Sheila Mahoney-Jewels Email and Phone Number
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Drug development SME (originally regulatory, have now worked in or with almost every functional area in R&D and some commercial), I now focus on "the business" of drug development- contracting, budgeting, and extending the investment runway via agility and innovation. Current focus- advanced data science including AI/ML and how applying it is transforming every corner of drug development.
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Safety Science: Operations And StrategyAsap Process ConsultingNew York, United States -
Advanced Data Science: Operations And StrategySmart Data Analysis And Statistics B.V. Apr 2024 - PresentThomas Debray is recognized as one of the industry's highest quality experts with respect to drug development data science, advanced analytics, and the application of AI/ML: the most sought after drug development skills today, also the hardest to find!I help Thomas and SDAS get the word out about the remarkable projects we are doing for drug sponsors, and connect with other drug sponsors who need these skills with ever-increasing urgency.My passion is enable drug sponsors to leverage niche "Micro Vendors" such as Thomas and SDAS, instead of look to their current large suppliers. "Large" is very good for pharma, but subjective to precipitous diminishing returns when it comes to cutting edge innovation and capabilities such as these. -
Safety Science: Operations And StrategyAsap Process Consulting Jan 2023 - PresentGreg Ball, PhD, is one of the world's leading experts on advanced safety science, analytics, and data visualization. Having built the aggregate safety assessment planning process (ASAP) at Merck, Greg realized other drug sponsors need help adopting these new methodologies, quickly, to not only get in greater alignment with the spirit of the IND Safety Final Rule, but because asset revenue streams are positively impacted by greater, more advanced command of safety data.Through LifeSciHub, I support ASAP Process Consulting, Inc. (ASAP PCI) with contracts, time tracking, invoicing, payment processing, reporting, business strategy, operations, business development, and any other small business support ASAP PCI requires. I also participate in ASAP PCI projects as needed as Drug Development Cross Functionalist.It is exciting to support Greg in his quest to help Drug Sponsors evolve their "efficacy mindset" and embrace all the abundance that advanced drug safety analytics has to offer! -
Biostatistics Leadership And Data Science Training: Operations And ContractingThe Effective Statistician Jan 2023 - PresentButzbach, Deutschland, DeAlexander Schacht, PhD, is a world-renowned biostatistician, Real World Evidence, and Medical Affairs expert who has recognized the need for biostatisticians to take a greater leadership role in this digital, data-drenched world we find ourselves living in. From his lengthy career in pharma (BI, Lilly, UCB) Alexander has his finger on the pulse of all the current and future skills pharma stats and data science needs to know. In lieu of internal training groups who struggle to put content together, drug sponsors are increasingly looking to Alexander and The Effective Statistician to upskill their statistical capabilities on a global basis, to great competitive advantage.I, through LifeSciHub, support Alexander with contracting, payment processing, and with developing creative, strategic offerings designed to increase drug sponsor statistical and data science competitive fitness.LifeSciHub is The Effective Statistician's provider of choice for any drug sponsor clients who need temporary biometrics expertise. It is a pleasure to, through Alexander and The Effective Statistician, help drug sponsors with the Sisyphian task of upskilling! -
Drug Development "Micro Vendor" EcosystemLifescihub Sep 2018 - PresentNew York, Ny, Us-Agile access to the highest quality, highly specialized drug development expertise.-Radically transparent contracting channel to the "micro vendor" ecosystem.-Micro vendor= 20+ years drug sponsor experience (R&D or commercialization) who now operates as an independently incorporated business of one.-LifeSciHub solves the procurement and legal barriers to engaging with the drug development microvendor ecosystem.LifeSciHub services: -For drug sponsors: highest quality and most experienced: all functional areas and highly specialized drug development needs; contracts and invoicing consolidation; vetting and compliance; radical transparency (of mark ups), total flexibility of payment terms-For microvendors: business administration, payment processing, time tracking and invoicing, business development, strategic marketing, networking, introductions, any other support for small businesses, incorporation assistance -
Life Sciences Executive Management ConsultantSelf-Employed May 2014 - PresentCross functional drug development expert, business analyst and utility player with experience and actionable insights in: regulatory, clinical operations, pharmacovigilance, biometrics, medical affairs and commercialization. Deeply knowledgeable of the global drug development vendor ecosystem and technologies relied on to support those functions, as well as emerging innovations such as the application of AI in multiple drug development functional areas. Administration and business management support includes P&L management; risk-benefit analysis, ROI and business case construction & presentation; budget planning, accountability, and reconciliation; projected revenue vs. actual analysis; strategic drug development resource planning; investor relations. Industry thought leadership in Regulatory Information Management, Medical Writing, Quality, and Strategic Safety Analytics.
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Vice President Business DevelopmentPhlexglobal Jun 2013 - May 2014Bad Homburg, De -
Vice President, Corporate DevelopmentVirtify, Inc. Sep 2011 - Jun 2013
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Senior DirectorImage Solutions, Inc. (Acquired By Csc) May 1998 - Aug 2011Whippany, Nj, UsCritical contributor to the start up operation. Change agent for successful corporate strategy during 13 year growth, including key strategic input on services output and offerings, software, internal infrastructure and business development. Direct focus on business development including US regional sales and management, partially responsible for Europe, key projects in Japan and China. -
President And FounderDocument Kinetics Jan 1996 - May 1998Recognizing the emerging demand for electronic document management in the pharmaceutical industry, created business to address the unmet need: nascent use of electronic document data management. Business model: transfer mature service offerings from litigation support to adaptable skill sets in the pharmaceutical industry. Provide pharmaceutical industry with significantly lower price points than newly emerging vendors in this space. After successful independent operation, acquired by ISI.
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Regulatory Affairs AssociateForest Laboratories Jan 1995 - Jan 1998UsManaged regulatory profile for SSRI product line. Interacted with FDA, reported progress, implemented extensive regulatory operations for key dossier management. -
Regulatory Document ManagerCenter Laboratories Nov 1993 - Jan 1995Submitted, maintained, managed regulatory document and database for entire regulatory profile, drugs and devices.
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Legal AssistantMorgan, Lewis & Bockius Llp Aug 1992 - Dec 1993Philadelphia, Pa, UsLitigation support focused on multi-million page paper and electronic document management.
Sheila Mahoney-Jewels Skills
Sheila Mahoney-Jewels Education Details
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Columbia Business SchoolEmba -
Smith CollegeThesis: Environmental Studies
Frequently Asked Questions about Sheila Mahoney-Jewels
What company does Sheila Mahoney-Jewels work for?
Sheila Mahoney-Jewels works for Asap Process Consulting
What is Sheila Mahoney-Jewels's role at the current company?
Sheila Mahoney-Jewels's current role is Safety Science: Operations and Strategy.
What is Sheila Mahoney-Jewels's email address?
Sheila Mahoney-Jewels's email address is sm****@****ies.com
What schools did Sheila Mahoney-Jewels attend?
Sheila Mahoney-Jewels attended Columbia Business School, Smith College.
What skills is Sheila Mahoney-Jewels known for?
Sheila Mahoney-Jewels has skills like Pharmaceutical Industry, Business Development, Cross Functional Team Leadership, Biotechnology, Business Analysis, Lifesciences, Project Management, Clinical Trials, Sales, New Business Development, Business Process, Change Management.
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