Primary

Act as principal link between the investigator and HMP for trial management, esp. on-site monitoring
 

Responsibilities

• Be familiar with trial execution process of assigned trial
• Be responsible for following activities:
  • Site selection
  • Prepare Site specific documents include but not limit to EC presentation slide, GCP office require documents, Inform Consent, study contract, site drug management manual, subject management matrix etc.
  • Site initiation
  • Site monitoring based on applicable monitoring plan
  • Site close out visit
  • Key personnel to coordinate with trial specific vendors to complete the trial related activities.
  • Complete all trial related reports within SOP defined timeline
• Site level trial master file and investigator site file management
• Deliver trial related training to site staffs
• Update site status to project manager at timely manner
• Prepare all required reports to line manager in a timely manner

Qualifications

• At least 1 year clinical trial on site management experience
• At least bachelor degree in Clinical Medicine or Pharmacy or related major
• Good communication skill and team player
• Good command of computer skill
• Adequate verbal and written communication skills in English
• Down-to-earth and hardworking spirit
• Willingness to travel (up to 75%) of working time

 
If interested, please forward your resume to KellyL@hutch-med.com

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Responsibilities

• Be responsible for CRA team management and operational management system.
• Oversees the performance of the CRAs within their specified team. Implements professional development and performance evaluations;
• Ensures that clinical monitoring activities of their assigned team are performed to the project’s satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements;
• Supports the training and development of clinical monitoring personnel within their remit and ensures team members’ consistent use of study tools and training materials;
• Tracks clinical monitoring metrics such number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings;
• Performs on-site Accompanied Site Visits with CRAs;
• Identifies quality issues related to clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, Accompanied Site Visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions;
• Serves as a point of contact for CRAs and other team members for assigned projects or initiatives;
• Assists with assessing and interviewing potential clinical monitoring candidates;
• May conduct on-site monitoring visits to offer support to project teams;
• May perform site visit report review and track site visit report metrics to ensure compliance;
• May review and provide feedback on related SOPs and TOOLs during updates;
• Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.

Education 

• Sc. in a field relevant to clinical research

Experience

• Minimum of 10 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry

Knowledge and skills

• Excellent oral and written English skills.
• Excellent line management skills
• Strong knowledge of ICH/GCP standards and applicable regulatory requirements;
• Quick learner, good adaptability and versatile;
• Excellent leadership, judgement and problem-solving skills;
• Strong organizational, communication, time management and multi-tasking skills.

 
If interested, please forward your resume to KellyL@hutch-med.com

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Responsibilities

• Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late stage clinical studies.
• Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
• Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage form.
• Work with CMOs or commercial plant to assist gap analysis, risk assessment, tech transfer, process DOE and optimization.
• Coordinate with external collaborators including international Pharmaceutical companies to co-develop formulations and to overlook the projects’ progress.
• Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
• Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA and TGA, etc.
• Prepare and participate interactive technical meetings with external collaborators and official reviewers in CDE.
• Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.

Requirements

• Ph.D in pharmaceutical science or related fields.
• Over 10 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
• Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance etc. IND and NDA experience for FDA or EMA is preferred.
• Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.

 
If interested, please forward your resume to yvonnew@hutch-med.com

COMPETENCIES; Knowledge, Skills and Abilities

• Must have a strong Quality Control mind-set with extensive knowledge and experience of cGMP operations as well as general industry (ICH, USP, etc.) and health authority (NMPA, FDA, EMA, PMDA, etc.) requirements for medicinal Drug Product.
• Knowledge of risk management principles and their implementation into routine production and/or testing strategies.
• Must be able to interpret problems and effectively communicate in a productive manner to management and teams.
• Must be able to evaluate technical/scientific attributes and drive compliant technical decisions under minimal supervision.
• Must have strong troubleshooting skills and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality requirements.
• Must have strong hand-on solid dosage QC testing/operation experience that could immediately form a preliminary decision for an OOS that might trigger a Field Alert Report.
• Must have strong experience of the OOS investigation.
• Must have strong experience for the method validation and transfer
• Must be fluent in both Chinese and English.

Duties and Responsibilities

• Oversee and perform cross-functional QC laboratory assessments and implement improvements to assure Hutch-Med QC expectations would be fulfilled.
• Collaborate with individual CMO QC team and individual cross functions (i.e. Analytical Development, Process, Formulation) to support strategies for improvement and implementation of best practices and automation.
• Responsible for handling the analytical related issues like OOS result at CMO for commercial product in a timely manner and make a quick proposal to management team if marketed product is impacted.
• In charge of the analytical method, specification, stability study, retain sample management for commercial products.
• Lead the Product Quality/Analytical QA team to provide daily oversight on the good compliance of analytical document at Hutch-Med and its CMOs;
• Provide product quality inputs to quality events, like product complaints.
• Participate in the project CMC programing from analytical compliance perspective.
• Develop product quality/analytical team members from both technical and soft skill perspective

Education and Experience

• Bachelors’ degree in analytical chemistry and/or Pharmacy
• Masters and above Degree preferred
• Minimum of 7+ years of Pharma industry experience in a QC or QA role(s) supporting programs in pre-clinical phases through commercial, with at least two years management role
• Strong project management skills and ability to communicate effectively across matrix functions
• Excellent verbal and written English communication skills

If interested, please forward your resume to yvonnew@hutch-med.com

Primary

The primary function for this position is to oversee analytical development’s daily activities, such as method development and validation, analytical testing and stability program.
 

Responsibilities

• Supervise a group of analytical development scientists, and give guidance in their method development and validation, analytical testing, process support, stability and product evaluation.
• Review method validation plans and reports to assure that the methods meet requirements during different phases of product development.
• Direct activities and design experiments toward troubleshooting/optimization of existing analytical methods when necessary.
• Assure accurate and timely testing and reporting all results, issuing technical reports which include certification and validation data.
• Provide guidance on analytical investigations of abnormal results.
• Work in collaboration with other departments, e.g. Process, Formulations, Regulatory Affairs, Production, Supply Chain, etc, to support timely new product development and submissions.
• Work with contract laboratories and collaborators.
• Participate in selection, evaluation and development of new personnel.

Qualifications

• PhD or Master Degree in Chemistry, Pharmaceutical Sciences or related fields. Master with over 8 years of experience and PhD with over 3 years of experience in the pharmaceutical analytical chemistry.
• Working knowledge of major analytical techniques. Ability to train scientists on new techniques.
• Strong experience with analytical development in pharmaceutical development, including method development, validation, stability and in-process control within CMC.
• Familiar with pharmaceutical industry regulations and NMPA/FDA/ICH guidelines
• Proven supervisory experience.
• Good analytical skills in sorting information, formatting directions and problem solving.
• Good communication skills and English language ability.

 
If interested, please forward your resume to yvonnew@hutch-med.com

Apply Now

Responsibilities

• Support medical director in drafting clinical trial protocol and study report.
• Contribute to  the  medical/scientific  input  given  for  the  development  of  trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
• Establish and maintain liaisons with investigators.
• Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team.
• Support regulatory filing where medical expertise is required.
• Support drug discovery when clinical experience is needed for the medical “translation”.
• Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
• Prepare and conduct regular meetings with investigators.
• Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
• Support the  regional clinical  strategy for  a  project  through  Clinical  development, in partnership with relevant matrix team members.
• Compliance with GCP, SOP and regulatory requirements.
• Study planning, preparation, conduct and report in terms of timeline, quality and quantity
• Other tasks as assigned.

Requirements

• Graduate from Clinical Medicine with bachelor degree or above.
• At least 3-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or hematology. Working experience with international pharmaceutical company or CRO is preferable.
• GCP experience is preferred.
• Proficiency in English and good computer skill at office software.
• Excellent planning, organization and problem solving abilities.
• Good communication and interpersonal skills.
• Good project management skill.
• Self-motivation and good risk management.

 
If interested, please forward your resume to winniew@hutch-med.com

Apply Now

Primary Function

The Senior statistician is responsible for all statistical aspects of a clinical development project of one compound, from early clinical development, to registration and marketed product support.
 

Responsibilities

• Serves as statistical representative in the cross-functional teams for the strategic planning, execution for product development and trial design.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.
• Prepare statistical related sections in clinical trial protocols, clinical trial reports, submission documents, and publications.
• Develops statistical analysis plans (SAP) or oversees SAP development.
• Oversees trial conducts from statistical perspective.
• Assist with or be responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations.
• Oversees process and quality of statistical work contracted out to a CRO or research collaborator.
• Performing statistical programming to validate the results produced by CRO or to meet internal need of data analysis (e.g. for publication, or for optimizing assumptions for study design), when needed.
• Mentors junior colleagues in techniques, processes.

Qualifications

• PhD degree in statistics/biostatistics or related discipline with a minimum of 2 years work experience as statistician in pharma/CRO, or a Master’s degree with a minimum of 4 years work experience as statistician in pharma/CRO.
• Thorough knowledge of statistical methodology, pharmaceutical research and development strategies and execution, GCP and regulatory guidelines.
• Good project management skills
• Excellent communication and presentation skills to interact with authorities and external bodies (specialists as well as non-specialists) on statistical-methodological issues
• Strong time management and prioritization skills
• Knowledge of statistical tools such as SAS, nQuery, PASS, East
• Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.

 
If interested, please forward your resume to winniew@hutch-med.com

Primary Function

• Management of clinical research project.
• Vendor (CRO, Lab, drug storage, etc.) supervision and management.
• Liaison with KOLs.
• Support IND and NDA filing.
• Quality control of the clinical research projects, such as co-monitoring.

Responsibilities

• Adhere to corporate SOPs and local WIs in the planning, conduct and reporting of clinical trials.
• Provide leadership in the conduct of clinical trials, protocol implementation, data analysis, management of project progress and timelines.
• Input operational part of the protocol for trials.
• Review and approve study CRFs.
• Prepare Monitoring Manual and ensure it is in agreement with the protocol and SOP.
• Contact with CMC department regarding design of labeling, packaging and drug logistics.
• Train, counsel and guide CRAs involved in a trial on the trial requirements, procedures, monitoring standards, reporting and current issues. Records of training should be maintained.
• Select clinical trial site and keep good relationship with investigators.
• Initiate and ensure timely submission to IRB/IEC and support investigator as necessary.
• Support contract negotiation with study sites.
• Select and cooperate with statistician to conduct data analysis when required.
• Participate in regular Data Quality Review Meetings.
• Coordinate final trial report.
• Support CRO Selection.
• CRO supervision at the trial level.
• Support IND and NDA filing: Document review and progress tracking.
• Do co-monitoring visits for the project.
• Review monitoring reports.
• Check TMF before archiving.

Qualifications

• At least bachelor degree in pharmacy, biochemistry or related major. Mater degree is preferred.
• At least 3 years industry experience with proven proficiency in clinical research management for drug development.
• Good understanding of ICH guidelines, GCP and regulatory requirements.
• Excellent planning, organization and problem solving abilities.
• Good communication and interpersonal skills.
• Proficiency in English and familiarity with standard IT office tools.

 
If interested, please forward your resume to KellyL@hutch-med.com

Primary

The Drug Safety Specialist/Senior Drug Safety Specialist is responsible for the collection, processing, follow-up, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed products and investigational products in accordance with company standard operating procedures and applicable regulations.
 

Responsibilities

• Process individual case safety reports
• Perform proper coding in the safety database
• Produce concise and accurate case narratives
• Submit individual and periodical safety reports to the regulatory agencies
• Appropriately follow up AEs and SAEs
• Conduct AE/SAE reconciliation
• Perform literature searching and review
• Generate data listings from the safety database

Experience

• Required Skills and Knowledge:
  • Attention to details
  • Good knowledge of medical terminology
  • Good written and communication skill
  • Fluent in Chinese (spoken and written) and in English (written)
  • Computer literacy
• Desired Skills:
  • Experience in pharmaceutical safety-related role
  • Previous Argus database experience

Requirements

• EDUCATION: Life science/Pharmacy/Nurse degree
• CONTACTS: Regulatory Affairs, Medical Affairs, Clinical Project Manager and other Safety Staff

 
If interested, please forward your resume to KellyL@hutch-med.com

Apply Now

Primary Functions

Responsible for executing end to end clinical database setup and management activities pertaining to clinical trials, including but not limited to: database setup and SAS programming development activities in compliance with Hutchmed Standard Operating Procedures (SOPs) and ICH-GCP guidelines, oversee the process and quality of DBD work contracted to a CRO.
 

Major Responsibilities and Duties

• Provide database setup service and SAS programming development service for clinical trials;
• Contribute to the review, maintenance, and ongoing update database setup and SAS programming in accordance with the database User Acceptance Test (UAT);
• Develop the System Edit Check (EC) and SAS Edit Check (EC) in accordance with the Data Validation Plan (DVP);
• Maintain and update System EC in accordance with the EC UAT results;
• Assist in review of study-specific demands including aCRF, database specs, DVP, SAS listing, and customized report specifications;
• Perform database configuration, access management, and training for assigned trials;
• Contribute to the eCRF development, annotation, modification, and database maintenance activities;
• Assist in the development of database training for assigned trials;
• Participate in the development and implementation of database technology or tool;
• Understanding of ICH-GCP and CDISC principles;
• Perform other activities as required.

Qualifications

• Specialized Knowledge:
  • Clinical Data Management System experience (e.g., RAVE, Clinflash, Inform, OC RDC) and understanding of database/programming concepts.
  • Knowledge of the clinical development process.
  • Knowledge of industry standards and practices, e.g. CDISC.
• Minimum Requirements:
  • Educated to at least Bachelor level in IT, Medicine, Pharmacy, Biological Sciences, or health care related disciplines.
  • At least 5-year DBD experience in pharmaceutical company or Clinical Research Organization (CRO)
• Preferred Requirements:
  • Familiarity with other clinical database tools like CTMS, IRT/RTSM, ePRO, IRC/MIRS，and PV/ Argus
  • Prior experience with SAS programming is preferred;
  • Strong programming skills in C++, Java, or Python is preferred;
  • Able to work under pressure and in a changing environment with flexibility;
  • Good communication skills with the ability to communicate with both the technical and business areas.

Internal-External Relations

• Internal:
  • Project team within HMP.
• External:
  • CRO/vendors, consulting experts, co-development/business partners as appropriate;
  • Must be prepared to describe and demonstrate the job attributes to regulatory authority inspectors during regulatory authority inspections.

 
If interested, please forward your resume to winniew@hutch-med.com

Apply Now

Responsibilities

• Prepare process R&D related documents and reports to support IND and NDA.
• Update technical documents and effectively communicate with process R&D team.
• Support process R&D team to provide documentation for IND, NDA, IMPD, DSUR, annual report and etc.
• Work effectively with regulatory, analytical R&D, formulation R&D to support all related documents preparation and updates.

Qualifications

• Bachelor or Master degree in chemistry or pharmaceutical science.
• Good understanding on process chemistry, pharmaceutical science, drug development.
• Good English oral and writing skills.
• Familiar with CFDA/FDA/EMA regulations and ICH guidelines, previous experiences with global filings are preferred.

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Primary Function

The Statistical programmer/Senior Statistical Programmer is responsible for all statistical programming aspects at project level. The position is a key contributor with biostatistics in ensuring that pharmaceutical drug-development plans are executed efficiently with timely and high quality deliverable.

Responsibilities

• Lead statistical programming activities at project level.
• Co-ordinate activities of all programmers either internally or externally assigned to the study/studies. Make statistical programming recommendations at study level.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope), e.g. as member of the Clinical Trial Team.
• Review eCRF, discuss data structures and review activities as member of the Data Review Team.
• Comply with company, department and CDISC standards and processes, review and develop programming specifications as part of the analysis plans.
• Provide input into statistical programming solutions and/or ensure their efficient implementation.
• Ensure timely and quality development and validation of datasets and outputs for CSRs, regulatory submissions/interactions, safety reports, publications or exploratory analyses (as required) in the assigned drug development study/project according to specifications.
• Responsible for quality control and audit readiness of all assigned statistical programming deliverable as well as accuracy and reliability of statistical analysis results.
• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as CDISC requirements (SDTM, ADaM, eCTD, Define.xml), attend functional meetings and training.
• Develop company SAS macros and utilities.

Complexity

• Knowledge of relevant aspects of therapeutic areas, especially knowledge of oncology and immunology
• Knowledge of statistical methodology

Specialized Knowledge

• Extensive programming experience in SAS including Data step, Macros, Statistical procedures, and Output delivery system
• Good knowledge of CDISC standards including:
• Study Data Tabulation Model (SDTM)
• Analysis Data Model (ADaM)
• Clinical Data Acquisition Standards Harmonization (CDASH)

Requirements

• BA/BS/MS or international equivalent experience in statistics, computer science, mathematics, life sciences or related fields is required
• At least 2-3 years’ experience in pharmaceutical company or Clinical Research Organization (CRO) as statistical programmer
• Positive working attitude

Preferred Requirements

• Working experience in oncology projects
• Self-management skills with a focus on deliverables
• Project management experience

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Responsibilities

• Review product registration dossier and relevant documents
• Obtain IND & NDA approval as well as product registration license renewal as planed
• Coordinate with each function within HMPL from registration pathway
• Establish and maintain relationship with external stakeholders
• Liaise with external stakeholders for regulatory needs of HMPL
• Implement regulatory activities as required by governmental regulations and internal SOPs
• Form accelerate Strategy for product registration

Qualifications

• Bachelor degree and above in Pharmacy or Pharmaceutical
• 5 years or more drug registration experience in pharmaceutical industry
• Prefer oncology drug registration background
• Good understanding of Chinese pharmaceutical & regulatory environment
• Good relation with stakeholders related to product registration
• Fluent English
• Strong communication skill
• Passion in drug development

Apply Now