Experience

GentiBio
• United States
• Biotechnology
• 1 - 100 Employee
• Senior Director Program Management

  • Jan 2022 - Present

Dicerna Pharmaceuticals, Inc.
• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee
• Director, Program Development

  • Jul 2020 - Jan 2022


Eloxx Pharmaceuticals

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Director of Program Management

  • Sep 2018 - Jun 2020

  •Created and maintain both Integrated Development and Target Profile Plans for drug development programs in the areas of Cystic Fibrosis, Cystinosis and Inherited Retinal Disorders, as well as, being one of the top contributors to the generation of Clinical Development Plans for these disease areas. •Drive program activities through teams and sub-teams; by generating dashboards, SWOT analyses, and scorecards, identifying and tracking key deliverables for each function and ensuring cross-functional alignment. •Strategically leading, as interim program head, a multi-million dollar development program with global external CRO’s, discussing bi-weekly project work flows, deliverables; capturing program development goal(s) and timelines to push toward IND. •Participate in annual portfolio analysis process to ensure accurate information and timelines are completed and presented recommendations to Senior Management and Board of Directors. •Facilitated communications with internal and external regulatory teams driving US, EU, Israeli and Canada health authority submission process, as well as, representing Eloxx at face to face FDA Meetings. •Present updates to stakeholders on significant activities, critical path dependencies, and overall timelines and milestones to align corporate strategy, guaranteeing effective program execution. •Interim Inherited Retinal Disorder program lead coordinating day to day operations defined in project scope; liaison between CRO/sponsor identifying study issues and solutions and anticipating potential study issues and preparing contingency plans with minimal oversight. •Identify and drive project and resource priorities that align with the business objectives that identify ways to accelerate the project execution where possible while maintaining high quality standards. •Lead multiple rare and ultrarare disease programs in defining and implementing the strategy and program plan by using program/project tools. Show less



Radius Health, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director, Research Operations

  • Aug 2016 - Sep 2018

  •Maximize project budgets by working with finance to develop, forecast, track program spend, identify variances, and anticipating changes, escalating issues that could impact overall project cost.•Responsible for proactively recognizing potential drug development program risks, identifying and evaluating mitigation's and contingencies, implementing action plans and following issues through until resolution. •Provide strategic planning and management support to various cross-functional areas including research, marketing, regulatory, manufacturing and clinical operations to develop short and long term goals, define project scope and product direction. •Nonclinical head of a development team that managed global regulatory submissions (IND, NDA and MAA) for Radius' first commercialized drug. •Lead Radius’ Post Marketing Commitment to the FDA by designing an immunogenicity study, authoring the protocol, overseeing outsourced central laboratories and reviewing/validating data and documentation.•Managed Research Operations to ensure that department goals align with corporate objectives by allocating resources and developing functional strategies. •Develop, execute, and maintain regulatory submissions including submission content plans, and provide status updates to designated stakeholders.•Identified as a high performing individual and was the only employee chosen to attended a 9-Month Organizational Leaders Program, in 5 interactive educational workshops and working with a personal executive coach, with the goal of transforming technical and functional experts into broader and more influential leaders. Show less

• Project Manager

  • Oct 2014 - Aug 2016

  •Managed program contracts and resourcing activities by developing and reviewing requests for proposals (RFPs), negotiating revisions to proposals and timelines and providing recommendations for vendor selection with clear rationale and justification. •Negotiated contracts (Master Service Agreements, Statement of Works and Confidentiality Agreements) and managed invoices with vendors, consultants and contractors, confirming all contractual obligations, commitments and deliverables are met. •Directed the development, execution and completion of multiple internal and external projects by managing scope, resources, , costand guaranteeing high quality project deliverables. •Tracked and reported the group’s activities, including requests, assignments, and meetings by maintaining the group’s documentation and project management databases.•Responsible for coordinating the timing and execution of preclinical studies and oversight of daily study activities as well as monitoring study activities at contract sites.•Designed and established a 4,600 sq. ft., offsite preclinical laboratory, now a fully operational R&D facility, for in-vivo and in-vitro studies, tissue culture, stem cell research, and microbiology. •Participated in clinical study strategy development for incorporation of laboratory specimen collection and analysis into both operational and scientific execution. Show less


