Director, Medical Science

main duty:

The position should be an experienced clinical researcher with clinical study experience. This position will work together with the clinical operation team with high-level medical insights according to the company development strategies. The positions function under the guidance of Chief Executive Officer and Chief Medical Officer, and externally they interact closely with clinical investigators, regulatory authorities, Contract Research Organizations (CROs), and other Health Care Professionals (HCPs) as needed to support business objectives.

Key Responsibilities

Responsibilities will be concentrating the efforts on global clinical trials include the planning, execution and interpretation of clinical trial studies and data collection activities. This position is expected to play a key role in the development and execution of regulatory filing, pilot and pivotal clinical trials intended to support regulatory registration of a new therapeutic product in worldwide market. Detailed job responsibilities include the followings:

·         Develops clinical development strategy and plan (including protocols) for global registration purposes.

·         Takes the role of medical monitor for clinical studies and responsible for protecting the integrity and conduct of clinical studies.

·         Selects study sites and investigators in partnership with clinical operation team.

·         Acts as the leading physician and be responsible of analyzing, interpreting and writing clinical study results with other functions.

·         Acts as the TA clinical science expert and supports regulatory filing and registration.

·         Acts as the clinical science physician and provides professional medical consultancy, ie, protocol related questions, to internal and/or external stakeholders.

·         Sets up advisory board meetings and interacts/communicates with KOLs. 

Key Qualifications

·         Medical degree in Medicine or a related field.

·         Minimum 8 years of clinical development experience and at least as clinical research physician for 5 years in industry.

·         Deep knowledge in the given TA.

·         Strong scientific knowledge in clinical research under global environments.

·         Successful experience in leading a compound’s development and registration in a given TA.

·         Strategic thinking and problem solving skills.

·         Excellent communication (written and oral) in both English and China, and vendor-management skills.

·         Ability to utilize various electronic systems and software- intermediate computer skills required

·         Ability to travel as required. 

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Clinical Trial Assistant (CTA)

main duty:

CTAs will provide administrative support to clinical projects under direction of line manager, Clinical Research Associate and/or other designated clinical team members. CTAs could be required to provide general administrative functions.

Key Responsibilities

·         Collection, scanning, copying, archiving and maintenance of clinical study documents.

·         Coordination clinical study events, e.g. the arrangement of investigator meeting and recording of meeting minutes.

·         Support CRA team to complete site monitoring.

Key Qualifications

·         Bachelor degree, or local equivalent, in clinical, medicine, or a related science field.

·         Good in written English as well as local language.

·         Good communications skills.

·         Proven ability to work within a team.

·         Must demonstrate good computer skills. 

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Clinical Research Associate (CRA)

main duty:

CRAs have the responsibility to identify, select, initiate and close-out appropriate investigational sites for clinical studies. CRAs will need to ensure that the rights and well-being of human subjects are protected and the reported trial data are accurate, complete, and verifiable from source documents.

Key Responsibilities

·         Act as the main line of communication between Company and the investigators.

·         Build relationships with investigators and site staff.

·         Manage on-site visits and logistics in accordance with the monitoring plan.

·         Verifying that the investigator follows the approved protocol and all GCP procedures.

·         Verifying that source data/documents and other trial records are accurate, complete, and maintained.

·         Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs.

·         Generate visit/contact report in accordance with monitoring plan.

·         Keep manager informed about work progress.

·         Maintain a working knowledge and ensure compliance with applicable GCP and local regulatory requirements.

Key Qualifications

·         Bachelor degree, or local equivalent, in clinical, medicine, or a related science field.

·         Strong computer skills including knowledge of MS-Office products.

·         Regulatory knowledge including GCP.

·         Excellent verbal and written communication skills.

·         Able to take initiative and work independently.

·         Effective time management.

