Sr. Manager, Biomarker Operations, Translational Sciences

Redwood Shores, CA 94065

Posted: 07/16/2020 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 17671

Job Description


Sr. Manager, Biomarker Operations, Translational Sciences

This role will be responsible for biomarker logistics and operations in a fast-paced, highly interactive, clinical development program in hematologic oncology indications. The Sr. Manager, Biomarker Operations will work with in-house scientists, clinical teams and specialty vendor labs, to implement comprehensive correlative/biomarker plans supporting development of novel agents in oncology. The corporate culture encourages communication between functions and rapid synthesis of clinical, biological and correlative studies, to inform scientific decision-making. Translational Sciences is responsible for nonclinical Pharmacology, Toxicology and clinical Biomarker Development programs. This role reports to the Sr. Director Translational Sciences, and may be located in Bellevue WA, or in Redwood City CA.

Key responsibilities:
  • Using protocol and clinical science as a guide, provides operational project support for the implementation of correlative sciences and biomarker plans. 
  • Participates in study management teams with responsibility for clinical specimen analysis.
  • Works closely with clinical/translational sciences to establish appropriate specimen collection, processing and testing to fulfill exploratory goals of clinical trial.
  • Negotiates and establishes contracts with biomarker vendors and manages day-to-day logistics to ensure timely delivery of sample analysis and transfer of results.
  • Supports vendor selection for Central Lab services; coordinates with Clinical Operations, Central Labs and Kit Build vendors to ensure study documents and kits support sample integrity. 
  • In collaboration with Clinical Science and Clinical Operations, generates tracking tools to monitor biospecimen lifespan from collection through archiving.
  • Meets corporate timelines for implementation of biomarker plans and coordinates data transfer logistics between specialty labs and the clinical study database.
  • Evaluates trends and study metrics; identifies emerging issues with data generation and moves quickly to resolve with help of Translational/Clinical leads.
  • Oversees management of clinical sample biorepositories associated with multiple ongoing and completed studies.

Qualifications:
  • BS or MS in a laboratory or health science; certification in project management and/or a health technology is highly desired, experience in field of oncology or hematology preferred.
  • Minimum of 5 years in drug development supporting clinical studies in industry: operations, translational science or laboratory analyses.
  • In-depth knowledge/proficiency in GCP requirements, GDPR and other laws pertaining to clinical sample uses and biorepository operations; experience working in a regulated environment.
  • Prior experience working with a Clinical Operations team to specify details for sample collection and logistics; including in support of global trials. 
  • Experience driving vendor relationships to result in timely, accountable and highly effective collaborations.
  • Proficient use of data spreadsheet, database, and data visualization (dashboard) software in addition to ability to learn new tools such as vendor interfaces for sample tracking. 
  • Additional computer proficiencies (bioinformatics, database, programming, project management, or document management software) are also highly valued.
  • Ability to independently synthesize information from multiple sources, identify and solve problems, and to escalate as necessary with multiple stakeholders.
  • Willing to travel multiple times per year, as needed for vendor qualification, laboratory audits, and participation in study team activities, and also to attend relevant scientific conferences. 

Critical integrative organizational interfaces for this position will include partnerships with:
  • Translational Scientists
  • Clinical Operations: Study Leads, CTM’ s and Study Management Team
  • Specialty vendor labs in field of genomics, proteomics, biomarker development
  • Biology Lab, Clinical Pharmacology, and Clinical Science Teams
  • Data Management and results end-users

Critical Success Criteria:

Independence 
  • demonstrated ability to initiate, track and complete projects for multiple stakeholders in a highly matrixed environment
  • willing to independently research topics and provide cogent recommendations for action

Teamwork
  • confidence to create and share information resources across many functions
  • experience identifying and building relationships with specialty laboratory vendors
  • able to reach across functional groups and keep communications open

Attention to detail
  • ability to monitor and differentiate data-streams to ensure completeness of reporting
  • capable of integrating project goals and noticing discrepancies and escalating points of error
  • willing to provide regular updates and address specific requests of the clinical team
  • able to manage multiple projects at once, without losing track of specifics

Clinical study experience
  • strong logistics understanding of conduct of early-phase to pivotal-phase studies in oncology  
  • thorough understanding of clinical laboratory practices and regulatory requirements for clinical specimen use (GCP and other legal frameworks)
  • capable of using study metrics and cost analysis to support process improvements

Judgment
  • willing to attend to details with consideration of multiple stakeholders’ needs
  • proactive nature; ability to prioritize and creatively propose solutions to problems
  • capable of working within established processes/regulations and using escalation pathways 

 

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Neyba Soto

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