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/Director, Biostatistics
SH
Biometrics
Starting Date : ASAP
Direct Report : Head of Biometrics, Sr. Director

Major Responsibilities and Duties :
1. Provide statistical leadership in support of I-Mab's China and/or Global pipelines, which includes guidance on statistical methods, appropriate study design and interpretation of results and strategic input into clinical development planning.
2. Contribute to develop company SOPs, process and practice.
3. Collaborate effectively with Clinical Development colleagues by driving statistical thinking, proper data interpretation and disciplined exploratory data analysis.
4. Develop statistical sections of clinical protocols, Statistical Analysis Plans (SAPs) and Statistical Programming Plans (SPPs).
5. Define and lead the analysis of relevant internal and external information to inform design decisions.
6. Be responsible for statistical content and data interpretation for Clinical Study Reports (CSRs),publications/presentations and/or regulatory documents.
7. Perform other statistical analyses duties as needed.
8. Help to develop and maintain I-Mab Lifecycle Data Standards.
9. Oversee CROs regarding statistical and programming activities to ensure compliance, quality and timely delivery.

Qualifications :
1. Education: MS or PhD in biostatistics, statistics or related field is required.
2. Experience: a minimum of 5 years (or 8 years for director) of relevant experience including lead statistician role at compound level within pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.
3. Comprehensive knowledge of advanced statistical methods and applications in study design and analysis.
4. Ability to implement innovative and advanced study designs, particularly in early phase oncology studies.
5. Ability to communicate with clarity and influence.
6. Proficient SAS and/or R programming skills, solid understanding of CDISC standards.
7. Knowledge of ICH/EMEA/FDA guidelines.
8. Demonstrated ability to serve effectively as a delivery team leader.
9. Ability to manage and mentor project/study statisticians.
10. Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.  
Send your resume
Associate RA Director
SH
Regulatory Affairs Department (RA)
Direct Report : Head of RA 
Direct Subordinates : RA Specialist/Manager 
Primary Function :
Provide regulatory strategy and plan. Provide regulatory advices and risk assessments on responsible compounds to project team/line manager.

Major Responsibilities and Duties :
• Develop regulatory strategy and define regulatory execution plans in line with company's strategy
• Ensure regulatory submission/approval in line with regulatory requirements
• Achieve successful submissions/approvals for responsible products.
• Manage whole life cycle of products all regulatory submissions process including dossier preparation with high quality, timely responses to deficiency questions and efficiently resolve technical issues from registration test and cause inspection for all applications within planned timelines.
• Work closely and swiftly with project team to update status of regulatory projects and share solutions for potential issues.
• Intelligence: monitor and forecast regulatory environment and intelligence news periodically, and assess impact to company business, if any critical news, alert team timely.
• Develop and coach direct reports by providing timely guidance on regulatory activities/necessary trainings and ensure deliverables of direct reports.
• Lead discussion on critical regulation/guidance and provide regulatory policy related training to the company.
• Lead the team to establish internal SOPs and maintain internal share disk, ensure all regulatory documentation archived in line with internal SOP.

Qualifications :
• 8 years or above regulatory affairs experience in pharmaceutical or biotech industry, including more than 2 years in the manager position.
• Experience with new chemical entities (NCE), biologics(preferred) applications, in-deep knowledge of regulatory guidelines and requirements.
• Good project management skill.
• Planning, prioritizing and problem-solving capabilities.
• Passionate, accountable, integrity and quality, innovative, focus with a sense of urgency.
Send your resume
Senior Manager/(Associate) Director, Program Management Lead
SH
PMO
Direct Report : Executive Director, Program Management Lead

Major Responsibilities and Duties :
• You will be responsible for product related business planning, timeline/resource/budget management, risk management, program/portfolio reporting;
• You will host cross-functional discussion, governance meetings and external meetings. Maintainconfluent information exchange flow and transparent team communications.
• You will work with other PMs to plan, execute, control, report and close-out product related work across all functions.
• You will ensure program work is conducted in compliance with PM best practice; You will utilize PMBOK methodology and facilitate lessons learned to ensure optimal performance.
• You will function as core team member in co-development programs, manage and align on cross company activities and objectives.
• You will contribute to the success of the portfolio and project management office and be encouraged to share and learn within PM community.

Qualifications :
• Life sciences or medical background is required. Post graduate degree in life sciences highly preferred;
• PMP or PgMP certification or MBA degree is preferred;
• At least 8 years of pharmaceutical industry experience is required; over 3 years'experience in research project management, clinical operations, 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
Manager or Senior Manager
SH
Clinical Data Management
Starting Date : 4Q2019 or 1Q2020
Direct Report : Associate Director
Direct Subordinates : Not Applicable

Primary Function :
1) Execute the clinical data management strategy to ensure high quality, high value and timely clinical trial data that enable data exploration and analysis to drive portfolio decisions.
2) Partner with Associate Director of CDM to improve the internal CDM process and platforms to meet corporate needs efficiently.

