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
BD Manager
NJ/NYC
GBD
Starting Date 任职时间:Aug 1, 2020
Direct Report 直线经理:Fernando Salles
Primary Function 主要职能:
The candidate reports directly to SVP of BD and is a member of the US BD team. He/She is responsible for searching, basic data analyzing and composing I-MAB business related information searching through database, public sources and other legitimate resources, generating quality weekly report for Sr BD managers and functional team heads to review and decision making purpose.

Major Responsibilities and Duties 主要职责和任务 :
Role Responsibilities:
• maintain up-to-date and accurate scientific intelligence databases for all I-MAB programs;
• master I-MAB licensed commercial database functionality and all processes of searching and report generation;
• Review, update, and advance information analysis of intelligence generated from medical literature/conferences, commercial database, and other information sources
• Provide weekly intelligence summary and provide highest quality data and support to I-MAB Sr managers;
• Provide prompt and accurate research support to I-MAB Sr managers
Team Support
• Learn roles and responsibilities of team and overall organizational structure of I-MAB;
• Support US BD team daily operation, as needed;
• Interact with BD team globally.

Qualifications 资格要求:
Role Requirements:
• PhD and/or MD in life science preferably in Immunology/immuno-oncology. MBA, a plus
• Ability to synthesize and assemble complex data concisely and coherently
• 5 years’ experience in Pharmaceutical/Biotechnology company preferred.
• Excellent command of the English language, Mandarin a plus
• Travel 10-25%
• Position to be based in NJ/NYC
Send your resume
Senior Scientist
SH
R&D
Direct Report 直线经理:Associate Director
Primary Function 主要职能:
The translational research group leads translational research, biomarker identification and novel targets exploration for I-Mab’s immunology and oncology pipelines.
We are looking for a highly talented and motivated bioinformatics scientist to support biomarker discovery and validation.

Major Responsibilities and Duties 主要职责和任务 :
• Analyzing and interpreting high-throughput genomic and biomedical data
• Designing, developing and deploying robust workflows to analyze high-throughput data, with emphasis on RNA-Seq/ExomeSeq /Panel Sequencing to explore drug target biology.
• Mining proprietary and public biological data/database (TCGA etc) `to generate novel hypotheses or insights
• Building and managing biological database (NGS data etc).
• Presenting analysis results in a clear and concise manner
• Collaborate closely and effectively as a member of global biomarker and translational research team, follow sound scientific practices and maintain effective documentation of activities and analyses.

Qualifications 资格要求:
• PhD degree in bioinformatics / computational biology / genomics related fields; or Master degree with 3 years working experience in the bioinformatics related fields
• Strong programming and scripting abilities in R, and proficient in at least one other programming language (Python, Perl, Shell scripting, Java etc.)
• Comfortably working with Linux system and server/cloud computing environmentJob Descriptions
• Excellent background in analyzing high throughput biomedical data (RNASeq, ExomeSeq and Panel sequencing): data cleaning, functional annotation, normalization, analysis, interpretation and visualization
• Strong statistics and math background
• Familiarity with public databases and tools: NCBI, Ensembl, TCGA, cBioPortal, Oncomine, dbSNP etc
• Experience in database design, analysis pipeline and Rshiny development
• Experience with open-source bioinformatics tools and packages (Bioconductor etc.)
• Self-motivated and enjoys teamworking within an international team and dynamic environment always with timeline in mind
• Thorough understanding and interest in tumor biology and immunology
• Fast learner and excited for new challenges
Send your resume
Corporate Communications, AD/D
US
Corporate Communications
Starting Date 任职时间:ASAP
Direct Report 直线经理:Gigi Feng, VP and Global Head, Corporate Communications

Primary Function 主要职能:
I-Mab is looking for a talented corporate communications professional for our rapidly growing global organization. With the primary focus on our home markets in China and United States, you will join us at a time when we’re transitioning towards a fully integrated global biopharma. From content creation to internal and external outreach, you will be a key player in shaping I-Mab’s narrative and efforts to help bring I-Mab’s vision to life.

Major Responsibilities and Duties 主要职责和任务 :
- This role is a combination of strategist, storyteller, problem solver and event organizer.
- You are able to execute on the company’s strategic goals, translate business needs into clear and action-oriented content and deliverables.
- You are a natural networker, bringing in media and external partners’ insights/needs and are able to respond with creative programs and initiatives.
- You will work as part of a team to shape and drive cross-functional projects, cutting through clutter with plans that put the right information in the right time at the right place for the right audience.
- You are a resourceful problem solver and have the ability to discover opportunities during times of issues and crises.

Qualifications 资格要求:
- Bachelor or master’s degree in journalism, communications, biology or related industry experience
- Experience in Pharma R&D Communications highly preferred
- Proven experience in media relations, content development, and agency management
- 8+ years developing and executing communication plans and strategies in an international biopharma company or within a media, publishing, PR agency setting.
- Excellent writing skills and natural ability to establish effective working relationship within cross-functional teams
- Strong learning agility; passionate about biotechnology; able to listen, learn and apply insights in changing environment.
- Bilingual in English and Chinese languages preferred; proficiency in English a must.
Send your resume
RA Manager &Sr. Manager
SH/BJ
R&D
Direct Report 直线经理:Associate Regulatory Affairs Director/Director
Primary Function 主要职能:
Provide regulatory strategy; Implement the submission, follow up until achieving the approval; Support to other functions on regulation affair issues。

