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正在招聘的职位请见下文。

Employment type: Full time

Title: Clinical Operations Director

Location: China/US

Responsibilities:

  • 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 10 years’ experience in clinical research and 3-4 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.

Employment type: Full time

Title: CDTL Senior Director or VP

Location: China

 

Responsibilities:

  • Act as scientific and clinical leader who serves as a key member of the core R&D Team and responsible for the overall clinical development plan for an asset or assets in one or more indications/tumor types, including registrational and non-registrational studies.
  • Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) 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.

Employment type: Full time or Part time

Title: Medical Director/Sr. Medical Director

Location: China/US

 

Responsibilities:

  • Provide strategic and scientific input in the clinical development plans and the corresponding target product profile from global perspective
  • Build understanding of and relationships with key stakeholders
  • Discuss the study protocol with the internal project team and the investigators;
  • Review and approve patient enrollment eligibility;
  • Review protocol compliance and evaluate manage protocol deviation;
  • Provide study medical data review;
  • Review serious adverse event and follow up as needed;
  • Manage medical queries from the clinical site staff;
  • Provide medical opinion/review of the clinical study reports;
  • Draft clinical study summaries and overview.

Qualifications:

  • MD is required; Board certification in medical oncology would be a plus
  • At least 10 years working experience of clinical development in the global biopharmaceutical companies;
  • Strong leadership, excellent communication and project management skills;
  • Excellent verbal and written communications skills in English.

Employment type: Full time

Title: PM

Location: China

 

Responsibilities:

  • 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.

Employment type: Full time

Title: Medical Writer

Location: China

 

Responsibilities:

  • 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.

Employment type: Full time

Title: Clinical Bioanalytical Scientist (Director or Associate Director)

Location: China

 

Job Summary:
This position has the responsibility for providing strategic bioanalytical leadership for all clinical development programs and participating in strategy implementation. This position will work closely with CRO partners and provide scientific oversight for development and validation of PK, PD, and immunogenicity assays to support all clinical programs. This position will collaborate with clinical study team and external partners and be responsible for managing clinical sample analysis at all stages of clinical development, ensuring that bioanalytical studies are conducted in a timely manner and in compliance with scientific principles and global regulatory standards. In addition, this position has the responsibility of authoring and reviewing bioanalytical sections of clinical and regulatory documents (IND, IMPD, NDA/BLA/MAA, IB, CSRs), including sections of CTD module 2.7.1 and Integrated Summary of Immunogenicity.

 

Strong initiative and capable of multi-tasking, working both independently and within a team environment. Experiences with CROs and with LC-MS/MS and immunoassay techniques are preferred. Knowledge and experience with PK, PD, and immunogenicity assays for biotherapeutics desired. Familiar with bioanalytical regulatory guidance and industry standard practice for conducting clinical bioanalysis. Strong project management, interpersonal skills, and knowledge in Oncology a plus.

Responsibilities:

  • Providing bioanalytical strategy to clinical development programs and knowledge input for emerging assay technologies.
  • Primary responsibility for scientific oversight of the development and validation (as well as lifecycle management) of PK, PD, and immunogenicity assays at CRO partner labs, facilitating resolution of assay method issues, reviewing/approving validation plans, method specifications and validation reports.
  • Other primary responsibility for closely collaborating with clinical study teams in managing clinical sample analysis at CRO labs including timeline, data quality, resolving issues, reviewing/approving bioanalytical study sample analysis plans and reports, and ensuring compliance with SOPs and regulatory guidelines.
  • Responsible for providing standardized sample collection, storage, and transmission specifications for use in clinical studies to ensure the integrity of samples and validity of subsequent sample assay. Work with study teams to ensure implementation of appropriate sample logistics, including meeting all appropriate labeling and legal requirements.
  • Author and review of bioanalytical contents needed for clinical study and regulatory communication and submission.
  • Establish, maintain, and improve standardized working processes to ensure uniform and cost-effective practices in clinical bioanalysis.

Qualifications:

  • Ph.D. or equivalent in analytical chemistry, biology, biochemistry, chemistry, or related scientific field required. Master’s degree may be considered pending on experience.
  • At least 8 to 10 years of experience in clinical development of the pharmaceutical or biotech industry; CRO monitoring experience is also required.
  • At least 4 years of experience in addressing inquiries from regulatory agencies regarding issues on bioanalytical methodology and in formulating strategies for regulatory interactions if required.
  • At least 4 years of experience with assay development for both small molecule and mAb drugs
  • 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 Chinese; fluent in English; able to independently use both English and Chinese to write documents and communicate with peers and experts.

Employment type: Full time

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

Location: China/US

 

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.
 

Responsibilities:

  • 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.

Employment type: Full time

Title: QA

Location: China

 

Responsibilities:

  • Responsible for receiving customers and official audits, preparing audit responses and tracking corrective measures.
  • Responsible for continuously improving the company’s pharmaceutical manufacturing quality management system and ensuring the effective operation of the system.
  • Responsible for drafting, revising and implementing systems and processes related to document management system.
  • Responsible for continuously improving the document file management system.
  • Responsible for continuously improving the company’s quality training system.
  • Responsible for organizing and promoting internal audit self-inspection.
  • Responsible for reviewing and evaluating any change requests related to the quality of drug production and approving minor changes.
  • Responsible for auditing deviation handling to ensure that all major deviations and exceedances have been fully investigated and properly handled.
  • Ensure that all quality-related user complaints have been fully investigated and properly handled, work with relevant departments to study improvements on quality issues, and report the status of complaints and results to the company leadership.
  • Participate in external audits of various suppliers.
  • Participate in annual quality review.
  • Complete other work assigned by the supervisor.

