We are visionaries.
We believe that the enormous challenge of making cancer curable can be overcome only with a different approach.
Our approach is entirely empirical, we don’t take anything for granted. We re-define the challenge itself, and combine expertise from multiple disciplines into new methods and tools.
Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection, at a time when intervention can bring the greatest impact for patients. Leveraging PCR-based epigenetics, our pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. Our non-invasive EpiCheck® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. Our global team operates from San Diego, United States as well as from Rehovot Israel.
Chris Hibberd, B.Sc., MBA Executive Chairman & CEO
Chris Hibberd, B.Sc., MBA
A proven team builder with over 20 years of experience in working with innovative teams to identify, create and build high value medical device products and biotech discovery technologies. Co-Founded and built Astute Medical, an innovative medical technology discovery and diagnostic company. Built an impressive team, secured VC funding, negotiated debt financing, built a product pipeline, launched the 1st FDA cleared product for Acute Kidney Injury risk and negotiated numerous global collaborations. One of the collaborators, bioMérieux, acquired Astute Medical in April 2018. Prior to Biosite’s $1.7B acquisition in 2007, he led a productive business development and strategic planning group and co-founded Biosite Discovery to leverage a world class antibody capability. After securing an MBA from the University of Western Ontario in Canada, he worked for 5 years as a management consultant with the Boston Consulting Group in the US, Canada, Mexico and Spain. Graduated with a Chemical Engineering degree from the University of Toronto.
Catherine Schnabel, PhDChief Scientific Officer
Catherine Schnabel, PhD
Dr. Catherine Schnabel brings over 20 years of scientific and leadership experience in the biomedical and molecular diagnostics industries. Prior to joining Nucleix, Cathy was the Chief Scientific Officer of Biotheranostics, where she led the development and translation of proprietary molecular signatures for breast cancer and metastatic disease, including incorporation of these novel technologies into clinical practice guidelines. An industry leader in evidence-based diagnostics, she has authored over 100 peer-reviewed publications and disclosures and is an inventor on several patents. Cathy previously held research positions at Genentech and Genoptix and gained medical affairs expertise at Amylin Pharmaceuticals, investigating and launching first-in-class therapies and biomarkers. Cathy holds a Ph.D. in cell and developmental biology from the Center for Advanced Biotechnology and Medicine at Rutgers University and was a fellow of the NIH and the Leukemia and Lymphoma Society at Stanford University.
Todd Myers, B.Sc.Chief Financial Officer
Todd Myers, B.Sc.
Todd has over 25 years of experience in both public and private companies, primarily in the life science and healthcare fields. As the CFO of multiple companies, he has negotiated with investors and strategic partners to raise over $320 million in capital through the issuance of equity and debt, and the out-licensing of technology. Prior to joining Nucleix, Todd was the chief financial officer of Astute Medical, which was acquired in 2018 by bioMerieux, a multinational biotechnology company headquartered in France. While with Astute, he played a lead role in raising equity and debt capital to support the research, clinical/product development and commercialization of NephroCheck®, the first FDA cleared diagnostic for acute kidney injury, as well a lead role in Astute’s sales process. He was responsible for all finance and general and administrative activities at both Astute and its wholly-owned subsidiary in Europe. Prior to Astute, Todd was the chief financial officer at SGX Pharmaceuticals, a publicly-traded company focused on the discovery, development and commercialization of innovative cancer therapeutics, until its acquisition by Eli Lilly & Company. He was also the Director of Finance at CombiChem, Inc., a publicly-traded computational drug discovery company, which was acquired by DuPont Pharmaceuticals. Todd began his career as an auditor in the San Diego office of Ernst & Young and obtained a B.S. in accounting from the University of Illinois, Champaign-Urbana.
Eli Frydman, Ph.D, MBA President EMEA
Eli Frydman, Ph.D, MBA
With over 20 years industry experience, Eli is a seasoned healthcare executive with comprehensive management, operational and Board level experience, including start-up, multi-national, incubator and VC companies. Prior to joining Nucleix, Eli was Managing Director of Aurum Ventures, a healthcare-focused VC, serving on the Boards of its 10 portfolio companies, across different healthcare segments. Prior to Aurum, Eli served as CBO at FutuRx, a J&J, Takeda and Orbimed incubator, where he made key contribution to FutuRx set up and the establishment of multiple start-up companies; COO at Aposense (a drug development company; TASE: APOS), where he managed the company’s business development, operations and finance, led several big pharma agreements and played a key role in the company's TASE IPO; and Senior BD Manager at GE Healthcare Europe, leading multiple M&A transactions. Eli holds a Ph.D in Chemistry from the Weizmann Institute of Science and an MBA from the Ecole-Des-Ponts, Paris; he is also a member of 8400, Israel’s healthcare executives network, and of the EU Horizon Europe Jury committees in Brussels.
