Dova Pharmaceuticals
Published
September 14, 2017
Location
Durham, NC
Job Type
Category

Description

Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.

Responsibilities will include, but are not limited to, the following:
• Lead and manage Outsourcing of Large Multi-Center Clinical Studies Lead Contracting/Outsourcing Process
• Identification of vendors (CRO’s, labs, medical writer, bioanalysis, etc.)
• Generation/tracking RFPs
• Vendor evaluation, selection and relationship management, including detailed assessment of vendor bids and proposals
• Documentation for contracting process (MSAs, SOW, etc.)
• Information maintenance to enable internal benchmarking for future clinical studies
• Training CRO and monitors
• Training clinical sites (via Investigator meetings or Site Initiation Visits)
• Oversee Study Set up Process
o Develop Clinical study proposal/protocol
o Set up Investigator meetings
o Create site source documentation tools
o Data collection – electronic database set up
o Informed consent form
o IRB process
o Procedures manual
o Site preparation for screening
o Clinical study supplies
o Lab services
o Coordinate drug supply
• Lead Study Conduct, Execution, and Close Out
• Identify recruitment goals
• Review/approve monitoring visit reports
• Manage interim data analyses
• Study close-out (archive appropriate, documentation, study records, study analysis archive, all remaining sponsor records as appropriate).
• Budget management (initial budget development + life of study/program budget management)
• Interface with CMC contact for management of study drug/supplies
• Manage outsourcing of CSR, CTR summary, etc. based on sourcing strategy for study.
• Draft Phase 2 and 3 Clinical Protocols
• Contribute to design of clinical development programs, clinical studies; drafting of high quality, regulatory compliant study protocols and other required clinical documents
• Due Diligence and Support
• Contribute to Clinical development plan (literature searches, competitor landscape, recruiting and treatment projections, etc.)

Requirements:
• Masters – level degree preferred (or higher) in life sciences or related field; bachelors-level degrees will be considered
• 5-7 + years in global/regional clinical drug development or in the Pharmaceutical/Biotech industry
• Understanding of Good Clinical Practice (GCP) and ethical study conduct
• Understanding of steps required to set up and successfully manage delivery of Phase 2-4 studies
• Understanding of clinical research process from program planning to regulatory submission
• Ability to contribute and collaborate with a team including issue identification and resolution
• Must be able to make independent, timely and appropriate decisions
• Must have good communication (oral and written). Must be able to interact effectively with people at all levels of the organization
• Solid computer/analytical skills Specialized Knowledge And Licenses
• General understanding of good clinical trial design, conduct and reporting
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
• Ability to assimilate technical and scientific information quickly.
• Proficient in Microsoft Word, Excel, PowerPoint

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