Major Responsibilities and Duties 主要职责和任务 :
• Perform and manage day-to-day product registration operations and ensure timely completion of the registration 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 资格要求:
• 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 Senior Manager
SH/BJ
R&D
Starting Date 任职时间:2019-Q4
Direct Report 直线经理:VP, Head of Medical Office
Primary Function 主要职能:
Medical Writer, working closely with I-Mab project team, provides high quality medical writing support toclinical 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 主要职责和任务 :
• 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 资格要求:
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
Head of Immunology
SH/BJ
R&D
Direct Report 直线经理:CEO
Primary Function 主要职能:To develop and drive Immunology strategy and portfolio management, and oversight the implementation.Deeply understand I-Mab’s global TA strategy and trend. Ensure I-Mab’s medical product development planbe in line with TA/portfolio strategies. Collaborate with different cross- function team to generally command academic direction of R&D strategies for I-Mab medical products. Establish and maintain connections and partnership with internal and external stakeholders. Train and develop Immunology team.
Major Responsibilities and Duties 主要职责和任务:
• To develop and drive Immunology strategy and portfolio management, and oversight the implementation. Deeply understand I-Mab’s global TA strategy and trend. Ensure I-Mab’s medical product development plan be in line with TA/portfolio strategies and key stakeholders.
• Obtain organizational view in the TA from China and global perspectives.
• Make sure the I-Mab medical product development strategy getting fully and timely alignment and endorsement with the key stakeholders.
• Co-drive the new compound Go/No Go proposal and propose compound team formation.
• Lead Immunology team to 
-Ensure the clinical development plan to fulfill I-Mab requirements for medical product registration.Develop clinical study design, study documents, clinical dossier, and guide publication plan.
-Guide and/or implement clinical tasks and activities during the conduction of clinical study (including medical monitor, etc.) to ensure clinically and scientifically sound of the clinical development strategy and development plan
-Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders.
• Train and develop Immunology team. Provide hands-on coaching and guidance to team members; acquire and identify talent and create talent development and retention plan and ensure the plan is well executed.
• Contacts of key internal and external stakeholders, such as cross-function teams in R&D(e.g. RA,Statistics, Discovery, PMO, Operation etc.), external KOL, specialized medical association and other key stake holders.

Qualifications 资格要求:
• MD. is mandatory; MSc. or PhD is an asset.
• Thoroughly understand and command knowledge of product and relevant diseases
• Solid knowledge of new drug development and clinical development process and HA (especially CFDA)requirements
• Thoroughly understand and command HCC
• At least 5-year clinical practice in relevant therapeutic area and 10-year working experience in pharmaceutical industry (especially clinical development, and people management) 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
• Strong written and spoken Mandarin Chinese communication skills
• An advanced science degree (MS, PharmD, PhD, MD) and/or relevant experience
Send your resume
QA Officer Associate Director
SH/BJ
R&D
Direct Report 直线经理:Head of Medical Office 医学办公室负责人
Primary Function 主要职能:
Responsible for all R&D Quality Assurance activities at I-Mab including responsible for driving the development of Global Policies and Procedures assuring that there is worldwide compliance with company policies for GCP/GLP/PV-QA and the laws and regulations governing drug discovery and development in all countries where we study our products; responsible for all R&D related audits and associated quality system processes within the GCP, GLP and GVP Quality Management System (QMS).

Major Responsibilities and Duties 主要职责和任务 :
• A full partner with the R&D functional groups by establishing and maintaining a quality-oriented organization that assures sustainable compliance with the laws and regulations governing drug discovery and development as well as the validation of computer-based systems to regulatory standards.
• Establish, maintain, standardize, and manage a GxP Quality Management System (QMS) covering all GxP activities and clinical studies.
• Ensures that there is an appropriate and systematic approach in place for the quality approval of documents such as Standard Operating Procedures, deviations, risk evaluation and management documents, validation documents and other quality related records as defined within the QMS
• Ensures regulatory requirements and I-Mab policies are implemented within SOPs within the QMS as appropriate.
• Provide Quality Assurance (QA) oversight of and Discovery, Pre-Clinical and Clinical Programs.
• Serve as a subject matter expert for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP) for Discovery/Pre-Clinical/Clinical R&D Project Teams
• Develops and manages an internal audit program to verify and improve the effectiveness of the quality management system。
• Conducts audits and assessments of clinical investigational sites, external service providers such as clinical research organizations, and pre-clinical sites et al., ensuring the effectiveness of their Quality Assurance Unit.
• Maintains and communicates performance of the QMS via the agreed Quality Key Performance Indicators – to ensure deviation, Corrective Actions and Preventive Actions et al are handled to a high standard in appropriate timeframe.
• Schedules and leads the periodic Management review for the quality management system.
• Leads the preparation for and actions arising from inspections by Regulatory Authorities/Notified Bodies,serves as coordinator for the onsite inspection

Qualifications 资格要求:
• A minimum of a Bachelor’s degree is required.
• A minimum of 6 years of business experience is required.
• A thorough understanding and experience with the application of Good Clinical Practice (GCP) is required.
• Experience working in a R&D/Clinical Trials/Clinical QA environment is highly preferred.
• Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations,QA, laboratories, etc.) is preferred.
• Ability to effectively negotiate with and influence project teams is preferred.
• Strong verbal and written communication skills are required.
• May require up to 25% domestic and/or international travel.
Send your resume
Senior Clinical Project Manager
BJ
R&D
Direct Report 直线经理:Head of Clinical Operation
Primary Function 主要职能: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 主要职责和任务 :
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) 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 资格要求:
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
➢ 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 Physician, Immunology
SH/BJ
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.
• 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 medical association and other key stake holders.

Qualifications:
• MD. is mandatory; MSc. or PhD is an asset. Medical practitioner’s qualification certification holder(拥有执业医师资格证书)
• 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
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