Ricardo A.J. ten Velden VP Sales & Marketing
Ricardo A.J. ten Velden
Ricardo has over 30 years of experience in business development and sales & marketing. He achieved a sustained record of success in the Life Sciences industry e.g. innovative (lifestyle) prescription drugs, generics, biologics, biosimilars, and medical devices. He started his career in Pharmaceuticals and later transitioned to molecular diagnostics. Before joining Nucleix he served as the Director Sales & Marketing EMEA of MDxHealth (ENX:MDXH), a multinational healthcare company that provides actionable genomic information to personalize the diagnosis and treatment of cancer. Prior to this he was commercial leader for international markets in companies such as Avery Dennison, Merck Sharp & Dohme and Organon (AkzoNobel). For Organon he worked more than six years as an expat in Italy. Back in the Netherlands he set up the Benelux subsidiary of Hikma Pharmaceuticals (LON:HIK). Ricardo studied law at VU University Amsterdam and marketing at the Netherlands Institute of Marketing.
Aharona Shuali, MD, MBA VP Medical
Aharona Shuali, MD, MBA
Aharona has over 10 years of experience in development and commercialization of oncology-targeted products in the pharmaceutical and medical device industries. Prior to Nucleix, Aharona served as Medical Manager at Roche Pharmaceutical Israel, Medical Director at AstraZeneca Israel, Senior Global Product Manager in Philips Healthcare and VP Oncology at Insightec. Aharona holds an MD from the Hebrew University, and an MBA from Tel Aviv University.
Danny Frumkin, PhDVP Research
Danny Frumkin, PhD
As co-founder of Nucleix, Danny brings extensive experience and know-how in molecular biology, cancer genetics, and DNA biochemistry. Alongside Adam, he co-developed a non-invasive high-resolution method for determination of cell lineage based on analysis of somatic DNA mutations, resulting in the establishment of an international lineage center at the Weizmann Institute. Danny is the author of 11 scientific papers and co-inventor of several patents. Danny holds an Ph.D. in Life Sciences from the Weizmann Institute, as well as an B.Sc. in Medical Sciences from Tel-Aviv University.
Adam Wasserstrom, PhDVP Software and Analytics
Adam Wasserstrom, PhD
Bringing deep knowledge in computer science, bioinformatics, and statistical analysis, Adam co-founded Nucleix and has been an instrumental part of building the company from its inception. Together with Danny, he co-developed a non-invasive high-resolution method for determination of cell lineage based on analysis of somatic DNA mutations, resulting in the establishment of an international lineage center at the Weizmann Institute. Adam is the author of 9 scientific papers and co-inventor of several patents. Adam holds a Ph.D. in Life Sciences from the Weizmann Institute, and a B.A in Computer Sciences cum laude and Music from Tel-Aviv University.
Eran Bram, PhD VP Product Development
Eran Bram, PhD
Eran is an experienced R&D manager with specific focus on the development and productization of In-vitro molecular diagnostics assays and software. Previously, Eran served as a Sr. Scientist and Manager at Asuragen Inc., and was the founder and CSO at Piercell Bio, Ltd. Eran is an author of 11 scientific papers, an inventor of 2 patents and has served as PI on multiple SBIR grants. Eran holds a PhD in Life Sciences from the Technion, Israel Institute of Technology and has completed his postdoctoral fellowship in biological engineering at MIT.
Shmuel Adler, B.Pharm, MSc VP Regulation, Clinical and QA
Shmuel Adler, B.Pharm, MSc
Shmulik carries over 15 years of experience in successfully leading the development and overseeing clinical trials, regulatory affairs, and quality assurance for companies. Shmulik has led many global FDA regulated multicenter studies. Shmulik is a licensed Pharmacist from the Hebrew University and has an M.Sc. in Pharmacology and Physiology from Tel Aviv University.
