About
MEET OUR TEAM
PRESIDENT AND CEO
Jeffrey M. Closs
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Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.
CHIEF TECHNICAL OFFICER
Russel Sampson
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A champion for the development of minimally invasive surgical systems, Mr. Sampson brings a proven track record of invention (over 80 U.S. international patents) to his position at Ancora Heart. Leveraging his deep experience with CE and PMA approvals, commercialization, profitability and acquisition for companies such as Cytyc, Novacept, Abbott Laboratories, Space Systems/Loral and Ford Aerospace, he is responsible for our core technology, intellectual property and product development efforts. Mr. Sampson is the co-founder of Sierra Surgical Technologies (SST) and holds a BS in Mechanical Engineering (AMES) from the University of California, San Diego.
CHIEF COMMERCIAL OFFICER
Mark Miles
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Mr. Miles brings 25 years of experience scaling medical technology companies to his position as chief commercial officer (CCO) of Ancora Heart, including his most recent post as CCO of Terumo Aortic in Glasgow, Scotland. In that role, he was responsible for global sales and marketing, custom solutions, portfolio strategy and expansion into new markets, helping guide the company during a period of significant growth.
Prior to his time at Terumo Aortic, Mr. Miles served as senior director of commercial strategy at Invuity, where he played a key role in driving adoption of their core product lines across key surgical specialties throughout the United States. He was instrumental in facilitating significant growth through the company’s eventual IPO in 2015. Previously, Mr. Miles held positions of increasing responsibility at Medtronic, serving as director of global marketing of the Endovascular Business Unit. He began his career at Eli Lilly and Company, serving various commercial leadership roles during his eight-year tenure. Mr. Miles received an MBA from Pepperdine University and a BS in health sciences from James Madison University.
VICE PRESIDENT OF BIOSTATISTICS AND CLINICAL DATA MANAGEMENT
Christine Tjossem
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Ms. Tjossem brings a 35-year track record of successful growth and leadership in biostatistics and data management to her position at Ancora Heart. Her experience includes key roles establishing and managing biostatistical and data management efforts at some of the world’s leading clinical research and medical device organizations, including Medtronic, Boston Scientific, St. Jude and Berlin Heart. Ms. Tjossem began her career working in medical research for Mayo Clinic in Rochester, Minnesota. As Vice President of Biostatistics and Data Management, Ms. Tjossem is responsible for all facets of her team’s success in advising and implementing appropriate techniques and methods for statistical and data management areas. In addition to managing these line-of-business functions, Ms. Tjossem’s vast breadth and depth of experience allows her to make significant contributions to the company’s overall business, regulatory and clinical strategy. Christine received her Bachelor of Science degree in Statistics from Iowa State University.
VICE PRESIDENT AND GM, INT’L CLINICAL, REGULATORY AND THERAPY DEVELOPMENT
Michael Zapien
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Drawing on his expertise in transitioning innovative medical devices from the developmental stage to commercial success at several emerging startups (Elixir, Nanostim), Mr. Zapien leads our clinical research. Previously the Director of Clinical and Medical Affairs at CardioDx, Inc., he also has clinical and commercial experience at Medi-Globe, Silk Road Medical, Abbott Vascular, and Guidant Corp. Mr. Zapien is a certified clinical researcher with a MS from the University of Maryland and a BS from San Francisco State University.
VICE PRESIDENT OF
STRATEGIC INITIATIVES
Bart Beasley
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A veteran of introducing early-stage and ground-breaking therapies to physicians, Mr. Beasley brings over 25 years of experience in healthcare marketing to Ancora Heart. By building partnerships with the clinical community, gathering first-hand insights towards procedure and product development, and enhancing clinical trial patient education and recruitment, he has helped drive the rapid growth of multiple revolutionary therapies and new therapeutic categories. Mr. Beasley served as Vice President of Marketing at Avinger, drove market development at Transcend Medical (acquired by Alcon), was Director of Marketing at Fox Hollow (acquired by ev3), and began his career at Perclose (acquired by Abbott). Mr. Beasley holds an MBA from IESE Business School in Barcelona, Spain and a BS in Economics from Santa Clara University.
