• Provide scientific research leadership in the design of Google's clinical studies and health impact assessments involving pioneering digital health solutions.
• Write study protocols, institutional review board submissions, clinical study reports, and peer-reviewed study publications.
• Train, educate, advise, and mentor Google colleagues on clinical research best practices.
• Promote and support the development of a digital health research community within and outside Google.
• Lead/support the development, execution, analyses, and interpretation of clinical research protocols.
• Ensure the health technology research team maintains the highest of clinical research standards to ensure validity and reproducibility of results.
• Develop and consult on study documentation, data analysis plans, and clinical algorithm development.
• Partner across research, engineering and product, providing health, physiologic, and clinical research expertise.
• Align health technology strategy and research with both internal (cross-functional) and external stakeholders.

Skills: Research Leadership, Protocol Compliance, Clinical Training, Community Building, Data Interpretation, Quality Assurance, Documentation Expertise, Cross-functional Collaboration

• Develop clinical evaluation plans, clinical evaluation reports, summary of safety and clinical performance, risk master lists
• Participate in defining the strategy of study (objectives, clinical evidence, countries, recruitment…)
• Develop and provide inputs for specific study-related documents (protocol, patient informed consent, monitoring plan, manual of operations, newsletter…)
• Develop data review plan and coordinate data review activities related to study
• Coordinate statistical activities (SAP development, statistical analysis, TLFs,…) related to study and internal analysis (pooled data…)
• Develop clinical study reports
• Manage clinical trial registrations and results postings
• Present at investigator, study coordinator and monitor meetings/training
• Oversight team member specific tasks (in-house CRA and Safety Specialist)
• Interact with study team and cross-functional teams (R&D, Marketing, RA) in order to assist in clinical strategy, development of plans and reports, and project deliverables

Skills: Clinical Evaluation, Strategy Development, Document Development, Data Coordination, Statistical Analysis, Report Writing, Trial Management, Team Collaboration

• Build strong relationship with KOLs and clinical trial investigators
• Support investigators with abstracts, congress presentations and publications
• Interpret results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
• Interacts with regulatory agencies
• Participates in the development of training and providing feedback and guidance
• Maintains the highest standards of ethics in all circumstances
• Ensure compliance with the Company quality system and all applicable guidance, standards and regulations.
• Support quality control & assurance activities (Internal QC, CRO & study site audit,…)
• Partner with national, state and local nursing organizations to support education on assigned disease states.
• Develop relationships with key nurse opinion leaders.
• Attend and participate in internal/external meetings, training classes conventions/conferences, and other business-related activities

Skills: Stakeholder Engagement, Scientific Communication, Regulatory Interaction, Clinical Data Interpretation, Training & Development, Ethical Compliance, Quality Assurance, Professional Development

• Conduct primary research and manage clinical studies needed to support product development, from planning through the definition of the study protocol to execution by external clinicians/researchers.
• Analyze and consolidate supporting evidence for product claims.
• Establish and manage relationships with outside agencies and organizations (such as OSHA, CDC, ADA, OSAP) to continually update the knowledge base of industry trends.
• Monitor research of other dental companies, to raise awareness and assess potential applicability to company products.
• Establish a strong network of contacts within the dental academic and research communities.
• Collaborate and support materials for the education and training of the Zyris team
• Helps identify and assess clinical sites for study participation.
• Monitors real-time study data to ensure study compliance and patient safety.
• Contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.

Skills: Clinical Study Management, Evidence Synthesis, Agency Collaboration, Market Research, Academic Networking, Educational Support, Site Assessment, Regulatory Support

• Applying experience and expertise, along with input from industry and scientific experts, to development of comprehensive pre-clinical and clinical trial strategy aimed at generating the evidence required for device development
• Developing study designs, protocols and plans to support overarching clinical strategy, incorporating input from leadership, consultants and other experts.
• Developing requests for proposals and evaluating vendor proposals, researching feasibility and the research partner landscape
• Performing medical and scientific review of study plans, materials and deliverables created by CRO’s to ensure studies achieve regulatory and business goals
• Review and input into clinical study protocols, informed consent forms, investigator brochures, data management plans, case report forms, clinical study reports, TFL shells, TFLs, and other study documentations and publications. 
• Providing scientific support for the site selection process and for site recruitment questionnaire development.
• Serving as the scientific point of contact providing scientific assistance and support for the study teams who oversee trials, providing clinical, therapeutic and scientific expertise to the study team and supporting the creation of trial deliverables
• Providing scientific support for the site selection process and for site recruitment questionnaire development.
• Performing medical and clinical research data review, including but not limited to assessments of safety and efficacy data, patient demographics, medical and disease history, concomitant medications, laboratory values, adverse events, disease response verification, and overall review to ensure that the data is coherent, complete, and accurate so that it is suitable to meet study deliverables.
• Creating data summaries and assists in the development and preparation of scientific manuscripts, abstracts, poster and oral presentations, and other meetings in collaboration with Study Chairs and/or sponsors, as requested.
• Following standard operating procedures, ICH-GCP, and all applicable regulatory requirements.