Radha Duttagupta, PhD VP Clinical Affairs
Radha Duttagupta, PhD
Dr. Radha Duttagupta brings over 10 years of experience in test development, trial strategy and pre- and post-market studies for LDT/RUO/IVD products in the clinical diagnostic industry. Prior to Nucleix, Radha served as Director of Clinical Operations and Clinical Development at Karius driving the clinical validity, utility and publication strategy for the Karius® Test (liquid biopsy for infectious diseases) in immunocompromised patients suspected with pneumonia. Radha has held previous positions at Cepheid (Danaher) leading clinical trials in the ID portfolio including Xpert® MTB/XDR (molecular DST for Extreme Drug Resistance TB) and Affymetrix (part of Thermofisher Scientific) in product and clinical development of pre and post-natal tests for copy number (CN) detection spanning CytoScan™ XON, CytoScan™ Optima and CytoScan™ Dx; the first-in-kind FDA and CE-marked blood test to aid in the diagnosis of developmental delay/intellectual disabilities, congenital anomalies, and/or dysmorphic features. Radha has a Ph.D in Biochemistry and Molecular Genetics from Rutgers University and University of Medicine and Dentistry of New Jersey (UMDNJ), Robert Wood Johnson Medical School, New Jersey and was a post-doctoral fellow in the Transcriptome group at Affymetrix.
OrbiMed Israel Limited Partnership
OrbiMed Israel Limited Partnership
OrbiMed have been investing globally for over 20 years across the healthcare industry: from early-stage private companies to large multinational corporations. Investments are made in one of three strategies: public equity, private equity, and royalty opportunities. Their team of over 80 distinguished scientific, medical, investment and other professionals manages over $13 billion across public and private company investments worldwide.
Zohar Zisapel
Zohar Zisapel
Zohar Zisapel is a successful Israeli entrepreneur in Israel’s advanced high-tech industry.
Aurum Ventures M.K.I. Ltd
Aurum Ventures M.K.I. Ltd
Aurum Ventures MKI provides value added growth capital to exceptional entrepreneurs in the healthcare area. While we focus on investing in unique, cutting edge technologies that will mature into successful business companies, our investments reflect our own values, so we prefer investing in companies that, through their sound commercial propositions, also contribute to the well-being of mankind. Our team is comprised of senior and experienced hands-on executives who work actively with the portfolio companies in enhancing their strategic and execution capabilities. We typically take a long-term approach, understanding that ventures in the life sciences and healthcare areas take time to mature and be successful.
RA Capital Management
RA Capital Management
RA Capital Management, LP is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, diagnostics, services and research tools. The flexibility of its strategy allows RA Capital to provide seed funding to startups and to lead private, IPO, and follow-on financings for its portfolio companies, enabling management teams to drive value creation from inception through commercialization. At RA Capital’s core is its TechAtlas research division, a scientifically trained team that maps out competitive landscapes to put data into context, identify breakthroughs, and originate conviction in new ideas. TechAtlas provides market intelligence, technical diligence, and other resources to RA Capital's internal Investment team as well as its portfolio companies.
Sands Capital
Sands Capital
Sands Capital is an active, long-term investor in leading innovative businesses globally. Our approach combines analytical rigor and creative thinking to identify high-quality growth businesses that are creating the future. Through an integrated investment platform spanning venture capital, growth equity and public equity, we provide growth capital solutions to institutions and fund sponsors in more than 40 countries. An independent, staff-owned firm founded in 1992 with offices in the Washington, D.C. area and Singapore, Sands Capital managed more than USD $80 billion in client assets as of September 30, 2021.
Chris Hibberd, Executive Chairman & CEO
Chris Hibberd, Executive Chairman & CEO
A proven team builder with over 20 years of experience in working with innovative teams to identify, create and build high value medical device products and biotech discovery technologies. Co-Founded and built Astute Medical, an innovative medical technology discovery and diagnostic company. Built an impressive team, secured VC funding, negotiated debt financing, built a product pipeline, launched the 1st FDA cleared product for Acute Kidney Injury risk and negotiated numerous global collaborations. One of the collaborators, bioMérieux, acquired Astute Medical in April 2018. Prior to Biosite’s $1.7B acquisition in 2007, he led a productive business development and strategic planning group and co-founded Biosite Discovery to leverage a world class antibody capability. After securing an MBA from the University of Western Ontario in Canada, he worked for 5 years as a management consultant with the Boston Consulting Group in the US, Canada, Mexico and Spain. Graduated with a Chemical Engineering degree from the University of Toronto.
Dr. Heiner Dreismann
Dr. Heiner Dreismann
Dr. Dreismann, is a seasoned executive with more than 30 years of experience in the health care industry, and is regarded as a pioneer in the early adoption of the polymerase chain reaction (PCR) technique, one of the most ubiquitous technologies in molecular biology and genetics research today. He had a successful career at the Roche Group from 1985 to 2006 where he held several senior positions, including President and CEO, Roche Molecular Systems, Head of Global Business Development, Roche Diagnostics and Member of Roche’s Global Diagnostic Executive Committee. Dr. Dreismann currently serves on the boards of several public and private health care companies. He earned a master of science degree in biology and his doctor of philosophy degree in microbiology/molecular biology (summa cum laude) from Westfaelische Wilhelms University (The University of Munster) in Germany.