BioBoston Contract Laboratories
• Preclinical Consultant

  • Aug 2014 - Aug 2015


Olympus Biotech

• France
• Human Resources Services

• Preclinical Manager

  • Jul 2011 - May 2014

  •Developed a novel carrier for rhBMP-7, which improved the current product formulation and handling, reduced the immunogenicity and increased the efficacy of bone formation, which addressed previous FDA concerns and supported a new PMA submission. •Executed in-house and external nonclinical efficacy, PD/PK, DMPK and Safety/Toxicology studies by leading study design, protocol generation, and data analysis/interpretation, establishing the minimally efficacious dose of rhBMP-7 for Foot and Ankle Fusion in support of 2 pilot clinical trials. •Conducted all CRO outsourcing activities by identifying, selecting and screening vendors, conducting bid reviews and negotiating bid price reductions, which decreased project costs by at least 25%. •Improved management of external projects by traveling to sites and reviewing documents for quality, accuracy and scientific integrity, taking direct responsibility for issue resolution, presenting multiple scenarios and recommending appropriate actions and solutions. •Executed all fixed asset transactions including procurement, negotiating applicable terms and conditions, and assessing maintenance contracts, reducing overall equipment costs while increasing laboratory capabilities. •Primary surgeon on in-house orthopedic in-vivo models including but not limited to Posterior Lumbar Fusion, Long Bone Segmental Defects and Femoral Condyle Defects. Show less



UMass Medical School

• IT Services and IT Consulting
• 1 - 100 Employee

• Veterinary Surgical Specialist

  • Jun 2006 - Jul 2011

  •Strengthened the veterinary surgical fee for service program offered to investigators, by specializing in various surgical procedures in large and small animal models, including invasive catheter placement, organ removal, adrenalectomies, spays/neuters/vasectomies, thymectomies, intracranial cell implantations, splenectomies and nephrectomies. •Supported training for physicians, nurses and medical students in Advanced Trauma Life Support (ATLS) skills, successfully teaching them the principles of rapid, effective assessment and stabilization of trauma victims. •Established and taught a mandatory course for all Principal Investigators requesting surgery as part of their IACUC protocol and gave them authorization to continue, guaranteeing proper procedures and guidelines were met. •Provided surgical support to the New England Center for Stroke Research, which was focused on cardiovascular imaging and intervention. Assistant surgeon on aneurysm creation in the carotid artery ensuring support of the ongoing research of neurointerventionalists, developing new techniques and treatments for stroke patients. Show less



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Research Assistant

  • Jun 2004 - Jun 2006

  •Functioned as a team leader responsible for conducting toxicology and pharmacology studies, under GLP, ISO, and FDA guidelines, utilizing various research models in a fast paced contract research organization. •Performed multiple GLP Pharmacology, Toxicology and Absorption, Distribution, Metabolism and Pharmacokinetics (DMPK) studies, focusing on the treatment of bronchospasms, asthma, and rhinosinusitis in non-human primates. •Executed bronchoalveolar lavages to assess inflammation levels of eosinophils, macrophages and neutrophils after inducing acute asthma attacks with a methacholine challenge test. Show less



HYPNION INC

• United States
• Insurance

• Research Associate

  • Jun 2003 - Jun 2004

  • Completed 100+ rat surgeries involving placement of a pinnacle three-channel EEG/EMG intra-cranial implant with 95% success rate allowing live streaming of EEG signal data to your desktop. • Implemented multiple early stage drug discovery programs using non-benzodiazepine hypnotics and wake promoting agents securing a collaboration with Eli Lilly. • Achieved small animal handling, test article administration (IP, SC, PO, IV, ID), blood collection (RO, IV, IC), tissue sampling and necropsy skills. Show less