Position Specification Empirical Spine, Inc. Title: Vice President, Clinical & Regulatory Affairs Opportunity: The Vice President, Clinical & Regulatory Affairs will play a key role in the success of this privately held, venture funded medical device Company founded in 2015. Empirical Spine has developed a novel dynamic stabilization system designed to stabilize the spine through optimizing lordosis, offering patients and physicians a minimally invasive surgical treatment alternative to spinal fusion for multiple conditions in the lumbosacral spine including degenerative spondylolisthesis. The device received CE Mark clearance in 2009. European commercialization, which began in January of 2011, led to the device being implanted in over 2,000 patients with excellent results. The Company s platform technology will allow surgeons to treat a variety of degenerative diseases of the lumbar spine through the implantation of a minimally invasive, flexion restricting, stabilization system. Empirical s technology, the LimiFlex Paraspinous Tension Band, has been specifically designed to stabilize spinal flexion, allowing substantially unrestricted spinal extension, to alleviate pain and stabilize the spine without the need for pedicle screws or more invasive fusion devices. The Company s unique product addresses a large and currently underserved need for patients who could benefit from additional stabilization but do not otherwise require fusion. The Company estimates degenerative spondylolisthesis is a worldwide market of ~$1 billion, growing in the mid-single digits, with the US accounting for the largest share. Located in the San Francisco Bay Area, Empirical Spine has assembled an impressive team of advisors and investors from the medical device, venture capital and academic communities (the Company s roots stem from the Stanford BioDesign Program). With its US Investigational Device Exemption (IDE) pivotal study approval, Empirical Spine has activated over 15 clinical study sites to date and is currently enrolling patients in this trial. With a product well suited to address market needs, a highly differentiated technology, strong IP, and a huge base of actual patient experience, Empirical Spine is poised to build a significant advantage in treating pain and instability associated with pathological flexion of the lumbar spine, which affects over 400,000 patients worldwide.
General Responsibilities: The Vice President, Clinical and Regulatory Affairs reports to the President and CEO. S/he will have complete responsibility for the Company s clinical and regulatory affairs and will provide the leadership, strategic insight, direction and implementation for all clinical and regulatory activities, including significant hands-on implementation work. S/he will be responsible for navigating the company through the challenges of conducting a multi-center IDE/PMA clinical trial on a Class III implantable device in the US, as well as preparing and filing the PMA submission with the FDA. The new Vice President will join as a pivotal member of the executive team and play a significant role in executing the clinical and regulatory programs with emphasis on facilitating recruitment and enrollment in the pivotal study. This individual will provide the strategy necessary to navigate the Company through the challenges of ensuring the appropriate structure and systems are in place to achieve enrollment at existing and future study centers, in time frames so that the Company s milestones are met. The VP Clinical and Regulatory Affairs will be responsible for managing the relationship with the CRO and any other subcontractors and/or advisors working on the trial and PMA submission. S/he will be responsible for managing relationships with the FDA, working in conjunction with the COO and Medical Director. In addition, the Vice President of Clinical and Regulatory Affairs will manage all aspects of the Company s clinical trials to demonstrate the safety and efficacy of their products to the satisfaction of the FDA. This VP will also hold responsibility for all aspects of the PMA submission, including assembling the filing, ensuring data quality and integrity, responding to all regulatory questions, and preparing and executing the company portion of a possible panel meeting. Specific Responsibilities: Summary of Objectives Effectively manage and execute a 300-patient clinical trial at 20-30 sites, to support a PMA application to the FDA Develop and submit PMA filing and gain FDA approval for Company s flagship product Develop worldwide clinical and regulatory strategy As a member of the Clinical and Regulatory Team, the successful candidate will: Lead the execution of US clinical studies to support regulatory submissions, product validation, marketing, and reimbursement, including protocol development, study implementation, and data management. Develop in-depth knowledge of clinical issues related to achievement of clinical, regulatory and market objectives. Lead the execution the PMA submission process to the FDA. Lead the execution of pivotal clinical study strategy to support appropriate selection of investigators and sites and develop initiatives to achieve Company milestones regarding recruitment/enrollment.
