Observational Research Senior Manager Job at Amgen (Thousand Oaks)

Observational Research Senior Manager

Your role as an Observational Research Senior Manager will be to lead projects a...

Location

United States

Salary:

165267.00 - 186141.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and at least 2 years of related research and scientific experience
Master's degree and at least 6 years of related research and scientific experience
Bachelor’s degree and 8 years of data sciences and scientific experience
Associate’s degree and 10 years of data sciences and scientific experience
High school diploma / GED and 12 years of data sciences and scientific experience

Job Responsibility

Develop study proposals using real-world data to address key business questions
Lead the design, completion, and delivery of RWE
Facilitate the dissemination of RWE through key presentations, publications and/or trainings
Collaborate on the development of an integrated evidence generation plan for the product team
Contribute to the development and implementation of innovative analytic methods
Partner with cross-functional colleagues to enhance the use of RWE
Build external partnerships to increase the opportunities to use real-world data
Contribute to CfOR’s mission in progressing innovative epidemiological methods and analytical capabilities

What we offer

A 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
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Observational Research Senior Manager, Inflammation

In this vital role you will responsible for research activities on the Inflammat...

Location

United States

Salary:

165267.00 - 186141.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of related research and scientific experience
Master's degree and 4 years of related research and scientific experience
Bachelor's degree and 6 years of related research and scientific experience
Associate’s degree and 10 years of related research and scientific experience
High School diploma / GED and 12 years of related research and scientific experience

Job Responsibility

Designing and performing studies to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, acquiring product registrations and label-expansions, meeting post-marketing requirements/commitments and product differentiation
Finding opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
Influencing cross-functional team members in the utilization and timing of non-interventional research to answer high-priority strategic business questions
Leveraging real-world data and CfOR analytic approaches to inform high-value business decisions for multiple partners
Tracking business and functional priorities and aligning resources for those priorities
Contributing to the mission of the CfOR including progressing innovative epidemiological methods and analytical capabilities to support the CfOR’s leadership role within Amgen and the industry

What we offer

A 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
Flexible work models where possible

Fulltime

New

Senior Manager, Information Security Office (AI) Consultant

At Capital One, the AIML Division is working to bring the transformative power o...

Location

United States , McLean; Plano; Richmond; New York

Salary:

209000.00 - 286200.00 USD / Year

Capital One

Expiration Date

Until further notice

Requirements

High School Diploma, GED or equivalent certification
At least 6 years of experience working in cybersecurity or information technology
At least 5 years of experience providing guidance and oversight of cyber security concepts
At least 5 years of experience performing cyber security risk assessments or cyber security architecture reviews
At least 4 years in securing a public cloud environment
At least 3 years of experience with API security, observability, cloud access control and privacy best practices

Job Responsibility

Lead the development of secure, enterprise grade AI/ML and agentic AI solutions
Establish Ai-First SDLC practices and build scalable platforms
Design and implement security controls for AI/ML systems, including LLM applications
Conduct threat modeling, risk assessments and security reviews using frameworks such as NIST AI RMF, OWASP, and MITRE ATLAS
Define and enforce AI Model guardrails, safety standards, and governance policies
Identify and mitigate risk in open -source AI ML models
Build and scale processes for AI security testing, monitoring and stress validation
Partner with engineering, research, and security teams to deliver secure and compliant AI solutions
Advise senior leadership on AI cybersecurity risks, strategy, and regulatory considerations
Drive continuous improvement through vulnerability assessments, risk remediation, and security innovation

What we offer

performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
comprehensive, competitive, and inclusive set of health, financial and other benefits

Fulltime

Biostatistical Programming Senior Manager

In this vital role you will provide operational and technical leadership for Rea...

Location

United Kingdom , Uxbridge; Cambridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Relevant statistical programming experience within life sciences, clinical development, or observational research
Experience leading people, projects, programs, or resource allocation activities within a programming environment
Experience working with real-world healthcare data, including healthcare claims and EHR databases
Strong programming expertise in SAS and SQL
Knowledge of observational research methods, drug development, and epidemiology principles
Strong communication, collaboration, and stakeholder management skills
Demonstrated leadership, problem-solving ability, innovation, and attention to detail
Experience with R and/or Python is preferred but not mandatory

Job Responsibility

Provide operational and technical leadership for Real-World Evidence (RWE) biostatistical programming within the Centre for Observational Research (CfOR)
Lead and develop programming teams, partnering closely with epidemiologists and cross-functional stakeholders across multiple time zones to deliver high-quality RWE from large healthcare data sources, including electronic health records (EHR) and healthcare claims databases
Oversee project delivery, resource planning, technical excellence, and compliance with departmental standards and processes to support regulatory, publication, and enterprise objectives
Leading and developing programming staff, including mentoring, workload planning, and performance oversight
Partnering with epidemiologists, RWE scientists, and programming leads to generate robust real-world evidence from healthcare data assets
Providing technical leadership and guidance in statistical programming methods, standards, and best practices
Managing programming activities, timelines, deliverables, and resource allocation across multiple projects and priorities
Ensuring programming activities comply with departmental standards, SOPs, quality expectations, and regulatory requirements
Authoring, reviewing, and approving programming plans, analysis dataset specifications, macros, and other key study documentation
Contributing to the development, validation, and execution of analysis datasets and outputs supporting regulatory submissions, publications, and scientific communications

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Senior Manager, Inspection Management

Location

United States , Cambridge

Salary:

130800.00 - 209400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.
Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with inspection coordination and logistical planning for regulatory authority inspections.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.
Leadership skills with ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization.
Ability to work both independently and in a team environment.

