Precision Medicine Global Biomarker Lead Job at Amgen (Remote)

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

Clinical Laboratory Study Manager

Parexel FSP is looking for a Clinical Laboratory Study Manager. The candidate ca...

Location

Argentina

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
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
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

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

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

New

Ai Engineer

We are recruiting an AI Engineer for a direct contract with a company based in t...

Location

Portugal , Porto

Salary:

Not provided

Precise

Expiration Date

Until further notice

Requirements

2+ years experience working within a software development team as an engineer
Comfortable writing and debugging code in Python. You understand the importance of readable code and are eager to learn best practices.
Familiarity with frameworks like FastAPI, Flask, or Django, with experience developing and exposing/consuming APIs.
Understanding of containerization and exposure to Docker.
Comfortable using Git for team collaboration (Gitlab pipelines exposure is a plus).
Machine Learning Fundamentals: Foundational knowledge of ML concepts and practical experience (academic or personal projects) deploying a simple model using libraries like scikit-learn, PyTorch, or TensorFlow.
Experience manipulating and analyzing data using libraries such as Pandas and NumPy.
A strong desire to learn MLOps principles, cloud infrastructure, and deployment practices (Kubernetes exposure is a plus).
BSc in Computer Science or a related technical field.

Job Responsibility

Implementing solutions for building and deploying AI models in production, with a focus on fault tolerance, scalability, maintainability and automation.
Leveraging modern LLM’s to include/enhance parsing capabilities for CVs/job adverts for existing supported languages and new additional languages.
Collaborating with the team to design, implement and optimise data processing pipelines and evaluation tools.

Fulltime

New

Branch Manager

Come and join us as a results driven Branch Manager to deliver sales and exceed ...

Location

United Kingdom , Lymington

Salary:

Not provided

City Plumbing

Expiration Date

Until further notice

Requirements

A great positive attitude
Enjoy customer interaction
Management Experience
Safe Practices
Forward Thinking
Tenacity and resilience
A pro-active approach to sales, with a strong desire and ability to win and grow new business
Experience of customer relationship management and developing a true partnership approach
Excellent communication skills
Self confident and self motivated, with the ability to work on own initiative or as part of a wider team

Job Responsibility

Effective management of the team and resource
Setting the standard of a sales orientated culture
Delivering against sales and customer demands while maximising profitability
Maximising margin and net profit
Keeping everyone safe
Build and maintain relationships with new and existing trade and retail customers
Ability to interpret and analyse financial and statistical information

What we offer

Bonus
Discounts, savings and cash back at numerous retailers
Life assurance
Extended family policy including maternity, paternity, additional annual leave and more
Mental Health First Aiders and Employee Assistance Programme, we look out for each other
Complete induction and a company that lets you grow and encourages development
Financial education and loans
Flexible working options
A business striving to create an environment of inclusion so everyone can be their true self

Fulltime

New

Guest Environment Expert

Our jobs aren’t just about giving guests a clean room and a freshly made bed. In...

Location

United States , Poughkeepsie

Salary:

18.00 USD / Hour

Marriott Bonvoy

Expiration Date

Until further notice

Requirements

Ensuring a safe work place
following company policies and procedures
maintaining confidentiality
upholding quality standards
ensuring professional uniform, personal appearance, and communications
ability to stand, sit, or walk for an extended time
ability to move, lift, carry, push, pull, and place objects weighing less than or equal to 50 pounds without assistance

Job Responsibility

Delivering guest requests
stocking carts
cleaning rooms and public spaces
maintaining the appearance and cleanliness of the whole hotel

Parttime

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Precision Medicine Global Biomarker Lead

Job Description

Job Responsibility

Requirements

What we offer

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