VICE PRESIDENT OF REGULATORY AFFAIRS
AND QUALITY ASSURANCE
Michael Fritz
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Mr. Fritz comes to Ancora Heart with decades of medical device industry experience including strategic leadership, management, operational, and hands-on roles in regulatory affairs, clinical research, quality assurance, and engineering. His career includes roles with small start-ups (Synapse Biomedical and Cyberkinetics) and larger companies (Medtronic, Boston Scientific, and Guidant) developing class III implantable devices and class II minimally invasive devices in diverse fields including interventional cardiology, cardiac electrophysiology, neurology, pulmonary/respiratory, laparoscopic surgery, neurosurgery, rehabilitation medicine, and neuroprosthetics. Mr. Fritz holds an MS degree in software engineering from the University of St. Thomas and a bachelor of electrical engineering degree from the University of Minnesota.
Meet Our Board of Directors
CHAIRMAN
Bob Croce culminated 12 years as Company Group Chairman through a 36-year career at Johnson & Johnson. Beginning in 1968, Mr. Croce held a series of senior positions beginning as a Sales Representative for Ortho Pharmaceuticals where he was later named Vice President of Marketing. Prior to that, he served as Worldwide Franchise Chairman of Cordis and Ethicon Endo-Surgery. In 1985, Mr. Croce was named Vice President of Business Development at McNeil. He was later transferred to Ethicon, Inc., where he served as Group Vice President, and was later named President in 1990. In 1992, he was promoted to Worldwide President of Ethicon Endo-Surgery.
SAVITR CAPITAL
Savitr Capital was founded by Andrew Midler in 2008. Prior to Savitr Capital, Andrew founded Standard Pacific Capital in 1995. The investment management firm launched with $75 million of assets and grew to over $5 billion. Until 2005, Midler managed the firm’s Global Long/Short Equity Fund for Standard Pacific’s flagship product. He also supervised the firm’s credit opportunities, commodity, quantitative, and Japan long/short equity strategies. He served as the CIO and CEO of the firm from 1995 to 2007 before selling his majority ownership interest in the firm in December 2007. Prior to founding Standard Pacific, Midler was the Director of Equity Portfolio Management at CS First Boston, a global institutional money management firm. Previously, he managed a significant portion of the global hedge fund, Odyssey Partners. From 1986 through 1993, he worked at Fidelity Investments where he was Portfolio Manager of the Fidelity Convertible Securities Fund, Fidelity Equity Income II Fund and Fidelity Growth & Income Fund.
LCP VENTURES
Lew Pell is one of the most prolific and successful medical technology investors. Since 1975, Pell has been the lead investor and co-founder of 24 different medical device manufacturers, eight of which have been sold for a collective net gain of $1.6 billion. Pell’s founding of medical technology companies began in 1975, when he and Katsumi Oneda co-founded Machida America to sell flexible endoscopes. In 1979, he created Pentax Precision Instruments and sold it to Asahi Optical eleven years later. Over a span of 15 years, Pell co-founded various medical device companies including: American Endoscopy (acquired by Medtronic), Heart Technology (acquired by Boston Scientific), InStent (acquired by Medtronic), and Vision Sciences. He was also co-founder of Biosense (acquired by Johnson & Johnson), Influence, Inc. (acquired by American Medical Systems), and Disc-O-Tech (sold to Kyphon).
MADORRA, INC.
Beverly Huss is a medical device entrepreneur, board director and mentor who brings with her more than 20 years’ experience as a leader of both large corporations and start-up companies in the medical device space. She is currently Executive Chair of Madorra, Inc., a women’s health company focused on improving quality of life after menopause. Ms. Huss was co-founder and CEO of Pagonia Medical. Prior to founding Pagonia, she was president and CEO of Qool Therapeutics, Inc., a tissue preservation company. Previously she was co-founder and CEO of Vibrynt, Inc., a company that developed a novel minimally invasive therapeutic device for treatment of morbid obesity. Prior to this, Ms. Huss was with Santa Clara, California-based Guidant since 1986, fulfilling a variety of executive roles within the company’s various medical device divisions. She managed the worldwide Endovascular Solutions business as President and quadrupled worldwide revenues to $150 million for the carotid and peripheral vascular business in four years. In addition, she built Guidant’s coronary stent business to $1B with 90% gross margins.