Major Responsibilities and Duties  :
1) Provides a study level data management CRO oversight and takes data management accountability for low to high complexity trials.
2) Collaborate with CDM team members and/or related clinical functions to build I-Mab data collection and validation standard in system.
3) Provide strong technical support to improve the efficiency of data quality control during trials setup,conduct and closeout.
4) Makes recommendations and influences decisions to trial processes or technical solution in line with business needs.
5) Maintain a positive, result oriented work environment, building partnerships and modeling team work,communicating to DM CRO and trial teams in an open, balanced, and objective manner.

Qualifications :
1) Minimum of a BS in life sciences degree or equivalent
2) Minimum of 5 years of experience in clinical data management or relevant experiences
3) Medidata Rave database builder experience preferred
4) Basic programming experience preferred
5) Understanding of clinical data system design / development / validation and system interoperability
6) Strong communication and interpersonal skill
Send your resume
Associate Director/Director, Statistical Programming
SH
Biometrics
Starting Date : 2019-Q4
Direct Report : Head of Biometrics, Sr. Director

Major Responsibilities and Duties :
1. Serve as the statistical programming functional head for the company.
2. Develop and maintain statistical programming infrastructure, environment, standards, process and SOPs for both China and US operations.
3. Contribute to development of outsourcing strategies and relationships with outsourcing vendors/CROs.
4. Responsible for all statistical programming tasks including submission-readiness datasets(e.g.SDTMs, ADaMs) and TFLs to support CSR, ad hoc analysis, publications, DSUR, and etc.
5. Prepare/Review electronic submission deliverables (e.g. Define.XML, Reviewers Guide, XPTs) consistent with regulatory guidelines.
6. Ensure compliance with FDA and NMPA regulations related to statistical programming including vendors/CROs.
7. Contribute to developing company SOPs, process, practice, guidelines and standards.
8. Oversee and ensure quality of all statistical programming activities performed by CROs.
9. Collaborate effectively with Clinical Operations, Medical/Clinical, safety colleagues and vendors/CROs in support of project deliverables and regulatory needs.
10. Represent statistical programming and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meetings with external vendors/CROs.
11. Help to develop and maintain I-Mab Lifecycle Data Standards.
12. Recruit and manage statistical programming staff.

Qualifications :
1. Education: Minimum of bachelor's degree in scientific, biological, statistical, computer science, or related field. Master's degree preferred.
2. Experience: A minimum of 8 years of relevant experience and 2 years of managerial experience in pharmaceutical or biotechnology industry is required. Oncology experience is highly desired.
3. Comprehensive knowledge of ICH/FDA/NMPA guidelines.
4. Expert knowledge in SAS is required.
5. Knowledge and experience of CDISC standards (SDTM and ADaM) are required.
6. Experience with electronic submission formats such as eCTD is a plus.
7. Demonstrated ability to serve effectively as a delivery team leader.
8. Ability to manage, mentor and motivate statistical programming staff.
9. Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
Send your resume
Regulatory Affairs Manager/Sr. Regulatory Affairs Manage
SH/BJ
Regulatory Affairs
Direct Report : Associate Regulatory Affairs Director/Director 

Primary Function :
Provide regulatory strategy; Implement the submission, follow up until achieving the approval; Support to other functions on regulation affair issues。

Major Responsibilities and Duties :
• Perform and manage day-to-day product registration operations and ensure timely completion of theregistration tasks assigned, in compliance with regulations, guidelines and internal processes.
• Lead responsible regulatory submissions including prepare and review related registration dossier to ensure dossier completeness and accuracy.
• Follow up the review status, keep line manager posted of any progress and propose solutions to critical issues before implementation.
• Lead regulatory related test required, monitor the process of test and help resolve technical issues.
• Provide regulatory guidance of GMP/GLP/GCP if required to on-site inspection during registration by NMPA.
• Intelligence: monitor regulatory intelligence news timely and inform project team if any impact.
• Collect regulatory information of competitors.
• Maintain/archive all regulatory documentation.
• Draft internal SOPs and maintain internal share disk.

