Working at I-Mab

As a young biotech company, I-Mab has been expanding rapidly and providing ample opportunities of career advancement for our employees. We believe that the team spirit and passion for innovation and perfection are critical for our continued success and our enduring corporate values. I-Mab is committed to creating a career development platform for our employees to explore their potential and fulfill their dreams.

Join us

We are passionate about bringing transformational therapies to patients around the world. If you share our passion, you are warmly welcomed to join the I-Mab family and our journey in making a positive impact on patients’ lives.

For consideration of any open positions, please send your resume to:

hrdept@i-mabbiopharma.com
Associate Director/Senior Manager
Beijing & Shanghai
Regulatory Affairs

Direct Report:Regulatory CMC Director

Primary Function:


 · Regulatory Affairs CMC will serve as the leader for global CMC regulatory strategy of one or more biological and/or small molecule products.

 · Provide Regulatory CMC leadership within RA and on cross-functional CMC teams

 · Maintain up-to-date knowledge and expertise of relevant regulatory authorities and ICH guidelines

 · Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for investigational and marketed products


Major Responsibilities and Duties:

 · Manage project planning, operation and reporting of assigned projects.

 · Prepare, review Chemistry, Manufacturing and Controls (CMC) documents for IND/BLA/NDA and their amendments/supplements to assure compliance with regulatory agencies’ requirements and industry standards.

 · Develop regulatory CMC strategy and identify key issues throughout the project.  

 · Evaluate manufacturing change controls, assess regulatory impact, and support their implementation.

 · Support QC testing for investigational and commercialized drugs.

 · Support GMP site inspection when required by regulatory agency.



Qualifications:

 · Experience or understanding of drug development process.

 · Strong organization, communication, and interpersonal skills is a must

 · Knowledge of CMC regulation is a plus

 · Excellent time management

 · Capability to multi-task and meet challenging timelines

 · Chinese writing skills 

 

Send your resume
Associate manager/Manager/Senior Manager/Associate Director, Program Management Lead
Beijing/Shanghai
PMO

Starting Date:Mar 1st, 2019

Direct Report:Director, Program Management Lead

Direct Subordinates:NA

Primary Function:

I-Mab Biopharma is a growing company aiming to be a China-based global player in innovative biologics.


Under portfolio and project management office, the Program Management Lead (PML) is the operational lead of a project team and will be the strategic partner to Project Team Lead (PTL). PML will implement program management principle through drug discovery to development process.


In this position of value creation, as a strategic thinker, PML will be fully involved in product strategy with concomitant goals and objectives in an alignment with I-Mab vision.


Job title and compensation will be decided based on the qualification and experiences of the candidate.


Major Responsibilities and Duties:

·Be responsible for product related business planning, timeline/resource/budget management, risk management and program/portfolio reporting;

·Host cross-functional discussion, governance meetings and external meetings. Maintain confluent information exchange flow and transparent team communications.

·Work with other functional PMs to plan, execute, control, report and close-out product related work across all functions.

·Ensure program work is conducted in compliance with PM best practice; utilize PMBOK methodology and facilitate lessons learned to ensure optimal performance.

·Function as a core team member in co-development programs, manage and align on cross-company activities and objectives.

·Contribute to the success of the portfolio and project management office and be encouraged to share and learn within PM community.

Qualifications:

·Life-science or medical background is required. Post graduate degree in life-science highly preferred;

·PMP or PgMP certification or MBA degree is preferred;

·5-7 years of pharmaceutical industry experience is required; over 3 years' experience in research project management, clinical operation, CMC project management and other functional line management is preferred;

·Skills in MS office is a must; skills in MS project is preferred; skills in other portfolio/program management system or tools (Planisware et al) is also preferred;

·The ability to work with cross-functional teams in a matrix environment is a must;

·Demonstrated ability to resolve conflict and influence teams without formal authority is required.

 

 

Send your resume
Associate Global Medical Safety Officer, Senior Manager/Associate Director
Beijing/Shanghai
Medical Office, Research & Development

Line Manager:Global Medical Safety Officer

Primary Function:

The Associate Global Medical Safety Officer (MSO) serves as the medical safety professional supporting the Global MSO for the global medical safety strategy and overall safety profile for the assigned products (investigational and marketed) throughout their lifecycle. This role need to effectively interface cross-functionally at all levels in the organization, Business Partners, Contract Research Organizations (CROs) as well as with Regulatory Authorities. This role supports all major pre- and post-marketing safety deliverables including signal detection, benefit-risk evaluation and risk management activities. This role will work together with other medical safety staff including Pharmacovigilance (PV) vendors in managing the safety assessment of products, including review of individual and aggregate AEs and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.