Erez Chimovits
Erez Chimovits
Erez Chimovits is a Partner at OrbiMed. Erez has 14 years of operational experience, including 10 years of senior managerial experience in public companies. Prior to joining OrbiMed Erez was the CEO of NasVax (TASE:NSVX). NasVax acquired Protea and struck agreements with GlaxoSmithKline and Novartis. Previously, Erez spent more than seven years with Compugen (Nasdaq:CGEN), as President, Compugen USA Inc. and Executive VP, Commercial Operations. At Compugen, he had responsibility for more than 100 people and led multiple transactions including J&J, Novartis, Teva, Abbott, Medarex and others. Erez earned his M.B.A., M.Sc. in Microbiology and his B.Sc. from Tel Aviv University.
Dr. Thomas Buchholz
Dr. Thomas Buchholz
Dr. Buchholz is a corporate SVP and Medical Director of Scripps MD Anderson Cancer Center in San Diego. His responsibilities include oversight of the clinical care of cancer patients, the development of clinical and translational research activities, and academic collaborations with MD Anderson. He also continues a radiation oncology practice focused on breast cancer. He previously has held a variety of clinical, research, academic and administrative leadership positions with MD Anderson Cancer Center in Houston, including division head and department chair of radiation oncology, Provost ad-interim, and Executive Vice President/Physician-in-Chief, during which he was responsible for all aspects of clinical care and operations of MD Anderson’s hospital and ambulatory clinics. Nationally he has held a variety of leadership roles including two terms as co-chair of the NCI's Breast Cancer Steering Committee. His academic efforts and efforts to improve the patient experience have been recognized with several national awards. Dr. Buchholz earned his medical degree from Tufts University School of Medicine in Boston. He completed his residency and a radiobiology research fellowship at the University of Washington Medical Center in Seattle. He is board certified by the American Board of Radiology and the National Board of Medical Examiners. He earned his bachelor’s degree in philosophy from Bucknell University in Lewisburg, Pa, and currently serves on Bucknell's Board of Trustees.
Ilan Lior
Ilan Lior
Ilan Lior serves as the general counsel of Aurum Ventures M.K.I. Ltd. and is member of Aurum’s senior management team. He also serves on various boards of Aurum’s portfolio companies. Prior to joining Aurum, Ilan was a partner in a boutique law firm where he headed the corporate and commercial practice group. Ilan is a member of the Israeli bar and holds LLW and a BA (eco), both from the Tel Aviv University.
Nate Davis
Nate Davis
Nate Davis is an Analyst on the Investment Team at RA Capital Management. Nate conducts due diligence on biotechnology companies at RA Capital and serves as a Board Director for The Covid Apollo Project and Nucleix. Previously, Nate worked closely with the Investment Team, as a Senior Associate within the TechAtlas division, to originate conviction in potential investments by identifying breakthroughs and putting data into context. Prior to RA Capital, Nate worked as an Investment Analyst at Wolfram Ventures. Nate has a BS in Biological Sciences from University of Vermont.
Parker Cassidy
Parker Cassidy
Parker Cassidy is a Partner at Sands Capital and focuses on the firm’s diagnostic investments. He has a BS in Mechanical Engineering from Boston University and an MBA from Darden Graduate School of Business Administration from the University of Virginia. Prior to Sands Capital, Parker was a Principal on the investment team at RA Capital Management. Parker also worked at Farcast Biosciences where he served as the Chief Commercial Officer and as the Head of Strategy and Business Development. Prior to Farcast Biosciences, Parker held various leadership roles of increasing responsibility at both Becton Dickinson and Serologicals.”
Dr. Peter Mazzone
Dr. Peter Mazzone
Dr. Peter Mazzone is a pulmonologist at the Cleveland Clinic where he directs the Lung Cancer Program for the Respiratory Institute and the Lung Cancer Screening Program for the hospital system. His clinical interests include prevention, screening, nodule management, lung cancer diagnosis, staging, and characterization. He has research interests in each of these clinical areas, including work on the development of molecular biomarkers for lung cancer detection. He has served in leadership positions within Chest and the American Thoracic Society which have allowed him to lead policy development projects related to quality metrics for the evaluation of lung cancer, components necessary for high-quality lung cancer screening, and the clinical application of molecular biomarkers for lung cancer detection. He has also been an active member of evidence-based guidelines related to lung cancer screening and lung nodule management.
