职业发展

葆元医药坚信员工是推动公司发展的最有价值的力量。公司一直致力于帮助员工实现职业生涯与个人生活的发展。

咨询招聘信息,请联系 hr@anhearttherapeutics.com
正在招聘的职位请见下文。

Department: R&D

Job Title: Compound Leader( Senior Director or VP)

Report to: CMO

Location: US

 

MAIN REPONSIBILITIES:

  • Act as scientific and product leader who serves as a key member of the core R&D Team and responsible for the overall preclinical and clinical development plan for an asset or assets in one or more indications/tumor types, including registrational and non-registrational studies.
  • Lead the different functions as product Lifecycle leader within the Clinical Team with his/her expertise and leadership (monitoring, preclinical, data management, biostatistics, medical, clinical, pharmacovigilance, regulatory affairs, QA, CMC) as well as interact with and support Project team members.
  • Ensure that studies are aligned with target label indications and commercial goals, and are properly designed and conducted.
  • Ensure that the operational development process is aligned with Company standards and help to review and improve current SOPs.
  • Inspire the team to strive for excellence in clinical design, execution, interpretation and successful filing and approval in relevant markets.
  • Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.

QUALIFICATIONS:

  • MD preferably with a background in clinical oncology or regulatory professionalism. PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.
  • At least 8 years of relevant experience, with excellent skills & knowledge with a whole/intense view of drug development and regulatory approval.
  • Demonstrated leadership in understanding of the drug development and in cross functional working.
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English.

Department: R&D

Job Title: US Development Head (SVP/EVP)

Report to: CMO

Location: US

 

MAIN REPONSIBILITIES:

  • Lead and manage the Clinical, PV, PMO and RA, leveraging strong process and knowledge to drive team deliverables.
  • Manage the day-to-day R&D department in US, overseeing planning and progress across the portfolio of programs from early development to regulatory filing
  • Create, modify and support the short- and long-term Onco products clinical strategies based on the company’s business objectives
  • Play a key leadership role in the development and improvement of business processes, tools and templates relevant to US clinical, cross-functional product development, and regulatory filing
  • Develop and drive continuous improvements in US clinical, establish KPIs/metrics, and implement US clinical best practices
  • Apply US clinical expertise, methodologies and standards to all programs, directly and through direct reports
  • Facilitate team and working group meetings, ensuring meetings results-driven and positive team dynamics
  • Collaborate with other clinical colleagues on developing and improving R&D and Arena business processes and performance as needed

QUALIFICATIONS:

  • MD and Ph.D preferably with a background in clinical oncology or regulatory professionalism. PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.
  • At least 15 years of relevant experience, with excellent skills & knowledge with a whole/intense view of drug development and regulatory approval.
  • Experience managing a diverse portfolio of global programs at various phases in the Oncology drug development lifecycle from early development through regulatory filing
  • Advanced understanding of program management and associated deliverables, tools and expectations
  • Effective written and verbal communication skills and an ability to inspire and influence at all levels
  • Excellent oral and written English.

Department: Pre-Clinical

Job Title: Pre-Clinical VP

Report to: CMO

Location: China/US

 

MAIN REPONSIBILITIES:

  • Design and execute preclinical studies to understand the pharmacokinetics (PK) and absorption, metabolism, distribution, and excretion (ADME) of drug candidates.
  • Manage CROs/Academic sites in the conduct of in vitro and in vivo ADME studies.
  • Responsible for the analysis, interpretation, integration, and reporting of preclinical DMPK data generated with CROs; Lead efforts for IND and NDA/BLA filings.
  • Work closely with business development group to evaluate external opportunities.
  • Build close relationships with partner functions and therapeutic areas.
  • Evaluate and implement novel technologies to characterize the disposition and clearance mechanisms of new chemical entities.

QUALIFICATIONS:

  • Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with over 10 years of experience in biopharmaceutical industry, with evidence of drug development experience is preferred.ß
  • Strong knowledge of drug metabolism, ADME concepts, PK, PD and bioanalytical principles is required.
  • Experience working with CROs to deliver on radiolabeling ADME studies, including rat QWBA, human ADME, and metabolite ID experiments
  • Experience working through IND to NDA package submission, Oncology project preferred.
  • Excellent oral and written English.

Department: Pre-Clinical

Job Title: Biomarker Coordinator

Report to: Biomarker Director

Location: US

 

MAIN REPONSIBILITIES:

  • Familiar with biomarker development and testing in Research and CRO central laboratories.
  • Coordinate meetings setup, maintain the communications with laboratory vendors, support Biomarker team ensuring a timely, effective, and compliant operation to meet clinical trial research requirements.
  • Troubleshoot and technical support for clinical study biospecimen processing, companion diagnostic assay development and validation.
  • Aid in reviewing lab related documents including clinical protocol, lab specifications, lab manual, flowchart, and validation plan/report.

