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Campus Hiring –Associate manager / Manager, Discovery and Translational Science
Working Location: Shanghai

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Number of Hiring:5


Primary Duties and Responsibilities:

• Identify and evaluate candidate predictive biomarkers and design experiments and/or diagonostic tests that will appropriately transition from early to late phase clinical development.

• Work directly with a variety of external contract research organizations/vendors as well as academic collaborators and key opinion leaders to execute and expand clinical translational research efforts.

• Work collaboratively within highly integrated, multi-functional program teams that includes scientists within Drug Discovery, Clinical Pharmacology and Development Operations groups, as well as Clinicians, Statisticians, and Asset Team Leads.


Qualifications:

• Education: A degree in Immunology, Cell Biology, Molecular Biology or related fields: PhD with 1-2 years of laboratory research experience or above, or M.S. degree with at least 3 years of laboratory research experience.

• Preferred PhD, MD, MD/PhD, Pharm. D or equivalent qualifications. 

• Basic knowledge and/or research background in immunology and/or a specific disease area is highly preferred.

• Previous work experience in pharmaceutical R&D and/or CRO is highly preferred.

• Highly motivated and responsible, good communicational skills and the ability to interact professionally in a team environment.

• Fluent in English, both written and oral. 


Campus Hiring -Research scientist, Chemistry
Working Location: Shanghai

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Number of Hiring:10


Main Accountabilities:

1. Responsible for compound synthesis, route design and solve chemistry issue.

2. Search literature, and design synthetic route independently.

3. Complete the experiment and necessary records.


Role related Qualifications/ Skills:

1. Master in medicinal chemistry, organic chemistry, or related discipline.

2. Severe work attitude, positive, strong responsibility.

3. Skills and proficiency in English.


Campus Hiring -CRA Trainee
Working Location: Shanghai

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Number of Hiring:15


Main Accountabilities:

• To ensure all related clinical research operations and procedures are in compliance with protocol, Reistone’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

• To be responsible for clinical study sites selection and to ensure these sites can meet the Reistone’s requirements and qualified with NMPA.

• To be responsible for clinical trail start-up at sites, include complete GCP submission, obtain the EC approval, and support for the OHGRA application and approval, contract negociation and sign-off.

• To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time. 

• To be responsible for submitting documents to site GCP office & EC correctly and on time.

• To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Reistone’s SOPs, ICH-GCP/Chinese GCP and applicable local regulations.

• To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly.

• To ensure AEs/SAEs are recorded correctly and reported approprately according to timeline stipulated in clinical study protocols and current regulation.

• To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.

• To be responsible for transfer Reistone study essential documents to TMF on time and consist with ISF.

• To build and keep good working relationship with clinical study sites.

• To be able to complete the above tasks under the help and supervision from senior team members with satisfaction.


Role Related Qualifications/ Skills:

• 0-1 year of CRA experience previousely.

• Bachelor’s degree or above in Medical, Pharmacy or related areas.

• Be familiar with ICH-GCP/Chinese GCP and applicable local regulations.

• With good communication skills and is expected to establish good relationship with the Investigators and other related site staffs. 

• Good written, verbal skills, and presentation skills in both Chinese and English.


Campus Hiring -Scientist, Biology
Working Location: Shanghai

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Number of Hiring:10


Main Accountabilities

1. Design and validate new biology assays to support drug discovery and development.

2. Conduct internal cellular, biochemical and molecular assays in the lab for compound identification and validation, with minimum supervision.

3. Under supervision, involve in ADME/DMPK, efficacy and toxicity studies and data analysis.

4. Analyse and interpret experiment data and lab notebook recording.

5. Engage with external CRO for study implementation if needed. Ensure successful assay performance, high data quality and timely delivery.


Qualifications 

1. Master degree in immunology/cell biology or related disciplines.

2. biochemical assay, cellular assay, molecular biology assay, especially assays in immunology studies. 

3. Able to design and perform assay independently. A good team player.

4. Good communication skills, and be able to supervise CRO to complete the experiment smoothly and timely.

5. Ability of English literature retrieval and trouble-shooting.

6. With chairness, responsibility and activeness. 


Campus Hiring -Scientist, Discovery and Translational Science
Working Location: Shanghai

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Number of Hiring:10


Main Accountabilities

1. Establish purification protocols, purifiy recombinant proteins from host cells and protein analytics to support the needs of projects.

2. Communicate efficiently with CROs to ensure the quality and deliveraable of the projects.

3. Ensure successful assay performance, high data quality and timely delivery.


Required Qualifications 

1. Master in biochemistry, Molecular biology  or related discipline.

2. Demonstrated evidence of strong scientific methodology and experimental execution required. 

3. Experience with construct design, protein expression, purification and analytics is required.

4. Technical experits with instruments such as AKTA, Octet or Biacore.

4. Cooperative with CROs and other professional functional teams to ensure rapid and high quality project advancement.

4. Ability of literature retrieval and trouble-shooting.

5. Expreience in antibody drug discovery is a plus.

6. Self-motivated with collaborative spirit. 


(Sr) Manager,Formulation Development
Working Location: Shanghai

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Role Title: (Sr) Manager,Formulation Development (Small Molecule Chemical)
Reporting to: Head of CMC
Organization Unit/Country: Reistone Biopharma,Shanghai, China

Role Purpose Statement (how does the role impact business achievements?):
The incumbent will support and lead new product development by developing formulations and/or providing analysis and evaluation of material and products at all stages of the development process, considering scientific and timing objectives. This individual would have various levels of involvement and leadership in the product design and formulation and process development of conventional and non-conventional ointment, cream and other formulations. 