Skills: Trial Strategy Development, Study Design, Vendor Evaluation, Scientific Review, Documentation Oversight, Site Selection Support, Scientific Liaison, Data Analysis Compliance

• Provide scientific input on clinical trial design and management of strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP) Develops strategies for clinical trials for US, EU and/or rest of world registration studies as determined by business priorities
• Scientific oversight for clinical trial strategy, clinical trial protocol development and clinical trial reports for FDA registration studies.
• Collaborates with a multidisciplinary team in the development, creation and execution of clinical trial protocols
• Establishes scientific methods for designing clinical trial study protocols
• Prepares scientific content of clinical study reports
• Review both clinical and analytical sections for regulatory submissions
• Develops good collaborations with scientists, internally and externally
• Has and maintains scientific, technical and clinical expertise in oncology especially with respect to molecular diagnostics
• Review pertinent literature, prepares white papers/manuscripts, and provides education to Cepheid staff as needed.
• Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
• Ensures clinical data meets all necessary regulatory standards
• Collaborate cross-functionally with Government Affairs, Medical and Scientific Affairs on PESP
• Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US, EU and China regulations as well as with Cepheid’s policies and procedures

Skills: Clinical Trial Design, Scientific Oversight, Protocol Development, Scientific Methodology, Regulatory Review, Collaboration Building, Oncology Expertise, Regulatory Compliance

• Management and leadership experience, with a proven track record of developing successful teams and promoting effective interdisciplinary collaboration
• Experience in relevant clinical/health outcomes research, digital health technology assessment, expertise in cardiovascular health and physiology, clinical algorithm development and or digital/consumer health product development
• Experience working in multidisciplinary research and/or product development teams
• Experience in oversight of planning, execution, reporting, and interpretation of clinical/digital health research studies (feasibility, validation and pivotal studies)
• Experience in digital health technology product development and/or research, with demonstration of success working within and across multidisciplinary teams (e.g. project/product managers, software engineers, research scientists, statisticians/analysts/data scientists)
• Experience with human subjects research IRBs and regulatory submissions for digital health technologies and/or innovative medical or health devices
• Scientific publication record
• Experience in leading new projects/initiatives, strategic planning, and successful implementation in ‘real world’ settings

Qualifications: BS in Biology with 10 years of Experience

• Experience in prenatal genetics
• Experience in the clinical setting, either as a provider or staff member
• Familiarity with research and data analysis
• Experience working collaboratively and cross-functionally
• Excellent communication skills and ability to confidently converse with clinical providers
• Eagerness to contribute to a supportive, interdisciplinary team
• Experience in infection control, epidemiology or microbiology strongly preferred
• Understanding of laboratory procedures and equipment
• Knowledge of statistical analysis techniques
• Experience in a commercial research setting strongly desired

Qualifications: BS in Biochemistry with 2 years of Experience

• Work experience in the Medical Device industry
• Ability to be agile with change in direction.
• Ability to manage multiple priorities simultaneously
• Ability to work effectively in a fast-paced culture.
• Ability to organize work effectively, set priorities, provide attention to detail
• Ability to maintain detailed and accurate records.
• Ability to establish and accomplish goals independently and to function as a positive and productive team member.
• Ability to build effective relationships with clinical trial center staff.
• Excellent customer focus with a high sense of urgency and excellent interpersonal and communication skills.
• Excellent verbal and written communication skills, strong presentation, project, and organizational skills.

Qualifications: BS in Biomedical Science with 4 years of Experience

• Related clinical and/or medical industry work experience with in-depth knowledge of interventional cardiology and/or neurology.
• Experience in data analytics, image processing, and medical imaging is a plus
• Experience in management and execution of collaboration contracts
• Ability to work within a team and as a senior individual contributor in a fast-paced, changing environment. 
• Ability to leverage and/or engage others to accomplish projects
• Demonstrated skill and tactfulness in working as a cross-functional team member
• Experience in conducting physician-initiated research studies and collaborating with cross-functional clinical research partners, physicians, and other healthcare providers
• Well-organized and self-motivated with an ability to initiate and follow through on assignments
• Ability to provide technical guidance, advice and support to professional staff 
• Knowledge of laboratory certification processes and standards

Qualifications: BS in Pharmacology with 3 years of Experience

• Ability to convey both written and verbal information effectively and efficiently.
• Understands need for growth and is receptive to constructive feedback.
• Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments.
• Industry clinical development experience, with experience in clinical trials is required.
• Extensive knowledge of clinical research, and experience across Phase I-III drug development projects.
• Familiarity with clinical trial design, and experience authoring clinical trial protocols (Phase I or II) 
• Experience in analysis, interpretation, and presentation of clinical data in order to inform decision making and clinical strategy are required.
• Must be well-versed in medical aspects of GCP, ICH, FDA, EMEA and other relevant guidelines.
• Ability to work well independently and to organize priorities and deliverables.
• Experience working in a busy and highly collaborative biotech atmosphere as a part of a cross-functional team is highly desired.
• Strong oral and written communication skills, including the ability to present complex findings to senior management and external audiences and experts

Qualifications: BS in Clinical Research with 5 years of Experience

• Experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective.
• Direct Hematology/Oncology experience in a Clinical Research and Development, Clinical Science capacity
• Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data.
• Ability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective.
• Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative
• Ability to communicate medical or clinical information to a physician.
• Experience in scientific research, including writing reports and/or academic manuscripts
• Familiarity with pipetting, dilution series, and following basic molecular biology protocols (ex: PCR, cloning, bacterial transformation)
• Experience interacting with clinicians
• Superior communication (written and verbal English) and organizational skills
• Self-starters who are results-oriented, resourceful, analytical, innovative, intellectually curious and who take initiative and risks
• Organized and meticulous with documentation
• Demonstrate strong ability to embrace and adapt to change, take initiative, showcase curiosity, and learn quickly in a fast-paced environment

Qualifications: BS in Microbiology with 2 years of Experience