Dr. Gerard A. Silvestri
Dr. Gerard A. Silvestri
Dr. Gerard Silvestri is the Hillenbrand Professor of Thoracic Oncology at the Medical University of South Carolina. He completed his training in Pulmonary and Critical Care Medicine and received an additional degree in health services research, both at Dartmouth. He is widely regarded as an international expert in lung cancer. His research includes screening for lung cancer, lung nodule evaluation, diagnosis and staging of lung cancer, development of biomarkers for disease risk and treatment, and disparities in delivering lung cancer care to underserved communities. Dr. Silvestri is a writer and editor of the American College of Chest Physicians lung cancer guidelines. He has authored more than 280 scientific articles, book chapters and editorials. He has served on multiple editorial boards and currently serves on the editorial board of the journal Chest. Dr. Silvestri is past president of the American College of Chest Physicians (CHEST), a society serving 20,000 chest physicians worldwide. He currently serves on the steering committee of the American Cancer Society’s National Lung Cancer Roundtable. Dr. Silvestri was the recipient of the 2020 lifetime achievement award in Lung Cancer from the American Thoracic Society. In 2022, Dr. Silvestri was named a Master Fellow of the American College of Chest Physicians, a distinction awarded to only 40 members in the nearly 90 years of that organization’s existence.
Prof. Martin C. Tammemägi
Prof. Martin C. Tammemägi
Prof. Martin Tammemägi has MSc and PhD degrees in Epidemiology from the University of Toronto. He served as co-investigator in the US NIH NCI sponsored National Lung Screening Trial. Currently, he is Professor of Epidemiology in the Department of Health Sciences at Brock University in Canada and is Scientific Lead on Cancer Care Ontario’s Lung Cancer Screening Pilot for People at High Risk. His research has a focus on lung cancer screening, lung cancer risk prediction modelling and prediction modelling of which pulmonary nodules detected on computed tomography screening are cancer. His lung cancer risk prediction models, including the PLCOm2012 (Tammemagi MC et al. NEJM 2013) and his nodule malignancy probability model (PanCan model; McWilliams A, Tammemagi M, et al. NEJM 2013) have received widespread validation and implementation. Regarding programmatic public health implementation of lung cancer screening, he has a strong research and applied interest in indicators and measures of screening performance through the different phases of lung cancer screening programs.
Dr. Stephen Lam
Dr. Stephen Lam
Dr. Stephen Lam is a Professor of Medicine at the University of British Columbia in Vancouver, Canada, a distinguished scientist, the Leon Judah Blackmore chair in lung cancer research, and MDS-Rix endowed director of translation lung cancer research at the BC Cancer Research Institute. He is the Medical Director of the Lung Cancer Screening Program in British Columbia. He chairs the IASLC Screening and Early Detection Committee and the Pan-Canadian Lung Cancer Screening Network of the Canadian Partnership Against Cancer. His research interest is in the risk-model-based approach to personalize lung cancer screening and chemoprevention. He was a recipient of the IASLC Joseph Cullen Award in lung cancer prevention research.
Prof. Mina Gaga
Prof. Mina Gaga
Dr. Mina Gaga MD, PhD is Director of the 7th Respiratory Medicine Dept and Asthma Centre at Athens Chest Hospital "Sotiria". The hospital is a center of excellence for lung disease, catering to more than 50000 inpatient and 100000 outpatient and emergency patient visits. Among those, more than 2000 new lung cancer patients are diagnosed, staged and treated per year. Dr Gaga is much involved in clinical work, focusing particularly in lung cancer and asthma, in clinical research and in medical education programs. She has been actively involved as PI in multiple clinical trials, has been active internationally in guideline development for screening in lung cancer and severe asthma and has published extensively in these research areas. She has moreover served as Director of Learning Resources of the ERS School, Secretary of the European Board of Accreditation in Pneumology (EBAP), Secretary General and president of the ERS, serves in the HERMES examination committee and the European Αdult and Thoracic Oncology HERMES Diplomas.
