Senior Director, Late Stage Clinical Development
June 2018 to July 2018
Medical Director, Late Stage Clinical Development
November 2016 to June 2018
Medical Director, MS Clinical Development
August 2014 to November 2016
Schneider Children's Hospital. Long Island Jewish Medical Center
July 1991 to June 1992
New Hyde Park, NY
February 2005 to February 2014
Lane Labs, USA, Inc.
Director, Scientific Affairs
June 2004 to February 2005
Head of Clinical Research
July 1997 to May 2004
Great Neck, NY
Eli Lilly and Company
Clinical Head Global Pain
Cambridge, Massachusetts, United States
Executive Medical Director, Clinical Development
July 2018 to April 2020
Senior Director, Late Stage Clinical Development @ Biogen From June 2018 to July 2018 (2 months) Cambridge,MAMedical Director, Late Stage Clinical Development @ Biogen From November 2016 to June 2018 (1 year 8 months) Cambridge, MAMedical Director, MS Clinical Development @ Biogen From August 2014 to November 2016 (2 years 4 months) Cambridge, MAResident, Pediatrics @ Schneider Children's Hospital. Long Island Jewish Medical Center - Administered patient care directly; participated with other physicians to ensure appropriate patient care; taught medical students; prepared patient case reports. From July 1991 to June 1992 (1 year) New Hyde Park, NYMedical Director @ Purdue Pharma - As clinical leader of programs for a transdermal patch and an abuse deterrent opioid product, I managed pre- and post-marketing medical research activities, including protocol development, medical and operational oversight of clinical trials, and medical monitoring. - I led and managed clinical aspects of development of patient recruitment strategies and materials, including brochures, educational videos and website.- As project leader of a transdermal patch program, I was responsible for U.S. activities from manufacturing to nonclinical and clinical, and including marketing planning and support of all international activities. - I led and managed a senior-level, cross-functional project team, ensuring high-quality project deliverables were achieved within approved plan and budget. I implemented project team-level decisions, overall project budget management, staffing and team operations.- Extensive NDA experience, as part of medical research teams contributing to submission-related and filing activities for the successful prosecution of NDA for a transdermal patch for chronic pain and submission-related and filing activities for an abuse-deterrent opioid product. - Responsible for drafting and review of clinical modules, preparation of scripts and slide decks for advisory committee meetings, and preparation for and participation in meetings with FDA.- Led pediatric programs, including Phase 1 through 3 trials; responsible to develop, coordinate and manage activities in support of meeting PREA requirements and in pursuit of gaining pediatric exclusivity for several pain management products.- Experience interfacing with External Experts and Organizations. - Developed and managed Pediatric Advisory Board, initiating and maintaining relationships with key opinion leaders. - Presented to and developed and managed relationships with pediatric organizations. From February 2005 to February 2014 (9 years 1 month) Stamford, CTDirector, Scientific Affairs @ Lane Labs, USA, Inc. - As Director, Scientific Affairs I evaluated existing clinical research on both current and potential products, focusing on efficacy and claim substantiation. - I designed clinical trials for potential products across therapeutic areas, including osteoarthritis, hyperlipidemia, and peptic ulcer disease; I provided guidance to the marketing department in support of new product development, substantiating accuracy of medical claims and determining product positioning. From June 2004 to February 2005 (9 months) Allendale, NJHead of Clinical Research @ RTL, Inc - In my initial role, I built and led a medical writing group. As I progressed to lead the clinical research program, I was responsible for all aspects of protocol development, supported NDA activities, including drafting of submission-related documents and communications with FDA, served as medical monitor for numerous multi-center clinical trials and as investigator for certain in-house studies, created and maintained budgets for clinical trials and managed scientific communications.- The studies for which I was responsible evaluated prescription drugs, over-the-counter products, dietary supplements, medical devices and novel delivery systems for previously approved drugs. - Therapeutic areas included pain, mental health, infectious disease, obesity, hyperlipidemia, smoking cessation, women's health, dermatological conditions, gastrointestinal disorders, upper respiratory tract illnesses and motion sickness. From July 1997 to May 2004 (6 years 11 months) Great Neck, NYClinical Head Global Pain @ Eli Lilly and Company Cambridge, Massachusetts, United StatesExecutive Medical Director, Clinical Development @ Sarepta Therapeutics From July 2018 to April 2020 (1 year 10 months) Cambridge, MA
What company does Deb Steiner work for?
Deb Steiner works for Biogen
What is Deb Steiner's role at Biogen?
Deb Steiner is Senior Director, Late Stage Clinical Development
What industry does Deb Steiner work in?
Deb Steiner works in the Biotechnology industry.
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2 year(s), 11 month(s)
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