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.
Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
Lead and manage post-inspection lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
Review and provide input into study team inspection preparation activities, storyboards, etc.
Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Senior Manager, Site Engagement, Sponsor Dedicated

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States , LOS ANGELES, COLORADO, CALIFORNIA, ARIZONA, WASHINGTON

Salary:

133736.00 - 167170.00 USD / Year

iconplc

Expiration Date

Until further notice

Requirements

Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development
Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
Oncology and/or Neurology and/or Immunology TA experience desired
Substantial (8+ years) experience in clinical operations in a CRO, pharma or biotech company including site management/oversight, and site-level clinical study conduct
Strong communication skills (verbal, written and listening) in both native language and English
Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
Ensuring compliance with applicable T&E Policy requirements
Role requires domestic and international travel up to 50% of time
Ability to work independently on assigned tasks or projects of increasing complexity
Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit

Job Responsibility

Establish and manage site relationships
Act as liaison between the company and investigational sites, building investigator and site staff awareness on client compounds
Develop and implement a plan, in collaboration with global and local teams, to raise the profile of the company and its global clinical development projects with current and potential investigators
Independently perform activities associated with the evaluation of investigational sites to build company network
Proactively work with Medical/Patient/Industry Associations to build company network and to promote company clinical trials
Develop knowledge of site capabilities and past performance to assess their potential as participating sites in client clinical trials
Ensure regular communication with local organization to align interactions with KTLs and other relevant local/regional stakeholders
Oversee site-level study start-up, conduct, and close-out activities outsourced to CRO(s) for global programs across Therapeutic Areas
Support Site Agreement negotiations, including stand-alone and Master Site Agreements
Identify trends, issues and risks across sites, and work with external vendors and internal Trial Team to resolve/mitigate those

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Manager, Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field, with at least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment
Ability to multitask priorities to align with program objectives

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Senior Manager, Staff Counsel

GEICO is seeking a Senior Manager of multiple Staff Counsel office activities in...

Location

United States , Nashville; Knoxville; Memphis

Salary:

Not provided

Geico

Expiration Date

Until further notice

Requirements

Must be able to travel as required, including but not limited, to attend trials, hearings, depositions, management meetings and conferences.
Must be able, with or without accommodation, to perform the essential functions which include, but are not limited to, thinking (concentrating, focusing, assimilating information), reading, writing, listening, typing, speaking, bending, reaching, lifting, and standing for extended periods.
Must be able to communicate in a professional manner in person, via telephone and written correspondence/email.
Must be able to document files in a clear, concise, professional written manner, to be understood by customers, clients, co-workers and other employees of the organization.
Must be able to follow complex instructions, resolve conflicts or facilitate conflict resolution, and have strong organization/priority setting and multi-tasking skills.
Must demonstrate successful performance in handling primary trial responsibility for cases of significant severity and complexity.
Juris Doctor degree REQUIRED
Must be licensed in good standing to practice law in applicable jurisdictions and meet and maintain licensing requirements including mandatory Continuing Legal Education (CLE) requirements where applicable.
Must have a minimum of 10 years of litigation experience, including insurance defense or personal injury.
Management experience required. Specifically managing a team of attorneys and support staff.

Job Responsibility

Manages subordinates in all activities relating to the defense of lawsuits and against GEICO insureds in liability and property damage cases, and on behalf of GEICO in UM/UIM and Subrogation suits.
Interviews and/or approves job applicants for employment.
Conducts and/or reviews associate Performance Appraisals.
Initiates or approves salary adjustments, performance ratings, and other personnel changes.
Counsels associates and take disciplinary action or terminate the employment of associates as appropriate.
May represent GEICO insureds in liability cases, and UM/UIM, subrogation, and PD suits filed in courts of limited and unlimited jurisdiction.
Research laws and prepare legal briefs, opinions, and memoranda.
Renders opinions on liability, damage, and value as requested by the Claims Department. May prepare and handle pleadings, motions, and discovery, to include depositions/examinations before trial and examinations under oath, and other deadlines.
Trains and supervises less experienced attorneys, including assisting attorneys as first and second chair counsel, and/or observing attorneys at trials and arbitrations
monitors all applicable bar requirements including mandatory Continuing Legal Education (“CLE”) requirements

What we offer

Comprehensive Total Rewards program that offers personalized coverage tailor-made for you and your family’s overall well-being.
Financial benefits including market-competitive compensation
a 401K savings plan vested from day one that offers a 6% match
performance and recognition-based incentives
and tuition assistance.
Access to additional benefits like mental healthcare as well as fertility and adoption assistance.
Supports flexibility- We provide workplace flexibility as well as our GEICO Flex program, which offers the ability to work from anywhere in the US for up to four weeks per year.

Fulltime

Select Country

Observational Research Senior Manager

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Observational Research Senior Manager

Observational Research Senior Manager

Observational Research Senior Manager, Inflammation

Senior Manager, Information Security Office (AI) Consultant

Biostatistical Programming Senior Manager

Senior Manager, Inspection Management

Senior Manager, Site Engagement, Sponsor Dedicated

Senior Manager, Evidence Generation Lead

Senior Manager, Staff Counsel

Our AI answers in your language