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Click here or scroll down to respond to this candidateDynamic, passionate leader with 20+ years of experience in progressively challenging clinical and drug development. Entrepreneurially-minded innovator with success launching new projects at scale.JOHNSON & JOHNSON INNOVATIVE MEDICINE, Raritan, NJ(Formerly Janssen Pharmaceuticals) Street Address PresentDirector, Global Development R&D, Street Address PresentKey Project: Janssen Retinal Research (www.retina.janssen.com), Street Address PresentSince Street Address , selected to lead global R&D operations for first-ever interventional gene-therapy development collaboration with UK-based biotech sponsor, MeiraGTxBuilt and executed a business case for new go-to-market clinical operations strategy, where J&J develops strategic partnerships with new, agile research partners and vendors to deliver rapid results on a global scaleLed J&J clinical operations into its first foray into a new therapeutic area of rare retinal indications, with the goal of becoming a leader in specialized precision medicine for retina impairment and blindnessIdentified key needs and recruited, hired, and staffed leaders for the projects; led with a solution-based mindset, prioritizing innovation amidst uncertaintyIntroduced best practice of collaborating with outside partners; managed hyper communication with colleagues and senior leaders, providing education and training for global J&J operations functionsSuccessfully managed 20 concurrent global clinical trials, providing research-backed data for the Association for Research in Vision and Ophthalmology (ARVO) and the American Academy of Ophthalmology (AAO) Global ConferencesDeveloped relationships with patient advocacy groups including Foundation Fighting Blindness and specialty clinics/hospitals in North America and Europe to recruit participants for studiesKey Project: Cardiovascular Metabolism, Invokana (www.invokana.com), 2014 2019Led lifecycle management program for type 2 diabetes drug, Invokana; identified additional uses for the product and potential line extensions, including protective benefit to patient kidneysProvided global operational leadership for clinical programs including CREDENCE and CANVAS studies, leading to sNDA approvals, results published in The New England Journal of MedicineOversaw mega trials with 5,000+ patients in each study, conducted in 40 countries at 1,000 sitesBuilt strategic relationships with key stakeholders, represented projects at leadership meetings, and guided direct reports through detailed planning exercises to create a shared long-term vision for the projectsReviewed potential opportunities in adjacent areas including obesity and liver disease, reviewed potential convergence projects between MedTech and PharmaOperational Experience:Planned and managed an annual budget exceeding $50 million for both financial and FTE spendNetworked across 10+ functional areas to ensure clear understanding of current portfolio state, provided clarity on priorities, and resolved resource constraintsInfluenced the development portfolio by completing > 30 due diligence exercises and financial scenario developments to support KEMs and cost-to-launchInstituted use of Data Sciences and Real-World Evidence to drive operational decision making and accelerate clinical trial recruitment by 25%Associate Director, Global R&D, Antibiotic Support, Doribax, 2013 2014Appointed to rotational position to oversee the global divestiture of Doribax, an antibiotic for serious infections; led the strategic return of licensure to original Japanese pharmaceutical companyLed a cross-functional team of 10 Sr. Directors and Directors during divestiture across 84 countriesOversaw marketing authorization (MA) transfers in 30 countries, MA withdraw in 54 countries; managed a patient access program to ensure ongoing medication availability and no unmet needsSpearheaded business continuity and market availability during divestiture, including global marketing and sales, regulatory, clinical, quality, and pharmacovigilanceExpanded alliance management with divest partners to chair monthly governance committee and collaboration with business development for contractual updatesSenior Manager, Global R&D, Infectious Diseases and Vaccines, 2010 2012Initiated and completed 4 research programs:Enrolled 1125 patients in 3 multinational clinical drug trials of an NS3/4A protease inhibitor (simeprevir), to enable approval of an NDA for treatment of HepatitisAchieved full enrollment of 100 patients in a Phase 3 study leading to an sNDA approval for treatment of HCV in patients co-infected with HIVInfluenced update to HCV treatment guidelines for patients co-infected with HCV and HIVReduced US site contract cycle times by 20% through a business improvement project in collaboration with R&D procurementManager, Global Development R&D, Neuroscience Therapeutic Areas, 2006 2010Coordinated operational management of multinational clinical trials across start-up, execution, and closeout, phases 1, 2, 3 and 4 (including pediatric)Demonstrated on-time start-up and closeout of 5 clinical studies in Neuroscience including:Launched a Phase 1 study (in patients) for a 3-monthly formulation of paliperidone palmitateLed a Phase 4 FDA post-approval commitment study for paliperidone (oral formulation)Initiated a $32 million, 936-patient relapse prevention study for adults with schizophrenia conducted in 17 countries globallyVolunteered for Global Clinical Operations initiatives in areas of process improvement, planning, project management, and trainingNOVARTIS PHARMACEUTICALS, East Hanover, NJSenior Clinical Scientist, 2004 2006, Clinical Scientist, 2003 2004Provided independent study leadership for start-up of a 2500 patient osteoporosis study with results published in Journal of Bone and Mineral ResearchDeveloped and managed a clinical trial budget of $25 million; partnered with 6 external vendors including a contract research organization, laboratories, and medical imaging vendorsChaired a 15-person Clinical Trial Team composed of representatives from CROs, data management, pharmacovigilance, medical, biostatistics, and other relevant departmentsChaired 4 global investigator meetings: preparation for meetings as well as delivering presentations to investigative staff and CRAs in conjunction with medical monitorTherapeutic Areas:Endocrinology Postmenopausal Osteoporosis, NASHInfectious Disease Hepatitis, HIVMetabolism Diabetes, Obesity, Liver & Kidney Diseases, PediatricsNeuroscience Schizophrenia, PainPulmonary Hypertension Pulmonary Arterial HypertensionRetinal Diseases Inherited Retinal Diseases, Diabetic Macular Edema, Diabetic Retinopathy,Age-Related Macular Degeneration, Geographic Atrophy, Thyroid Eye Disease, PediatricsVarious Compound Types Small molecule, Large Molecule, and Gene Therapy based productsEDUCATIONCOLUMBIA BUSINESS SCHOOL, New York, NYMBACompleted 3-year Executive MBA programSponsored by JanssenMIT SLOAN SCHOOL OF MANAGEMENT, Cambridge, MAExecutive Certificate in Management and LeadershipSponsored by JanssenBATES COLLEGE, Lewiston, MaineBA, Biology, Magna Cum LaudeVOLUNTEERTRIAGE CANCER, Board Member, 2023 PresentNational organization providing practical, financial, and legal advice to patients diagnosed with cancer and their caregivers, assisting 1M+ people per yearSETON HALL UNIVERSITY, Advisory Council Member, 2021 PresentStillman School of Business, Advisor for Transformative Leadership ProgramPersonal Interests:Volunteerism, Running, Arts for Kids, Classical Music, Cello Performance |
