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(Sr.)Medical Director
Working Location: Reistone Biopharma, Shanghai, China

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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.




Clinical Research Liaison
Working Location: Shanghai, Beijing, Nanjing, Hangzhou, Wuhan

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Role Title: Clinical Research Liaison
Reporting to: Head of Clinical Research liaison Team
Base city: Shanghai, Beijing, Nanjing, Hangzhou, Wuhan
Organization Unit/Country: Reistone Biopharma, CN


Role Purpose Statement:


To facilitate patient recuiring in and outside site, support clinic operation team in site selection, site initiation and smooth trial operation.


Role / Responsibilities:

    • Provide inputs in site selection and PI selection based upon understanding towards the site, relevant departments and trial related disease knowledge (cooperate with clinic operation team: CRA/PM, familiar with site and departments, justified feasibility assessment)
    • Support CRA to initiate site in an efficient way, which includes communicating with GCP center, EC and PI to get approval and contract negotiation and sign-off (cooperate with CRA, engage with stakeholders on site)
    • Facilitate on-site patient recruiting in a comprehensive way to meet recruiting timeline and budget,
    • Act as general liaison to provide timely and efficient feedback from site to medical and clinic operation team in terms of questions, challenges and suggestions from site and facilitate the follow-up steps (help generating APACT, etc)
    • Organize academic meetings to introduce trial designing to related departments (doctors, nurses, test center technicians, etc)
    • Comply with all GCP related regulations and process as well as AE report policy


Qualifications / Competency:


    • Bachelor degree or above in Medical, Pharmacy or related areas
    • 3+ years of sales experience in pharmaceutical, dermatology/reumatoloby product experience will be a plus
    • CRA experience will be a plus
    • Basic understanding of ICH-GCP/GCP and clinic trial process




Clinical Research Associate
Working Location: Reistone Biopharma, Shanghai, Beijing,Guangzhou,Wuhan,

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Role Title: Clinical Research Associate
Reporting to: AD of Clinical Operation (site monitoring)
Organization Unit/Country: Reistone Biopharma, Shanghai, Beijing,Guangzhou,Wuhan,Chengdu,CN


Role Purpose Statement:


Ensure study sites are well managed and provide high quality study data to Reistone.


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




(Sr.) Clinical Trial Manager
Working Location: Reistone Biopharma,China

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Role Title: (Sr.) Clinical Trial Manager
Reporting to: Associate Director, Clinical Operations
Organization Unit/Country: Reistone Biopharma,China 


Main Accountabilities


1. Prepare a clinical trial plan including all elements listed in the clinical trial plan template as appropriate for the clinical trial (Time Schedule, Budget, Recruitment Plan, Roles and Responsibilities, Work Breakdown Structure, Management Service Provider, Communication Plan, Risk Management Plan, etc).
2. Accountable to drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
3. Provides clinical, scientific and operational input into concept sheets and protocol (rational, objectives, design), Case Report Form, and other key protocol/program documents and activities.
4. Leads multiple cross-functional trial teams through start-up activities including study/site budgets and contracts, global geographic deployment (country/site identification, feasibility, selection), and country/site protocol approvals (MOH, IRB/EC) to study conduct, analysis and reporting.
5. Acts as a central point of contact for communication between the team and the external partners, developing mitigation and resolution strategies, and promptly responding to action items
6. Drives oversight of CROs and vendor management at trial level according to the applicable partnership model
7. To be responsible for the co-ordination of timely trial supplies with IMP department.
8. To be responsible for initialing, monitoring and closing the clinical study sites and ensure that the clinical trial progress according to quality standards, Reistone’s SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.Perform co-mornitoring visits, if approprite.
9. To be responsible for using CTMs in clinical trial and ensure that information entered into CTMs is accurate and updated on a regular basis.
10. To be responsible for public discloure of clinical trial according to the Reistone’s SOPs.
11. To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding.
12. Provides training and coaching to CRAs with regard to all aspects of the clinical trial process.


Role related Qualifications/ Skills:


1. Education: Bachelor’s degree or above in Medical, Pharmacy or related areas.
2. Languages:Fluent English (oral and written).
3. Preferred substantial professional experience (approximately 6-8 years as a guide) in clinical research in CRO or a Pharmaceutical or Biotechnology Industry environment with at least 1 year of them in clinical trial management;
4. Extensive experience in all aspects of clinical trial planning and start up (including budget and resource planning), and in executing the complete range of clinical trial activities, from start up through final trial report 




Business Development Manager
Working Location: Reistone Biopharma, Shanghai, CN

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Role Title: Business Development Manager
Reporting to: Head of Business Development
Organization Unit/Country: Reistone Biopharma, Shanghai, CN


Role Purpose Statement:


The Business Development mananger will be a key point of contact for new and existing licensing and acquisition partners. The BD Manager will be expected to continuously identify new product opportunities, negotiate deal terms, and strengthen and manage partnerships.
In addition to identifying new product opportunities the Manager will be required to understand the competitive environment, identify opportunities to export proprietary products, work with internal teams to advance products of interest, and Project Management the pipeline of BD products to ensure that the company continuously meets the timeline for filing approval, and launch of new products.