Spearhead all aspects of clinical trial recruitment management, as well as the initiation and maintenance of strong professional relationships with principal clinical investigators, clinical and scientific advisory boards needed to support the Company s clinical trial programs. Develop in-depth knowledge of patient/site referral patterns related to achievement of clinical and market objectives. Develop site-specific marketing, outreach and PR strategies to help maximize patient enrollment at clinical sites. Manage the clinical affairs function designed to support domestic and international product approval and ultimately commercialization efforts. This will encompass all aspects of clinical trial management including identification, evaluation and development of personnel experienced with requirements of Good Clinical Practice (GCP). Prepare all documents and clinical reports necessary to support all regulatory filings with the FDA and international regulatory agencies. Set internal standards and review all FDA submissions and foreign filings to assure adequacy and regulatory accuracy. Prepare all processes and procedures necessary to support all aspects of recruitment. Be an effective team player interfacing well with Reimbursement, Marketing, R&D, Engineering and Quality. Direct all administrative activities associated with the department. This will include the establishment of departmental goals and objectives, preparation and maintenance of operating, expense and capital budgets, issuance of relevant operating procedures and the recruitment, training and assessment of key department personnel. Assume full financial responsibility for departmental budget. Effectively negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers. Develop and foster strong relationships with key opinion leaders in spine through direct interactions with medical advisors and clinical leaders. Review promotional and educational materials for appropriate clinical and regulatory content. Manage the relationships between Empirical and Institutional Review Boards, Scientific Advisory Boards, the Food and Drug Administration (FDA), and FDA Panels. Develop and implement the worldwide clinical and regulatory strategic plan relating to clinical testing, clearance/approval and commercialization. Provide timely feedback to the executive team and company s Board on a variety of topics related to worldwide clinical programs. Expertise and Personality: The profile of the desired candidate will include: Currently serving as a Vice President/Senior Director in a medical device organization (preferably Class III/PMA devices), with a minimum of 10 years of experience in clinical research and regulatory affairs. Experience in spinal implants and/or related orthopedic devices is highly desired. Demonstrated success in development of clinical strategies for innovative new medical technologies or first generation technologies, through all phases of development, site selection and trial execution. Successful management of a major U.S, multi-center, prospective pivotal clinical trial, preferably targeting PMA submission. Successfully recruited and enrolled sites, PIs and patients.
A history of effective collaboration with the FDA (preferably Spine Branch) and other regulatory agencies through clinical studies and market releases. Demonstrated success of obtaining FDA approval for a complex PMA device, including a successful panel meeting in a timely manner. Proven leadership in compliance, with an ability to troubleshoot within FDA regulations and guidelines including, but not limited to, clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. Experience managing budgetary requirements and ensuring compliance of expenditures to meet budgets. Demonstrated success in developing clinical and regulatory affairs departments, including supervisory responsibility for clinical and regulatory affairs staff. Evidence of leadership and a management style characterized by vision, teamwork, preparation, communication and negotiation. Successful management of relationships at all levels of the organization. High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. Small company, hands-on experience. Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinions leaders with respect to the company s products and clinical/regulatory strategies. Experience providing the necessary reporting materials and communicating effectively with senior management and the Board of Directors. The Company: Empirical Spine is focusing on the development and commercialization of a new spinal implant that is designed to provide minimally invasive, flexion-restricting, dynamic stabilization. Available surgical options for degenerative spinal disorders are highly invasive and can lead to a cascade of back problems, so surgeons and patients are often torn between more conservative treatments and highly invasive surgery. This compromise creates a major unmet need for a treatment option which offers the potential benefits of the surgical option while minimizing risk, invasiveness, and recovery time. The magnitude of this unmet clinical need creates a substantial market opportunity. The Company s lead product, the LimiFlex Paraspinous Tension Band, is designed to provide spinal stabilization for patients who could benefit from additional stabilization but do not otherwise require fusion. A complete LimiFlex Device consists of two dynamic titanium rods with attached Ultra-high Molecular Weight Polyethylene (UHMWPE) Straps that wrap around adjacent spinous processes. The attachment mechanisms for the straps are integrated into the rods and allow for intraoperative readjustment of the device. With recent US Investigational Device Exemption (IDE) pivotal study approval, Empirical Spine is currently enrolling patients into its IDE clinical program. Under the IDE, the company s lead product is being studied in conjunction with a surgical decompression for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. The pivotal study is a non-randomized, concurrently controlled, propensity score-matched study in patients suffering from lumbar degenerative spondylolisthesis with spinal stenosis. Patients will receive either decompression + LimiFlex or decompression + transforaminal
lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) and will be followed from baseline through to 24 months (LimiFlex patients will additionally be followed to 60 months during the PMA process). Empirical is dedicated to fulfilling the promise of flexion-restricting stabilization and to improving clinical outcomes for patients and surgeons around the globe. Flexion is the most important motion of the lumbar spine and is the type of motion most exercised during activities of daily living. Empirical Spine closed its first equity financing of $8.3 million in January 2017. The Company expects to raise a Series B round in the second half of 2018 on the order of $10 million. Management Team: The Company s current management team consists of: Richard Treadwell, President and CEO Richard is an experienced MedTech executive who has worked in the US and several European countries. He commercialized new technologies while at Biosensors International and Nellcor, and cofounded two Bay Area medtech startups. Before joining Empirical Spine in March 2018, Richard was Vice-President of Global Marketing at Biosensors International in Geneva, Switzerland.
Todd Alamin, Chairman of the Board and Medical Director Todd Alamin is an Associate Professor and an active orthopaedic spine surgeon at Stanford University, School of Medicine, Department of Orthopaedics in California. He is an original inventor of the LimiFlex Paraspinous Tension Band, co-founder of Empirical Spine, and has extensive involvement in the R&D and clinical study development of the LimiFlex technology. Dr. Alamin previously founded InnoSpine, Inc., which was acquired by Kyphon, Inc. in 2006. Louie Fielding, Chief Operating Officer Louie was the original inventor of the LimiFlex concept, in the Stanford Biodesign Innovation program. Louie led the technical development and testing of the LimiFlex device from conception through European commercialization, as well as IP development and strategy. Louie also negotiated the IDE study design with FDA. Previously, Louie led the mechanical design team in the Intel Digital Health Group (now Care Innovations) developing platforms for remote care of patients with chronic diseases.