Precision Medicine Global Biomarker Lead Job at Amgen (Remote)

Clinical Laboratory Study Manager

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry
Working knowledge of clinical drug development process and clinical databases, as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Requires bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience. Biology or equivalent major preferred.
Strong project management and organization skills in a matrix environment
Analytical and problem-solving experience
Excellent written and verbal communication skills
Effective communication and interpersonal skills, with proven ability to build relationships internally and externally
Fluent in speaking/writing English
Proficiency in Microsoft Office applications, including strong excel knowledge, as well as relevant role specific systems
Proficiency in Python, R, Perl, SQL or other programming languages, as well as familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

Job Responsibility

Participates in cross-functional study team meetings and workstreams to support the delivery of the precision medicine strategy for the assigned studies
Supports clinical study teams as subject-matter expert for technical and operational matters related to sample management and testing, including anticipating challenges, managing risk across projects and responding queries from internal and external stakeholders
Works with clinical study teams on the development and review of sample-related sections of study-specific documents such as the clinical protocol, Informed Consent Forms (ICFs) and sample management guidelines
Supports project management and study set-up teams in the creation and validation of specialty laboratory databases for data collection and sample kit tracking
Manages all activities related to biosample process planning and execution, including storage, shipping, and data transfer throughout the study lifecycle
Oversees the acquisition and testing of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc.), liaising with relevant stakeholders to assess biosample vendors, review proposals/bids, and define contractual scope
Forecasts operational costs and timelines, and manages budgeting, invoicing and reporting for study-related operations
Works closely with data management and biostatistics leads to determine how biomarker data will be captured, blinded, transferred and reported for clinical trials
Develops and reviews data transfer specifications and related documents
Provides guidance and training to clinical teams and investigative sites regarding collection, storage and shipment of biospecimens to ensure compliance with the clinical protocol

Oncology Early-Stage Clinical Scientist

You will lead and coordinate the development of multiple studies of novel biolog...

Location

United States , Cambridge; La Jolla; Bothell; Groton; New York City

Salary:

176600.00 - 282900.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO
MS and a minimum of 7 years of experience in a similar role in industry/CRO
BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
Experience in or strong understanding of Oncology Drug Development especially in Early Development
Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
Strong scientific writing skills and communication skills (written and verbal)
Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance

Job Responsibility

Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s)
Responsible for scientific leadership and execution of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results
Support execution for all FIH programs through proof-of concept
Set the clinical data review strategy, ensure quality data and conduct review of emerging clinical data and trends
review and query data
present and discusse relevant data to appropriate teams, governance bodies, and other internal and external stakeholders
Conduct data review, analysis and interpretation of clinical trials data together with the GDL, Clinical Safety, and Biostatistics
Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors
Support and assist in the development of publications, abstracts, and presentations
May sit on project teams to support clinical development implementation and contribution to key development milestones, e.g. start-up and delivery of ESoE and PoC trials

What we offer

Eligibility for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Global Development Product Lead

Leads multiple cross functional oncology product teams from pre-clinical candida...

Location

United States , La Jolla; Cambridge; Bothell; South San Francisco; New York City

Salary:

295900.00 - 478800.00 USD / Year

Pfizer

Expiration Date

Until further notice

Requirements

MD or MD-PhD with 10+ years of industry experience in oncology drug development is preferred, track record in oncology clinical research including early phase drug development
Clinical oncology experience: Board certification in oncology preferred
Significant industry leadership experience in clinical, translational or basic research in biomedical sciences or one of the disciplines related to drug development
Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Proven scientific writing skills and good communication skills
Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
Capacity to adapt to a fast-paced and changing environment
Demonstrated history of effective leadership
including cross functional and matrixed teams, managing direct reports when applicable, and experience in seeking and maintaining alignment with cross-functional leaders