QUALIFICATIONS:

  • Scientific background in tumor immunology, immunohistochemistry and biomarkers, experience in relevant CRO services. 
  • ability to independently design research immunohistochemistry and biomarker protocols to provide scientific and technical support for clinical trials of novel antitumor drugs (e.g., immune checkpoint inhibitors and other cancer therapeutics, etc.) through biomarker discovery and development of concomitant diagnostic products. 
  • Good communication, interpersonal, and team skills.
  • Ability to critically review own work before sending out for internal/external review by team.

Department: Pre-Clinical

Job Title: Scientist / Manager in Preclinical Development

Report to: Pre-Clinical, Senior Director

Location: China

 

MAIN REPONSIBILITIES:

  • Coordinate and oversee all aspects of outsourced preclinical safety and toxicology studies, including communicating to study directors at the CRO, finalizing study plans, carrying out scientific monitoring during study conduct, and finalizing reports.
  • Ensure the excellent and proactive communication and collaboration with Study Managers, project leaders, other experts in drug development.
  • CRO evaluation, including documentation of study-based visits as necessary.
  • Aid in reviewing lab related documents including clinical protocols, lab specifications, lab manuals, flowcharts, SOPs and validation plan/reports.   
  • Work effectively with colleagues from cross-functional disciplines.
  • Critically analyze and interpret complex data, and effectively document and communicate results to a variety of audiences.
  • Collaborate and deliver on objectives successfully in a fast-paced, highly-matrixed work environment.

QUALIFICATIONS:

  • MSc degree in Veterinary Medicine, Toxicology, or Biology, to higher degree level.
  • Preclinical experience in Pharmaceutical/Biotech Industry/CRO setting with 3-5 years
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.

Department: Clinical/Medical -Medical Science

Job Title: Medical Writer

Report to: Clinical Research Physician Director

Location: China

 

MAIN REPONSIBILITIES:

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Serves as the Medical Writing representative on product teams. Coordinates all activities related to the preparation and compilation of data and information into a single comprehensive package for new and revised domestic and international regulatory submissions, market labeling, clinical labeling, troubleshooting guides, training aids, and customer communications for diagnostic assays and instruments. Communicates deliverables needed and writing process to team members.
  • Accesses resource needs as timelines progress and communicates those needs to management.
  • Utilizes submission templates (if available) and format/style guidelines established by Medical Writing.
  • Obtains relevant product data and information. Assesses accuracy of information.
  • Understands sources of information. Converts relevant product data and information into a form that meets submission requirements. Reviews, circulates, edits, assembles, inspects, and duplicates product submissions.
  • Uses ADD manufacturing/ testing documentation systems. Determines format for submissions and documents.
  • Interprets data and verifies that results are consistent with protocols. Confirms completeness of information to be presented.
  • Confirms label and package insert claims are supported by and consistent with data presented in the submissions.
  • Acts as interface to resolve issues and questions arising during writing process.
  • Arranges and conducts review meetings with teams on submission and related labeling.
  • Coordinates responses to inquiries, questions, and deficiencies received from submission reviewers both in the US and internationally.
  • Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables.
  • Explains the data in a manner consistent with the target audience and regulatory requirements.
  • May recommend and implement process improvements.
  • Responsible for implementing and maintaining the effectiveness of the Quality System.

QUALIFICATIONS:

  • Bachelor’s degree in Science, Medical Technology, English, or equivalent experience.
  • Minimum 4-6 years relevant professional experience, in a related area such as R&D, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing.
  • 4 years writing experience as a medical writer in the health care industry preferred.
  • 2-4 years’ experience in experimental design and data interpretation preferred.
  • Knowledge of Abbott Molecular Division products desirable. Good written and oral communication skills.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
  • Fluent in word processing, flow diagrams and spreadsheets. Good working knowledge of personal computer software programs in Windows environment.
  • Good communication, interpersonal, and team skills.
  • Ability to critically review own work before sending out for internal/external review by team.

Department: Clinical/Medical -Medical Science

Job Title: Clinical Research Physician (Director or Senior Director)

Report to: SVP, Clinical Strategy Development

Location: China/US

 

MAIN REPONSIBILITIES:

  • Discuss the study protocol with the investigators.
  • Review and approve patient enrollment.
  • Review protocol compliance and manage protocol deviation.
  • Study medical data review
  • Serious adverse event review and follow up.
  • Managing queries from the clinical site staff
  • Provide medical opinion/review in the clinical study reports.
  • Draft clinical studies summary and overview

QUALIFICATIONS:

  • Bachelor’s degree in clinical medicine is essential, and MD/PhD is preferred.
  • At least 5+ year working experience in clinical medicine is must.
  • At least 5+ years working experience in clinical development function of global biopharmaceutical industry is must.
  • Strong leadership, excellent communication, and project management skill.
  • Excellent in both English and Chinese.

