Job Description : About the Company :
BeiGene (NASDAQ : BGNE; HKEX : 06160; SHA : 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 8,000 colleagues across five continents.
Description for focusing on Japan :
- Supports Senior Director to build Japan organization and required process such as Local SOP and WI.
- Conducts Country level feasibility.
- Supports country activity for new studies until reginal / country COM is identified.
- Supports Senior Director for vendor management for FSP partner / Full Outsourcing in Japan.Oversees FSP studies performance in Japan.Improves FSP’s study execution process in Japan in collaboration with FSP partner.Maintains FSP Quality Metrics.Takes onboarding actions for FSP new hires.
- Oversees and support regional COM for Japan specific regulations and tasks.
- Takes trial management responsibility if required.
- Conducts Site Motivation visits and Study Oversight Visits for all studies in Japan.
- Prepares and supports PMDA inspection
- Other tasks, if needed.
Purpose of Job in APAC :
Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilitiesLeads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through to closeout to ensure both internal and external deliverables are on time and on budget working under the guidance and direction of the Clinical Program Lead.Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activityWorks to ensure adherence to a standardized approach to clinical trial managementEnsures successful clinical trial planning, execution and delivery – within specified quality, time and cost parametersEnsures alignment of clinical project goals with Clinical Operations program objectivesMajor Responsibilities in APAC :
Participates in clinical trial scenario planning (estimates timeline and cost, request internal resource)Works with Strategic resourcing team to select study vendorsOversees study vendors to ensure quality and deliveryOversees the development of and adherence to clinical trial project timelinesEnsures senior Clinical Operation staff, Development Core Team (DCT), and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risksCoordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection / feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development processEnsures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timelyCoordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sitesEnsures site monitoring reports are accurate and reviewed on a regular basisClosely monitors Case Report Form (CRF) data entry and source document verification (SDV) statusEnsures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basisReviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecastsAdheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if requiredQualification Required :
Fluent in EnglishExcellent organizational skills and ability to prioritize and multi-task5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant fieldDocumented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials requiredManagement experience of CROs and other Vendors preferredTherapeutic or medical knowledge preferredExperience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection / feasibility as required.Exhibits a strong understanding of methodologies and approachesStrong written and verbal communication skillsWhat we offer to our valued employees :
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant and performance-based annual equity plan!)
Full-time working from home
In-house and external learning and development opportunities
Fantastic benefits program as per the current policy including;
Health Insurance provided
Medical Check-up, flu vaccine reimbursement
Home-office setup allowance
Monthly reimbursement for home office expenses (i.e. internet, mobile..)
Wellness benefits (Employee Assistance Program)
Paid parental leave
Annual leave
Marriage leave and allowance, condolence leave and allowance
And more as the benefit programs keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear : Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer :
