Oncology Biomarker Operations Manager/Leader

Location
Austin, TX, USA
Posted
Nov 18, 2020
Ref
195459
Required Education
Bachelors Degree
Position Type
Full time
Position Overview:

MTEM is recruiting an individual to plan, manage and coordinates all operational and logistical activities required for the biosample collections supporting preclinical and clinical efforts for the Translational and Early Development team. This individual will be the interface between internal colleagues and external partners to support and execute of these efforts. Applicant must be able to handle a dynamic and fluid environment in support of efforts to bring new therapies to patients.

Job Responsibilities:
  • Manage clinical PD, and biomarker sample logistics as laid out in study protocol, and coordinate between the central laboratory and testing facilities as well as manage external laboratories supporting these efforts
  • Provide input on clinicals study protocol development for PD biomarker collection sample timepoints, type of sample, sample acquisition, storage conditions, and analysis.
  • Manage timelines for sample testing and data transfer with external vendors and/or internal teams.
  • Single point of contact for all clinical sample management. Manage sample transfer/discrepancy resolution with Central Lab, Clinical Site. CRO vendors.
  • Manage on-site storage of preclinical samples with routine inventory reviews
  • Work with Translational Science team to identify vendors, plan and execute on novel PD assays to determine drug activity.
  • Execution of Biomarker strategy
  • Coordinate agreements between MTEM and external vendors in support of these efforts
  • Assist in the development and maintenance of a central biorepository database (e.g. Laboratory Information Management System)
  • Review and provide feedback on clinical study protocols, laboratory documents, and service provider laboratory scope of work documents for sample handling details
  • Consistent evaluation of improvement to processes

Qualifications:
  • BS/MS/PhD in Biochemistry, Immunology, Biology, or a related field is highly preferred
  • Effective organization, planning, and time management
  • Minimum 2 years experience in Biomarker Assays and Sample Management and working with clinical samples processing in an industry or academic setting
  • Flexibility and resilience are required to work in dynamic environment. Proven ability to work under pressure and deadlines.
  • Excellent communication and written skills.
  • Proven ability to work with teams of different background
  • Ability to master the use of needed software is required (min. Excel, Prism)
  • Technical knowledge to maintain electronic files and experience with database entry (e.g. LIMS) is a bonus

Reporting Structure:

This role reports to the SVP of Translational Research and Early Development.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com