Department: Clinical Operations

Job Title: Clinical Operation VP

Report to: CMO

Location: China/US

 

MAIN REPONSIBILITIES:

  • Perform overall management for assigned projects to ensure timely delivery, data quality and budget within control.
  • Act as a study team leader to set up team goals and lead cross-function communication to get there, including but not limited to medical, regulatory, CMC, HR, and finance.
  • Implement and drive resource strategy for Clinical Operations to meet project deliverables and timelines and changing workloads.
  • Be accountable in the country for strategy related to Clinical Operations activities including but not limited to, feasibility, allocations, recruitment enablers, trial execution and local customer relationships related to Clinical Operations (Performs management to but not limited to clinical study start up from any stages, budget control, initiation, patient enrollment, protocol adherence, CRF compliance, data quality to meet specified ethical, scientific, regulatory needs. Develop and maintain KOL relationships).
  • Maintain good communications and relationships with 3rd party vendors, including but not limited to CRC, CRA, PM or DM/Stats if applicable.
  • Ensure the clinical trials conduction in compliance with ICH – GCP guidelines, local regulatory requirements, SOPs, and protocols.
  • Be accountable for department SOP development as well as renewal.
  • Support the organization of appropriate training programs. Provide management coaching to the staff.

QUALIFICATIONS:

  • Minimum of 15 years’ experience in clinical research and 5-7 years management experience in related fields such as clinical operations (Minimum 5 years of monitoring experience in clinical research).
  • Master’s degree or above in biological science, pharmacy, or other health related discipline.
  • Good knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Clear and compelling communication.
  • Strong leadership and influencing skills across geographies and culture differences.
  • Advanced ability to problem-solve and conflict resolution.
  • Operational expertise in risk management and contingency planning.
  • Proven ability to manage budgets and resource.
  • Experience in international CROs preferred.
  • Competent in written and oral English is must.

Department: Clinical Operations

Job Title: Clinical Drug Supply

Report to: SVP, Clinical Strategy Development

Location: China

 

MAIN REPONSIBILITIES:

  • Accounts for program level and study level clinical supply deliveries with cGMP standards and oversight of end-to-end process from API to finished products delivery to clinical sites.
  • Manage drug supply activities related to planning, label development, labelling & packaging, and distribution for one or more clinical programs.
  • Represent the Clinical Supply Chain on Clinical Study Team and provide high service level to internal stakeholders (eg. Clinical Operations, Regulatory, Quality, manufacturing site and CMC).
  • Through a solid understanding of clinical study design and drug supply processes and risks, develops supply strategies that balance cost, timelines, and risks to support the development of global Research & Development.
  • Act as a subject matter expert on all information regarding the global use of investigational material in clinical studies.
  • Providing broad consult on all aspects of clinical drug supply to Clinical operation team.
  • Actively oversees depot inventory vs. actual order request to ensure accurate and continuous supply delivery while reducing risk and minimizing waste.
  • Predicts any risks and implements mitigation plan aligned within the team.
  • Manages and maintains relationships with external supply partners/vendors

QUALIFICATIONS:

  • Master degree/PhD’s degree in Pharmacy.
  • At least 10+ year industry working experience, MNC, CRO and bio tech preferred.
  • At least 5+ years working experience in clinical supply management, clinical trail logistics.
  • Strong leadership, excellent communication, and project management skill.
  • Familiar with ICH-GCP, cGMP, IVRS
  • Excellent in both English and Chinese.

Department: Clinical Operations

Job Title: PM(M-Sr. Manager)

Report to: Clinical Operations Director

Location: China

 

MAIN REPONSIBILITIES:

  • Plan and organize the implementation of clinical studies to ensure that the studies are delivered on time, on budget and to quality as expected from planning, initiation, implementation, to completion.
  • Organize clinical study teams and identify appropriate external vendors.
  • Plan and manage clinical study budgets.
  • Develops and tracks quality and risk management plans for clinical studies, organizes feasibility studies at the study, country and/or study center level, identifies participating countries and/or study centers, and develops subject recruitment strategies.
  • Responsible for the preparation of clinical operation related documents, including clinical study required documents, ethics committee review materials, genetic resources related filings, and domestic and international clinical trial disclosures.
  • Promote the establishment and operation of scientific committees or advisory boards related to research support.
  • Develop the supply and management plan of clinical research drugs and equipment.
  • Organize investigator/monitor meetings and ensure that they receive adequate and appropriate training
  • Develop clinical monitoring plans and oversee their implementation and ensure the quality of clinical monitoring through co-monitoring or other means.
  • Cooperate with audit planning and execution, and assist in the inspection activities of regulatory authorities when necessary.
  • Organize regular internal and external meetings to maintain good communication and cooperation with internal study teams and external vendors.
  • Regularly review clinical trial required documents to ensure their completeness and archive within the required timelines.
  • Regularly report on study progress, milestones, and major risks and issues.