Qualifications :
• Over 5-year regulatory affairs experiences in pharmaceutical.
• Familiar with regulatory regulation, guideline and requirements.
• Good written and oral communication skills.
• Cooperative, dedicated and responsible.
Send your resume
Medical Writing, Sr. Manager or Associate Director
SH/BJ
Medical Office
Starting Date :2019-Q4
Direct Repor :VP, Head of Medical Office

Primary Function :
Medical Writer, working closely with I-Mab project team, provides high quality medical writing support to clinical regulatory documents (generally protocols/amendments, Investigator's Brochures/updates,clinical study reports, safety reports and regulatory authority response documents) across product development stages.
In addition, Medical Writer is responsible for overseeing medical writing services outsourced to CROs to ensure quality and timely delivery.

Major Responsibilities and Duties  :
• Actively participate in project team meetings in the development of clinical documents
• Collaborate with study physician, clinical PM, regulatory team to prepare, consolidate review comments, update and finalize protocol, ICF including any amendment, IB development and update, writing support to support authority responses etc.
• Collaborate with biostatisticians, clinical colleagues to interpret study results and ensure timely and accurate integration of data presented in the statistical tables and listings and other information sources into the CSR
• Ensure all medical writing deliverables prepared per ICH and other relevant regulatory guidelines• Ensure that appropriate quality control (QC) checks are performed on protocol, IB, CSRs, other
documents and other medical writing deliverables, as required
• Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready and appropriately stored in an agreed document management system
• Provide thorough and critical review or peer QC support of documents prepared by others, as needed

Qualifications :
1. Master's degree from Chinese universities or bachelor's degree from overseas universities
2. Major in clinical medicine, pharmacy, biology or other related fields
3. 10 years pharmaceutical industry experience with at least 5 years in medical writing
4. Excellent English, both written and spoken
5. Demonstrated ability to communicate clinical data succinctly, clearly and accurately in writing
6. Knowledge of ICH guidelines and regulatory requirements and demonstrated ability to interpret and
apply these guidelines in a report writing setting
7. Competence in the use of relevant software applications (e.g., Microsoft Office), templates and other electronic formats
8. Experience of working with electronic document management systems
Send your resume
Clinical Research Associate (CRA)
SH/BJ
R&D
Direct Report: (Sr.) Project manager / (Asso.) Project Management Director

Primary Function:
Support (Sr.) Project manager / (Asso.) Project Management Director on Clinical projects to sets up, monitor and report in accordance with ICH/GCP, the company's requirements and the local/regional regulation to achieve clinical operation and study target on timeline, quality and cost

Major Responsibilities and Duties:
1. Participates in the development of clinical trial documents in collaboration with the project manager.
2. Identifies and selects investigators/sites in collaboration with the project manager
3. Prepares / collects all documents needed prior to study initiation.
4. Performs study feasibility visits in the investigational sites
5. Organizes / participates in study site initiation visit in which are provided scientific and technical knowledge concerning the study procedures and its organisation.
6. Ensures monitoring follow up:
• Maintain the relationship with the investigational site
• Follow up of trial progress and quality control of data (source document check)
• Documentation of protocol violations, adverse events and premature treatment cessation.
• Identification and resolution of all problems: logistical, methodological, human technical, which occur during the trial.
• Management of the local trial files
• Management of the investigator's trial file
• Management of trial related logistics
• Detection and reporting of deviations, finding and implementing corrective measures
7. Provides timely monitoring reports for all visits / contacts in appropriate reports.
8. Performs study close out visits to close investigational site.
9. Prepares, organizes and participates in investigator's meetings
10. Manage study TMF filing and archiving
11. Participates in internal & external education and training

Qualifications:
1. Bachelor's degree and above
2. Major in clinical medicine, pharmacy and biology or relevant;
3. Have 1-2 years of relevant monitoring experience in clinical trial, and have knowledge reserve of clinical trial management specification (GCP)
4. Strong communication and coordination skills with internal /external clients
5. strong team spirit, sense of responsibility, proactive, careful and meticulous
6. Good computer skills, including proficiency in Microsoft Word, Excel and PowerPoint.
7. Good oral and written communication skills.
8. Good organization and problem-solving skills
9. Have a talent with effective time management. 
Send your resume
Sr. Project manager / (Asso.)Project Management Director
SH/BJ
R&D, Clinical Operation
Direct Report: Head of Clinical Operation
Direct Subordinates: CRA and/or (Asso.) Project manager

Primary Function:
Be accountable for the implementation, management and reporting of assigned clinical trials, drive the execution of the clinical studies in compliance with ICH-GCP, including but not limited to study planning ,study start-up, execution, control study budget and quality, monitor progress, CRO/vendor selection and management, develops and manage all study plans in collaboration with the CRO if applicable.
Be a key member of product project team working closely with R&D key functions on product development plan and execution, provide input and contribute from clinical operation function.