Main Accountabilities
1. Responsible for design and execution of proof-of-concept studies, formulation development, manufacturing process development and optimization;
2. Lead pre-clinical and clinical formulation development;
3. Oversee tech transfer and validation of drug product manufacturing processes, and manage CROs in reviewing batch records and specification;
4. Effectively involves or leads in every stage of activities including preformulation, prototyping formulation and/or new dosage form development, new process development and technical transfer to manufacturing site via close collaboration with CMC Head or CROs;
5. Independently design experiments and carries out scientific work with an awareness of state-of-the-art technology to make the decision based on expertise and technical knowledge. Creates research and development plans to fit overall project objectives under rapidly changing circumstances.
6. Ensure all work is conducted in accordance with written procedures (e.g. quality and safety), methods & batch documents, etc.
7. Identify, challenge, develop and implement written procedures (e.g. quality and safety)
8. Produce or Lead departmental quality documentation (including SOP’s, batch documentation, validation protocols & reports, formulation risk assessment).

Role related Qualifications/ Skills:
1. Work experience:PhD in pharmaceutical sciences with NLT 2 years of industrial or postdoctorial experience in topical product development or innovation drug delivery systems.
2. Good understanding of CH / FMCG product development process and regulatory requirements.
3. Demonstrated success of formulation and/or development of products, preferably topical products.
4. Demonstrated ability to take initiative, think and work independently, problem-solve, work effectively in teams, and multitask.
5. Ability to apply scientific principles and techniques, creativity and innovation to assigned projects.
6. Ability to connect consumer needs to product development.
7. Basic understanding of statistics and its application to experimental work.
8. Ability to organise and report study data from internal and external sources.
9. Ability to communicate problems / challenges and solutions in a clear and concise manner in a complex, matrix environment.
10. Fluent in oral and written English.

Associate Director, Clinical Trial Management
Working Location: shanghai

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Role Title: Associate Director, Clinical Trial Management
Reporting to: Head of Clinical Operations
Organization Unit/Country: Reistone Biopharma,China

Role Purpose Statement (how does the role impact business achievements?):
Responsible for managing a clinical operation team consisting of Clinical Trial Managers\ Clinical Trial Assistants. This role will oversee several clinical trials within defined budget and timeline and is responsible to ensure that all the operational activities to have good adherence to ICH-GCP, legal/regulatory requirements and Reistone’s policies and SOPs.

Main Accountabilities
1. Lead the CTMs to manage and oversee the initiation and conduct of clinical trials either by Reistone’s team or via CROs ensuring timely recruitment and finalization with high quality
2. Lead CTAs to be responsible for Trial administration and project management support
3. Prepare budgeting input for the planned clinical trials. To control the overall expenses of each clinical trial within predefined budget
4. Oversee outsourcing and vendor management
5. To conduct the oversight and management of clinical sourcing strategies ; to select and manage suitable third party for out-sourced services necessary for the operation of clinical trial
6. Identify suitable investigators and SFDA accredited sites. Establish and maintain good network with KOLs within key therapeutic areas
7. Liaise with Medical team on study design and statistical consideration in order to finalize the clinical study protocols
8. Organize, initiate, monitor and manage clinical trials according to China Good Clinical Practice (cGCP) and ICH-GCP, Reistone’s SOPs and other relevant clinical research guidelines
9. Participate and support the development of company SOPs
10. Act as a Clinical Trial Manager as needed

Role related Qualifications/ Skills:
1. University degree in medicine, pharmacy or other life sciences
2. Minimal 8 years of international pharmaceutical industry experience in clinical study planning, execution activities as Clinical Trial Manager, or manager of clinical operations
3. Good leadership skills and can inspiring other people
4. Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment, ICH/GCP Guidelines and International regulations
5. Fluent in both English and Chinese
6. Proficiency in computer skills

Associate Manager, Clinical Pharmacology
Working Location: shanghai

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Role Title: Associate Manager, Clinical Pharmacology
Reporting to: Dan Pu, Director, Clinical Pharmacology & DMPK • Medical
Organization Unit/Country: Reistone Biopharma

Role Purpose Statement (how does the role impact business achievements?):
This role is the member of multidisciplinary drug development project team of DMPK & CP to support discovery and development projects by working closely with colleagues across research and development. This role is responsible to design, conduct, oversight and report DMPK and clinical pharmacology related experiments.