QUALIFICATIONS:

  • Bachelor degree or above in life science related field, preferably in clinical medicine or pharmacology.
  • 5 years or more clinical research related experience, preferably in clinical research projects or quality management.
  • Experience in clinical research, familiar with ICH GCP and NMPA GCP, working experience in foreign pharmaceutical companies is preferred
  • Strong communication and coordination skills.
  • Excellent oral and written English.

Department: RA

Job Title: RA Director

Report to: Global RA Head

Location: US

 

MAIN REPONSIBILITIES:

  • Ensure all clinical trials are executed in compliance with domestic and international GCP guidelines/regulations and applicable SOPs.
  • Oversee coordination and planning of interactions, communications and submissions to relevant regulatory authorities in North America and ethics committee, as appropriate.
  • Provide direction of CRO and consultant activities performed for company clinical programs as related to regulatory submission activities, including management of submission strategy, content and timelines, as well as identification and resolution of any performance issues for the CRO services.
  • Participate in development and writing of INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents Direct the preparation and submission of regulatory agency applications, reports and all other correspondences.
  • Oversee documentation for regulatory submissions to ensure compliance with domestic and international regulations and standards.
  • Identify and guide the cross-functional project team relevant for requirements for submissions, ensuring accuracy, consistency and completeness while adhering to regulatory standards, SOPs and guidelines as appropriate.
  • Develop, manage and maintain regulatory affairs SOPs; implement regulatory affairs policies and procedures to ensure regulatory compliance is maintained.
  • Participate in evaluation of system for internal file storage for all regulatory submission and correspondence documents and implement controlled document management.
  • Participate in the development of departmental timelines, as well as review and approval of relevant vendor invoices.
  • Functional representative on project and/or study teams, leading by interacting with multi-disciplinary teams for preparing relevant regulatory tasks.

QUALIFICATIONS:

  • Proven organizational skills with the ability to prioritize and work with a sense of responsibility in an environment with competing demands. Ownership and accountable for functional deliverables.
  • Regulatory Affairs experience in biopharmaceutical industry and knowledge of relevant regulations and requirements pertaining to clinical trials.
  • Motivated, ability to adapt to small-company’s hands-on culture and willing to learn new things.
  • Proactive and well-organized, ability to plan, focus, coordinate and monitor activities according to priorities, established schedules and deadlines.
  • Teamwork spirit, strong interpersonal skills, with an ability to communicate and influence key stakeholders at all levels effectively.
  • Knowledge of ICH, GXPs, Data Privacy and other applicable regulations and requirements in the pharmaceutical industry.

 

Department: RA

Job Title: RA (Senior Director or VP)

Report to: CMO

Location: China

 

MAIN REPONSIBILITIES:

  • Fully responsible for the registration and reporting of the company’s products, including registration strategy formulation, document writing and submission, obtaining approval timely. Regularly monitor registration regulations and competitive product information to provide regulatory support for the company’s innovative drug registration.
  • Analyze, evaluate, and set up the registration strategy.
  • Keep contact with R&D department from research and development to project registration, follow up and supervise project progress.
  • Master the FDA’s requirements for registration information, and understand the relevant ICH, FDA, WHO guidelines for drug registration.
  • According to FDA, responsible for writing, reviewing, editing of international drug registration documents, tracking, and controlling the progress and quality of data writing of relevant departments within the company.
  • Tracking the progress of the drug registration, timely obtaining, and updating drug registration information, effective communication with the official, grasp the registration dynamic information, and obtain the registration certificate as planned.
  • Establish and maintain good working relationships with customers and drug regulatory agencies.

 

QUALIFICATIONS:

  • Fluent in English listening, speaking, reading, and writing, able to independently write (review) English application materials and conduct academic exchanges with foreign experts.
  • Familiar with the CFDA drug registration process, have a comprehensive understanding of the drug development and declaration process, and registration regulations; prior experience with US FDA drug registration is preferred.
  • Agile thinking, good ability to find problems and solve problems independently, have strong flexibility.
  • More than 10 years of experience in drug registration and registration, and successful registration of new drugs.
  • Requirement to go through the entire process of registration and marketing of original research tumor drugs in China and achieve successful marketing.

Department: Clinical Pharmacology

Job Title: Pharmacometrician/Quantitative Clinical Pharmacologist (Director or Associate Director)

Report to: SVP, Head of Clinical Pharmacology

Location: China

 

JOB SUMMARY:

This position is responsible for implementing model-based analysis to optimize doses, dosage regimens and study designs, identification of patient and product related factors that impact pharmacokinetics, efficacy and safety, and other clinical and regulatory support for clinical development programs. This position will work closely with CRO partners and provide scientific oversight for population pharmacokinetics, pharmacokinetics/pharmacodynamics, and exposure-response analyses to support all clinical programs. The pharmacometrician in this position should have significant knowledge of pharmacometrics/pharmacology-based modeling to establish quantitative relationship between pharmacokinetics & response (safety, efficacy, biomarker), address product development questions and contribute to clinical pharmacology NDA/BLA packages.