Prof. John Field
Prof. John Field
Prof. John Field, PhD, FRCPath has a Personal Clinical Chair in Molecular Oncology at the University of Liverpool. He is a Visiting Professor at University College London, holds the post of Director of Research of the Roy Castle Lung Cancer Research Programme. He is the Chief Investigator for the UK Lung Cancer Screening Trial (UKLS). Previous Chair of the IASLC Screening Prevention & Early Detection Committee and he formed IASLC Strategic Screening Advisory Group. Member of the ILCCO Steering Committee He was presented with the IASLC Joseph Cullen Award at the WCLC 2011, in recognition of lifetime scientific achievements in lung cancer prevention research. He is Chair of the IASLC Strategic Screening Advisory Committee. He is the principle investigator of the Liverpool Lung Project, a molecular- epidemiological study into the early detection of lung cancer (~12,000 recruited), funded by the Roy Castle Lung Cancer Foundation. The UKLS and the LLP form part of the NCRI Lung Cancer portfolio. He is also a Partner in the FP7 CURELUNG and LCAOS projects and the NIH GWAS non-smokers and the Oncoarray studies. He is also heavily involved in the identification of molecular diagnostic markers in lung and head & neck cancers. His research funding has been provided mainly by the RCF, NWCRF, MRC, CRUK, EU, NIH and the HTA. Professor Field is the author of over 270 international (peer reviewed) papers in his area of expertise and has given more than 350 presentations at medical and scientific conferences around the world.
Prof. Fred Witjes
Prof. Fred Witjes
Prof. Fred Witjes is professor in oncological urology. His research interest is translational and clinical research in bladder, prostate and testicular cancer. He has many training and teaching activities. He is a member of several international societies, and he chairs, amongst others, the Dutch guidelines committee on bladder cancer and the EAU guidelines committee on metastatic and muscle-invasive bladder cancer. He is reviewer for many, and editor of several urological and oncological journals. He is involved in and leads many studies and projects which has resulted in many lectures and over 550 (peer reviewed) publications, reviews and bookchapters.
Dr. Barton Grossman
Dr. Barton Grossman
Part-time Professor in the Dept. of Urology M.D. Anderson Cancer Center. Dr. Grossman was awarded his medical degree from Temple University. He then completed a residency in Urology at the University of Michigan. He obtained additional training in a clinical and research fellowship at Memorial Sloan-Kettering Cancer Center and returned to the University of Michigan where he rose to Professor. In 1994, he joined the faculty of The University of Texas M. D. Anderson Cancer Center where he is Professor and Deputy Chairman of the Department of Urology. Dr. Grossman has numerous publications and continues to have an active research laboratory.
Dr. Seth Lerner
Dr. Seth Lerner
Dr. Seth P. Lerner, MD, is Professor of Urology and holds the Beth and Dave Swalm Chair in Urologic Oncology, in the Scott Department of Urology, Baylor College of Medicine. He is Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program and Vice-Chair for Faculty Affairs. His research interests include use of selective estrogen receptor modulators for treatment of bladder cancer, gene therapy, surgical quality and outcomes and integrated genomic characterization of bladder cancer. He has 27 years of experience as a clinical investigator for both NCI and industry funded clinical trials. He is chair of the Local Bladder Cancer committee of SWOG, co-chair of the GU Steering Committee for CTEP and co-chaired the Analysis Working Group of The Cancer Genome Atlas Project for muscle invasive bladder cancer.
Prof. Maria J. Ribal
Prof. Maria J. Ribal
Prof. Maria J. Ribal received her medical degree in 1994, followed by her PhD in 2002, both at the University of Barcelona. After 5 years residency in urology at the University Hospital Clinic in Barcelona, she became a member of the Spanish Board of Urology in 1999. She did a research Fellowship with an Investigation Grant at the Hospital Clinic in 2000-2001. She attended as Visiting Clinician at Mayo Clinic in Rochester (USA) in 2002. Fellow in Laparoscopic Surgery at the University College London Hospital (UCLH) from June till December 2006. She has been member at the Oncology Unit of the Department of Urology at Fundacio Puigvert (2002-2005). Since February 2005, she is member of the Department of Urology at the University Hospital Clinic of Barcelona. Currently, she is Associated Professor of Surgery at the University of Barcelona. From December 2011 she is the Head of the Multidisciplinary Unit of Uro- Oncology at Hospital Clinic. Her main interests include urologic oncology, major oncologic surgery, laparoscopic surgery and transplantation and genetic research of urological tumors. She is the author of 53 national and 22 international publications, 10 book chapters, and 195 invited lectures at conferences and courses. She is an active member of European Association of Urology: Member of the Muscle Invasive and Metastatic Bladder Cancer Guidelines Group of the European Association of Urology (EAU) since 2006, Member of the ESUT Working group from European Association of Urology since 2010. Board member of the EUSP Office of the European Association of Urology since April 2012. In 2009, during the EAU Annual Meeting held in Stockholm, she received the Crystal Matula award.
