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
(Sr. )CPM
SH/BJ
R&D
Direct Report :Associate Director
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 planning and 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) thatare 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
Regulatory Effectiveness( Asso. )Director
SH
R&D
Direct Report :Regulatory Affairs VP
Primary Function :
The Regulatory Effectiveness Director is responsible for set related system, draft SOPs, intelligence, and eCTD implementation.
• To set the related system and draft internal SOPs, this responsibility will be accomplished through the development, implementation and maintenance of sound regulatory team work system /work flow/procedure for all IND/NDA and in-line product maintenance related activities.
• To support regulatory team by developing and overseeing, procedure and practices to ensure quality outcome that meet regulatory team objectives.
Major Responsibilities and Duties :
• Work closely with RA project registration team in providing effectiveness support for entire product registration lifecycle.
• Mapping the work model to standardize internal work flow for all types of registration work includingIND/NDA and in-line product maintenance activities.
• Develop and implement registration archiving system for all types of registration dossier, approval documents, and ensure good maintenance.
• Oversee the compliance by operating to the regulatory related system/database in accordance with SOP/WI requirements and conducting regular quality reviews for regulatory related system/documentations.
• Intelligence: monitor regulatory intelligence news timely and inform project team, if needed, to develop/update SOP/WIs pertaining to NMPA/CDE Regulatory requirement.
• Monitor CDE requirement/timeline on eCTD, set eCTD working process including vendor selection, to ensure eCTD readiness and implementation in advance.
• Lead team for the internal audits and external inspection.
• Collect regulatory information of competitors.
Qualifications :
• At least 8 years' experience in pharmaceutical, with more than 5 years' experience in RA operation.
• Good working knowledge of international and local regulatory guidelines and codes.
• Familiar with regulatory regulation, guideline and requirements. Familiar with eCTD is preferred.
• Good written and oral communication skills.
• Cooperative, dedicated and responsible.
Send your resume
Bioanalysis Manager
SH/BJ
R&D
Direct Report :Jane Meng
Primary Function :
1. Responsible for the implementation of third party’s bioanalysis.
2. Ensure that the third party complies with NMPA, OECD and US FDA GLP regulations, SOPs.
3. Understanding of new regulations on new technologies and knowledge.
Major Responsibilities and Duties :
1. Cooperate with third party and I-Mab colleagues during method development.
2. Review plan, method, report and related file or data from third party.
3. Audit third party with I-Mab QA colleagues.
Qualifications :
1. Be experienced with standard analytical techniques, LBA assay, immunoassay and cell-based assay.
2. Understanding of method development, method validation and sample analysis.
3. Strong organizational and communication skills, as well as reading and writing skills in Chinese and English.
4. 5 years’ experience in PK/ADA/Nab assay development and validation for large molecule are quired, with hands-on experience and capability of trouble shooting. Good communication skills are needed. 
Send your resume
(Associate/ Sr.) Clinical Research Manager
SH/BJ
R&D
Direct Report :(Associate) Clinical Research Director
Direct Subordinates :(Sr.) Clinical Research Associate (CRA)
Primary Function :
Manage clinical monitoring operation to ensure projects are appropriately resourced. Ensure that clinical staff (CRAs) gains the necessary skills to perform their respective job responsibilities.
Major Responsibilities and Duties :
 Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and
resolving problems. Approve actions on human resources matters.
 Participate the hiring and selection process through participation in the interviewing process.Management of onboarding training for new CRAs.
 Ensure that staff has the proper materials, systems access and training to complete job responsibilities.
 Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies that are appropriate to their experience and training.
 Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
 Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
 Ensure that staff is meeting defined workload, quality and other metrics through regular review and reporting of findings.
 Participate in clinical operations quality or process initiatives.
Qualifications :
 Bachelor's degree or above.
 Major in clinical medicine, pharmacy and biology or relevant.
 At least 6 years clinical trial related experience and 2 years as people manager or equivalent.
 Knowledgeable to China regulatory and clinical requirements.
 Strong leadership skills.
 Effective presentation and communication skills.
 Excellent organizational and problem-solving skills.
 Effective time management skills.
 Strong oral and written communication skills in Chinese and English.
Send your resume
Regulatory CMC AD/D
SH
R&D
Direct Report :VP, RA
Primary Function :
• 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
Medical Writing
SH/BJ
R&D
Direct Report :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
IP Manager
SH
Legal
Starting Date :ASAP
Direct Report :Patent Management, Associate Director
Major Responsibilities and Duties  :
1) Responsible for daily maintenance and management of company’s patents/patent applications and licensed-in patents/patent applications, including but not limited to communicating with R&D team and external patent agents, drafting patent technical documents, filing patent applications and tracking application status, as well as the payment of annual fees and agent service fees, etc.
2)Familiar with patent retrieval and analysis, including but not limited to project approval retrieval, invalid retrieval,patent infringement or non-infringement analysis, free to operate (FTO) of patents, etc.;
3) Assisting completing the IP DD of License-in & license-out projects;
4) Recognizing and providing solutions to the risk in the patent management system,assisting updating the system.
5) Taking initiative to completing other assignments.