 

MAIN REPONSIBILITIES:

  • Responsible for strategy and execution of relevant quantitative analyses which may include population pharmacokinetics, pharmacokinetics/pharmacodynamics, exposure-response, model-based meta-analysis, and decision analysis supporting clinical development projects.
  • Collaborate closely with clinical pharmacologist, clinical, stats, data management and programming, and regulatory to ensure modeling and simulation are performed to address critical clinical questions in a timely and efficient manner.
  • Work closely with CRO partners to provide scientific oversight for population pharmacokinetics, pharmacokinetics/pharmacodynamics, and exposure-response analyses; independently perform these analyses when needed.
  • Review and/or write modeling & simulation analysis plans and reports. Provide input for standard operation procedures and best practices in pharmacometrics.
  • Participate in cross-functional project teams and provide quantitative input for dose selection and study designs using modeling and simulation when needed.
  • Contribute to the summary documents for regulatory submissions (e.g., integrated summary, briefing books, and regulatory responses).
  • Be familiar with literature and regulatory guidelines as relates to pharmacometrics and quantitative clinical pharmacology.

QUALIFICATIONS:

  • Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
  • At least 5 years relevant experience.
  • Strong quantitative skills with hands-on experience in analyses and tools of pharmacometrics (e.g., NONMEM, R, and Phoenix WinNonlin).
  • Relevant regulatory experience (written/oral) in submission and in addressing inquiries from regulatory agencies regarding issues on pharmacometrics.
  • Significant demonstrated expertise within the field of quantitative pharmacology including PK, PKPD, and PBPK modeling.
  • Demonstrated leadership in understanding of the drug development and in cross functional working.
  • Advanced ability to problem-solve and conflict resolution.
  • Operational expertise in risk management and contingency planning
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.

Department: Clinical Pharmacology

Job Title: Clinical Pharmacology (Senior Manager or Manager)

Report to: Clinical Pharmacology, Senior Director

Location: China

 

MAIN REPONSIBILITIES:

  • Conducts clinical pharmacology studies in line with product development strategies, ensure working process following regulatory requirement and scientifically sensible.
  • Work with Leader for Clinical Pharmacology and/or Pharmacometrics Development Plan for Company compounds.
  • Performs and assists PKPD analysis for understanding of PKPD relationship for drug effect and dose selection to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development.
  • Participates in project meeting, and actively involved in data analysis, study preparation for the update and issue solving.
  • Interacts with Clinical Pharmacology Key Opinion Leaders and Healthy Authority reviewers; Ensures Company Clinical Pharmacology strategies adapts to science and regulatory advances.
  • Main author of clinical pharmacology/pharmacokinetic reports and regulatory submissions and be responsible for PopPK section for clinical protocols.
  • Works closely with Clinical Pharmacology CROs for outsourced studies.
  • Proactively identifies and resolves Clinical Pharmacology related issues as they arise.
  • Acts as QC SME in Clinical Pharmacology function.

QUALIFICATIONS:

  • Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
  • At least 5 years relevant experience.
  • Rich experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
  • Extensive knowledge of Good Clinical Practice
  • Demonstrated leadership in understanding of the drug development and in cross functional working.
  • Advanced ability to problem-solve and conflict resolution.
  • Operational expertise in risk management and contingency planning
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.

Department: Clinical Pharmacology

Job Title: Clinical Pharmacology Director

Report to: SVP, Head of Clinical Pharmacology

Location: US

JOB SUMMARY:

 

MAIN REPONSIBILITIES:

  • Conducts clinical pharmacology studies in line with product development strategies, ensure working process following regulatory requirement and scientifically sensible.
  • Work with Leader for Clinical Pharmacology and/or Pharmacometrics Development Plan for Company compounds.
  • Performs and assists PKPD analysis for understanding of PKPD relationship for drug effect and dose selection to ensure development of safe & effective dosing regimens for various patient sub-populations & also ensure optimal drug development.
  • Participates in project meeting, and actively involved in data analysis, study preparation for the update and issue solving.
  • Interacts with Clinical Pharmacology Key Opinion Leaders and Healthy Authority reviewers; Ensures Company Clinical Pharmacology strategies adapts to science and regulatory advances.
  • Main author of clinical pharmacology/pharmacokinetic reports and regulatory submissions and be responsible for PopPK section for clinical protocols.
  • Works closely with Clinical Pharmacology CROs for outsourced studies.
  • Proactively identifies and resolves Clinical Pharmacology related issues as they arise.
  • Acts as QC SME in Clinical Pharmacology function.

