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R-290721 Associate Director Clinical Assay Strategy

CSL

Waltham, Massachusetts • Today

Full-time

R-290721 Associate Director Clinical Assay Strategy

CSL

Waltham, Massachusetts • Today

Full-time

Associate Director, AI for Discovery - New Target Discovery

AstraZeneca

Cambridge, Massachusetts • Today

Full-time

USD 144,649.00 - 216,973.00 per year

Associate Director, Molecular Cloning Technologies

Flagship Pioneering, Inc.

Cambridge, Massachusetts • Today

Full-time

USD 161,000.00 - 203,500.00 per year

Scientific Data & Technology Strategy Associate Consultant - Discovery

ZS Associates

Boston, Massachusetts • Today

Full-time

USD 120,000.00 - 137,000.00 per year

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Takeda Pharmaceutical

Boston, Massachusetts • Today

Full-time

Compensation information provided in the description

Senior Associate, Clinical Data Standards Management (CDSM)

Gilead Sciences, Inc.

Remote • Today

Full-time

USD 123,930.00 - 160,380.00 per year

Sr Clinical Data Management Associate

Gilead Sciences, Inc.

Remote • Today

Full-time

USD 115,260.00 - 149,160.00 per year

Associate Director, Biostatistics & AI

BridgeBio Pharma

Remote • 12d ago

Full-time

USD 173,800.00 - 217,000.00 per year

Associate Director, Data Partnerships - Oncology

Novartis

Remote • Today

Full-time

USD 145,600.00 - 270,400.00 per year

AI Strategy Associate Director - State Health

Navigant Consulting

Remote • Today

Full-time

USD 122,000.00 - 203,000.00 per year

Job Details

Skills

Knowledge Base
ADA
Mentorship
Due Diligence
Data Quality
Marketing
Concordance
Resource Management
Leadership
Outsourcing
KPI
Budget
Resource Allocation
Design Of Experiments
Regulatory Compliance
Collaboration
Partnership
Research and Development
Risk Management
Innovation
Data Analysis
Workflow
Artificial Intelligence
Assays
Analytical Skill
Communication
Computer Networking
Management

Summary

The Opportunity:

The incumbent will part of a specialised non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies.

This role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential.

The incumbent will have a broad and deep knowledge base in relation to development and validation of PK, ADA and biomarker assays. This role requires high excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams and execute externalisation of compliant bioanalytical and biomarker assays . The candidate will need to have a deep understanding the regulatory requirements across bioanalytical and biomarker assay as it relates to different platforms, assay types and context of use.

The Role:

Leadership and Strategy

Develop and implement bioanalytical/biomarker strategies to support clinical bioanalysis that aligns with the company?s overall goals and objectives, supporting clinical programs with moderate complexity.
Within a matrix environment provide leadership and mentor scientists within and across functional groups, fostering innovation and excellence.
Participate in external due diligence and provide expert advice on bioanalytical and biomarker assays, data quality, regulatory expectations, clinic/submission readiness and associated risks.

Research and Development

Ensure the timely support for progression of projects from nonclinical development through all phases of clinical development, including submissions and post marketing requirements.
Direct the strategy and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance.
Identify and proactively manage risk with externalisation of critical bioassays.
Establish operational plans to ensure the success technical transfer of assays to external vendors with required compliance, concordance, quality and within timelines to meet project requirements.

Project and Resource Management

Work with Clinical Bioanalytics and Biomarker leadership team to execute robust insourcing outsourcing strategy, ensuring strategic decisions and effective utilisation of available resources.
Support the selection of vendors through in depth technical, strategic and scientific review. Contribute to governance meetings, escalation of issues and tracking of KPIs.
Optimize workflows to ensure optimal turn around times, assay transfers, budgets, and resource allocation.

Scientific Oversight

Interpretation of moderate complexity data, ability to troubleshoot and define next steps across areas of expertise for often complex issues.
Recognized subject matter expert in job area typically obtained through advanced education and work experience.
Provide scientific guidance and expertise across the Clinical Bioanalytics and Biomarkers function.
Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements to support project needs.
Contribute to the preparation and review of regulatory submissions, providing expert input on bioanalytical and biomarker data responding to regulatory queries
Communicate scientific results clearly and concisely to appropriate audiences.

Collaboration and Networking

Initiate and foster partnerships with cross-functional CSL R&D teams, external vendors, industry experts, and collaborators to ensure timely project progression and risk management.
Represent the organization at scientific conferences and industry meetings.

Innovation and Technology

Drive innovation by using up-to-date latest advances in platforms, bioanalytical/biomarker formats, assay design and data analysis, automated workflows and use of AI in regulated environments.
Stay updated on advancements throughout the field to support current and emerging modalities.

Skills and Experience:

Postgraduate degree (preferably PhD) and extensive experience in clinical biomarker/bioanalytical assays or a related field.

Minimum of 5-10 years\' relevant industry experience and / or equivalent experience in a relevant academic environment.

Strong and proven scientific background in relevant Life Sciences discipline..

Demonstrated ability in managing highly effective teams that are cross-functional, multicultural and international.

Deep understanding of relevant regulatory guidance?s and industry best practices.

Excellent analytical skills, ability to address complex problems through investigation and analysis.

Outstanding written and verbal communication skills, with the ability to present complex scientific concepts to diverse audiences.
Strong networking skills and proven experience managing external partners.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: apblokecp
Position Id: 21922_R-290721
Posted 18 hours ago

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Waltham, Massachusetts

•

Today

Job DescriptionThe Opportunity: \nThe incumbent will part of a specialised non-laboratory based team and provide high level expertise and leadership capacity in the area of bioanalytical and biomarker assays to support nonclinical and clinical studies. \n \nThis role will lead the external tactical execution of bioanalytical/biomarker assays to ensure delivery of innovative assays and key data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry

Full-time

Senior Biostatistician, Regulatory Submissions

Boston, Massachusetts

•

4d ago

Overview About Analysis Group's HEOR, Epidemiology, & Market Access Practice: Make an impact at Analysis Group, where we collaborate with our clients to develop and implement regulatory and analytical strategies to support life sciences products throughout their life cycles. Founded in 1981, Analysis Group is one of the largest international economics consulting firms, with more than 1,500 professionals across 15 offices, including more than 250 professionals who focus on health care. Analysis G

Full-time

USD 195,000.00 - 255,000.00 per year

Managing Consultant - Life Sciences Data & Analytics

Boston, Massachusetts

•

Today

Job Family: Strategy & Transformation Consulting Travel Required: Up to 10% Clearance Required: None What You Will Do: We are looking for a Managing Consultant to join our Life Sciences team, which supports pharmaceutical and biotech companies with commercial insights and strategy as well as data and business analytics. This role will be a primary member of our Life Science advisory team, and collaborate closely with our firmwide Data, Advanced Analytics, and Technology Transformation teams to

Full-time

Compensation information provided in the description

Senior Automation Engineer

Lexington, Massachusetts

•

Today

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Senior Automation Engineer is responsible for leading lab automation and digital capability initiatives that supp

Full-time

USD 137,000.00 - 215,270.00 per year