PRESIDENT & CEO
Mr. Closs brings proven leadership in medical devices, health policy, and technology to the Ancora Heart team. He has dedicated his career to working at the intersections of change to promote innovative, life-changing solutions. He has extensive experience founding new ventures (Benu), driving a successful IPO (Perclose), and having leadership roles at Fortune 500 companies (Fox Hollow, Edwards, Guidant, Bentley). Formerly a director at Nellix Endovascular, which was acquired by Endologix, and BioIQ, a health tech company, he is also an adjunct professor at Stanford University Center for Health Policy and the former president of the St. Raymond School Board. Mr. Closs holds an MBA from Emory University and a BA from the University of California, Los Angeles.
WORK WITH US
It has come to our attention that an unknown entity is impersonating our organization and extending illegitimate job offers via email, purportedly in an attempt to defraud intended applicants.
Please be advised that these email solicitations appear to be part of a fake job scheme. For additional information, please see https://www.fbi.gov/contact-us/field-offices/elpaso/news/press-releases/fbi-warns-cyber-criminals-are-using-fake-job-listings-to-target-applicants-personally-identifiable-information.
Authorized Ancora Heart employees will reach out to potential candidates directly via telephone or email from ancoraheart.com but will never issue questionnaires or request personal information. Job offers will only be extended after a thorough interview process and multiple interactions with Ancora Heart staff members. When communicating, please be very cautious of fictitious email addresses.
Ancora Heart is looking for talented professionals to join our growing team. We value creativity, drive, accountability, and the ability to work collaboratively with one another. If you thrive in a fast-paced setting and are passionate about changing the way heart failure is treated, consider the following opportunities:
Clinical Research Associate (Device Accountability)
PURPOSE OF POSITION:
Support the Clinical Affairs team to ensure investigational device accountability such that the clinical trial is operating in accordance with the clinical protocol(s); Federal Regulations 21CFR821; any other applicable policies, regulations, procedures, and/or guidelines to ensure data integrity and Trial Master Files are maintained. Support the Clinical Operations team to ensure integrity of clinical and/or compliance data.
MAJOR DUTIES AND RESPONSIBILITIES:
- Verify, in conjunction with the Operations team, quantities, lot numbers, and expiration dates of outgoing shipments.
- Verify data in outgoing shipment manifests to include specific details regarding packing lists, device accountability log information, addresses, site specific information (i.e., contact name and number).
- In a timely manner, confirm receipt of product at the site and ensure the completion and collection of manifest documentation.
- Troubleshoot and resolve any issues that arise during transit, delivery and receipt of shipments.
- In conjunction with Site Management and Field Operations, ensure the completion of site training for the receipt and handling of investigative product.
- With Therapy Development and Field Operations teams, review and reconcile post-implant devices.
- Collect and review Device Use Forms and Device Accountability Logs prior to return shipments.
- Coordinate and expedite device returns including creation of FedEx labels. Ensure complete and accurate documentation.
- With the Operations staff, ensure the accuracy of return shipments, restocking, and tracking of devices.
- With Operations and Clinical Operations staff, create and maintain a system for the accurate tracking of devices returned and dispositioned (i.e., restocked, disposed, or recommissioned.)
- With Operations and Clinical Field Operations staff, fully review, reconcile, and file all documentation related to device accountability.
- Order, track and manage Clinical Trial materials.
- Manage in-house filing of critical materials.
- As needed, complete projects and tasks as assigned by the Clinical Affairs team.
- Work with Site Management to generate information and distribute EU and US study newsletters.
- Review, assess, create and update clinical quality and monitoring SOPs, monitoring plans, and other clinical affairs forms.