Major Responsibilities and Duties:
Ensure successful clinical trial startup and conduction, accountable for all study aspects and ensuring meeting timeline, budget and quality requirement.
1. Support IND filing on study related documents preparation, e.g. protocol, ICF, IB etc.
2. Manage study planning and startup all activities including not limited to country/site selection,EC/HGRAC submission, study TMF preparation, vendor/system set
-up, Clinical trial materials planningand readiness at depot, study plan development etc.
3. Manage trial enrollment and monitor overall progress, make mitigation/action plans and execute ensuring enrollment hit target.
4. If applicable, lead I-Mab functional team on CRO selection, manage and monitor performance of all CROs ensure delivering on time and high quality.
5. Manage various of clinical vendors contract and overseeing their performance
6. Have responsibility for the financial management of the clinical trial including budget planning,resource allocation and preparation of quarterly reports. 7. Train and coach CRAs in various aspects of management (e.g. HR, budgets, resource allocation) that are relevant to project issues
8. Work as product level project team member and contribute from clin. Ops perspective.
9. Identify/monitor risks, and develop mitigation, contingency plans as necessary

Qualifications:
1. Bachelor's degree and above
2. Major in clinical medicine, pharmacy and biology or relevant;
3. Experienced in clinical trial area and preference on
➢ >6 years clinical trial related experience & >3 years trial management for Sr.PM
➢ >8 years clinical trial related experience & >5 years trial management for (Asso.) Project Director
➢ Previously worked in global pharma or CRO and/or early development functions
4. Knowledgeable to China regulatory and clinical requirements, with experience of interacting with regulatory agencies, e.g. CDE, HGRAC, CFDI
5. Solid understanding of GCP and Drug development
6. Ability to work independently and collaborate
7. Strong communication skills and leadership
8. Strong oral and written communication skills in Chinese and English 
Send your resume
Clinical Research Physician
SH/BJ
Medical / Clinical Research, Research and Development
Direct Report: Director
Primary Function:
The Clinical Research Physician is part of the project team for compound development, providing oversight and execution of clinical development program from clinical study design, protocol development, safety and efficacy data analysis and interpretation and clinical study report. This position will be located in Shanghai or Beijing, China. 
 
Major Responsibilities and Duties:
• To provide medical and scientific expertise to the design, planning, initiation and completion of clinical trials (from phase1 to phase 4 studies); and develop key documents (e.g. protocol, report, etc) in collaboration with cross-functional team.
• To be responsible for communication of key clinical assumptions, risks and mitigation strategies by study/project.
• To leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings.
• To provide medical input into ongoing clinical studies:To perform medical monitoring for the projects;To manage and communicate with investigators; To support training and other scientific support for clinical operation and relevant third parties.Confidential and Propriety
• To provides input to publication strategy for the projects/products. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
• To provide medical support to deliver regulatory submissions (IND and NDA, etc).
• Relevant medical document preparation.
• Communication with regulatory agency and relevant material preparation.
• To provide medical and scientific input for other company business, e.g. business development.

Qualifications:
• With hospital physician experience to take care of patients.
• Minimum master's degree in clinical medicine or related bioscience.
• Prior experience (2-5 years) working in the pharmaceutical and/or biotechnology industry with a superb track record of accomplishments.
• Ability to provide an oversight on clinical design, generation of protocols, case record forms and clinical study reports.
• Understanding of requirements for successful development, registration and commercialization of a new product.
• Knowledgeable in drug development process and the competitive environment.
• Strategic thinking, strong problem-solving skills for developing creative solutions and contingency plans and meeting project objectives.
• Strong oral and written communications skills in both Chinese and English.
• Presentation skill.
Send your resume
Clinical Physician
SH/BJ
Immunology & Early Development, R&D
Direct Report: Head of Immunology & Early Development 
Primary Function:
Act as clinical leader for the assigned compounds, responsible for clinical development strategy and clinical development plan(CDP) in line with target project plan(TPP) and I-Mab strategies. Accountable for all clinical deliverables according to Clinical Development plan. 

