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

Employment type: Full time or Part time

Location: USA

Major 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-functional communication, 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(ies) 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 at any stage, 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 trial conduction in compliance with ICH – GCP guidelines, local regulatory requirements, SOPs and protocols;
  • Be accountable for department SOP and working procedures 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 5 years management experience in related fields such as clinical operations  
  • Master’s degree or above in biological science, pharmacy or other health related discipline; MD or PhD preferred.
  • 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 with or in international CROs preferred;
  • Competent in written and oral English is a must.
Employment type: Full time
Title: Project Manager/Assistant Project Manager
Location: China

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 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
Location: China or USA

Major 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, PharmD 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: USA & China

Major 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
Location: China or USA

Major responsibilities:
  • 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;
  • 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 in IND to NDA package submission, Oncology project preferred.

Employment type: Full time

Title: Senior Manager/Associate Director

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: Senior Manager/Associate Director

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.
Anheart Entryway
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