Mgr Clinical Biomarkers & Diagnostic

Clinical Biomarkers & Diagnostic Manager

Location : Thousand Oaks, CA / San Francisco, CA / Remote

Duration : months with possible extension

Description :

Role will be supporting general medicine therapeutic areas

Experience in general medicine preferred (Inflammation, Cardio Metabolic, Neuroscience)

Specific Job Requirements :

The Clinical Biomarker and Diagnostics (CBD) Operations Lead plans and coordinates all project management and operational activities required to operationalize the Client biomarker and diagnostics strategies for programs in the Inflammation and Cardio Metabolic therapeutic areas of Client (General Medicine).

He / she ensures continuity and integrity across projects, coordinates assay development and implementation activities and acts as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities including collection, delivery and analysis of biomarker and diagnostics bio samples within one or more clinical projects or clinical studies.

He / she is also responsible for biomarker and diagnostics sub-team meeting management, dashboards, following up on actions, organizing meetings and tracking biomarker deliverables.

Essential Duties and Job Functions :

Drives the implementation and execution of the clinical biomarker and diagnostic plans for therapeutic programs in early and late-stage clinical development across therapeutic areas

Accountable for the development of a project’s and / or clinical study’s biomarker and diagnostics bio sample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness

Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies

Accountable for planning and implementing the biomarker and diagnostics bio samples collection within a project(s) or clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc

Accountable for ensuring that data received is consistent with collection and assay plan and protocols

Serves as first point of contact for biomarker and diagnostics bio samples operational questions and issues within a project(s) and coordinates with internal and external partners (, Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads, and CROs)

Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s)

Provide regular reports on sample tracking to select samples for analysis based on varying criteria

Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.

Participate in site initiation visits to train sites on sample collection

Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay / data results and is a key contact for the assay lab.

Project manages contracts, budgets and timelines for biomarker / Dx activities within studies to ensure timely completion of biomarker and diagnostic activities.

Preferred Education / Qualifications

Life Sciences degree (higher qualification MSc or equivalent preferred).

Further qualification, project management certification is desirable.

Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization ICH , Global Regulations, Ethics and Compliance)

years related professional experience in a clinical research setting, clinical / diagnostic laboratory, or pharmaceutical / biotechnology R&D environment

Must Have Experience, Skills, Knowledge

Extensive + years Biomarker Operations experience

Experience with biospecimens management, must know the different types of biomarker samples and specifications for collection and lifecycle

Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development

Extensive Project management skills and knowledge of project management tools is a must, prepare to demonstrate during interview

Critical reasoning skills including the identification and resolution of complex problems

Detail oriented with the ability to work independently and manage multiple competing priorities

Excellent planning, organizational and time management skills

Effective communication skills

Basic Qualifications :

Doctorate degree

Master’s degree and years of experience

Bachelor’s degree and years of experience

Associate’s degree and years of experience

High school diploma / GED and years of experience

In addition to meeting at least one of the above requirements, you must have experience directly managing people and / or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Your managerial experience may run concurrently with the required technical experience referenced above

Top Must Have Skill Sets :

Biomarker Operations experience managing Biomarker samples, biomarker vendors and central labs.

Project management experience and knowledge of project management tools, experience with software building timelines, experience organizing meetings, recording agenda and minutes.

Extensive clinical development experience of working in teams running clinical studies, must be able to contribute to protocols and ICFs development.

This is NOT a clinical trial manager role or clinical science role a background of this is OKAY but they MUST be able to speak to why their looking to move into this area (it is a biomarkers role who does work closely with clinical team)

Employee Value Proposition :

Unique industry opportunity

Red Flags :

No clinical trial management experience.

No industry experience - anything under years.

Unexplained gaps in work history.

Lack of biomarker operations experience and understanding of biomarker samples lifecycle management.

Poor communication and emails writing technique.

Lack of project management experience, including building timeline, agenda and minutes