Israel Innovation Authority
Israel Innovation Authority
The Office of the Chief Scientist was established in 1974. It was renamed the Israel Innovation Authority in 2016. The main aim of the department is to increase economic empowerment within the civilian sector of the Israeli economy. Main activities include the funding of research and policy-making within its sphere of influence. The development and prominence of the OCS was further strengthened by the development of the Venture Capital industry within Israel in the 1990s. A variety of ongoing support programs offered by the Authority provide financial and developmental resources to entrepreneurs and companies of all sizes and stages performing industrial R&D research within Israel.
HORIZON 2020
HORIZON 2020
Horizon 2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020) in addition to the private investment that this money will attract. It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. Horizon 2020 is the financial instrument implementing the Innovation Union, a Europe 2020 flagship initiative aimed at securing Europe's global competitiveness. Seen as a means to drive economic growth and create jobs, Horizon 2020 has the political backing of Europe’s leaders and the Members of the European Parliament. They agreed that research is an investment in our future and so put it at the heart of the EU’s blueprint for smart, sustainable and inclusive growth and jobs. By coupling research and innovation, Horizon 2020 is helping to achieve this with its emphasis on excellent science, industrial leadership and tackling societal challenges. The goal is to ensure Europe produces world-class science, removes barriers to innovation and makes it easier for the public and private sectors to work together in delivering innovation.
Nucleix is a leading commercial stage liquid biopsy company, developing and marketing best in class non-invasive molecular cancer diagnostic tests. The company has offices in Israel and in the US; its highly sensitive and specific tests are based on the identification of subtle changes in DNA methylation patterns. Nucleix’s technology is based on a combination of a novel, proprietary biochemical platform in conjunction with sophisticated algorithms.
We are looking for an exceptional and highly experienced Data Scientist to lead the field of data science / Bioinformatics in the company, including advanced analyses of very large and unique NGS and PCR datasets and the development of novel biomarker panels. This person will report to the VP Software & Analytics.
To apply for this opportunity, please send your resume and a cover letter to:[email protected]
Requirements:
• MSc./PhD. in Computer Science / Physics / Mathematics / Engineering
Exceptional BSc. Candidates with experience and knowledge will also be considered
• 6+ years’ experience in leading a data science team and 10+ years’ industry experience as a data scientist / bioinformatician working on biological data
• Ability and desire to work hands-on in data analyses
• Proficient in Python/MATLAB
• Experience in Machine Learning and big data infrastructure and databases
• Ability to work independently and collaboratively, while meeting deadlines in a fast-paced environment
• Exceptional attention to detail
• Team player, responsible, excellent communication skills
• Ability to communicate with the Company’s international colleagues outside of the standard business hours of the Tel-Aviv office
• Experience working on cancer / methylation data – Advantage
• Expertise in NGS data and pipelines – Advantage
• Knowledge of cloud tools such as Amazon's AWS, Google Colab – Advantage
The Director of Clinical & Regulatory Affairs is a key leadership position leading the planning and execution of critical Clinical and Regulatory Affairs activities for the company’s current commercial product – Bladder EpiCheck, a non invasive test indicated for the detection and recurrence monitoring of bladder cancer and upper tract urinary cancer. This role provides overall program leadership and management, and ensures cross-functional alignment as well as effective collaboration with external partners.
To apply for this opportunity, please send your resume and a cover letter to:[email protected]
JOB SUMMARY:
The Director of Clinical & Regulatory Affairs is a key leadership position leading the planning and execution of critical Clinical and Regulatory Affairs activities for the company’s current commercial product – Bladder EpiCheck, a non invasive test indicated for the detection and recurrence monitoring of bladder cancer and upper tract urinary cancer. This role provides overall program leadership and management, and ensures cross-functional alignment as well as effective collaboration with external partners.
Responsibilities:
• Overall responsibility for conducting Bladder EpiCheck regulated in vitro diagnostic (IVD) clinical trials in Europe and in the US, with and/or without company collaborators.
• Lead and manage cross-functional team(s) in the planning and execution of clinical trials in compliance with good clinical practices (GCP), department procedures and regulatory requirements.
• Oversee the preparation of all applicable documents required for the conduct of the study (i.e., Trial Master File (TMF), Clinical Protocols and Reports).
• Build and maintain clinical program timelines and drive clinical timelines in line with clinical and regulatory strategy and core team.
• Lead the development and implementation of Bladder EpiCheck regulatory strategies and processes (CE, IVDR, FDA) to gain and expand product approvals in US, EU and other markets; work with relevant regulatory consultants as may be required.
• Serve as regulatory affairs expert in company development programs by identifying, planning, driving, tracking and delivering on key regulatory milestones/objectives
• Interact with FDA, EU Notified Bodies and other global regulatory bodies and registration authorities as required to ensure timely, well thought, effective dialog and submissions
• Proactively partner with R&D, Product Development, Marketing, Quality, and other groups to provide regulatory advice and guidance on meeting necessary requirements to place products on the market globally
• Lead the Company’s clinical and regulatory activities associated with Bladder EpiCheck collaborations with external partners.
