Experienced Data Manager having worked in the following therapeutic areas:
* Oncology
* CNS
* Diabetes
* Infectious Diseases
* Respiratory
Also, experience in Phase I, II, III and IIIb studies in both the EDC environment (primarily in OC RDC and Medidata) and the paper CRF environment.
Provides process development and evaluation.
Develops training for data manager in areas from GCP and the CDM role to query writing and CRF development.
Provides mentoring and general consulting to the DM group.
Specialties: Vendor Management
Risk Analysis & Management
Problem Solving
Team Building and Communication
Training
Mentoring
GCDMP
SQL and SAS Programming
Tableau
Juliet is a biopharma leader with experience in clinical development, business development, portfolio strategy, finance, marketing, and sales. She has worked in venture backed start-ups and global pharmaceutical companies. At AstraZeneca, she led the launch of Imfinzi in lung cancer, which achieved blockbuster status the fastest of any AZ product. Prior to AZ she worked at Bristol-Myers Squibb, where she led the marketing team for Erbitux in head & neck cancer, and was the global commercial lead for lung portfolio strategy, providing commercial input for early oncology clinical development programs. Prior to BMS, Juliet worked at EMD Serono, where she was a member of global product teams overseeing development of early and late-stage oncology molecules. She began her oncology work at Genentech, where she worked on the Avastin clinical development team. Juliet started her biopharma career at Eyetech Pharmaceuticals, a venture backed start-up which went public and was acquired by OSI. There she focused on finance and business development, working on the Pfizer Macugen deal, the 3rd largest biotech licensing agreement at the time, and in-licensing ophthalmology candidates. Juliet has an MBA from Columbia Business School and a BA from Bryn Mawr College.
Steve has 20 years of clinical research experience and has spent the majority of that time working within oncology. He is driven to help patients by developing new therapies that improve outcomes. He started his career as a Study Coordinator in the Neuroimaging Center at a McLean Hospital before moving to his first industry position at Genzyme where he worked in various roles within clinical operations and has worked in small biotechs, as well as big pharma. Steve has spent the last 7 years at GSK working as a Clinical Operations Program lead, and helped the team move an asset from a first-in-human trial through numerous phase II and III trials which have resulted in multiple marketing authorizations around the globe within endometrial cancer and dMMR solid tumors. He takes a pragmatic approach while focusing on quality, timely delivery, and efficiency.
Sergio Santillana is a medical oncologist with more than 25 years of oncology drug development and clinical practice experience. Prior to providing strategic consultancy services to a variety of life science companies, including Ikena Oncology, he was Chief Medical Officer for Merrimack Pharmaceuticals, focused on developing biologics and nanotherapeutics for solid tumors. Before joining Merrimack, he was Chief Medical Officer for ARIAD Pharmaceuticals, a commercial-stage biotechnology company that was acquired by Takeda. Under Sergio’s leadership, ARIAD obtained US regulatory approval of Brigatinib for the treatment of ALK+ NSCLC, and had continued growth of its portfolio of targeted agents in solid tumors. Preceding his executive role at ARIAD, he served in various oncology clinical development leadership roles at Takeda, GlaxoSmithKline and Eli Lilly. Before entering the biopharma industry, he was a practicing board-certified medical oncologist for 15 years, including tenure at the National Cancer Institute of Peru (INEN) where his research focus was in clinical studies of novel agents. He holds an M.D. and B.S. from the Universidad Nacional Federico Villarreal School of Medicine in Lima, Peru and a M.Sc. in Experimental Therapeutics from Kellogg College at the University of Oxford. He also holds an MBA from the MIT Sloan School of Management.
For more than 20 years, Mick Ribeiro, MSc., PMP, has been a leader in clinical research, managing and overseeing the development of various compounds and vaccines from Phase 1 to Phase 4 studies. He has worked with biotechs and Fortune 500 companies, bringing perspective and balance to an industry that thrives on discovery.
As the Vice President Clinical Operations at Ribon Therapeutics, he is responsible for the strategic planning, execution, and oversight of the company’s clinical programs, ensuring quality, compliance, and efficiency. He also runs his own consulting business, Biotech Clinical Consulting LLC, providing services to start-ups and early stage biotech companies in clinical operations, business operations, vendor selection and management, and inspection support. Multi-lingual and globally minded, he coordinates operations across diverse regions and cultures, applying his expertise in Good Clinical Practice (GCP) and Project Management.
Carla Compte works as the Affiliate Manager at GNT Iberia as well as managing sales with a strong focus on the beverage category. Carla’s background is technical, having studied Chemical Engineering at IQS in Barcelona and completed this background with a Master in Marketing and Sales at ESADE for a more business oriented approach to her day to day activity. After her over 10 years’ experience working at GNT, with EXBERRY® coloring foods, she brings expert advice to her customers and supports them throughout the development process to produce colorful, natural, trend setting and sustainable products to the market.
Helen Vine is a Key Account Manager at GNT in the UK and is also focussed Commercial Category lead for Non-Alcoholic Beverages EMEA, with extensive experience supporting the industry to create colourful and appetising food and drink products using EXBERRY® plant-based colours. Helen’s background is technical, having studied Food Science and Nutrition at Nottingham University and she subsequently spent 5 years in alcoholic beverage development for a major international brewery prior to joining GNT in 2005. Helen is passionate about delivering colour in the most healthy, sustainable, and natural way using plant-based solutions and takes pride in supporting successful product development and marketing from concept to launch.
Stefan has been working in clinical technology for over 20 years, including product management and project leadership roles for IQVIA Interactive Response Technology. He is currently leading teams responsible for the IRT Drug Supply Center of Excellence and key customer accounts.
Stefan is very passionate about finding innovative solutions to clinical supply challenges. He holds a Master of Science in Molecular Biology and an International Executive MBA from the University of St. Gallen.
As Vice President of Commercial Strategy at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.
Professional performance
– Former member of Pistrelli, Díaz y Asociados (Arthur Andersen & Co.).
– Director, trustee and member of the auditing team of several companies, coordinating the development and implementation of different application systems.
– Author of different articles on taxes and accounting in national media and industry publications.
Teaching background
– Professor of the PIADeF – International Fraud Audit and Detection Program organized by SMS Latin America and the University of Bologna.
– Guest professor and speaker in numerous academic fields on topics of his specialty (University of Buenos Aires, ITBA, University of Palermo, Xavier University, State University of New York, etc.).
– Frequent speaker at Seminars and Technical Conferences of his specialty
– He was a professor of Accounting and Management Chairs at the University of Buenos Aires and Intermediate Accounting at the University of Salvador.
– Participated as an instructor in various training courses in different companies on Accounting and Auditing.
Proffesional Training
– Current Professional Meetings (EPA).
o Current Professional Meetings
o Performance Factors / Emotional Intelligence
o Personality / Myers-Briggs Model
o Writing Workshop
o Fraud Prevention Workshop
o Gender and Diversity