Job Responsibility

Leads multiple (~2-4) cross functional oncology product teams from pre-clinical candidate nomination (CAN) through Phase 1-2 clinical development and proof of concept (POC) stages
In close collaboration with functional experts on the product teams, drives the effective integration of an end-to-end cross functional molecule strategy and risk mitigation plan and ensures delivery of data-driven milestones through successful risk identification and mitigation
Support clinical trials and the development strategy for early development assets and lead development programs across multiple functions within Pfizer Oncology, as well as represent the program with the external clinical community
Develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
To ensure the cross-functional components of the product plans including clinical expertise are provided to project teams, including medical monitoring of clinical trials
Substantial support of CDP development and diligence for external innovation activities
Lead key enterprise level cross-functional workstreams to accelerate R&D decision making
Lead, develop and execute strategic development for early development assets
Ensure timely execution and delivery of product milestones within budget
Communicate with executive management and governance committees to address program needs and provide recommendations

What we offer

Participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary
Eligibility to participate in our share based long term incentive program
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Relocation assistance may be available based on business needs and/or eligibility

Fulltime

Associate Vice President, Quality

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Thousand Oaks

Salary:

266028.00 - 359920.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 7 years of Clinical & Research Quality experience OR Master's degree and 10 years of Clinical Quality experience OR Bachelor's degree and 12 years of Clinical Quality experience AND 7 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Ensures proper quality oversight strategies of research activities and RBQM in clinical trials
Lead a global team and manage all trials across the Amgen portfolio globally
RDQ has a key role and responsibility in driving embedded quality partnerships across critical R&D programs
RDQ has a key role in advancing data driven oversight capability across the organization
Responsible for inspection readiness, inspection execution and follow up
Expanding our capabilities beyond GCP compliance and audit mindset focus include: Biosimilars, Rare Disease, Precision Medicine, Digital technology, Labelling, Product Complaint/Safety Reporting, PASS Study Management, Clinical trial simplification, Data analytics, Metrics development, R&D activities in response to regulatory trends and external pressures, Quality and compliance oversight over Amgen General Medicine: cardiovascular, obesity
Oncology, Inflammation and Biosimilar Portfolios
RDQ is transforming into an organization that provides quality assurance through proactive quality oversight in clinical trials on quality by design, critical to quality measures and risk-based quality assurance
Oversight of FSP and ensures performance of vendors is adequately executed for each study
Leads health authority inspection readiness and inspection strategy for clinical globally

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models where possible

Fulltime

New

Martech Platforms Lead

Commerce media is one of the fastest-growing segments in advertising, and Citi i...

Location

United States , Irving

Salary:

144480.00 - 216720.00 USD / Year

Citi

Expiration Date

June 05, 2026

Requirements

10+ years of experience in implementing and managing MarTech capabilities across data, offer, content and orchestration domains
Experience with marketing technology architecture, backend systems, data dependencies, and front-end interfaces that are required to implement and execute digital marketing campaigns
Customer-centric and tech-savvy product leader that has driven technical and operational teams to solutions that focus on delivering outstanding experiences supported by agile and efficient operational processes
Proficiency in Agile/Scrum methodologies
Act as a change management champion, educating the greater marketing organization on how to leverage new capabilities to drive their strategy
Track, measure, monitor and manage the performance, availability and usage of martech platforms
Identify and evaluate new technologies, tools, and trends in the data domain and recommend solutions that enhance the data platform capabilities and value
Strong analytical skills for evaluating digital performance, user behaviors, and platform metrics
Excellent communication, collaboration, and organizational skills
ability to explain complex concepts to non-technical stakeholders

Job Responsibility

Platform Ownership: Oversee Google Ad Manager, ensuring it meets business requirements, user needs, and performance expectations. Integrate data and content platform with Commerce Ad platforms (GAM, LiveRamp) to enable onsite and offsite marketing
Strategic Vision: Develop and communicate a strategic roadmap for Commerce Media capabilities in alignment with organizational goals and evolving marketing strategies
Tech Development: Steer the design, development, testing, deployment, and maintenance of the platforms, including data ingestion, data processing and enablement of audience using Customer Data Platform (CDP)
People Management: Oversee a direct and indirect team responsible for defining and driving the MarTech strategy and transformation in support of growth initiatives
Stakeholder Collaboration: Partner with stakeholders from marketing, IT, and product teams to understand and fulfill digital content and experience needs
Project Management: Collaborate with project teams to prioritize, plan, and execute key platform initiatives, ensuring alignment with platform capabilities and compliance standards
Optimization & Upgrades: Manage ongoing platform optimization, including regular upgrades, feature enhancements, and content performance tuning to achieve a high-performing digital experience
Vendor Management: Lead RFPs, evaluate/liaise with third-party vendors and support teams to ensure the efficient operation of the platform
Performance Monitoring: Implement and manage tools to monitor/optimize for platform performance
User Support & Training: Provide guidance and training for content authors, designers, and developers to maintain consistent quality and usability standards across digital content

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays

Fulltime

!