Main Accountabilities:


• Identifies trendsetter ideas by researching industry and related events, publications, and announcements; tracking individual contributors and their accomplishments.
• Locates or proposes potential business deals by contacting potential partners; discovering and exploring opportunities.
• Screens potential business deals by analyzing market strategies, deal requirements, potential, and financials; evaluating options; resolving internal priorities; recommending equity investments.
• Develops negotiating strategies and positions by studying integration of new venture with company strategies and operations; examining risks and potentials; estimating partners' needs and goals.
• Closes new business deals by coordinating requirements; developing and negotiating contracts; integrating contract requirements with business operations.


Role Related Qualifications/ Skills:


• 3-4 + years of experience in business development or pharmaceutical analysis or investment field
• Master’s degree or above in Medical/ Pharmaceutics/ business
• Excellent written, verbal skills, and presentation skills in both Chinese and English
• Strong analytical and communication skills with a clear understanding of both the customer and the marketplace




Quality control & Training manager
Working Location: Reistone Biopharma, Shanghai, China

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Role Title: Associate Quality control & Training manager / Quality control & Training manager
Reporting to: Associate director of quality control & training
Organization Unit/Country: Reistone Biopharma, Shanghai, China 


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


To develop and implement quality strategies in clinical operation department, ensure clinical trials conducted according to GCP and SOP requirements in Reistone.
To identify training needs, deliver and coordinate training program in clinical operation department. 


Main Accountabilities:


1. Develop and implement clinical quality standard and strategy in clinical operation department
    1.1 Develop a comprehensive clinical quality strategy centered on Reistone SOPs and GCP principles and built-in with the key considerations essential for effective implementation in clinical operation department;
    1.2 Monitor the implementation of QC guidance;
    1.3 Work with associate director of quality control & training to develop a clinical quality QC/Co-monitoring plan;
    1.4 Support the execution of clinical quality monitoring to ensure the highest possible standard of clinical research is maintained;
    1.5 Be responsible for conducting QC visit which is important part of clinical quality monitoring plan and identify quality improvement actions based on the results;


2. Identify, Deliver and Coordinate training program within CMD

    2.1 Act as a trainer to identify training needs, deliver and coordinate training program within clinical operation department;

    2.2 Coordinate and/or deliver initial and ongoing clinical research related training;
    2.3 To deliver the new hire orientation training ;
    2.4 Organize and manage the on line and F2F trainings to ensure that training needs & objectives are met;
    2.5 Be responsible for incorporating quality issues into training program.

Role related Qualifications/ Skills:


1. Minimum bachelor degree in clinical medicine or Life/Biological Sciences;
2. Previous experience in clinical medicine, pharmaceutical and services industry is required;
3. Minimum of 3 years’ experience in clinical research;
4. Good command of English (written and spoken);




(Sr.) Manager, Medicinal Chemistry
Working Location: Reistone Biopharma, China

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Role Title: (Sr.) Manager, Medicinal Chemistry
Reporting to: Director, Head of Chemistry
Organization Unit/Country: Reistone Biopharma, China

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

Participate analytical activities to support medicinal chemistry and preclinical development.

Main Accountabilities:


• Act as a leader in the laboratory, executing on program and chemistry strategy.
• Independently design and carry out efficient synthesis, purification and characterization of drug candidates for target validation, hit-to-lead and lead optimization projects.
• Develop and apply innovative synthetic and medicinal chemistry problem solving skills to build structure-activity relationships.
• Work under supervision of senior members to design biologically active molecules and conduct SAR studies to meet the project goals.
• Work with computational chemistry group to develop structure-based target molecules for projects.
• Provide scientific mentorship and technical training of the team members.
• Supervise and manage the external chemistry team to execute all chemistry plan on projects with superb performance.
• Establish a substantial external scientific presence including authoring significant scientific publications and presentations.

Role related Qualifications/ Skills:


• Ph.D. in chemistry or related discipline with a minimum of one-year industry experience in drug discovery.
• Strong background and experience in organic chemistry (methodology, catalysis, total synthesis etc) is required, along with a proven track record of solving complex problems.
• Good problem solving and interpersonal skills with the ability to work well with members of the research teams in a dynamic and highly collaborative environment.
• Experience in leading and collaborating with CRO chemistry teams is a plus.