- Prepare Essential Document Tracker Status report as needed. Perform comprehensive eTMF audits.
- Work with Field and Clinical Operations teams to maintain accurate study documents.
- Complete projects and tasks in an aggressive manner consistent with corporate objectives. Keep supervisor informed of changes in work schedule and/or workload.
- Regularly recognize problems and recommend and implement methods of conduct of clinical study.
- Perform other duties as assigned.
- Support company goals and objectives, policies and procedures, and compliance with Ancora Heart SOPs, Good Clinical Practices, Good Manufacturing Practices and FDA regulations. Ensure compliance with Quality System Regulations and ISO 9001, EN 46001, and MDD requirements.
EDUCATION REQUIREMENTS:
- BS preferred in Life Sciences, Medicine, or other technical discipline.
EXPERIENCE REQUIREMENTS:
- Minimum five years related experience in health-related field in addition to working knowledge of FDA regulatory requirements.
OTHER QUALIFICATIONS:
- Must possess excellent written and verbal communication skills.
- Able to travel and work in the Santa Clara Office
- Must be willing and able to travel to work related meetings and seminars, as needed.
- May require the ability to deliver speeches and/or presentations effectively to a variety of audiences.
Clinical Safety Associate
PURPOSE OF JOB:
The Clinical Safety Associate assists the Safety Manager and is responsible for the oversight of the adverse events and product experiences reported within a clinical trial as directed by the Safety Manager. The Clinical Safety Associate assists with ensuring the appropriate reporting of the events to the necessary internal departments and applicable Authorities throughout the life of the trial.
The Clinical Safety Associate assists the Safety Manager who acts as a liaison between the internal departments as well as to external customers such as CROs, Clinical Events Committees and Data Safety Monitoring Boards associated to the trial.
MAJOR DUTIES AND RESPONSIBILITIES:
- Assist with all activities related to establishing and managing all safety-related processes as directed by the Safety manger to include:
- Participate in the formulation of case report forms, specifically with regards to reporting and management of adverse events.
- Support preparation of safety section of clinical study reports, Clinical Expert reviews, clinical section of device reports, and other report documents as needed to support regulatory filings to US and International regulatory bodies.
- Review clinical safety databases for adverse events and device deficiencies and compose safety narrative reports.
- Assist sites with subject evaluation and protocol adherence for adverse event reporting timelines.
- Assist managing Clinical Events Committee (CEC), Data and Safety Monitoring Board (DSMB) and Safety outsource activities.
- Collaborate with team to resolve complex or unclear situations.
- Maintain a professional and credible image with clinical investigators, hospital staff and other customers, FDA, Notified Bodies, and other regulatory bodies, consultants, vendors, and co-workers.
- Maintain current knowledge of applicable clinical literature.
- Attend relevant meetings as appropriate.
- Support company goals and objectives, policies and procedures, and compliance with Good Clinical Practices and FDA regulations.
- Perform other duties as assigned.
- Keep manager informed of changes in work schedule/and or workload.
EDUCATION REQUIREMENTS:
Registered Nurse (Associate degree); Bachelor’s degree in a Scientific discipline, Life Sciences, Medicine, or other technical discipline.
EXPERIENCE REQUIREMENTS:
- Experience of at least 5 years in the medical industry in addition to at least 2 years of Safety monitoring experience.
- Experience in conducting clinical trials.
- Clinical knowledge and understanding in medical record and medical diagnostic report review.
OTHER QUALIFICATIONS:
- Excellent internal and external customer service skills
- Excellent written and verbal communication skills
- Detail oriented and ability to problem solve
- Able to make evaluative judgements
- Able to work independently and in a team environment
- Able to develop and deliver presentations to a variety of audiences
- Able to provide technical advice, guidance, and support to others in your area of expertise
Ancora Heart offers a competitive compensation and benefits program as well as a progressive work environment. We are an equal opportunity employer. If you or someone you know might be interested in this position, please submit a resume and an introductory email to careers@ancoraheart.com