Qualifications :
1) Master degree or above in biomedical related field;
2) Minimum five years working experience of patent practice in patent agency or biomedical company, work experience at MNC or foreign law firm is preferred;
3) Excellent patent agent practice and professional writing ability in both Chinese and English, with strong ability to search, analyze and solve problems;
4) Good communication and coordination skills in both Chinese and English, able to clearly express professional opinions, and good at cross-departmental communication.
5)Patent Agent Qualification Certificate is preferred;
6) Good professional ethics and rigorous working attitude, team spirit, and can work under certain pressure.
Send your resume
BD Head
SH
Commercial
Direct Report :Chief Commercial Officer
Primary Function :业务拓展
Major Responsibilities and Duties  :
1. 根据公司战略定位,寻访目标客户并进行商务谈判,引进新产品,编写可行性报告;
2. 建立系统的新业务拓展渠道,发现新的业务类型、新的合作伙伴、新市场机会,对公司进行新业务拓
展;
3. 确定意向客户,建立商业合作关系,洽谈、促进项目合作达成;
4. 制订新产品相应市场推广策略。
Qualifications :
1. 医药或生命科学相关专业,博士学历优先;
2. 医药行业背景,10 年以上 BD 经验,有肿瘤项目经验优先(大/小分子皆可);
3. 英文听说读写流利;
4. 具备丰富的并购项目、late stage 项目引进的经验;
5. 掌握国内外医药市场信息获取渠道和调研立项分析方法;
6. 熟悉医药营销、药品研发、市场调查,了解药品报批、临床试验、药品专利分析等相关工作;
7. 熟悉各大类产品线主要产品,明确制药行业的现状和发展趋势,在医药行业有丰富的人脉资源优先;
8. 优秀的商务谈判能力、项目管理能力、团队管理能力,能适应经常短期出差。 
Send your resume
Formulation Development, Director
SH
CMC
Primary Function :
The Director, Formulation Development will be responsible for leading formulation development of biologics. This individual will lead phase appropriate formulation and drug product process development for biologics programs to advance the portfolio. This position will work collaboratively with the various
functional areas within process and CDMOs. This role will be a key contributor within the CMC organization at I-Mab. The successful candidate will be a formulation specialist with a proven track record in managing and leading biologic formulations.
Major Responsibilities and Duties :
1. Lead the development of formulation strategies in the design and implementation of stable formulations of monoclonal antibodies;
2. Provide technical and scientific direction to CDMOs and external laboratories to ensure project deadlines and performance standards are met;
3. Lead the development/optimization of scalable, efficient, and cost-effective formulation efforts;
4. Responsible for technical leadership in technical issue resolution with CDMO partners,including design of experiments and interpretation of results;
5. Oversee the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions;
6. Oversee the development of technical transfer protocols and supervise the transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities;
7. Review analytical and clinical data to make scientific conclusions;
8. Create and review technical documents, reports, and presentations for cross functional teams;
9. Manage SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices.
Qualifications :
1. Masters or PhD (preferred) in pharmaceutical sciences, biochemistry or another relevant field;
2. Eight-plus years of relevant biopharmaceutical industry experience with experience in formulation of biologics;
3. Demonstrated ability to successfully work with and influence contract manufacturing partners while maintaining a positive working relationship;
4. Proven leadership in developing new formulations/processes and scaling them up for implementation;
5. Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals;
6. Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills;
7. Desire to work in a fast-paced, innovative environment;
8. Natural collaborator who enjoys working on a cross-functional team. 
Send your resume
Medical Director
SH
R&D
Starting Date :ASAP
Direct Report :US Site Head
Primary Function :
In the Medical Director role, he/she is responsible for designing and executing clinical trials for I-Mab’s global portfolio of assets. The position will report to the head of US Site.
Role Responsibilities:
1. Design study protocols and clinical development plans in collaboration with different function teams in US and China for oncology or autoimmune therapeutic areas.
2. Author key clinical sections of IB, IND sections, regulatory briefing books, Annual Reports, CSR as well as prepare strategy presentations, present and discuss data with governance, external consultants, KOLs and potentially within regulatory meetings in conjunction with members of the development team.
3. Create and/or review study documents/plans including monitoring plan, data management plan,safety review plan, etc.
4. Performing ongoing data reviews, and leadership of safety review meetings.
5. Communicate internally and externally (oral and written communication) on clinical trial design and results.
6. Analyze and synthesize clinical data for publication, conducting and evaluating clinical trials.
7. Proactively identify clinical development risks and propose risk mitigations.
8. Supervise project team members in planning conducting and evaluating clinical trials.
9. Serve as medical monitor with significant responsibility for safety surveillance.
10. Collaborate with R&D and other senior management in assessing requirements for emerging products, including next generation candidates.
11. Identify, select and train clinical research centers and investigators.  Overseas planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol (e.g. independent reviews, DSMB’s etc.).
12. Participate in the selection of sites, CROs, and vendors.
Qualifications :
Role Requirements:
1. MD with 2-5 years of experience within a pharmaceutical company environment required.
2. Working knowledge of medical, scientific and clinical research in the oncology and autoimmune therapeutic areas.
3. Excellent command of English
4. Position to be based in MD
Send your resume
Copyright I-MAB Biopharma Co., Ltd. all rights reserved 2019 沪ICP备17007960号-1