Main Accountabilities
1. Assit in preclinical DMPK assays and animal studies to support discovery projects by interdisplinary interaction with experts from pharmacology and translational medicine in day to day project work.
2. Assist in clinical protocol drafting and execution.
3. Provide support in indication assessment for potential projects.
4. Identify, evaluate and CRO to ensure successful design, planning, and delivery of DMPK and clinical pharmacology studies with high quality standard and on timely basis.
5. Review and interprete DMPK and clinical pharmacology data and report and presentation at internal and external meetings.
6. Contribute to pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, IND / IMPD’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager.
7. Other DMPK or translation related tasks.

Role related Qualifications/ Skills:
1. PhD in Pharmacology, DMPKor related field.
2. Strong desire to seek career path in DMPK and clinical pharmacology.
3. Good verbal and written communication skills in both Chinese and English
4. Knowledge of DMPK and clinical PK. .
5. Understanding and knowledge on drug research and development.
6. Basic understanding and knowledgeof analysis of small and large molecules..

(Sr.) Manager,Discovery and Translational Science
Working Location: Shanghai

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Role Title :(Sr.) Manager/Associate Director, Discovery and Translational Science
Reporting to: Director, Discovery and Translational Science
Organization Unit/Country: Reistone Biopharma China,Shanghai

Role Purpose Statement (how does the role impact business achievements?):
The successful candidate will play a key role in building and managing Reistone’s discovery team of Biologics in Immunology. The candidate will work with internal and external biologists across multiple research and development programs. The candidate will help advance the research therapeutic strategy, assess and make go/no-go dicesions, and serve as a project leader on selected programs.

Main Accountabilities
1. Leads / participates in development projects together with other scientists.
2. Devises and implements clear concise strategies to identify potential targets.
3. Calls upon broad experience of in vitro cell-based assays and/or in vivo models to assist with the team’s research.
4. Makes high quality contribution to development strategies.
5. Makes data driven decisions to advance programs within timeline and budget.
6. Responsible for overall project leadership.
7. Maintains good collaborative relationships with CRO/Partners and ensure high quality standards of their deliverables.
8. Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance).
9. Attends meetings with external parties including investigators, outside experts, and health authorities.

Role Related Qualifications/ Skills:

1. Master or PhD, PhD preferred, with demonstrated scientific and technical strengths
2. A minimum of 6+ years of work experience, preferably with industry experiences in Immunology or antibody development
3. Highly self-motivation and integrity
4. Strong interpersonal skills and team work spirit with ability to work independently or in a team
5. Ability to mange multiple projects/initiatives in a fast-paced environment


(Sr.)Medical Director
Working Location: Shanghai

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Role Title: (Sr.)Medical Director
Reporting to: CMO
Direct Reports: 2~3 CRP/Clinical Scientist
Organization Unit/Country: Reistone Biopharma, Shanghai, China 


Role Purpose Statement (how does the role impact business achievements?):


The purpose of the Incumbent is responsible for creating a comprehensive clinical development strategy & plan for assigned coumpund, and she/he will lead 2~3 CRP/scrp to implement the CDP and provide medical supervision and management of responsible clinical trials. 


Main Accountabilities


• Clinical Development Planning:
    o Stays abreast of internal and external developments, trends and other dynamics relevant to the work of clinical development to maintain a fully current view and perspective of internal/external influences and/or implications for the assigned molecule(s) and disease area(s)
    o Contributes clinical science input into the relevant therapeutic/disease area scientific strategy. Helps research and clinical development groups to ensure consistency of scientific and development strategies with target product profiles and corporate goals. As appropriate/needed, performs clinical assessments on relevant drug discovery projects
    o Supports internal partners in transitioning new drugs/indications into Phase I and II studies. May review protocols and other information and provide clinical development input.
    o Creates and implements, or delegates creation and implementation of, the clinical development plan for assigned molecule(s)/indication(s) and/or other programs


• Clinical Development Plan Implementation
    o Provides clinical oversight across all relevant/assigned studies and programs, Designs and develops, or oversees others in design and development of, clinical studies in designated therapeutic areas
    o Plays a lead role in the development and implementation of communications strategies to support the assigned existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
    o Works with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Supports others with clinical science information and input for regulatory submissions and other regulatory processes.
    o Completes and/or leads other special projects, as and when assigned, or otherwise requested. Consistently complies with, and ensures the same among relevant clinical science team members, all governing laws, regulations, Reistone Standard Operating Procedures (SOPs) and other guidelines


• Cross-Functional Team Leadership & People Management
    o Leads and mentors the relevant clinical scientists/CRPs
    o Assists with the recruitment, training, assigning, and coaching of new or less experienced clinical science team members
    o Manages direct reports and is accountable for hiring, training, developing and retaining talent.


Role related Qualifications/ Skills:


1. MD or PhD is preferred;
2. Minimal 5 years of local/international pharmaceutical industry experience in clinical study planning, execution activities as clinical research physician. Previous clinical experience in hospital environment is preferred.
3. Strong insight of the overall drug development process, clinical trial methodology, China regulatory environment.