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Working Location: Chicago
Role Title:Medical Director or Senior Medical Director
Reporting to:US Site Head  

Organization Unit/Country: Reistone Biopharma, US

Role Purpose Statement:
This role is to provide medical and scientific input to research and clinical programs. Assess, design, and lead clinical study programs. Coordinate and manage International medical activities locally.
Main Accountabilities:
1.Provide Medical and scientific support to international clinical trials.  
2.Provide Input to investigators brochures, study protocols. Prepare IB and Protocols if needed. 
3.Support the representation of the assigned products in connection with scientific, clinical, and regulatory activities.
4.Collection, processing, and production of information including reviews of science, briefing notes, situation papers in science and various documents used to advise on program activities
5.Interaction with external scientific and clinical experts (KOLs, advisory boards) in relation to Reistone’s R&D activities
6.Writing of clinical documents for regulatory dossiers and answer questions from authorities
7.Appropriate compliance with GCP, SOP’s, guidelines and regulatory requirements
8.Preparation of publications from clinical studies initiated and sponsored by Reistone.
Role Related Qualifications/ Skills:
1. Medical Doctor 
2. At least 2 years’ experience in clinical research – US/international including  study planning, execution, reporting and publication activities
3.Immunology programs experience/background is preferred 
4.Demonstrated Competencies: Functional/Technical Skills, Integrity and Trust, Priority Setting, Problem Solving, Drive for Results
Working Location: Chicago
Role Title: Medical Director or Senior Medical Director 
Reporting to: US Site Head  
Organization Unit/Country: Reistone Biopharma Inc, US
Role Purpose Statement:
This role is to provide medical and scientific input to research and clinical programs. Assess, design, and lead clinical study programs. Coordinate and manage international medical activities.
Main Accountabilities:
1.Provide Medical and scientific support to international clinical trials for the Dermatology projects.  
2.Provide Input to investigators brochures, study protocols. Prepare IB and Protocols if needed. 
3.Support the representation of the assigned products in connection with scientific, clinical, and regulatory activities.
4.Collection, processing, and production of information including reviews of science, briefing notes, situation papers in science and various documents used to advise on program activities
5.Interaction with external scientific and clinical experts (KOLs, advisory boards) in relation to Reistone’s R&D activities
6.Writing of clinical documents for regulatory dossiers and answer questions from authorities
7.Appropriate compliance with GCP, SOP’s, guidelines, and regulatory requirements
8.Preparation of publications from clinical studies initiated and sponsored by Reistone.
Role Related Qualifications/ Skills:
1. Medical Doctor, with specialty training in Dermatology, or significant experience in leading Dermatology clinical development programs in the Pharmaceutical Industry
2. At least 2 years’ experience in clinical research – US/international including study planning, execution, reporting and publication activities
3.Required Competencies: Functional/Technical Skills, Integrity and Trust, Priority Setting, Problem Solving, Drive for Results
Working Location: Chicago
Role Title:Director or Senior Director, Regulatory Affairs 
Reporting to: Reports to US Site Head, with functional accountability to Regulatory Affairs Head    
Organization Unit/Country: Reistone Biopharma Inc, US
Role Purpose Statement:
To lead the development and planning of the international regulatory strategies (especially USA and Europe) and lead the implementation of the strategies to deliver agreed product registration milestones to support the business in a timely and effective manner within Reistone US.   
Main Accountabilities:
1.Independently perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with local applicable laws, regulations, guidelines, and policies and SOPs.  
2.Lead the development of product registration strategy and action plan related to international registrations, as well as regulatory affairs activities assigned.
3.Draft product registration strategy plan for review and approval
4.Compile registration dossier and prepare other regulatory documents (e.g., package insert, packaging components) and ensure timely regulatory submission upon internal review and approval.
5.Coordinate internal departments in product registration process
6.Communicate with regulatory agencies/institutes (e.g., FDA, EMA) on product registration.
7.Closely monitor regulations and review processes to ensure data presented fully represent what is practically required and satisfy the constantly changing regulations to be followed. Meet or accelerate Regulatory milestones.
8.Properly maintain all regulatory documentation.
Role Related Qualifications/ Skills:
1.5 or more years of pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 3 years working in regulatory affairs
2.A minimum of bachelor’s degree, preferable higher (e.g., pharmacy, medical or related discipline).
3.Experience with at least one major marketing application (IND/NDA/BLA/MAA, etc.), or extensive experience with late stage development.
4.Self-motivated to achieve challenging goals. 
5.Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
6.Direct interaction/negotiation with regulatory authorities (e.g., FDA, EMA)
7.Understanding of the US pharmaceutical marketplace and familiarity with medical concepts and terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
8.Required Competencies: Functional/Technical Skills, Integrity and Trust, Priority Setting, Problem Solving, Drive for Results
Role Title:(Sr./Asso.) Clinical Trial Manager 
Reporting to: Executive Director, International Clinical Operations
Organization Unit/Country: Reistone Biopharma, Chicago or Boston, US
Role Purpose Statement(how does the role impact business achievements?):
This role is to manage and oversee the clinical trials conducted within Reistone.
Main Accountabilities:
1.Prepare the 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 arranging and preparing of Advisory Board Meeting and Investigator Meeting.
8.To be responsible for the co-ordination of timely trial supplies with IMP department. 
9.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.
10.Perform co-mornitoring visits, if approprite.
11.To be responsible for using CTMS in clinical trial and ensure that information entered into CTMS is accurate and updated on a regular basis.
12.To be responsible for public discloure of clinical trial according to the Reistone’s SOPs.
13.Ensure the quality of the data.
14.Maintain appropriately and safely all necessary documents in Trial Master Files.
15.To be responsible for working to coordinate for audits and take responsibility for the responses and corrective actions to audit finding.
16.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 2 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 
5.Proven track record of having successfully led one or more multinational clinical trials.  
please contact us at: HR@reistonebio.com