Head of Global Clinical Affairs Job at FOCAL ONE (Los Altos)

Job Description

The Head of Global Clinical Affairs will be based in the metropolitan Bay area and will lead all aspects of all EDAP’s clinical affairs activities. This position will work with EDAP’s global leadership to define and execute the overall clinical evidence strategy, and will be responsible for the clinical operations, study governance, data integrity, and post-market clinical activities in support of regulatory approval, reimbursement, and commercialization of expanded indications. The Head of Global Clinical Affairs will work closely with Product Development, Regulatory and Quality Affairs, and Marketing teams, and study investigators to ensure successful clinical investments and study outcomes to support the continued adoption of EDAP’s proprietary Focal One Robotic HIFU technology.

Job Responsibility

Design and oversee the execution of clinical trials, including protocol development, site selection, and recruitment strategies
Develop and execute the clinical evidence strategy to support regulatory approval, reimbursement, health economics, and market access, including CMS and private payer engagement where applicable
Lead the clinical strategy for new products, ensuring clinical trials support product development goals, regulatory requirements, and commercialization efforts
Collaborate with regulatory teams to ensure clinical trials align with regulatory guidelines and support FDA, CE Mark and other global regulatory submissions
Support IDE submissions, post-approval studies, and global regulatory filings through robust clinical evidence generation
Oversee the analysis and interpretation of clinical data, ensuring results are communicated effectively to stakeholders
Lead the preparation of clinical study reports and presentations for regulatory bodies and Key Opinion Leaders
Develop and manage the clinical affairs budget, ensuring cost-effective execution of clinical trials while meeting timelines and quality standards
Partner with cross-functional teams (product development, marketing, regulatory, etc.) to integrate clinical findings into product development and go-to-market strategies
Initiate and maintain strong relationships with external clinical investigators, contract research organizations (CROs), clinical research sites, and Key Opinion Leaders
Ensure all clinical activities comply with Good Clinical Practice (GCP), regulatory requirements, and internal standard operating procedures (SOPs)
Identify and manage clinical risks
Manage post-market clinical studies and surveillance programs to monitor product performance and safety in the real-world setting
monitoring of trends, innovations, scientific communications and peer-reviewed publications in the diagnosis, prevention, management and treatment of prostate cancer, BPH and endometriosis
collaborate with internal and external resources to track submission and acceptance of peer-reviewed publications, abstracts and scientific presentations on our technologies
Provide data analysis and scientific writing support when needed
Assume additional responsibilities as assigned

Requirements

10+ years of relevant and current work experience in clinical affairs management including successes in therapeutic treatments and medical device technologies
Prior experience in urology, prostate cancer, benign prostatic hyperplasia and surgery preferred
Strong familiarity with FDA guidance and medical device regulations regarding clinical studies
Experience in launching and managing clinical trials for medical devices
Expertise in designing and managing U.S. and global clinical trials
Previous experience in post-market clinical studies and real-world evidence (RWE)
Proven track record working with thought leaders, KOLs, and clinical investigators
Excellent communication, presentation, project management and negotiation skills with the ability to influence decision-makers and stakeholders at all levels
Adaptable and able to thrive in a fast-paced environment with a continuous improvement mindset
Proven leader who enjoys building and managing a high performing team
Demonstrated success leading cross-functional project teams
Authentic and approachable personality that connects with a diverse range of people
Motivated self-starter who works well both independently and as part of a team
Exhibits high integrity, strong sense of urgency and professional courage
Driven by a continuous improvement mindset
Expert understanding of clinical trial methodologies, protocol design and adaptive clinical trial design
Experience initiating and supporting IRB and IDE studies
Proven ability to analyze and synthesize large data sets and draw meaningful conclusions
Proficient in Excel, Word, Outlook, PowerPoint and other business operating systems
Bachelor's degree in Life Sciences, or related field
advanced degree (MS, PhD, MD) preferred
10+ years of experience in therapeutic medical device technology
7+ years of progressive experience clinical affairs leadership
Proven track record of managing clinical trials and supporting submissions expanding indications

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Head of Global Clinical Affairs

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