QUALIFICATIONS:

  • Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
  • At least 8-10 years relevant experience.
  • Rich experience in a pharmaceutical/biotech company, CRO, or academic medical center, or related experience
  • Extensive knowledge of Good Clinical Practice
  • Demonstrated leadership in understanding of the drug development and in cross functional working.
  • Advanced ability to problem-solve and conflict resolution.
  • Operational expertise in risk management and contingency planning
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.

Department: Clinical Pharmacology

Job Title: Clinical Bioanalysis Director

Report to: SVP, Head of Clinical Pharmacology

Location: US

 

MAIN REPONSIBILITIES:

  • Oversee bioanalysis assay development, including supporting the early discovery research assay, establishing qualified or validated method for preclinical and clinical use, method transferring and monitoring CRO.
  • Responsible for preclinical and clinical bioanalysis strategy planning and study design, data interpretation according to regulatory requirement (FDA and NMPA).
  • Responsible for internal bioanalysis platform setup and management.
  • Responsible for IND documentation of bioanalysis part.
  • Undertake bioanalysis team leader and expertise role in project team and department.
  • Effectively manage the people group of project specialists/managers. Extract and transform learnings from group member’s first-hand experience or external sources into SOP/working instruction or other training material.
  • Serve as a major critical reviewer of immunogenicity reports used in both domestic and international new drug application and other clinical research documents about PK/PD/ immunogenicity tests.
  • Evaluate the immunogenicity risk of new drug compounds and propose clinical immunogenicity research plan accordingly.

QUALIFICATIONS:

  • Ph.D. or equivalent in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, or similar disciplines where quantitative pharmacology is emphasized.
  • At least 8-10 years relevant experience.
  • Master’s in chemistry analysis, bioanalytical chemistry or other related discipline. Advanced degree preferred.
  • More than 5 years experience in industry, and over 3-year team manager experience, major in bioanalysis background.
  • Experience in RNA analysis is a plus.
  • Outstanding oral and written communication skills and ability to interface effectively with all levels.
  • Excellent oral and written English; fluent in Chinese; able to independently use both English and Chinese to write documents and communicate with peers and experts.

Department: PV

Job Title: PV Operation Manager or Director

Report to: PV Senior Director

Location: China

 

MAIN REPONSIBILITIES:

  • Supervision and management of collection, processing, documentation, reviewing, reporting and follow-up of all adverse event reports for products from clinical trials, non-interventional studies, literature, Spontaneous Reports, etc.
  • Manage reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, SUSAR,) to Local Health Authorities and/or clinical operations
  • Managing all safety operation activities in clinical trial globally, including trial safety operation related documents preparation, trial study start-up, trial safety operation training, query management, SAE reconciliation, support trial data clean activities, trial closure activities and global inspection readiness to ensure trial safety operations are continuously met
  • Protocol and ICF review, to ensure compliance with the pharmacovigilance requirements.
  • To prepare the DSUR and PSUR/PBRER in collaboration with PV lead, and other functional team and send it to the HA according to the pharmacovigilance regulatory requirements
  • Oversight outsourcing PV activities including training, oversight monitoring, performance metrics review of vendor activities
  • Assist in the development of department-specific SOPs and Work Instructions

QUALIFICATIONS:

  • At least 5 years of drug safety operation experience in pharmaceutical company
  • Knowledge of China, US and EU’s regulations for pharmacovigilance
  • Knowledge of pharmacological and medical terminology
  • Experience working with Argus, EDC and MedDRA coding dictionary
  • Good team player and excellent communications, interpersonal skills
  • Medical, biology, pharmacology, or healthcare related bachelor’s degree, or above
  • Fluent in both written and spoken English and Chinese
  • Computer literacy; MS Office suite, Excel, PowerPoint, etc.

Department: Biometrics

Job Title: Principal Statistical Programmer (Manager)

Report to: Senior Manager, Programming

Location: China

 

MAIN REPONSIBILITIES:

  • Configure software and write programs that produce deliverables such as data sets, tables, listings, and graphs to support research and development projects, including materials for internal decision-making and for submission to regulatory agencies
  • Lead project workload, including prioritization to meet company objectives, estimation of resources required to meet timelines, securing team resources, defining quality and completion criteria and tracking team progress to completion
  • Attend multi-disciplinary team meetings, representing the programming function.
  • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Transfer Specification, SAPs, etc.)
  • Oversee work of internal contract programmers and external vendors.
  • Perform ad hoc analyses and data validation using pharmaceutical industry knowledge, experience and advance statistical analytics
  • Provide training and development of less experienced staff within the department.

