• Phone: +86 21 63862192
  • Mailbox: info@alphabiopharma.com
  • 上海: 黄浦区太仓路233号新茂大厦505-508室
  • 北京: 朝阳区光华路9号世贸商业中心4号楼天阶大厦2512室

招聘信息

Regulatory Affairs Specialist

  • 工作地点:Shanghai
  • 发布时间:2021-05-08
  • 招聘人数:1人
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岗位描述

Support to collect, compile and internal review for the submission dossiers based on determined application timeline and plan, to ensure submission in timely.

Follow up the registration process, and communicates with NMPA, CDE and other governments or departments effectively.

Support to prepare and submit the communication meeting documents, supplementary documents during the CDE review, annual report, etc.

Have a good understanding of Chinese regulatory environment.

Implement regulatory activities as required by governmental regulations and internal SOPs.

Summarize, classify, compile and archive the regulations, dossiers and guidelines issued by HA, to provide support for RA strategy.

Collect, analyze and report the information from competitors.

Establish and maintain good relationship with authorities to enusre effective communication.

Deliver working instruction and requirement correctly and timely, ensure that we make effective communicate with partners to achieve the goals.

Other assignments.

任职要求

IND/NDA experience
Good proficiency in English with fluent english speaking
Bachelor degree or above with relevant majors
Fresh graduates or 1~2 working experience in RA
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Head of Statistics

  • 工作地点:Shanghai
  • 发布时间:2021-05-08
  • 招聘人数:1人
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岗位描述

This role provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or product needs at Alpha Biopharma.

Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience
Be effective in the use of relevant computational tools for study, experiment, or trial research objectives.
Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability
Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.
Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support.
Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances.
Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical Operation team, and Sr. VP, Medical.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
Oversee the quality of data management if it is outsourced.
Demonstrates full proficiency in systems as well as a working knowledge of other relevant computational tools as required.
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

任职要求

Ph.D. in Statistics or related field with 5-10 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.
Experience in data analysis and reporting in NDA filing
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Principle Scientist

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

Lead overall cell therapy projeccts, contribute the cell therapy strategy; manage study timelines, objectives and budgets, ensure data accuracy and integrity.
Analyze and interpret the data generated during discovery, early and/or full development; responsible for timely and effective communication of data, strategy and results to the project teams.
Adhere to the appropriate SOP and GxP guidelines, and embrace a collaborative culture; Coauthor and prepare key preclinical and clinical, and regulatory documents, scientific manuscripts, including, but not limited to: study protocols, study reports, modeling reports, investigator brochures, IND/IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements.
Identify potential project hurdles, suggest solutions and contribute to contingency plans. Works collaboratively within cross-departmental teams, department-wide initiatives and work streams.
Provide cell therapy expertise on due diligence of BD projects and prepare appropriate documentation.

任职要求

PhD and/or MD, strong scientific background in immunology or oncology, international Post-doctoral training is an advantage.
5-8 years' R&D experience in cell therapy and immunooncology, solid scientific publication.
Project management skills are required.
At least 3 years managerial experience.
Program leader in cell therapy, including discovery, procss development and manufacture.
Expertise in technology of cell and gene therapy, such as CRISPR, viral vector, T cell culture and assays; QC and QA mindsets.
Sufficient skill in advanced cell biology and molecular biology, including cell sorting, ELISA, qPCR, in vitro and in vivo assay development.
Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results, and build the confidence as well as trust of stakeholders.
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QA Lead, Cell Therapy

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

贯彻执行药品管理及相关法律法规,围绕企业质量体系,组织和规范企业细胞治疗项目质量管理工作;指导日常研发、生产过程的合法合规,指导QA,QC以及验证岗位的质量管理工作。
与公司各部门沟通合作,创建/修订程序/实践和规范,负责部门SOP的起草、审核和管理,并提供细胞治疗项目有关质量体系和程序的培训。
负责审核细胞治疗项目中物料、产品的放行,确保放行程序的合规性。
负责督促物料、产品、中间产品稳定性考察工作;建立偏差处理管理制度,审核偏差处理记录。
负责处理细胞治疗项目中生产运营、质量体系中的重大问题及难题。
负责公司细胞治疗项目研发、工艺开发、GMP 生产等涉及产品生命周期内不同阶段的质量体系的建立,满足各模块日常运营对质量管理的基本需求,确保符合法规质量要求以全面支持公司产品的临床开发及注册。

任职要求

Education/Certification (教育/认证): 具备药学或相关专业硕士及以上学历
Professional Experience (专业从业经历): 具有8年以上中大型药企质量部门工作和管理经验;拥有细胞治疗类企业的质量管理岗位经验优先,经历过FDA 审计、GMP认证、药品注册现场核查者优先。
Project and/or Process Experience (项目/流程经历): 负责过生物药项目。
Leadership Experience (管理经历): 3年以上团队管理经验。
熟悉药品研发的药学、质量研究、质量保证工作,熟悉美国、欧洲GMP及药品注册相关的法律法规、指导原则,熟悉药品研发及其申报流程;熟悉GMP流程,有QC相关项目管理经验。
熟悉厂房、设备、工艺的验证以及质量管理体系的建立及完善工作。
具有良好的职业素养、良好的大局观、团队协作精神和高度的责任心,能承受较大压力。
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PV Physician

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

The role is responsible for the accuracy, integrity of safety data collected in clinical trials, ensuring the benefit-risk balance of company products.

