• Work closely with the worldwide user base, interacting with Marketing, Sales, as well as QA/RA management 
• Participate in maintaining a strong image for society and its successful technology, creating a trustworthy relationship with the key opinion leaders in the fast-growing, highly competitive interventional radiology community.
• Understand and master the power of compelling clinical data. 
• Support Medical Director, Rare Disease with review of protocol deviations 
• Identify cause and propose appropriate resolution as well as review PD trends and take appropriate actions
• Proactively provide insight into emerging clinical/competitive trends
• Understanding competitive landscape and providing insights on strategic development pathways. 
• Identify the need for and develop as-needed work instructions, process guidelines and standard operating procedures and ensure processes and procedures meet SOP/GCP requirements.
• Work closely with the development teams to translate science into medicine to help impact patients' lives.

Skills: Cross-Functional Collaboration, Relationship Building, Data Analysis, Protocol Deviation Management, Trend Analysis, Competitive Intelligence, SOP Development, Translational Science

• Drafting key clinical trial documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs 
• Support the medical monitoring of efficacy, safety, and laboratory data received from the clinical trials 
• Work directly with the investigational sites to ensure a seamless exchange of support and information during the study workup, ongoing trials and closure 
• Be responsible for the clinical aspects of the Data Review Plan 
• Support the analysis and drafting of clinical trials and scientific publications 
• Work closely with Clinical Operations and Data Management for CRF design 
• Support investigational site startups and will present on behalf of Clinical Development 
• Ensure the TMF is completed for Clinical development requirements 
• Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness and organizational support 

Skills: Document Drafting, Data Analysis, Stakeholder Communication, Clinical Monitoring, Trial Management, CRF Design, Presentation Skills, Organizational Support

• Assist in the timely, medically and scientifically sound development of the clinical development plan
• Assist with the quality and timely preparation of all Product Development Clinical (PDC) documents submitted for approval.
• Assist in preparation of the scientific content of regulatory documents/interactions
• Ensure GCP and Standard Operating Procedures are followed
• Liaise with appropriate departments inside and outside PDC to support interactions with the regulatory bodies.
• Liaise and communicate with Commercial and Medical Affairs and coordinate clinical efforts on the project-related issues and you assist in the preparation of abstracts, posters, and oral communication for scientific meetings.
• Ensure correct data interpretation including interim and final study reports
• Hold primary responsibility in the planning and preparation for trials 
• Working with relevant stakeholders to develop study design, identification of study site and trial animals, preparation of study protocols and reports

Skills: Clinical Development Planning, Document Preparation, Regulatory Compliance, GCP Adherence, Cross-Departmental Liaison, Scientific Communication, Data Interpretation, Trial Design & Management

• Participate in the process of adding and removing clinicians from a study and ensuring are assigned within designated timeframes.
• Communicate with other departments (e.g., Project Management) to meet project objectives. Coordinate resources and develop materials for Investigator Meetings.
• Assist with or take responsibility for the development of project deliverables (e.g., scale verification, electronic form development, training materials for in-person or online training, etc.)
• Work with Business Development to review potential studies, RFPs, etc.
• Participate in the development, execution, and integration of research that tests the scientific and conceptual basis for the MedAvante-ProPhase approach to issues of applied measurement
• Develop and maintain business and scientific relationships with external consultants, key opinion leaders, and Clinicians, both regionally and in research areas of interest, for the purposes of instudy delivery as well as academic projects
• Report research results externally through peer-reviewed journals, conferences, or other appropriate venues
• Maintain calibration on relevant clinical scales.

Skills: Project Coordination, Interdepartmental Communication, Material Development, Business Development Collaboration, Research Execution & Integration, Relationship Management, Scientific Reporting, Clinical Scale Calibration

• External facing clinical representative responsible for the independent clinical management of large, international clinical trials.
• Liaise with sponsors and sites.
• Oversee site rater qualification and training for Clinical Science.
• Resolve assessment results inquiries raised by sites by working with Project Managers, and Clinical Science leadership 
• Attend internal and external project meetings (e.g., weekly external client call, Investigators’ Meetings).
• Review and monitor study level metrics, present study dashboards to sponsors 
• Determine and inform appropriate management staff of study requirements (resource and training needs) while managing project specific rater resource requirements based upon projections.
• Ensure clinical quality standards are met by monitoring internal clinician and team level performance across studies and scales and resolve clinical quality or training related issues.
• Ensure calibration of clinical team members and conduct rater training events as specified in Training plans.
• Provide clinical consultation to MedAvante-ProPhase Clinicians and site raters

