Contract, Hybrid work schedule in Bothell WA location.
$95-105/hr
Full time hours
Responsibilities:
Lead the development of evidence generation strategies for assigned projects, aligning with the value proposition to address the evidence needs of key stakeholders.
Deliver comprehensive Clinical Development Plans that outline strategies for clinical evaluation in accordance with internal and external requirements (e.g., US, EU, China).
Collaborate with internal stakeholders (e.g., project owners, regulatory teams, statisticians, clinical study managers, business leaders) and external partners (e.g., clinical consultants, key opinion leaders, subject matter experts) to ensure study outcomes are robust and well-supported.
Design and develop study protocols adhering to project standards, regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR), and oversee study execution, analysis, and reporting to support regulatory clearances, claims, and market access.
Partner with Clinical Operations to deliver assigned clinical programs effectively.
Develop and disseminate evidence generated from clinical evaluation plans, including Clinical Evaluation Reports, Clinical Study Reports, and manuscripts, ensuring alignment with global requirements.
Lead discussions related to clinical evidence and epidemiology/surveillance with regulators, advisory boards, and professional societies.
Stay updated on global regulatory guidance and requirements, ensuring compliance across clinical programs.
Interpret and disseminate evidence through reports, peer-reviewed publications, abstracts, and presentations.
Support medical safety initiatives, including signal detection and evaluation.
Drive the development of innovative data partnerships to advance data network strategies.
Create systematic processes for data infrastructure, such as data dictionaries, and evaluate real-world data vendors and access models.
Support the Data Governance Council in implementing de-identification and data use standards, including data tokenization.
Qualifications:
Advanced degree (MD, PhD, or MS in Biomedical Science, Epidemiology preferred).
A minimum of 7 years of experience in clinical research, development, or real-world evidence (RWE), with a preference for medical device expertise.
Strong scientific background and expertise in evidence generation, clinical evaluation, and RWE methodologies, including innovative trial design and data network development.
Proficiency in machine learning/artificial intelligence algorithm validation.
Deep knowledge of global clinical evidence requirements, including regulatory pathways, and standards such as GCP, FDA regulations, EU MDR, and ISO14155.
Knowledge of RWE applications for regulatory decision-making.
Ability to critically assess clinical literature and write original scientific documents, including clinical study reports, regulatory filings, and peer-reviewed publications.
Strong communication skills, including the ability to present scientific materials effectively.
Proven ability to lead cross-functional teams, influence without direct authority, and deliver clinical evidence strategies on time and within budget.
This role reports to the Director of Clinical Affairs and requires a collaborative, detail-oriented professional with a passion for clinical innovation and regulatory excellence.