Individual case safety report (ICSR) review:
1) Perform medical review of individual case safety report (ICSR) according to SOPs and liaising with other functions, as required
2) Writing Pharmacovigilance/MAH comment and assessing company causality
3) Assessing seriousness and expectedness of reported events
4) Providing medical advice to case processing team

Safety data review:
1) Perform safety data review for ongoing clinical trial from PV perspective

Risk management:
1) Identify, evaluate and confirm the safety risks in clinical trial
2) Generate dRMP and RMP
3) Communicate and execute the mitigation plan for risk minimization

Other assignment instructed by line manager

任职要求

Bachelor of medicine (or above), Board certified or Board eligible or equivalent medical training is preferred. 3-5 years related working experience. More requirements are listed as below:

1) Familiar with PV e-system such as Argus
2) Excellent interpersonal, verbal and written communication skills
3) Good knowledge of medical terminology (both Chinese and English)
4) Ability to manage multiple and varied tasks and prioritize workload with attention to detail
5) Ability to assess the clinical relevance of medical data and to interpret its clinical meaning
6) Strong knowledge of international drug regulation including GCP, GVP
7) Relevant experience into pharmacovigilance/Drug Safety field is preferred
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Regulatory Affairs Manager/Director

  • 工作地点:北京
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

Propose registration strategy of drug products in China, Asian countries and America, including timeline, budget and acquire agreement of related stakeholders
Collect information of drug registration regulations, guidelines, change trend and share with the team
Build and maintain good relationship with health authorities, as well as keep effective communication
Support R&D team to conduct the studies according to related regulations and technical guidelines
Be responsible for the organization, monitoring of pre-clinical, clinical and other related outsourcing researches, to fulfill regulations requirements
Complete registration dossiers by guiding related stakeholders
Review of technology transfer documents and change controls.
Ensure submission of satisfactory and timely responses to deficiency letters
Be responsible for organization, coordination, implementation of authorities’ inspection according to registration-related regulation
For licensed products, prepare and co-ordinate timely submission of post licensing commitments and legal obligations of the Marketing Authorization Holder via appropriate procedures, e.g. renewals, annual reports, variations, responses to questions, PSURs etc.
Ensuring the upkeep of regulatory databases
Other job assigned

任职要求

Bachelor of pharmacy degree or above
At least 8 years of experience in drugs registration
Fluent in oral English and effective communication
Strategic thinking and good planning skills
Performance driven
Self-motivated and able to motivate the team
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Clinical Project Manager/Sr. Manager

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

• Project planning—Create a project team, communicate final protocol and explain scientific approach/performance to the team (e.g. cost, time, quality).
• Project Monitoring and Guiding—Monitor/evaluate/review the scientific performance of the study.
• Project Problem Management—Suggest solutions and actions to solve study problems, manage the impact on time and cost, review protocol changes.
• Learn Process—Perform scientific mentoring activities (e.g. training study specific techniques, assisting with complex analytical work/problem solving). Participate in post project assessment by providing input on team performance (accomplishments and glitches). Responsible for the design, conduct and reporting of studies to meet scientific, regulatory requirement.
• Initiate a long-range planning and technical policies of the department
• Responsible for the planning and delivery of the clinical component of the project in accordance with the scope of work and timeline, and for managing the clinical portion of the study budget.
• Responsible in resource allocation, task oversight and delegation, development of monitoring plans, contingency planning, and management of communications and reporting.
• Lead in preparation and delivery of study documents for example SDV plan, study management plan for deliverables, confidentiality agreement and clinical trial applications.
• Provide clinical monitoring expertise and leadership for large, complex protocols and/or international programs
• Lead and motivate the clinical team. Act as a mentor and train CRA in the responsibilities of the position
• Promote effective teamwork among project team members
• Provide performance evaluation and feedback of team members
• Work independently and to effectively prioritize tasks, actively seek input, problems solve and work within a matrix team environment
• Effective verbal and written communication skills. Highly effective interpersonal and organization skills. Effective presentation skills, is able to prepare a presentation for an investigators meeting.
• Coordinate operational aspects of study and lead and participate in activities and ensure quality, consistency, and integration of study data and progress deliverables to time cost and quality from study concept through database lock and study close-out activities.
• Provide input into non-project work, training activities, and development of procedure as needed.
• Manage external service provider.
• Help in the development and implementation of plans associated with audits and regulatory inspections.
• Planning and conduct of investigator/monitors meetings.
• Manage/coordinate the supply and reconciliation of Study Materials and Investigational product.
• Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.
• Quality contact person of the department and in charge on the development and implementation of all SOP
• Assist the staff recruitment
• Assist in business development in proposal generation and undertake feasibility work.
• Perform other related duties as assigned.

