Experience

Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Medical Director, Clinical Development- Multi-Tumor

  • Nov 2019 - Present



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Study lead/Study Director

  • Nov 2018 - Nov 2019

• Medical Monitor Clinical Development

  • Apr 2017 - Nov 2018

  • Safety Trial Medical Monitor, mainly responsible for the implementation of Phase 3 Crucial Trial• Responsible for Working alongside the Clinical Trial Lead/Program Lead• Early Asset Development Lead and clinical Operation cross-functional study team to monitor the safety parameters of ongoing oncology studies, and support database locks• Work with clinical team to review the safety data using tools: such as JReview, CIOMS and CFR’s, and imaging tool• Prepare/Present/discuss study updates as needed• Design and implement safety monitoring plan• Review safety signal for DBL (final listing review, review of blinded TLF’s, protocol deviation, participate/contribute in DBL meeting)• CSR writing (review final TLF’s, work with medical writer to review, revise CSR document, draft discussion and conclusion, participate in comment resolution meeting)• Respond to site and Health Authority question related to the protocol• Weekly investigator call for Phase III studies as needed• Monthly review of JReview and CRO data listing and QNET lab data• Review ad-hoc lab alert and SAE• Communicate with CRO sites regarding follow-up until resolution• Monthly review of protocol deviation• Participate, prepare present at Investigator meeting



Merck

• Sr. Clinical Scientist

  • May 2015 - Apr 2017

  Served as the lead responsible for the design and implantation of the assigned protocol and led the scientific aspect of the protocol Led all aspect of the protocol, from initiation to completion, including the conduct of clinical trials Developed study specific documents abstracts, manuscripts for external meetings, and authors clinical sections of regulatory documents IND, update IB, and SPURS Supported colleagues in overseeing the preparation of clinical sections of INDs, CTAs, ISS’s Presented data and findings at internal, DSMC, and applied recommendations Prepared and presented the safety portion of the protocol in the investigator meeting Established and fosters effective working relationships with study investigators, KOLs, clinician and internal colleagues Ensures adherence to GCP/ICH Responsible for trial design and endpoint development in collaboration with CD Authored protocol, protocol amendment, synopsis and PI clarification letter Collaborated with MW, participated in DRC/DVC/PRC/FORCe and authored to study specific documents (e.g., SMP, MMP), reviewed/updated ICF Provided scientific input to SM for data management activities including clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO), co-authored newsletters with SM Provided scientific assessment for operational review Monitored central lab reports and other external data for safety and critical values data issues requiring clinical input Prepared scientific slides, attended and presented protocol information at investigators meeting Led the Clinical Trial Team and Outsourced Trial Team Authored the MMP Worked with Pharmacovigilance to ensure all Safety issues are addressed/reconsolidated Reviewed specs, initiates allocation (randomization) requested form (ASRF) and approved schedule in CSGS Coordinated planning of lab, biospecimens and imaging specifications



Eisai US

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Clinical Research Scientist, Oncology PCU

  • Mar 2013 - May 2015

  Support Lead MD implementing Global Clinical Development Plan. Responsible for on-going review of protocol development, DMC, and scientific steering committee meetings. Review of narratives, safety report, preparation of regulatory documents. Briefing documents such as CSR, NDA’s and MAA’s. Primary interaction to influence across multiple functions such as DM, ClinOps & Drug safety.Clinical lead in cross-functional & clinical meetings. Presenting activities in Monthly Oncology Meeting.Lead the preparation of key clinical documents for regulatory submission e.g. IB, narrative, clinical section of registration dossier document such as ISS, ISE, CSR.Support database cleaning, review of study results, in addition to interpreting of results.Serve as Study Director for selected trials.

• Sr Clinical Research Scientist, Study Director

  • Mar 2013 - Mar 2015



Roche Pharmaceuticals

• New Jersey

• Clinical Science Specialist

  • Jan 2009 - Nov 2011

  Reviewed safety and efficacy data, in addition post-marketing safety review for phase IIIB Reviewed safety parameter, including but not limited to adverse event AE/SAE’s, concomitant meds laboratory values, medical history, protocol deviation Generated discrepancies, followed through to resolution, in complex cases, scheduled PI call, speak to PI to ensure adequate resolution Wrote, and QCed safety narrative for CSR Worked with pharmacovigilance in support of global IMS, including but not limited to individuals cases, and reconciliation of cases Worked with data management colleagues, field monitor, and clinical trial manager to ensure prompt and accurate discrepancies resolution/reconciliation were documented Managed CRO’s performance and deliverables Reviewed SAE/AE, concomitant treatment, laboratory values, and medical history, supplemental medical records, and diagnostics procedure Reviewed analyses of statistic outputs Worked in three interim analyses during a two-year period in support of regulatory filings and periodic safety updates Actively contributed in aspects such as safety parameters of an LTE extension study for a Phase IIIB Reviewed sections for NDA submission such as index, in addition to performing literature searches to answer medical questions Contributed with the lead in the overall study planning, management, evaluation, and documentation Compiled clinical scientific input for the final study report Presented cases of interest to global drug safety peers during safety meetings & clinical and safety review of CRF’s • Performed SAE reconciliation and aggregate review listing of all the safety parameter for the study in support of our numerous database lock Reviewed line listings utilizing MedDRA coding and queries Collaborated providing the response to regulatory agency questions and preparation of advisory committee meeting



Novartis Pharmaceutical

• Clinical Research Associate

  • Jan 2007 - Jan 2009

  Site initiation, monitoring visits, closeout visits, drug accountability visits for multiple therapeutic clinical trials pre-screen sites & PI CTMF Participated in investigator meetings Assured continuity and compliance of GCP, ICH, EDC. Facilitated preparation and collection of site level documents for IRB submission for drug release Monitored visits in compliance with protocol monitoring plan, drug accountability, closeout visits and authored study monitoring reports Oversaw approximately 20 sites as the primary CRA of multi Therapeutic areas Managed drug site supply management. IVRS. WVRS and drug reconciliation Resolved site level updates of technical systems, such as EDC



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research associate

  • Mar 2007 - Nov 2007

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