• Support / advise regarding possible clinical studies performed by, or with research partners / KOLs
Required Qualification:
• At least 8 years of experience in medical device or IVD clinical and regulatory affairs, with progressive management experience managing trials and vendors
• M.Sc or higher degree in a scientific discipline
• Extensive experience managing clinical programs, CROs, budgets, and timelines, including hands on experience in the performance and execution of key clinical trial activities (writing study protocols, contracting and managing clinical sites, managing recruitment challenges, ensuring adequate data collection and recording, analyzing and reporting study data etc.)
• Strong knowledge of Notified Bodies, CE/IVDD/IVDR and FDA requirements, and regulations of IVD products
• Hands on experience in the performance and execution of key regulatory activities (writing regulatory applications, writing responses to regulatory agencies etc.)
• Demonstrated problem solving capabilities, along with strong organizational skills and a collaborative attitude
• Excellent written and verbal communication skills
• Ability and willingness to travel up to 20% of the time, as needed
• Fluent English
Nucleix Ltd. develops, manufactures, and brings to market innovative non-invasive cancer molecular diagnostics tests. The company’s EpiCheck® core technology combines robust and highly sensitive biochemistries with sophisticated algorithms, to detect subtle cancer-specific changes in DNA methylation patterns and deliver excellent clinical performance. Bladder EpiCheck® is the company’s first on-market urine test for monitoring bladder cancer recurrence and is followed by an active pipeline focused on developing best-in-class yet affordable blood tests for early detection of lung cancer.
JOB SUMMARY: The Clinical Trial Associate (CTA) will be responsible for assisting the Clinical Operations team with clinical study, site, sample, data, and document management activities during all phases of study execution to achieve and maintain compliance with clinical study protocols, standard operating procedures, ICH/GCP regulatory guidelines and other applicable regulatory requirements. Reporting into the Sr.Director of Clinical Operations and working closely with the broader Nucleix Clinical Operations team and Clinical Research Organization, the CTA is expected to provide support across a spectrum of operational activities.
To apply for this opportunity, please send your resume and a cover letter to: [email protected]
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Collaborate with Nucleix Clinical Operations and the Contract Research Organization to ensure proper conduct of clinical studies in accordance with study protocols, timelines, and budgets.
• Assist clinical team to motivate and manage sites to achieve study deliverables (meeting, sample collection/shipment, quality data reporting).
• Create and maintain study tools and trackers.
• Provide feedback and guidance to sites for study sample collection, processing, and shipping.
• Continuously track and manage clinical trial collected biospecimens and service schedules for Nucleix equipment at sites.
• Work with relevant parties to track biospecimen specific information to assist researchers with selection of biospecimens for testing.
• Track the use and distribution of biospecimens for various projects.
• Fulfill biospecimen release requests to Laboratory Operations team.
• Work with Data Management to develop and maintain dashboards representing metrics and trends related clinical trial sample quality and testing.
• Address biospecimen related queries from internal stakeholder
• Track and manage blood collection kits and ancillary supplies inventories at vendor and sites, place initial and resupply orders.
• Participate in routine data review and cleaning exercises (utilizing systems and data listings/reports), and any special data-related initiatives as needed.
• Support the review of study-related documents such as protocols/amendments, consents CRFs, study tools, trackers, and forms.
• Build strong relationships with internal teams
• This position may assume additional duties as appropriately assigned.
• This position requires less than 10% travel.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
• Ability to work with moderate supervision in a fast-paced, collaborative startup environment.
• High degree of self-motivation, flexibility, and adaptability.
• Good verbal, written, and interpersonal communication skills.
• Detail oriented with a high level of organizational skills.
• Ability to work across time-zones to support the needs of a global team
EDUCATION AND EXPERIENCE REQUIRED:
• Bachelor’s Degree in a life science field.
• Previous experience in an administrative support role, preferably at a biotech or life sciences company.
• Experience with IVD clinical studies with a focus in oncology a plus.
• Familiarity regarding medical terminology and ICH/Good Clinical Practice guidelines.
• Competency with MS Office programs (Outlook, Word, Excel, Powerpoint).
PHYSICAL DEMANDS:
While performing the assigned duties the employee is frequently:
• Operating a computer/laptop
• Operating a phone/teleconferencing equipment
• Sitting
WORK ENVIRONMENT:
This is an office-based role located San Diego.
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