任职要求

• Experience conducting clinical trials with strong knowledge of GCP/ICH-GCP guidelines
• Experience making decision on the detailed execution of clinical trials
• Proven clinical trial experience with more than 3 years project management
• Medical life science background
• Fluent English is preferred
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Sr. Investor Relations Manager

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:1人
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岗位描述

Responsible for the establishment and improvement of the investor relationship management system.
Keep the track record of existing/potential investors and collect updates from business departments on a regular basis.
Responsible for investors visits, interviews and researches.
Participate in organizing IR related events including performance presentations, internet conferences and road shows; actively develop and maintain good relations with investors and industry analysts.
Participate in corporate financing activities with knowledge of capital market.
Participate in brokerage strategy meetings, investor relations meetings, and regularly visit major investment institutions to ensure that the capital market understand the company's dynamics timely, objectively and comprehensively.
Assist to advance future IPO procedures and responsible for information disclosure and compliance related to listed company.
Pay attention to the media reports on the listed entity, take the initiative to verify the contents of the reports with the company and relevant information disclosure obligors, and urge the Board of Directors to disclose them in time.
Formulate and improve the company's information disclosure management derective.
Take the lead in organizing the company's management team and intermediary team to draft, revise and disclose the periodic and irregular reports that should be disclosed according to the listing rules.
Formulate and implement the market value management plan for the listing entity.

任职要求

Relevant experience in HK listed company is a plus. Direct experience in VC or PE is preferred.
In-depth understanding of biopharmaceutical industry in China and globe.
Strong analytical, writing, communication and presentation skills.
Knowledge in HK listing rules.
Good at capturing market information and sensitive in data analysis.
Ability to work in a fast-paced environment and able to cope with pressure.
Fluent English in oral and writing.
Bachelor degree or above in biology, finance, legal and other related majors. MBA is a plus.
At least 5 years working experience in IR work
Familiar with pharmaceutical or investment industry, with working experience in domestic (Overseas) listed companies
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CRA/SCRA/Lead CRA

  • 工作地点:上海
  • 发布时间:2021-04-12
  • 招聘人数:多人
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岗位描述

• Pre-Study/Start up Site Management Activities
-- Identify potential sites, investigators and site staff;
-- Establish site-level recruitment strategy/plan
-- Ensure required documents, e.g. subject informed consent(s) and protocol, are approved by the applicable local Ethics Committee(s)
-- Ensure all required study start-up documentation and supplies (drug and non-drug) is in place and the site is able to start on time and according to plan
-- Establish investigator file and submit essential documents to trial master file
-- Ensure adequate contract is signed and payment is defrayed according to contract
-- Ensure timely site initiation in line with project timeline
-- Build and maintain positive relationships with the site and investigators
-- Create site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution

• Study conduct site monitoring activities.
-- Complete site recruitment according to recruitment strategy/plan
-- Carries out monitoring activities, on-site visits or remote communication, in line with monitoring plan, ensuring adherence to protocol and study procedure, ICH - GCP guidelines and local regulations.
-- Perform SDV during on-site monitoring visits according to the protocol SDV plan
-- Perform site-level drug accountability (ensuring proper handling, storage, administration, record-keeping and disposition) and emergency codes check
-- Verify storage and shipment of biological samples and other protocol specific diagnostics requirement
-- Maintain and update investigator file, submit essential documents to trial master file
-- Verify timely, complete and accurate reporting of SAE/Pregnancy Forms. Ensure site receives all safety information and submits these reports, as appropriate, to the local ethics committee/Health Authorities
-- Submit update study information (e.g. protocol, subject informed consent form, regular study progress report) to the applicable local Ethics Committee(s) and get approval within time frame
-- Update site information in CTMS and project tracking tools on site level
-- Complete timely reports/correspondence to record issue, action plan and resolution
-- Ensure timely and accurate payment to site according to contract and progress

•Conducts Study Site Close-Out Activities.
-- Ensure proper return and disposition of all study-related supplies and equipment
-- Notify site and EC of the completion of the study and submit study reports as requested
-- Ensure site information in CTMS and project tracking tools is complete
-- Ensure site reports and correspondence is complete
--Complete audit finding solution, if the study is registration study, CRA need to do the CFDI inspection readiness preparation and handle the site inspection activities.

• Project Management Activities (As the senior CRA)
--Partial working time could be spent on small-scale clinical trials management activities refer to CPM’s Job Responsibilities as requested under line manager’s support, as a part of achieving personal development in the CRA position.
--In one study, support PM to do the part working of project management as the lead CRA.

任职要求

• Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)
• At least 1-2 years (CRA level) clinical operation monitor experience for senior position.
• Good knowledge in GCP for senior position
• Good command of written and verbal English
• Good communication and organization skills
• Good and proactive working attitude
• Value importance of teamwork
• Ability to work independently
• Experience in oncology study is preferred
• Travel needed
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