Qualifications:

  • Bachelor degree or above in Pharmaceutical Analysis, Pharmacy, Biology or related majors.
  • More than 5 years of QA experience in biopharmaceutical or related companies, and experience in GMP quality documentation management and GMP quality audit.
  • Familiar with domestic and international GMP, GLP and other regulatory requirements, and familiar with pharmaceutical industry documentation requirements.
  • Have experienced at least 1 (as the main participant) GMP site verification.
  • Experience in quality management of biological products (e.g. antibody drugs) is preferred.
  • Good command of common office software, and good English reading and writing skills.
  • Team management skills, good coordination and communication skills.
  • Teamwork spirit and sense of work responsibility.

Employment type: Full time

Title: RA

Location: China

 

Responsibilities:

  • Responsible for obtaining, preparing, submitting, and maintaining regulatory filings for domestic and international regions, coordinating submission activities with internal team members and external parties (e.g., regulatory bodies; vendors; consultants), maintaining up-to-date information on regulatory requirements and product submissions.
  • Participate as RA CMC representative in CMC project-related team meetings; will involve multiple CMC projects (investigational and commercial)
  • Work with RA therapy area lead and SMEs on preparing the regulatory submission strategies, authoring and review of the submission content, creating and maintaining submission timelines to meet business objectives.
  • Capable of leading and coordinating the timely compilation and critical review of the CMC data package from other functional team representatives to provide complete and appropriate documentation necessary for timely submissions.
  • Work with SMEs to provide timely responses to CMC questions from regulatory agencies.
  • Keep up to date on industry and regulatory trends as well as CMC-related regulatory requirements and/or national law and communicate with CMC team.

Qualifications:

  • Bachelor’s degree in a scientific discipline; advanced degree preferred (MS, PhD)
  • 7+ years pharmaceutical industry experience with minimum of 3 years of regulatory CMC experience
  • Experience in the preparation and management of high-quality CMC regulatory submissions for investigational and/or commercial products; must be a self-starter and capable of working independently.
  • Demonstrate understanding of small molecule CMC attributes and pharmaceutical development process of new molecular entities.
  • Solid knowledge of U.S. regulations and guidelines; experience with European regulations and guidelines desirable
  • Possess excellent organizational skills; experience must include ability to effectively interact with research functions, QA, manufacturing, and analytical teams at all levels.
  • Team management skills, good coordination, and communication skills.
  • Teamwork spirit and sense of work responsibility.

Employment type: Full time

Title: Principal Biostatistics

Location: China

 

Responsibilities:

  • Work collaboratively with other members of the Medical Affairs team to develop and provide scientifically sound analyses that answer questions to support and enhance publications and knowledge of products.
  • Participate in Publication Planning Meetings as a Biostatistics representative contribute to publication planning including timelines, statistical and analytical requirements for publications, projects, and publications plans.
  • Develop, design, and oversee or perform post-hoc analyses of existing databases and meta-analyses as needed and appropriate.
  • Support clinical development biostatistics with exploratory analyses necessary for submissions and regulatory queries.
  • Review publications, marketing materials, and education and training materials that contain clinical data and product claims.
  • Stay informed with data being generated in current clinical development programs.
  • Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results, as necessary.
  • Provide guidelines and standards to CROs to ensure quality of deliverabes.
  • Provide support for approval for payers at the country level.

Qualifications:

  • Bachelor or master’s degree in statistics, mathematics, computer science or other related fields.
  • Experience supporting Medical Affairs/publication of analysis results (e.g., abstracts, posters, manuscripts) a plus.
  • Proficient in drug development regulations pertinent to statistical analysis.
  • Proficient SAS programming skills, solid understanding of CDISC SDTM and ADAM models and standards.
  • Excellent writing and communication skills.

Employment type: Full time

Title: Senior Director or VP

Location: China

 

Responsibilities:

  • 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.

Employment type: Full time

Title: Legal Manager

Location: China/US

 

Responsibilities:

  • Review, draft and negotiate a broad range of commercial contracts, including IP licensing, consulting agreements, employment agreements, clinical services, software-as-a-service, vendor, and outsourced services agreements. Ensure contracts are in compliance with organizational policies and standards.]
  • Address legal questions from the business across a variety of legal topics.
  • Collaborate with and facilitate decision-making among multiple internal stakeholders.
  • Engage in process improvement projects and collaborate with other team members on maintaining and creating templates, processes, and policies.
  • Provide support on a range of legal issues, including intellectual property and privacy, and liaise with legal department subject matter experts and outside counsels, as needed.
  • Supervise and coordinate engagements with outside counsel.

Qualifications:

  • Juris Doctor (or equivalent) and an active license to practice law in applicable jurisdictions.
  • Strong organizational, planning, project management, communication, presentation, and influence skills
  • Strong business acumen, understanding of the government regulations that effect the operation of the organization preferred.
  • Understanding of the pharmaceutical industry and/or drug development process preferred
  • Demonstrated ability to work creatively in a fast-paced environment.
  • Demonstrated sound decision-making skills.
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