Skills: Clinical Trial Management, Sponsor Liaison, Training & Qualification Oversight, Problem Resolution, Meeting Facilitation, Data Analysis & Reporting, Quality Assurance, Clinical Training & Calibration

• Experience in drug development and clinical trials methodology and execution (Phase 0-2 preferable )
• Knowledge of GCPs and regulatory agency guidelines.
• Able to acquire knowledge in different disease indications and therapeutic areas
• Able to collaborate and thrive in a matrix environment and interact with a variety of individuals outside (e.g. investigators) and inside the company (e.g. regulatory affairs, biostatistics, clinical pharmacology, project management)
• Ability to conduct a limited review of related literature and references to obtain the required information and subsequently apply it.
• Experienced with clinical data review, analysis, interpretation and reporting.
• Excellent analytical and quantitative skills. 
• Advanced data analysis skills e.g. SPSS, Python, Spotfire
• Strong project-management skills and ability to prioritize tasks in a dynamic environment
• Excellent written and oral communication skills in English and is skilled in data interpretation.

Qualifications: BS in Biomedical Science with 3 years of Experience

• Experience in pharmaceutical/nutraceutical product development
• Understanding of cosmetic and OTC/drug/foods claim language
• Demonstrated project planning skills
• Ability to work independently and implement multiple projects in a timely manner.
• High energy, positive drive, and commitment to setting and meeting aggressive goals.
• Demonstrated strong leadership, communication (including technical writing), and interpersonal skills to work in a collaborative team environment.
• Ability to work with multi-functional groups and interface with external partners.
• Demonstrated passion for the consumer. 
• Ability to find insights through consumer interaction
• Creative problem solver with a record of creating innovative products.

Qualifications: BS in Genetics with 5 years of Experience

• Experience in clinical research and drug development within biotech, biopharmaceutical industry, or academia.
• Experience in all phases of clinical trial planning, start-up, conduct, reporting, and publishing.
• Extensive knowledge of the clinical development process is required and an ability to understand various phases and principles of study design.
• Innovative and driven with excellent written, electronic, and verbal communication skills and an ability to effectively and clearly communicate complex scientific subjects with diverse stakeholders with a range of scientific and non-scientific backgrounds.
• Working knowledge and thorough understanding of all relevant regulatory guidelines and standards (e.g. GCP, ICH, and FDA guidance documents), as well as practices and expectations of Quality within GCP.
• Proven experience interacting with medical monitors, development operations, and clinical investigators
• Highly analytical with strong problem-solving, organization, and critical-thinking skills
• The collaborative mindset with the ability to work individually, within a multi-disciplinary team and with external partners, and in close collaboration with Medical Director of rare Disease.
• Ability to assimilate technical and scientific information quickly
• Proficient in Microsoft Office (Word, Excel, PowerPoint)

Qualifications: BS in Pharmacology with 2 years of Experience

• Experience in clinical development, including Phase I or clinical pharmacology studies (ideally in global pharma company), or equivalent educational background in the CP field
• Knowledge of CP and basic or advanced knowledge of PK
• Effective English ability to be able to communicate verbally and in written form with global counterparts
• Japanese capability of a level to be able to write scientific papers
• Logical thinking, critical thinking
• Problem-solving skills
• Ability to active listening, assertiveness
• Excellent presentation skills for both internal and external audiences
• Proficiency in navigating IP and Claims 
• Comfortable with navigating various clinical trial management systems (CTMS) and databases.

Qualifications: BS in Molecular Biology with 4 years of Experience

• Technical, operational, and managerial experience in planning, executing, reporting, and publishing clinical studies in a pharmaceutical company and/or contract research organization
• Scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research
• Ability to work effectively in multifunctional and multinational teams, as well as the ability to multitask and prioritize
• Proven experience in developing effective relationships with key investigators
• Able to manage priorities and competing demands in a growing biotechnology company with a broad pipeline of products
• Experience working cross-culturally
• Ability to operate strategically and tactically
• Sense of urgency and ability to work effectively to timelines
• Highly motivated, independent, and a self-starter
• Strong communication skills and ability to interact in a cross-functional matrix and represent science in study management teams, projects team and across the whole organization

Qualifications: BS in Biochemistry with 3 years of Experience