Join our exciting team as a Director, Clinical Development! 

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. 

The Director, Clinical Development will 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, conduct clinical risk assessment through product development process (PDP), influence and lead scientific discussions with FDA, KOLs, Advisory Boards, etc, and support legacy and new clinical programs by building evidence to support therapies.

· 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

Education:

· MD, Masters/PhD degree in Science, or Bachelor’s Degree with equivalent experience.

Experience:

· Minimum of 10 years of direct managerial and leadership experience in related work within the medical device sector, global and Class III product experience preferred.

· Deep knowledge and understanding of US and international standards / regulations including GCP, FDA requirements, EU MDR, QSR, ISO13485, MDD, CMDR, MHLW etc,

· Experience in development of Clinical Development strategies and effective implementation; related experience in Medical Affairs and Clinical Operations preferred.

· Experience in executing complex global Medical and Clinical 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.

· Strong scientific background and deep expertise in the development of clinical evaluation methods, including innovative clinical trial design

· Expertise and knowledge of products, patient treatment trends, clinical trials, and scientific activities within vascular and peripheral vascular disease state

· Capable of building successful relationships and seamless interfaces at the protocol/project team level and provide timely and effective communication to the study team and functional leads.

· Excellent verbal, written and interpersonal skills required for working successfully in a cross-functional team environment and externally with key thought/opinion leaders

· Practical knowledge of ICH, FDA, and GCP regulations and guidelines.

· Strong communication and people management capabilities. Ability to speak effectively before groups of employees or customers.

· Proven managerial and leadership skills. Ability to develop and manage team members to an expected level of productivity and results.

· Excellent analytical and decision-making skills. Experience in a fast paced, high growth environment. Ability to handle multiple tasks.

Compensation: $190,000/yr-$230,000/yr + discretionary bonus

Join us, and bring your point of view, talents, and contributions so we can all grow together!

Endologix, LLC. 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.