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Process R&D scientist

main duty:

Responsible for drug molecular research, amplification and production.

description of job:

1, independent of the existing process to optimize, improve yield and simplify the operation;

2, can improve the proposed process is feasible and feasible;

3, commissioned by the company CMO raw material kilograms of production;

4, write a project report;

job requirements:

1, organic synthesis or related professional undergraduate and above, have a deeper knowledge of chemical theory;

2, more than three years of work experience, completed more than kilograms of production projects, a wealth of raw materials pilot technology amplification and process transfer experience;

3, a process to enlarge, route optimization, pilot production experience, familiar with the production equipment and process priority;

4, familiar with the GMP system and its certification requirements, GMP workshop production experience;

5, familiar with the synthesis workshop workflow and operation, and commonly used raw material drug production equipment;

6, the work has a strong sense of responsibility, organic synthesis has a strong interest and hobbies, can be hard-working; with motivated and responsible and good team spirit.

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Organic synthesis scientist

main duty:

The position will be responsible for the synthesis and identification of innovative drug molecules, to complete the designated R & D goals.

Job Responsibilities:

1, according to the technical director of the arrangements and guidance to complete the target compound route design and synthesis;

2, independent commitment to the target compound synthesis, separation, purification and characterization;

3, proficient in the use of laboratory laboratory equipment, and proficient in laboratory safety requirements;

4. able to solve most of the problems in the experiment;

5. report to the technical supervisor on the progress of the work, feedback the problems, and coordinate the solution;

6, the independent completion of the relevant information collection, literature search and written work;

7. Complete the experimental record clearly and completely, the report is true, detailed and reliable.

8, to complete the other tasks assigned by the supervisor;

job requirements:

1, organic chemistry, materials chemistry, pharmaceutical chemistry and other related professional, undergraduate and above;

2, more than one year of organic synthesis work experience, a strong laboratory safety awareness;

3, able to skillfully complete and optimize multi - step organic synthesis reaction;

4, active thinking, with the ability to analyze and solve problems;

5, hands-on ability, serious and careful, have a good sense of communication and team spirit

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Formulation scientist

main duty:

Responsible for prescription screening, optimization, amplification and production of pharmaceutical preparations.

description of job:

1, involved in drug preparation prescription screening, process research and optimization, and to achieve the pilot and large production transformation;

2, tracking the development trend of formulation technology research and technology market dynamics, the project preparation design, development and development work;

3, to complete the preparation of new drugs and related reporting materials finishing work.

job requirements:

1, drug preparation and related professional undergraduate and above, more than two years experience in drug preparation research and development;

2, familiar with the pharmaceutical production process, familiar with the solid preparation process of various unit operation and related equipment;

3, familiar with GMP regulations and requirements, familiar with the production process validation and so on;

4, has a wealth of pharmaceutical preparation theory and practical work experience, with a strong literature search, prescription screening and process design capabilities;

5, to understand the registration of drugs related laws and regulations and processes, with a certain amount of data to declare the experience;

6, with a good team spirit, work proactive, strong sense of responsibility.

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Senior medicinal scientist

main duty:

The position will be responsible for the design, synthesis and identification of innovative drug molecules, and lead the R & D team to complete the specified R & D goals.

Job Responsibilities:

1, independent commitment to the project research and development work;

2, engaged in innovative drug molecular design;

2, to develop project R & D plan to lead the project team to complete the established research tasks, to guide the project team members to complete their daily work;

3, skilled to complete a variety of chemical reactions, open up the synthetic route, optimize the reaction conditions, the preparation of complete, systematic experimental report;

4, responsible for the literature, patent search, the proposed project synthesis route, in time, cost, efficiency and achieved a better balance;

5, according to the company to prepare and send the project report;

6, other tasks arranged by the supervisor.

job requirements:

1, organic chemistry, materials chemistry, pharmaceutical chemistry and other related professional, doctoral degree or more than three years of work experience, a drug research and development background is preferred;

2, master the rich organic chemistry expertise and related practical experience, with excellent synthetic route design capabilities, and skilled completion of multi-step route synthesis;

3, master the laboratory commonly used compounds separation and purification technology and structural identification methods;

4, skilled application of commonly used literature search tool, can independently search the literature and timely and accurate reading translation of foreign literature;

5, with a strong sense of laboratory safety;

6, with a good level of English, can use English for professional writing;

7, hands-on ability, careful and careful, have a good sense of communication and team spirit.

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