulations desirable
Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring
Strong experience in management of CROs and other vendors
Proven project management skills and study leadership ability
Must have excellent interpersonal, written and verbal communication skills including in English
Experience leading global clinical research activities, both early and late development experience preferred
Exceptional project management, cross-functional team leadership and organizational skills
Ability to make decisions, set priorities, and share resources based upon an enterprise approach, ensuring the benefit to the whole organization.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Management
Strong analytical skills with a data driven approach to planning, implementing, and problem solving
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

About Angitia:

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.

Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.