Job tittle: Clinical Affairs Consultant II
Location: Bothell, WA or Cambridge, MA
Hybrid Role: 3 days in office
Contract Length 8 months with possibility of extension You are responsible for:
• Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders
• Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc)
• Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.)
and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions.
• Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR).
Manage and oversee study execution, analysis of results and generation of final study reports to support *** regulatory clearances, claims, epidemiology/surveillance, reimbursement, health economic outcomes and/or market access.
• Deliver assigned clinical programs, working in partnership with Clinical Operations.
• Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts
• Lead clinical evidence, epidemiology/surveillance discussions with regulators (deficiency requests/FDA, Notified Bodies, etc.
), advisory boards, associations, and societies
• Keeping current with regulatory guidance and requirements in the global environment.
• Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc.
• Support Medical Safety function to help support signal detection, signal evaluation
• Advance the *** Data network strategy by developing innovative data partnerships
• Support the creation of data infrastructure efficiency through creation of systematic processes including data dictionaries, including the evaluation of real-world data vendors, and data access and transfer models.
• Support the Data Governance Council in leading understanding of deidentification and data use standards (including, data tokenization)
You are a part of Clinical Affairs
The Clinical Development Scientist reports to the Director of Clinical Affairs in the business. To succeed in this role, you should have the following skills and experience:
• An MD, PhD/MS Degree in Biomedical science, Epidemiology strongly preferred.
• 7+ years' experience in clinical research/development/real world evidence (RWE) function; (medical devices preferred)
• Strong scientific background and deep expertise in the development of evidence generation and clinical evaluation / RWE and research methodologies, including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
• Experience in Machine Learning / Artificial Intelligence algorithm clinical performance validation
• Deep understanding of global clinical evidence requirements, including regulatory paths, and deep knowledge and understanding of all applicable standards/regulations in clinical evidence generation and dissemination, including Good Clinical Practice (GCP), FDA requirements, EU MDR (ISO14155, CFR Part 812, Med Dev 2.7.1 (rev4))
• Knowledge of RWE to support regulatory decisions
• Strong ability to critically assess clinical literature
• Excellent communication skills, including written communication (e.g., peer- review publication) and oral presentation of scientific materials and research results.
Ability to write original scientific documents such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
• Ability to work collaboratively with cross-functional partners, shape, and lead without direct reporting authority, highly enthusiastic, self-motivated individual who will accept accountability
• Proven track record in successfully developing and executing clinical evidence strategies for regulatory submissions, on-time within budget and in compliance with SOPs and regulations.