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Click here or scroll down to respond to this candidateCandidate's Name , MD MSStreet Address (H) PHONE NUMBER AVAILABLE (C) PHONE NUMBER AVAILABLE EMAIL AVAILABLEProfessional Summary MD, MS in Epidemiology with Medical Director experience in R&D, Operations and Marketing including Clinical Study Director at Sanofi over 2 years in CVD, Pediatrics, Metabolism, and CNS. At Sanofi, I earned 2 Breakthrough Awards for demonstration of Sanofi corporate values (Integrity, Cooperate Transversally, Strive for Results, Teamworking, and Commitment to Customer) for alircoumab/Praluent in Diabetes (Type 1 and Type 2) and CVD. At Novartis, I helped work on digital Skype tools for Medical Education in CNS, Oncology, and Endocrinology. At Sanofi, I helped evaluate the feasibility of digital tools (facebook) for patient recruitment and dose delivery to expedite clinical trial completion, accuracy, and patient convenience. Now, I direct global investments as an independent director.SkillsMedical DirectorR&D, OperationsMarketingDigital Education toolsMultiple therapeutic areas, including:1.Cardiovascular Dise2.Pediatrics3.Metabolism - Diabetes4.CNS5.Oncology6.NuclearMedicineWork HistoryIndependent Investment Director 08/2018-PresentDirect intestment risk distribution, content, quarterly adjustments and opportunities in light of global economic drivers andchallengesAssociated with TIAA-CREFClinical Study Director, Medical Operations, Sanofi (role closed) 01/2015-01/2018Provide expertise and act as a reference for all medical operational activities (protocol writing, risk/benefit analysis, CAPA, operational feasibility assessment, safety monitoring, KRM preparation, CSR leadership) for Praluent in Diabetes, CVD, and PediatricsWrite/contribute/review/QC/validate study related documents: clinical protocols, informed consent forms, trial disclosure forms case report form, study plans (e.g. study risk management plan, central monitoring plan), study reports, material for training and meetings (such as investigators meetings). Contribute to publications and communications of the study resultsCollaborate and communicate appropriately with all stakeholders for optimal study execution including but not limited to: feasibility managers, clinical scientists, pharmacovigilance (GSO), biostatistics, CTOMS, CROs, Regulatory affairs, Trial Transparency, and Medical AdvisorsStrategically support development of feasibility questionnaires (pre-assessment and operational) to challenge/simplify protocols for site execution eliminate barriers pre-execution and thus permit trial execution in a timely manner aligned with development plans and real life constraints across global sitesChallenge appropriately the study extended synopsis based on feasibility pre-assessment, taking into account protocol complexity and associated costResponsibility and accountable for overall supervision/execution of validation/review of study data, including writing or supervision of study related documents (e.g. medical review plan, guidelines, etc.)Organize/contribute/participate in Investigators meetings, Steering Committees, Data Monitoring Committees meetings, adjudication committees and prepare related material (e.g. charter, presentations)Provide medical answers to questions from Health Authorities and IRB/EthicsDirector of Neuroimaging and Nuclear Medicine 09/2014 to 12/2015The Neuro-Cognitive Institute West Orange, NJCo-investigator for Phase 2 & 3 pharmaceutical studies in CNS (Alzheimers disease) for various MOA class targetsand partners including Accera, Merck, Otsuka, and LundbeckMedical consultant: protocol design, publications, and marketing materials for various clients, including Belrosepharma (type 3 Gauchers disease), Piramal Healthcare (Amyloid PET imaging in Alzheimers disease), and Axsome therapeutics (Complex Regional Pain syndrome)Directed internal research on using demographics, neurocognitive baseline scales for mild cognitive impairment, baseline IQ, sLoreta EEG and Amyloid PET imaging to predictconversion from mild cognitive impairment to Alzheimers diseaseDeputy Director, US Medical Affairs, Bayer Pharmaceuticals Whippany, NJ 01/2014 to 06/2014(Full time: Bayer restructured)Active participation and effective interaction with Global teams to ensure appropriate US direction of the company's research and marketing efforts relative to the US environment as well as responsible for the execution of an overall medical strategyProvide support and medical expertise to US cross-functional teams within the Business Units regarding the development of educational materials, monitoring of published literature, addressing and resolving international, regional, and local issues related to products under their responsibility and provide input to company documents