QUALIFICATIONS:

  • Bachelor’s Degree in Computer Science, Statistics, Mathematics, Public Health or other relevant scientific fields; Master’s Degree preferred
  • Minimum of 6 years of experience in developing software for clinical trials using the SAS system
  • Expert in programming with SAS. Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for NDAs/BLAs
  • Experience overseeing the work of internal contractors and external vendors (CROs)
  • Familiarity with CDISC standards, including SDTM and ADaM models
  • Solid verbal and written communication skills

Department: Biometrics

Job Title: Statistical Programmer- Contractor

Report to: Senior Manager, Programming

Location: China

 

MAIN REPONSIBILITIES:

  • Reviews and provides feedback on protocol, CRF, SAP and other study-related documents to ensure all programming requirements are met.
  • Creates SDTM, ADaM datasets following CDISC compatible standards.
  • Performs statistical programming for statistical deliverables.
  • Performs ad-hoc and exploratory analysis as requested.
  • Performs quality control for statistical programming.
  • Prepares the eCTD package for NDA submission.
  • Responsible for timely and quality programming documentation at study level.

QUALIFICATIONS:

  • Bachelor or masters degree in statistics, biostatistics, mathematics, epidemiology, computer science, or relevant field.
  • Good SAS programming skill is required.
  • Solid knowledge in CDISC standards and FDA/EMA/ICH guidelines is preferred.
  • Effective English verbal and written communication skills.
  • Ability to work effectively in a multi-cultural context as a good team member.

Department: Biometrics

Job Title: Principal Biostatistician

Report to: Biostatistician Director

Location: China

 

MAIN REPONSIBILITIES:

  • Contribute to the study design and sample size calculation
  • Prepare and finalize the statistical analysis plans.
  • Review and comment statistical methods sections and the interpretation of results.
  • Contribute to the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to the type of project.
  • Provide input into general standardization efforts (e.g., CRFs, query checks, statistical methodology, standard statistical programs, data presentations).
  • With direction, interact with regulatory agencies regarding statistical issues.
  • With direction, develop responses to regulatory agency requests that maintain perspective and are within the appropriate context.
  • With limited direction, write accurate, logical, clear, concise, thorough, and objective statistical methods sections for clinical trial reports.
  • Review the clinical trial reports ensuring the accuracy of the statistical interpretation.
  • Provide statistical support for manuscripts and review manuscripts for accurate statistical interpretation.
  • Communicate routine and complex statistical concepts and results to non-statistical internal and external colleagues in a clear, concise, focused, and articulate manner.
  • Participate effectively on clinical trial teams when required.
  • Produce assigned work within the timelines provided ensuring deadlines are met.

QUALIFICATIONS:

  • Ph.D. or MS in Statistics, Biostatistics, or related discipline
  • Fluent in English
  • At least 5 years’ experience in the Pharmaceutical/Biotechnology industry in clinical development
  • Knowledge of relevant regulatory guidelines, ICH Statistical and Clinical Report Guidelines applicable to clinical development.
  • Self-directed, technically strong regarding to clinical and methodological development
  • Good working knowledge of oncology therapeutic areas

Department: DM

Job Title: Senior Data Coordinator

Report to: Head of Data Management

Location: China

 

MAIN REPONSIBILITIES:

Serves as clinical data coordinator for one or more projects,Supports and works closely with study lead data manager(s) for assigned clinical studies.

  • Review clinical trial data based on protocol, edit specifications to identify erroneous, missing, incomplete, or implausible data
  • Assist with the aggregate review of clinical data by patient, site and/or project to identify data trends(compliance, etc.) and/or data in consistencies that require further investigation
  • Generate, resolve and track queries to address problematic data identified during data review activities
  • Contribute to DM part of EDC UAT for clinical database build and modifications
  • Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled
  • Assist with the reconciliation of central laboratory and/or third party vendor data, in addition to serious adverse event reconciliation
  • Participates in UAT activities for data transfers and programmed listings/report
  • Prepare data listings or data extracts for medial reviews and progress report specifically
  • Generates and delivers reports to study team members
  • Assists with Site and User management in clinical database of assigned clinical studies.
  • Maintain data management study documentation as appropriate
  • Perform other duties as assigned by management
  • Produce assigned work within the timelines provided ensuring deadlines are met.

QUALIFICATIONS:

  • Bachelor degree or equivalent
  • 2+ year’s working experience in data management in pharmaceutical industry, experience in oncology studies is preferred.
  • Understand clinical data management systems or electronic data capture software
  • Functional expertise (including understanding of data management process, industry guideline, etc)
  • Good understanding of regulations and guidelines (e.g. ICH, GCP)
  • Strong written and oral communication skills in local language and English – Ability to work in a matrix organization
  •  

Department: CMC

Job Title: CMC VP, Small molecule

Report to: Head of CMC

Location: China

 

MAIN REPONSIBILITIES:

  • CMC Strategy and Planning: Collaborate with the Company Teams to closely plan CMC programs (drug substance and drug product manufacturing and analytical activities), from preclinical development through clinical supplies for Phase 3 registration studies, including projection of API/DP needs, budgets, and timelines. Develop and implement a strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs. Execute plans in accordance with GMP, ICH and FDA regulations. Partner with and maintain regular contact with key stakeholders including, Quality Assurance, Regulatory Affairs, Medical, Legal, Finance, and Program Management. Write and review relevant sections for regulatory submissions.
  • Partner Collaborations: Identify, select, and manage Contract Manufacturing Organizations (CMOs) for process optimization, GMP/GCP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs.
  • Program Execution and Oversight: Oversee the tactical implementation of the manufacturing programs, including delivery of scalable and cost-effective manufacturing routes that meet or exceed the target clinical profile. Manage supply chain and logistics in support of clinical studies. Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents.

