Job Opportunities

1. Clinical Project Manager

Department: Clinical Development

Report to: Clinical Operation Director

Location: Shanghai

 

Major responsibilities 

  • Responsible for lead the application and integration of key Clinical Project Management processes and tools across clinical teams and/or subsets of clinical teams to deliver clinical milestones on time, on budget, and within scope.

  • Responsible for developing and maintaining up-to-date clinical plan timelines,driving clinical project meetings or other appropriate forum to prospectively manage upcoming team-related activities, key milestones, and decisions as well as to proactively identify updates to clinical schedule.

  • Supports and coordinates the clinical team for documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; may ensure when appropriate, the archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.

  • Attends appropriate training programs and project teleconferences as applicable.

     

Qualifications

  • Bachelor degree in health-related /science discipline or equivalent

  • At least 3 year’s clinical project manager or lead CRA experience

  • Good English skills in writing and reading

  • Experience in management of clinical trial and/or regulatory documents

 

 

2. Director of Clinical Operations

Department: Clinical development

Report to: CEO

Location: Shanghai

 

Job introduction

In this position, the Clinical Operations Director is responsible for leading and manage the clinical operation team and provides leadership, strategic direction and oversight for all study, people and stakeholder management activities conducted by his/her team. The Clinical Operations Director will ensure clinical trials conducted in China within defined budget and timeline. He/she will lead the process of vendor selection and contract negotiation. The Clinical Operations Director is responsible to ensure that all the operational activities to have good adherence to ICH-GCP, Chinese legal/regulatory requirements and Connect’s policies and SOPs.   

 

Major responsibilities

1. Strategic Direction:

  • Develops the strategy and drives implementation of tactics for Clinical Operations to meet both long-term and annual goals of the company.

  • Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.

  • Oversee the initiation and conduct of clinical trials by CROs ensuring timely recruitment and finalization.

  • Manage suitable third party for out-sourced services (such as clinical research organization, central laboratories, data management, statistical analysis) necessary for the operation of clinical trial.

  • Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Connect’s SOPs and other relevant clinical research guidelines.

  • Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.

  • Accountable for ensuring clinical operation budget forecasts are accurately produced and submitted in time for the functional budget rounds. Ensures adherence to budget forecasts.

 

2. People Management:

  • Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.

  • Accountable for resource management, performance management and career development of Clinical Operations staff.

 

3. Stakeholder Management:

  • Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with company policies and country legislation.

  • Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical team, safety, and other functions.

 

Qualifications

  • Master degree in medicine, pharmacy or other life sciences, MD/Ph.D. is a plus.

  • Minimal 5 years of international pharmaceutical industry experience in clinical study planning, execution activities as senior manager/director of clinical operations.

  • Good leadership skills and can inspiring other people

  • Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations 

  • Fluent in both English and Chinese

  • Good communication and interpersonal skills - works well with others, motivates and encourages

  • Proficiency in computer skills, CTMS

  • The ideal candidate is required to have experiences in clinical operations in multi-national companies. Previous Experiences in involving global or regional trials are preferable.

  • Availability to travel nationally and internationally

     

 

3. Study Physician, Manager

Department: Clinical Development

Report to: Clinical Development Head

Location: Shanghai

 

Job introduction

Study Physicians design and ensure successful conduct of clinical studies with highest integrity in China and review study results. Study Physicians are core members in Product Clinical Development Team and responsible for compound’s China development strategy and plan. Study Physicians are also responsible for supporting global team on compound global development strategy and global study conducting.    

 

Major responsibilities

  • China clinical development strategy and plan  (including protocols) for responsible projects

  • Ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)

  • Co-owners of clinical study delivery (with Clinical Operations and Stats)

  • Development documents (IB, protocol and CSR, etc) content owner

  • Analysis and interpretation of clinical study results in partnership with Stats, Clinical Operations and Safety (as well as Clinical Pharmacologist If necessary)

  • Forming and running China protocol review committee

  • Forming and running advisory board for portfolio projects;

  • Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design

  • Liaise with safety physician for program-level assessment of safety information, evaluation of safety signals, regulatory compliance of safety reporting including updating safety profile in the Investigator’s Brochure, Risk Management Plan, DSUR, etc.

  • Liaise with clinical pharmacologist on PK/PD programs to ensure the deliverables

  • Setting strategic direction for addressing medical issues in regulatory submission and communication/interaction

  • Be a TA clinical science expert and supporting China regulatory filing and registration

  • Be a TA clinical science expert and leading discussions with regulatory officials on clinical science subjects of a given project

  • Oversight the delivery of CRO company and related vendors to ensure the study meet the timeline and ensure the quality

  • Interfacing with CRO study teams and study related vendors on clinical sciences matters

  • Providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

  • Summary

  • A core function on Product Clinical Development Team representing TA Clinical Science

  • Be the interface with Regulatory/KOLs/CROs on clinical sciences matters

  • Provide clinical science support and training to internal team on needed base

  • Liaise with BD to support pre-launch marketing activities, publications, conferences and early market access to the compounds  

  • Maintain up-to-date medical/scientific knowledge as well as clinical trial landscape and competitive intelligences in the TA

 

Qualifications

  • Medical Degree/Medical training, Physician License is a plus.

  • At least 3 years of clinical development experience (at least as clinical research physician for 1~2 years) in pharmaceutical and/or biotech industry or CRO company, clinical practice in TA is desirable.

  • Medical expertise in related therapeutic areas

  • Good GCP knowledge and deep clinical trial related knowledge

  • Experience of study design and drug development plan

  • Regulatory guidance for the TA

  • Experience of medical monitoring, safety reporting and Risk Management Plan

  • Familiar with CSP/CSR content & data analysis

  • Fluent English and Chinese, written and oral.

  • Good Presentation & communication skill

  • Can work independently as well as a good team player

  • Demonstrate the leadership in the cross function work and can adjust to the fast speed work

  • Prioritize and focus with attentive to detail and excellent analytical skill

  • Clinical practice in related TA, Stats knowledge, Investigator & site knowledge, Industry/competitor knowledge are highly desired

 

 

4. Clinical Scientist / Senior Clinical Scientist

Department: Clinical Development

Report to: Senior director of Medical Science

Location: Shanghai

 

Job introduction

Medical Scientists are a resource for Product Development Clinical Team. Medical scientists work synergistically with physicians in projects as an expert in medical scientific aspects of the products and their development.    

 

Major responsibilities

  • Work closely with study physician for Compound China development strategy and plan  (including protocols) for responsible projects

  • Work closely with study physician to ensure successful conduct and integrity of all in-scope clinical studies (i.e., providing medical monitoring)

  • Work closely with study physician  to co-owners of clinical study delivery (with Stats and Clinical Operations)

  • Work closely with study physician for development documents (IB, protocol and CSR, etc.)

  • Work closely with study physician to analysis and interpretation of clinical study results in partnership with Statistician.

  • Work closely with study physician to forming and running China protocol review committee.

  • Work closely with study physician to forming and running advisory board for portfolio projects;

  • Be responsible for interacting and communicating with China KOLs for China development strategy and protocol design

  • Work closely with study physician to setting strategic direction for addressing medical issues in regulatory submission and communication/interaction

  • Supporting China regulatory filing and registration

  • Providing consultation to clinical operation colleagues on protocol design questions and answering protocol related questions from site investigators

  • Work closely with study physician to interface with CRO study teams and study related vendors on clinical sciences matters

  • Work closely with study physician to provide clinical science support to internal team on needed base  

 

Qualifications

  • A graduate degree of clinical, biomedical, pharmacy, nursing, scientific degree with significant drug development experience is required, MD/Ph.D. is a plus.

  • 1-2 years clinical drug development or medical affairs or medical writer experience within a pharmaceutical company or CRO Company, clinical doctor experience are priorities. Expertise of therapeutic area and knowledge of relevant products is highly desired

  • Have general disease/compound/regulatory knowledge, knowledge about clinical development

  • Safety monitoring and evaluation of signals

  • CSP/CSR content & data analysis

  • Presentation & communication skill

  • Clinical trial landscape and competitive intelligences

  • Statistical knowledge, medical monitoring, industry/competitor knowledge are highly desired

 

5. Clinical Drug Safety Associate Director

Report to: Senior director of Medical Science

Location: Shanghai

 

Job Introduction

Serves as scientific safety leader for assigned Connect Biopharmaceuticals projects/products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle management (post-approval) and externally. 

 

Major responsibilities 

  • Responsible for safety issue management from formation through Life Cycle Management (post-approval) 

  • Develops and is responsible for key internal safety documents from the formation through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent with one another 

  • Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team. Ensures that this team appropriately reviews all safety data from various sources (e.g. pre-clinical, clinical trial data presented by Clinical Trial Head or Medical Scientific Expert, post-marketing, literature) throughout the development process 

  • Provides expert safety input to the clinical development program for assigned projects/products

  • Provides expert medical input to trial and project level Drug Safety Monitoring Board activities for assigned projects/products, as required, whilst remaining blinded 

  • Responsible for initial development and updates of safety information in Basic Prescribing Information, including addressing safety issues optimally in all project/product labeling claims 

  • Responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards.

  • Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Science, Medical Information, Statistics, Safety Data Management and other related departments 

  • Provides support as needed for licensing activities, regulatory authority inspections and for project recall activities 

 

Qualifications

  • Medical Degree or equivalent scientific education. 

  • Fluent in spoken and written English and Chinese.

  • At least 7 years of safety experience or an equivalent experience

  • Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/submissions involving safety information 

  • Experience in leading cross-functional teams 

  • Experience with (safety or others) issue management 

  • Strong leadership skills with outstanding communication skills with fast pace work environment

 

 

6. Statistics Senior manager/Associate director

Department: Clinical development

Report to: Senior director of Medical Science

Location: Shanghai

 

Job introduction

Statistics head provide statistical expertise to the design and interpretation of clinical studies and programmes.

  

Major responsibilities

  • Application of statistical skills and thinking to develop design options that address cost time uncertainty and probability of success with the appropriate use of modelling and simulation or other techniques to enable the business to make informed decisions.

  • Providing specifications and direction to outsourcing partners/providers to ensure clarity and appropriateness of specifications and standards, early resolution of emerging issues. They hold partners and providers accountable for the quality of their deliverable.

  • Internal delivery of statistical analysis plan, statistical analysis report, or statistical analysis wherever as needed.

  • Application of statistical skills to provide support to the regulatory submissions including specification of overview documents and response to regulatory questions.

  • Contributing to the development, sharing and/or statistical support of new procedures, tools or techniques in order that the quality, efficiency or effectiveness of the Group is improved.

  • Identifies and applies statistical methodology to improve the methodology and provide practical solutions for clinical development activities

  • Network with colleagues and experts, providing statistical expertise and serving as a resource for others by sharing experience within and beyond project team.

 

Qualifications

  • MS/MSc in Statistics, Medical Statistics or related field with at least 8-years’ experience as a statistician in the health care environment or relevant areas of statistical applications

  • Application of statistical techniques in the analysis of data from clinical studies or other relevant areas

  • Ability to communicate statistical concepts to non-statisticians both verbally and in writing

  • Ability to influence others in a team environment.

  • Presentation of statistical methods and results to a variety of audiences especially non-statisticians.

  • Proficiency in computer skills

  • Availability to travel

 Prefer:

  • PhD in Statistics with experience as a statistician in the health care environment or relevant areas of statistical applications

  • Experience of study design from more than one phases of drug development

  • Experience of regulatory submissions and commercial support.

  • Knowledge of Pharmaceutical drug development and marketing

 

  

7. Scientist/Group Leader, Cell Biology/in vitro Pharmacology

Base: Taicang (Suzhou), Jiangsu Province

Major responsibilities

  • Lead the effort in cell line development and developing in vitro biological assays

  • Responsible for the implementation of a broad range of biochemical and cellular assays that address project needs

  • Responsible for providing robust in vitro screening and drive lead optimization and obtain mechanistic insights for all internal research programs

 

Qualifications

  • PhD or equivalent in a relevant scientific discipline and at least 3 years of drug discovery experience, robust experimental design and troubleshooting skills, and excellent data analysis/mining/statistics capabilities, In-depth expertise in immunology/inflammation is preferred

  • Strong hands-on experiences in cellular biology/pharmacology, Experience with automation technologies is preferred

  • Excellent communication and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

  • Highly motivated self-starter, proficient in English and Chinese

 

8. Senior Scientist/Director, Antibody Engineering

Base: Taicang, Jiangsu

Major responsibilities

  • Organize and coordinate the internal and external resources, and participate in the early discovery, humanization and affinity maturation optimization of the new antibody, until the commercialization of cell lines can be built.

  • Lead to build the internal technology platform for antibody scale-up process development and formulation, and drive the scale-up and formulation exploratory studies that address project needs

 

Qualifications

  • Ph.D. degree or equivalent in Life sciences or a relevant scientific discipline, familiar with antibody sequence analysis, related antibody display, humanization and affinity transformation technology, have antibody drug research and development experience, especially antibody technology amplification and preparation research experience preferred.

