Clinical Affairs Consultant - 8 month contract + possible extensions/conversion
- Can sit in Bothell, WA OR Cambridge, MA - HYBRID, 3X week on-site.
Requirements:
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 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.
The Clinical Affairs Consultant reports to the Director of Clinical Affairs in the business. • 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 Philips 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 Philips 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.