JOB FUNCTION: Clinical Sourcing Management
GRADE/TITLE: Level 7/Senior Manager
EMPLOYER: Brii Biosciences (腾盛博药)
DEPARTMENT: Clinical Operation
JOB LOCATION: Beijing, China
REPORTS TO: Head of Clinical Operation & Innovation
EFFECTIVE DATE: 3/15/2019or earlier
SUMMARY: This position will be responsible for developing, enhancing and implementing the end-to-end sourcing strategy and operation in support of Brii Bio’s clinical development in an effort to effectively meet the business needs and deliver the maximum value for Brii Bio. This includes business engagement, sourcing, contracting, requisition to pay activities, vendor management, and sourcing strategy & enablement activities.
DUTIES AND RESPONSIBILITIES:
Provides primary management of clinical outsourcing needs in support of Brii Bio’s current and planned clinical trials, including identification and selection of all clinical vendors, such as CRO, SMOs, Patient Recruitment, Flexible insourced staffing, Central Imaging, Central Labs, Drug Monitoring, Pharmacovigilance, IVRS, Clinical Logistics, Clinical Ancillary, etc.
Provides end-to-end support though out the entire sourcing process and activities, mainly as:
Identifies potential vendors, generates Request for Information (RFI), Request for Proposal (RFP) and budget grids, coordinates Bid Defenses and proposal review meetings and provides analysis to study teams.
Negotiates and secures the best cost-effective price consistent with required quality and specifications.
Reviews and executes clinical Master Service Agreement (MSA), Work Order (WO), Change Order (CO) as contract lifecycle management, including active negotiation of scope of work, commercial terms, payment terms and budgets.
Ensures quality oversight of vendor mainly from study timeline, delivery, budget, compliance perspective by:
Partners with vendors and internal stakeholders to identify, manage, escalate and resolve issues related to vendor performance (KPI).
Measures vendor performance utilizing scorecard/metric activities; and communicates feedback to the vendor, encourages adaptation on best practices across vendor types and development of continuous process improvements/ maintenance.
Facilitates and executes vendor governance meetings, performance meetings and operating reviews as needed.
Identifies, develops and implements outsourcing processes and procedure.
Supports clinical operation team for budget/ timeline forecasting or reconciliation needs, such as accruals, project budgets, etc.
Facilitates vendor quality oversight and audit including implementation of improvement actions.
Together with clinical operation team to drive innovations through sourcing activities and vendor collaboration, update market movement or trends and identify opportunities as needed.
Supports selective sourcing needs outside of Clinical Operations
Minimum BS/BA degree in procurement, business management or health-related discipline.
At least 8+ yearsof pharmaceutical industry experience and 4+ years of R&D procurement or clinical sourcing experience or equivalent combination of experience.
Experienced in vendor sourcing (CROs/CMOs), bidding, vendor selection, compliance monitoring and contract negotiation, execution, etc.
Good knowledge of different cost structures and cost calculation.
Excellent negotiation skills and teamwork spirit.
Ability to drive with cross-functional team and can-do attitude.
Ability to adapt to changes in the work environment, to change approach or method to best fit the situation and to manage competing demands.
Efficient in Microsoft Office.
Excellent writing and speaking skills in both Chinese and English
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.