to ensure scientific accuracy as well as implementSupport completion of NDA reports for respective brands through evaluation of clinical data and literature and provide USMA input in preparation of key medical documents for INDS and NDAs, including ensuring appropriate USMA input interactions with the FDAParticipate in scientific review of investigator initiated studies and be answerable medically for clinical studies under the direction as well as directing the design, conduct, and analysis and reporting of Phase IV US clinical trials.Explore and evaluate new product ideas to assist in identifying new market opportunities and perform medical evaluations and due diligence of pharmaceutical products for in-licensing in the USInterface with both internal and external (KOLs, advisors, consultants) experts and medical organizations in order to develop and maintain productive contactsProvide feedback with respective line manager in the recruitment, development and performance management of appropriate team members (including cross- functional partners)VP, Medical DirectorAgency RX - Cline, David, & Mann New York, NY 06/2013 to 12/2013(Bayer recruited me)Worked collaboratively with cross-functional teams, internal and external, to define strategic medical objectives (disease burden, MOA messaging, drug label templates) for brands in Oncology, CNS, Cardiovascular Disease, and NephrologySpearheaded medical and market research initiatives for clients including Roche, Novartis, Pfizer, Keryx, and prospective clients (Astellas- Medivation)Developed and won new business for current and prospectiveclientsDesigned workshop for Strategic Services team on core principles of enduring brandingMedical strategy onboarding and market opportunity analyses live reviews for Agency RX and Global CDM partners (EU)Projected Scope of Work Annual costs for assigned products and projectsMicrosoft Dynamics Ambassador (finance software)Multiple contracts in Oncology and CNS from 06/2009 to 02/2013Nuclear Medicine Resident & Neurology ResidentYale New Haven Hospital New Haven, CT01/2005 to 06/2009Nuclear Medicine Resident & Chief ResidentYale New Haven Hospital New Haven, CTNuclear medicine diagnosis, triage, and cutting edge diagnostic imaging and coupled treatment (coupled radionucleotides and drugs) with particular specialization in Oncology, CV, CNS, Nephrology, Pediatrics. High volume in Oncology PET and Heme diagnosis and treatment.Triaged and diagnosed acute and chronic CNS patients with a high volume (30%) of Multiple Sclerosis and Parkinsons disease patients (30%) on a day to day basisHigh volume and specialization in patients in Epilepsy, Parkinson's Disease, and Multiple Sclerosis and Stroke including specialized inpatient and outpatient clinic rotationsChildcareChildcare Summit, NJChildcare for our daughter (ages 6-8)Clinical and Research Fellow in Radiology Massachusetts General Hospital Boston, MA07/2009 to 06/201209/2000 to 12/2001Designed, ran and monitored data to safety for phase 3 clinical trials including patient recruitment, selection criteria, statistical methodology choice for novel MRI perfusion imaging studies to monitor anti-angiogenic drugs and other treatments for CNS glioma in collaboration with Siemens corporationDesigned, ran and monitored data to safety for phase 3 clinical trials including patient recruitment, selection criteria, statistical methodology choice, for study correlating diffusion tensor FA values with Rankin scores to predict hospital day (duration) for brain trauma patients in the ICUPrepared abstracts and manuscripts for presentation to publication at Global medical conferences in Oncology and Diagnostic RadiologyPreliminary Medicine in Internal MedicineRoger Williams Medical Center & Rhode Island Hospital Providence, RI07/1999 to 08/2000Inpatient and outpatient diagnosis and management of internal medicine patientsEducationMaster of Science: EpidemiologyHarvard School of Public Health - Boston, MAM.D.: Medicine09/2001-05/2002Brown Medical School - Providence, RI09/1995-05/1999Bachelor of Science: NeuroscienceBrown University - Providence, RI09/1991-05/1995Bachelor of Arts: Religious StudiesBrown University - Providence, RI09/1991-05/1995CertificationsLran In Circle Leader 6/23Present.American Management Association Certification in Leading with Emotional QuotientWorld Tae Won Do Federation Certified Black Belt, with grey stripeG. Milton Shy Award from American Academy of Neurology for breakthrough research on placebo response in Parkinsons Disease.American Board Certification in Nuclear MedicineBrown University: Phi Beta Kappa, Sigma Chi, and Magna Cum LaudeBrown Medical School: Stanley A. Aronson Award for best medical student in Neuroscience and NeurologyNew York Medical License (lifetime): 257834New Jersey Medical License: 25MA09672300 |