Major Responsibilities and Duties: 
• Leads the clinical development for the assigned compounds or products.
• Deeply understands I-Mab's clinical development strategy and plan. Responsible for I-Mab's clinical development strategy and CDP in line with TPP and I-Mab strategies.
• Leads cross-functional team to develop and drive clinical development strategy and plan. Keep the China clinical development plan updated.
• Propose clinical study design and develop clinical study protocol based on the clinical development plan.
• Be accountable for all clinical deliverables (e.g. protocol, investigator meeting training, medical monitor,medical review, clinical study reports and submission summary / HA response document, contribute to HA interactions, such as CDE panel meeting and responsible for the clinical questions, etc.
)) if applicable.
• Ensure the medical and scientific sound and fully meet HA requirements for the compound registration.Provide physician guidance and expertise on patient care to clinical studies (including medical monitor,etc.) if necessary.
• Provide clinical input for commercial assessment and portfolio prioritization. Medical support to cross function, such as RA, STATs, Operation, Discovery etc.
• Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders. Undertake tasks as agreed with the Head of Immunology & Early development.Confidential and Propriety 
• Contacts of key internal and external stakeholders, such as cross-function teams in R&D(e.g. RA,Statistics, Discovery, PMO etc.), global TA person in charge, external KOL, specialized medicalassociation and other key stake holders. 

Qualifications:
• MD. is mandatory; MSc. or PhD is an asset. Medical practitioner's qualification certification holder 
• Thoroughly understand and command knowledge of product and relevant diseases
• Solid knowledge of clinical development process and HA (especially CFDA) requirements
• Thoroughly understand and command GCP
• Thoroughly understand and command HCC
• At least 3-year clinical practice in relevant therapeutic area and 3-year working experience in pharmaceutical industry ,especially clinical development is preferred
• Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.
• Excellent English abilities of listening, speaking, reading and writing; same level of CET-6 
Send your resume
Associate Director / Director for CMC Technical Project Management
SH
CMC
Direct Report: Executive Director

Primary Function:
1. Act as CMC lead to manage integrated IND enabling projects outsourced to CDMO, be responsible for overall CMC budget, timeline, deliverable and IND filing, 1-2 projects annually
2. Act as function lead to manage functional activities of CMC development at CDMO site, multiple projects in parallel, including experimental designing, report reviewing, on-site support, dossier writing etc.
3. Coordinate internal and external communications for in-licensed and out-licensed projects
4. Support other functions for IND application
5. Continuously screen and select suitable CDMOs for outsourced projects 

Qualifications:
1. Master's degree and above for biotechnology, cellular biology, molecular biology and other related subjects.
2. More than five-year experience in bioprocessing development for antibody and recombinant proteins.
3. Extensive knowledge and experience in the development of biopharmaceutical products, including IND as well as regulatory affairs and requirements(both China and US).
4. Good communication skills.
5. Teamwork spirit.
Send your resume
Manager/Senior Manager for CMC Development Lab (Upstream)
SH
CMC
Direct Report: Executive Director

Primary Function:
1. Lead cell culture process development for antibody based therapeutic proteins, including seed train,medium screening, feeding strategy, bioprocessing optimization etc.
2. Set up the SOPs for upstream development platform, batch record preparation, perform data review and ensure data integrity.
3. Lead the communication between CDMO and internal projects, tech transfer and following on project management.
4. Maintain the equipment in cell culture lab.
5. To be involved in the cell line development and downstream development, understand the whole process development workflow in CMC development.
6. Technical project management as functional lead for cell culture for multiple in house or license - in projects.

Qualifications:
1. Bachelor's degree and above for Biotechnology, Chemical engineering, cellular biology and other related subjects.
2. More than three-year experience in bioprocessing development for antibody and recombinant proteins,an exporter for CHO cell fed-batch process development.
3. Good communication skills.
4. Teamwork spirit. 
Send your resume
Formulation/DP Development Manager / Sr. Manager
SH
CMC
Direct Report: Associate Director

Primary Function: 
Biologics formulation/ DP development

Major Responsibilities and Duties:
1.Work closely with CDMOs on biologics formulation and process development plan design and project execution.
2.Work as a SME in biologics formulation and process development and provide all kinds of technical support to biologics DP development and production as needed.
3.Oversee CDMOs for biologics formulation and process development, DP manufacturing, stability study, etc.
4.Monitor the project progress in CDMOs and assure timely deliver each milestone.
5.Manage formulation development for liquid and lyophilized product, DP tech transfer, process development, optimization, scale-up, non
-GMP and GMP manufacturing, process validation, etc.
6.IND/BLA dossier preparation.

Qualifications:
1. Has MS or Ph.D. degree in biochemistry, chemistry engineering, pharmacy and related fields with at least 2~5 years of industry working experience in big pharma or biotech company.
2. Familiar with biologics drug formulation and process development from early to late stage and to commercialization.
3. Has at least 2 years of experience in biologics formulation, lyophilization process development, optimization, scale-up, tech transfer and process validation, etc.
4. Familiar with ICH, IMPA, FDA, EMA policies.
5. Familiar with regulatory procedure of IND/BLA filing to IMPA, FDA and EMA.
6. Fluent in both English and Mandarin.
Send your resume
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