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
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
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
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
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.
• 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
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：Shanghai, Beijing，Guangzhou，Wuhan，
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.
• 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
Role Title: (Sr.) Clinical Trial Manager Reporting to: Associate Director, Clinical Operations Organization Unit/Country: Reistone Biopharma,China
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
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.
• 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
(Sr.) Manager, Medicinal Chemistry
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.
• 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.