New

Media Lead Analyst

Commerce media is one of the fastest-growing segments in advertising, and Citi i...

Location

United States , Irving

Salary:

114720.00 - 172080.00 USD / Year

Citi

Expiration Date

June 05, 2026

Requirements

6-10 years of experience in consumer marketing, advertising and/or media
Bachelor’s/University degree, Master’s degree preferred

Job Responsibility

Develop integrated media campaigns from inception to execution, including day to day management of multiple agencies and strategic oversight
Drive successful integration of campaigns across all marketing channels/touchpoints
Manage legal and product review process for all media creative
Effectively partner with internal business teams to manage expectations
Provide guidance to internal business partners in the development of marketing materials
Partner with and leverage research team to understand consumer insights for brief development
Manage day-to-day relationship with our agencies
Proactively solve issues to ensure consistently breakthrough, relevant, consumer-centric creative
Take ownership over competitive insights for your products/services
Appropriately assess risk when business decisions are made

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays

Fulltime

!

New

Universal Banker

The Universal Banker is an entry level position responsible for the assistance i...

Location

United States , Sherman Oaks

Salary:

47510.00 - 61990.00 USD / Year ▼

Citi

Expiration Date

June 05, 2026

Requirements

1-3 years of relevant experience
Previous Retail Banking or similar experience required
Consistently demonstrates clear and concise written and verbal communication skills
High School diploma or equivalent

Job Responsibility

Assist in basic account opening for existing customer
Provide service delivery to internal/external customers to resolve account service issues
Execute financial transactions in accordance with bank policies and procedures
Refer opportunities to segment partners where appropriate
Create sales opportunities out of service transaction and resolve customer complaints/issues promptly and effectively
Support sales/service activities within the branch by participating in seminars, micromarketing events, promotional campaigns, product initiatives, etc.
Adhere to operational controls, including legal, corporate, and regulatory procedures to ensure the safety and security of customer and bank assets
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages (planned time off, unplanned time off, paid holidays)

Parttime

!

New

Personal Banker Safe Act

The Personal Banker SAFE Act is an entry level position responsible for the assi...

Location

United States , Bethesda

Salary:

58190.00 - 81210.00 USD / Year

Citi

Expiration Date

June 29, 2026

Requirements

0-2 years of relevant experience
Previous banking, retail, or sales experience preferred
Knowledge of Smart Banking tools and technologies
NMLS registration
Safe Act compliant
Consistently demonstrates clear and concise written and verbal communication skills
Bachelor's Degree/University degree or equivalent experience

Job Responsibility

Work with business credit requests less than $250K, recognize/refer larger lending opportunities and cross sell treasury and related small business products
Build referral business opportunities through Centers of Influence (COIs) and the Member Get Member (MGM) Program
Assist in strategies to grow the small business client and implement appropriate sales plans to target Book of Business customers
Deliver client services/outbound calls/inbound calls to acquire new relationships and deepen existing relationships through the cross-sell of relevant products and services while delivering remarkable client experience
Provide Tellers and other branch staff with coaching and guidance on products and special programs, identifying client needs, and providing appropriate referrals
Recognize transaction needs of clients, educate clients on all service and digital channels and leverage technology/ marketing tools available to uncover opportunities, and present product offers/financial solutions
Understand and comply with Citibank policies, standards and procedures
Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency.

What we offer

Medical, dental & vision coverage
401(k)
Life, accident, and disability insurance
Wellness programs
Paid time off packages including planned time off (vacation), unplanned time off (sick leave), and paid holidays

Fulltime

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Precision Medicine Global Biomarker Lead

Job Description

Job Responsibility

Requirements

What we offer

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