  • At least 8 years experiences in antibody drug discovery, successful track record in antibody scale up and formulation is definitely preferred

  • Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

  • Highly motivated self-starter, proficient in English and Chinese

  

9. Scientist, Antibody Pilot Expression and purification

Base: Taicang (Suzhou), Jiangsu province

Major responsibilities

  • Participate in establishment of the technology platform for antibody pilot production, including cell culture medium screening, shake flask cell culture process optimization, and bioreactor cell culture process optimization, and etc.

  • Organize and participate in the development and optimization of related antibody drugs, provide technology transfer to support the scale-up production process.

  • Undertake the pilot production of related antibody drugs.

 

Qualifications

  • M. Sc. Degree or equivalent in life sciences or a relevant scientific discipline

  • In-depth knowledge of cell culture bio-reactors, hands-on experiences antibody expression and purification

  • Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

  • Highly motivated self-starter, proficient in English and Chinese 

 

10. Manager, Quality Assurance and Laboratory operation

Base: Taicang (Suzhou), Jiangsu Province

Major responsibilities

  • Lead to organize and coordinate the internal and external resources for establishing Connect’s quality management system

  • Plan the QC/QA work and responsible for the implementation

  • Participate in the plan of laboratory operation, and be responsible for monitoring the implementation

  • Participate in the plan and implement of EHS system as a core member

  • Responsible for budget and cost control of quality management system, laboratory operation and EHS system

 

Qualifications

  • A bachelor degree or equivalent or above in relevant fields such as biology, chemistry and etc.

  • Knowledge of quality control and assurance system (e.g. GLP, GCP and GMP), minimal of 3 years working experience as a QC/QA staff in biotech industry setting

  • Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

  • Highly motivated self-starter, proficient in English and Chinese

     

     


11. Financial supervisor

Base: Taicang, Jiangsu

Major responsibilities

  • Organized and improved the company's financial system, expense reimbursement system and other relevant implementation rules, took charge of the implementation of relevant implementation, made Suggestions on problems found in implementation and promoted solutions.

  • Organized the budget for the use of funds and took charge of the management and scheduling of funds. Responsible for the compilation and filing of required financial data, such as monthly, quarterly and annual financial statement and analysis, and reporting the company's operation situation to company leaders.

  • Responsible for monthly accounting vouchers, be responsible for all the subsidiary ledger and general ledger accounting, invoicing, check it, as well as the company's annual accounting reports, accounting books shall be binding and keeping accounting information work.

  • Responsible for external liaison work (such as tax bureau, bank, accounting firm, etc.) related to finance.

  • To be responsible for the preparation of bank receipt and payment vouchers, cash receipt and payment vouchers, monthly statements with the bank and balance of bank deposits, and the preparation of balance adjustment forms.

  • Responsible for organizing and completing relevant tax and audit work (monthly tax return related work).

  • Finish other work arranged by the leader.



Qualifications

  • Major in finance, accounting or related field, 3-5 years working experience in corporate finance/accounting, experience in pharmaceutical industry, intermediate accounting title preferred.

  • Familiar with operating financial software, Excel, Word and other office software.

  • Good learning ability and self-motivation, strong sense of responsibility, good organization, teamwork spirit, self-motivation and effective completion of tasks under certain competition and pressure.

  • Finish other work arranged by the leader.



12. IT information system operation supervisor or manager

Base: Taicang, Jiangsu

Major responsibilities


  • Organized and planned the company's IT and database systems, and formulated operational implementation and execution plans.

  • Organize the screening, coordination and docking of qualified external professional resources to implement efficient IT operations.

  • Develop, maintain and update IT policy/SOP according to company business development needs.

  • Finish other work arranged by the leader.


Qualifications

  • Bachelor degree or above, major in IT or bioinformatics.

  • At least 3 years of working experience, including at least 2 years of corporate IT operation experience; Good learning ability and self-motivation, strong sense of responsibility, good organization, teamwork spirit, self-motivation and effective completion of tasks under certain competition and pressure.

  • Familiar with database planning and construction, ERP, CRM, Office 365 and Share point maintenance and management of network era business operation system.

  • Good sense of service, good execution and team spirit.

  • People who are familiar with new media and have experience in informatization construction in the biomedical industry (such as server management and cloud platform construction, etc.) are preferred.

  • Participate in ERP system implementation.


 

TEL/FAX: 0512-53577866

E-MAIL: qchang@connectpharm.com

ADD: Science and Technology Park, East R&D Building , 3rd Floor , 6 Beijing West Road, Taichang, Jiangsu, China 215400

Copyright: Suzhou Connect Biopharmaceuticals, Ltd.

Technical support: Epower