Experience

Celldex Therapeutics

• United States
• Biotechnology Research
• 100 - 200 Employee

• Clinical Scientist, Director

  • Nov 2020 - Present

  Collaborate within cross-functional teams, and with senior/executive leadership to develop and conduct immunology/allergy clinical programs in phases, 1 to 2. Responsible for scientific oversight of clinical program conduct and reporting by leading developing protocols, protocol amendments, investigators brochures, contributing to INDs and other regulatory documents, to ensure accuracy, and consistency across the clinical program. Ensure the quality and ethical conduct of clinical studies within clinical development programs. Follow research advances in applicable diseases and diagnosis that may be have scientific and regulatory relevance to clinical research programs Establish and maintain relationships with KOLs and investigators in collaboration with the cross functional clinical team Lead the development of publication strategies, and draft and manage the development of abstracts presentations and manuscripts with internal and external authors. Attend appropriate scientific congresses and represent the scientific team at Celldex Therapeutics Show less



BioCryst Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 300 - 400 Employee

• Clinical Research Scientist (contract)

  • Mar 2020 - Nov 2020

  6+-month contract- Work within a cross-functional matrix environment to provide scientific input and expertise to clinical trials and ensures quality to clinical studies (as assigned) for the berotrylstat program. Write, edit and review medical and scientific elements of clinical research documents to ensure accuracy, consistency, validity, relevance and completeness. Identified recent therapeutic area advances relevant to clinical research programs and provide scientific advice to the clinical and regulatory teams Contribute to the development of global regulatory strategies Show less



Covance

• United States
• Research Services
• 700 & Above Employee

• Project Director

  • Jun 2017 - Nov 2018

  Project leadership role, serving as key client contact for assigned projects; responsible for provision of client deliverables on-time, within budget and scope, and with required quality for assigned projects or program • Lead core project team and facilitate team’s ability to lead extended/complete project team. • Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services Project leadership role, serving as key client contact for assigned projects; responsible for provision of client deliverables on-time, within budget and scope, and with required quality for assigned projects or program • Lead core project team and facilitate team’s ability to lead extended/complete project team. • Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services



Takeda

• Japan
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Clinical Program Manager

  • Mar 2017 - Jun 2017

  Contracting through Randstad Lead and direct execution of clinical studies in early clinical development programs in CNS and GI, supporting clinical strategy in close collaboration with Clinical Operations Managers: •Responsible for execution of studies in assigned clinical program in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. •Oversight of Strategic Partners and other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. Show less



RRD International, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Global Program Leader

  • Jan 2016 - Oct 2016



UCB

• Belgium
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Program Director

  • Jun 2015 - Dec 2015



United Therapeutics Corporation

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Manager, Clinical Sciences

  • Nov 2014 - Apr 2015



Clinical Trials Transformation Initiative (CTTI)

• United States
• Research Services
• 1 - 100 Employee

• Sr Project Manager/ Project Leader

  • Jun 2012 - Nov 2014

  Development, management and implementation of CTTI projects in collaboration with partners. CTTI is a public-private partnership to identify practices that will increase the quality and efficiency of clinical trials. CTTI comprises of representatives from national and international government agencies (FDA, NIH, etc.), industry representatives (pharmaceutical, biotech, device, and CRO), patient advocacy groups, professional societies, academic institutions, and other interested parties. www.ctti-clinicaltrials.org Show less



Salix Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Clinical Development Manager

  • Jun 2007 - Apr 2012

  Therapeutic area Gastroenterology Therapeutic area Gastroenterology



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead Clinical Development Scientist

  • Jul 2000 - Jun 2007

  Therapeutic areas Respiratory, Neuroscience Therapeutic areas Respiratory, Neuroscience



UNC Eshelman School of Pharmacy

• United States
• Higher Education
• 100 - 200 Employee

• Resident

  • 1999 - 2000



Duke University Medical Center

• Post-doctoral Fellow

  • Jan 1994 - Jun 1999