Sr. Manager, Clinical Development

Job title:

Sr. Manager, Clinical Development

Company:

Endologix

Job description

Overview:Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.JOB SCOPE AND PURPOSE:Utilize experience and technical expertise to support the cross-functional team in the delivery of clinical development plans including plan for clinical evaluation (EUMDR, etc). Develop and support clinical evidence strategy, including clinical and economic evidence generation & dissemination. Clinical risk assessment through product development process (PDP). Influence and lead scientific discussions with FDA, KOLs, Advisory Boards, etc. Support legacy and new clinical programs by building evidence to support therapies. Responsibilities:

• Lead the clinical development strategies for assigned projects, working within the cross-functional team
• Create the subsequent clinical development and evaluation plans
• Create the clinical development and evaluation plans
• Serve as clinical lead to provide strong critical thinking related to technology / therapeutic domain to develop innovative solutions for evidence strategy development
• Lead interpretation & dissemination of evidence generated from clinical development activities (CSRs, CERs, manuscripts, etc)
• Partner with internal teams to ensure accurate dissemination of clinical data/information for external communications
• Lead and participate in deep dive data discussions and provide analytical strategy for management, KOL’s and other key stakeholders
• Develop peer-level relationships with medical and scientific experts; act as the main point of contact for scientists and clinicians to provide clinical/scientific information in academic, community, and healthcare provider settings.
• Lead analysis and interpretation of signals and trends from multiple inputs including clinical data, literature, complaints.
• Collaborate with cross functional teams including R&D, Quality, and Regulatory for relevant analyses
• Present analysis in a clear, concise manner to cross functional peers and management.
• Maintains a broad understanding of relevant clinical disease state and trends/directions of data management and analysis

Qualifications:

• MD, Masters/PhD degree in Science, or Bachelor’s Degree with equivalent experience.
• Deep knowledge and understanding of all applicable standards / regulations in clinical evidence generation and dissemination, including GCP, FDA requirements, EU MDR, etc, and a broad understanding of the clinical operations required to execute evidence generation strategies
• Good working knowledge in evidence processes for PDP & lifecycle management
• Ability to perform comprehensive review of literature and analysis of scientific and technical published literature to support health agency requests, product submissions, etc.

Compensation: $170,000 to $200,000 annual, plus discretionary bonus potentialEndologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Expected salary

Location

Californie – Cers, Hérault

Job date

Thu, 23 Jan 2025 00:25:17 GMT

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