Ref #: 29644

Employment type: Permanent - Full-Time

Location: US - Raleigh - NC

Posted: 02-Jun-2021


As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them? Consider joining our team!

At ICON DOCS, we have an incredible opportunity for an expert home-based Clinical Bioanalytical Scientific Monitor to join the team in the US.

Position Overview:

DOCS is currently seeking a Clinical Bioanalytical Scientific Lead for the US. This role is both a Scientific and Operational role, within the BioSample Operations group. The Clinical Bioanalytical Scientific Lead will provide scientific and technical oversight, enable operational processes and deliver clinical bioanalytical data from Contract Research Organizations (CRO) to support clinical development programs.

Position Responsibilities:

• Represent BioSample Operations group on multiple clinical study teams
• Responsible for addressing clinical study teams’ requests related to Pharmacokinetic (PK) data either directly or via coordination with other clinical study team members, particularly the project representative and clinical pharmacologist
• Responsible for all scientific and technical oversight required for delivering high quality clinical PK data including but not limited to reviewing raw PK concentration results, reviewing bioanalytical reports, trouble-shooting PK sample analysis issues
• Oversee clinical PK and immunogenicity sample flow and data transfer process
• Support contracting activities with bioanalytical CROs including execution of contracts and change orders, organizing and filing all contract documents
• Support budget planning for outsourced studies
• Support publication of bioanalytical study reports in the regulated database
• Accountable for ensuring CRO oversight activities related to outsourced bioanalytical studies are performed according to the agreed timelines and quality and in compliance with current guidelines and internal standards

Position Requirements:

• Experience (3+ years) in NCE bioanalytical assay development, assay validation, and sample analysis
• Experience (3+ years) in NBE bioanalytical assay development (PK and ADA), assay validation, and sample analysis
• Experience in ADC bioanalytical assay development, assay validation, and sample analysis
• Experience with clinical PK sample analysis
• Clinical Study management experience is required
• Experience working with a CRO or external partner
• Good understanding of drug development and discovery processes
• Prior project coordination and/or project management experience

Education Requirements:

• PhD, Master’s, or Bachelor’s degree in Biomedical Sciences or related fields with 5+ years (for PhD candidates),
• 10+ years (for candidates with Master’s degree)
• 15+ years (for candidates with Bachelor’s degree) of post-graduate experience in the life sciences industry

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.