QUALIFICATIONS:

  • PhD/MS in science (e.g., organic chemistry, chemistry, pharmaceutical sciences, or related discipline)
  • Pharmaceutical/biotechnology industry experience (minimum 10 years) in managing China CRO/CMOs for the manufacture of GMP/GCP APIs and DP. Experience with projects preclinical through Phase 3 including multiple dosage forms and small molecule; biologics experience a plus)
  • Strong leadership skills with ability to be hands-on and lead/manage the CMC programs.
  • Thorough knowledge of GMP manufacturing and IND, CTA, and NDA filings; thorough and relevant knowledge of FDA and EMA regulations
  • Strong skills in identifying and resolving critical issues.
  • Strong track record in effectively working with senior management.
  • Proven ability to work collaboratively internally and externally, with the ability to manage multiple stakeholders.
  • Results oriented and self-assured. Ability to push timetables while keeping the team motivated.

Department: CMC

Job Title: CMC Analysis/QC Director

Report to: CMC Head

Location: China

 

MAIN REPONSIBILITIES:

  • Directing teams in the biological characterization of protein drugs, routine physicochemical analysis, and package material analysis.
  • Directing/responsible for the development, optimization and validation of analytical methods for protein drugs.
  • Responsible for the construction and management of the protein drug analysis team.
  • Complete other work tasks as assigned by the supervisor.
  • Responsible for establishing QC team.
  • Responsible for establishing company product quality analysis/quality management system.
  • Responsible for product technology transfer and establishing product quality standards.
  • Responsible for the company’s product analysis and quality control.
  • Responsible for the quality supervision of the company’s R&D, production and inspection process.
  • Responsible for/involved in IND & NDA declaration of CMC information writing.

QUALIFICATIONS:

  • Ph.D. in biochemistry, analytical chemistry, medicinal chemistry or related fields, M.S. or equivalent education or experience.
  • Familiarity with various types of protein drug analysis instruments and extensive experience in protein drug characterization and physicochemical analysis.
  • Familiar with GMP/GLP and can guide/conduct method development, sample analysis and data management in a compliant manner
  • Strong sense of responsibility and stress tolerance, with good English communication skills.
  • Extensive international pharmaceutical industry resources, strategic thinking and efficient execution, proactive, flexible and result oriented.

岗位职责:

  • 指导团队进行蛋白药物生物表征、常规理化分析以及包材分析;
  • 指导/负责蛋白药物分析方法的开发、优化与验证;
  • 负责蛋白药物分析团队的建设和管理。
  • 完成上级领导交代的其他工作任务。

岗位要求:

  • 生物化学、分析化学、药物化学或相关领域的博士,硕士或相同学历或经验;
  • 熟悉各类蛋白药物分析仪器,具有丰富的蛋白药物表征和理化分析经验;
  • 熟悉GMP/GLP,可以合规的指导/开展方法开发、样品分析和数据管理等工作
  • 责任心和抗压能力强,具备良好的英文沟通能力。
  • 有广泛的国际医药行业资源,具有战略思维和高效执行力,积极灵活,结果导向。

Department: Finance

Job Title: Finance Manager

Report to: Finance Director

Location: China

 

MAIN REPONSIBILITIES:

  • Maintain daily accounting affairs, including accounts receivable, accounts payable, general ledger.
  • Make accounting planning and preparation, such as accruals and provision plan, ensure a stable accounting profit and loss by monthly, quarterly and yearly.
  • Responsible for the accounting closing process, ensure the complete records of expenses, assets and owner’s equity.
  • Prepare financial statements, including balance sheet, income statement, cash flow statement and statement of changes in owner’s equity.
  • Prepare tax returns and local reports.
  • Assist finance director to complete financial statement analysis.
  • Assist financial director to provide audit support.
  • Maintain the company’s authorization system to ensure that the approval process of daily business is in line with the internal control regulations.
  • Maintain the office system of the company to ensure a smoothly working environment.

QUALIFICATIONS:

  • Bachelor degree or above and major in Accounting or related field required.
  • 5 years above experiences in finance and accounting.
  • Good at communication and problem finding.
  • Be able to work under pressure, strong ability of work planning.
  • Strong team spirit.
  • Good at office software, especially excel.
Anheart Entryway