• Phone: +86 21 63862192
  • Mailbox: info@alphabiopharma.com
  • Shanghai: Unit 04-08, 5F, Platinum Building, No.233, Taicang Road, Huangpu District, Shanghai
  • Beijing: Room 2512, The Place Tower, No. 9 Guanghua Road, Chaoyang District, Beijing

Talents Value

Organizational capability refers to the combat effectiveness of the entire team

  • Sustainable and embedded in the organization rather than the individual

    Sustainable and embedded in the organization rather than the individual

  • Create values to the customer

    Create values to the customer

  • Significantly surpass the competitor

    Significantly surpass the competitor

The organizational capability of the smart company needs a focus, which demonstrates 2-3 aspects as core competencies. The organizational capability also needs to be clearly defined, which aims to focus on development of those capabilities.

  • Employee Mindset

    Employee Mindset

    whether employees show their values, behaviors and engagement to match their organizational capabilities?

  • Employee Capability

    Employee Capability

    whether employees have knowledge/skills/qualification required for organizational capabilities?

  • Employee Governance

    Employee Governance

    whether the company can provide management support & resources, allowing employees to give full plays to their strengths?

3 dimensions to strengthen organizational capabilities

2 Principles for 3 dimensions to strengthen the organizational capabilities:
Balance - 3 dimensions to be equally strong;
Matching - focus of 3 dimensions to be aligned with the necessary organizational capabilities.
3 dimensions to strengthen organizational capabilities

Employee Activities

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ICON

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Employee Development & Training

  • New Employee Orientation

    New Employee Orientation
  • General Management Skill Training

    General Management Skill Training
  • Professional Skills Training

    Professional Skills Training

Training System

  • On-site trainingOn-site training
  • Live-stream trainingLive-stream training
  • Lunch-time seminarLunch-time seminar
  • Offline salonOffline salon

Employee Welfare

  • Annual Leave
    Annual Leave
  •  Sick Leave
    Sick Leave
  •  Business Insurance
    Business Insurance
  •  Annual Outing
    Annual Outing
  •  Physical Examination
    Physical Examination
  •  Birthday Party
    Birthday Party
  •  Afternoon Team
    Afternoon Team
  •  Vacation Welfare
    Vacation Welfare
  •  Team Building
    Team Building
  •  Shuttle Bus#
    Shuttle Bus
  •  Employee Dormitory#
    Employee Dormitory
  •  Welfare Lunch#
    Welfare Lunch

icon exclusive welfare for factory employees

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Talents Acquisition

Head of Statistics

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:1 Person
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Job Description

Statistical Expertise
1. Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience.
2. Be effective in the use of relevant computational tools for study, experiment, or trial research objectives.
3. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability.
4. 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.
5. 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.
6. 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.

Data Management & Quality
1. 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.
2. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical Operation team, and the CMO.
3. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
4. Oversee the quality of data management if it is outsourced.

Programming
Demonstrates full proficiency in systems as well as a working knowledge of other relevant computational tools as required.

External Engagement
Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.

Job Requirements

1. 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.
2. Experience in data analysis and reporting in NDA filing.
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CRA

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:2 Person
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Job Description

• 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.

Job Requirements

• Bachelor degree in biomedical/science discipline or equivalent (e.g. BSc, Registered Nurse , BPharm)
• At least 1-2 years 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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Clinical Research Physician

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:1 Person
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Job Description

Oversight on study-level responsibilities
1 ) Responsible for interacting and communicating with China KOLs for China development
strategy and protocol design.
2) Be responsible for detailed study designs and develop study synopsis and protocol to meet
scientific and regulatory requirements for product registration.
3) Lead study protocol amendment based on cross-functional cooperation to meet scientific
and regulatory requirements.
4) Review essential study documents (e.g., eCRF, ICF, IB, BICR chart, DSUR, CSR, etc) with
appropriate medical inputs.
5) Provide medicalinputs in product TPP, CDP, product positioning and differentiation.

Medical leadership demonstration by physician expertise
1 ) accountable for managing medical monitoring of the clinical trials including review and
approval of subject eligibility and protocol deviation, review of medical data and adverse
events/serious adverse events, medical coding review, medical inputs in data clean and
addressing clinical queries from investigators, and ensure study protocols be implemented
with good medical quality.
2) Oversight the delivery of CRO and related vendors on clinical science matters to ensure
study meets timeline and quality.
3)Provide closely cooperation from medical perspective with study stats on SAP, interim
analysis, patient profile, SAR based on study protocol.
4)Liaise with responsible PV person for safety assessment at individual, study and product
levels as assigned, evaluation of safety signals, and risk mitigation plan development and
implementation.
5) Provide adequate medical review and inputs in preparation and documents development
for IDMC meeting.
6) Liaise with study pharmacologist on PK/PD programs and conduct medical review on PK
deliverables (e.g., PK SAP, SAR).
7) Be a product and protocol expert, prepare and deliver product and project presentations
at the investigator's meeting, answer medical questions from the investigator and maintain
scientific communication with investigator to ensure continuous adequate understanding of
product and study protocol.

Enhancement on drug registration
1)Provide clinical expertise to the clinical section of regulatory documentations & submission
and address medical questions in regulatory submission, communication and interaction.
2) Lead scientific interpretation on clinical trial data and ensure clinical study report reflects
scientific value with regulatory requirements.
3) Prepare clinical slides as needed and deliver medical presentations to health authority (e.g.,
CDE) communication meeting.
Medical intelligence & Publication
1)Maintain up-to-date medical knowledge and competitive intelligence in the TA and act as
a speaker at internal and external meetings to provide state-of-the-art medical knowledge
of study projects as required.
2)Be responsible for data publication of clinical study, support pre-launch marketing activities
and early market access to the compounds.

BD support
Provide clinical expertise and medical assessment to pipeline expansion.

Product lifecycle support
Be responsible for medical evaluation and provide medical leadership in IIS study.

Process standardization and optimization
Involve in the process standardization and optimization for clinical development projects (e.g.,
SOP development and support).

Job Requirements

• Bachelor degree or above with major in clinical medicine/related
• 3 year's working experience in medical TA or clinical practice with at least 2 year's experience in clinical study
• At least 2 years' experience in clinical study protocol development and/or medical monitor (Phase 1, 2, 3)
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