Major Responsibilities and Duties:

Supporting Global MSO for below activities:

· Provide safety leadership for Clinical Development including Clinical Study, Investigator Sponsored, Compassionate Use, and other Programs; liaise with Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, CROs, Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.

· Provide safety leadership to Commercial organization to support global launch activities for assigned products if applicable

· Responsible for the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned products.

· Responsible for the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling

· Responsible for signal detection activities to ensure signal identification, evaluation, validation, for assigned products including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with key internal/external stakeholders.

· Chair and/or co-chair on Safety Management Team (SMT), Product Benefit Risk Committee (PBRC), and other executive forums for assigned products.

· Contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products.

· Lead risk-benefit evaluations and contribute to preparation of Risk Management/Control Plans (RMPs/RCPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.

· Provide medical review of individual case safety reports (clinical and spontaneous) and all safety analyses, to ensure accurate coding, seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners.

· Develop or support to the development of I-Mab or department processes including policies, Standard Operating Procedures and other relevant safety documentation (eg. Safety Management Plans, data entry guidelines, etc.)

· Support inspection readiness activities, internal audits and external inspections.

· Participate in the PV vendor selection activities and contribute to vendor governance activities and key performance indicators to ensure safety operation excellence;contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs).

· Provide safety expertise to due diligence activities as needed.

· Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.

· Mentor junior medical office staff; develop and provide training within specific areas of knowledge.


Qualifications:

· MD required; clinical research and/or fellowship training in oncology, immunology, genetics, pediatrics, pharmacology or other relevant specialty is a plus.

· Minimum 2-4 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered.

· Excellent understanding of global PV regulatory environment with working knowledge of international regulations, initiatives, standards and Good Pharmacovigilance practices (GVP) including but not limited to China, Americas, European Union and Asia-Pacific territories including a thorough understanding of case processing and other pharmacovigilance processes. Exposure to working relationship with the NMPA, FDA and other regulatory authorities is preferred.

· Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position

· Strong Leadership Skills.

· Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.

· Some national/international travel may be required. 

 

Send your resume
CRA
Shanghai, China
Department of clinical operation, R&D

Job description:

Position summary


Be able to carry out the clinical supervision of the program and research center independently. To ensure that clinical studies are carried out in accordance with test protocols, standard operating procedures (SOP), drug clinical trial quality management (GCP) and ich-gcp and applicable laws and regulations.Duties and responsibilities


· screening, starting, monitoring and closing of visits to the research center according to the test plan, the scope of work specified in the contract, the requirements of SOP and GCP.

· can be responsible for the supervision of research centers in multiple programmes, research centers and therapeutic areas at the same time.

· carry out programme and research related training for the research center in charge and conduct regular communication with the research center to manage the requirements and problems in the project.

· evaluate the quality of the work of the research center, the completeness and authenticity of the data, and determine whether the research center is conducted according to the plan and applicable regulations. Report quality issues to responsible PM and/or line manager.

· management is responsible for the progress of the research center, through the screening of the central case, the completion of the group, the case report (CRF), and the data query generation and resolution.· create and maintain documents related to the management of the research center, monitor visits and action plans, and submit the visit report and other required research documents.

· responsible for the financial management of the corresponding research center.

· work with other functional departments.

· complete other tasks assigned by line manager and/or project manager (PM).Knowledge, skills and abilities required.

· good knowledge of clinical research and understanding of applicable regulatory requirements.· master the knowledge of the program requirements through the company training.

· good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.

· good verbal and written communication skills.

· good organization and problem-solving skills.

· effective time management skills that can handle conflict work at the same time.

· ability to establish and maintain efficient working relationships with researchers, colleagues, line managers and customers.

· always comply with SOP requirements.

· can think independently and improve process.Minimum education and experience requirements.

· bachelor degree in clinical medicine, pharmacology, nursing, health management or other related disciplines.

· 1 year clinical research or clinical supervision experience.

· at least cet-4.

Send your resume
Copyright I-Mab Biopharma (Shanghai) Co., Ltd. all rights reserved 2019 沪ICP备17007960号-1