Clinical Scientist Associate Director Job at Amgen

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Scientific Associate Director - Pharmacokinetics and Drug Metabolism

In this vital and exciting role, you will oversee Pharmacokinetics and Drug Meta...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 12+ years of experience in the Biotechnology/Pharmaceutical Industry
Solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
Ability to drive the progression of SM discovery and development within project teams
Expertise with in vitro ADME, in vivo ADME, PK/PD etc
Experience in supporting preclinical components of regulatory documentations
Excellent interpersonal, technical, and communication skills
Past experience as a laboratory scientist in a pharma or biotech environment
Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
Record of scientific contributions through peer-reviewed articles and external presentations

Job Responsibility

Lead/mentor a team of scientists involved in ADME characterization of small molecules
Directly responsible for leading a team of scientists involved in undertaking mechanistic in vitro ADME assays
Develop/implement novel tools to efficiently support mechanistic ADME work
Oversee activities/establish workflows for small molecule bioanalytical and ADME screening teams
Serving as a subject matter expert of small molecule ADME to support the programs and recommend strategies to PKDM project team representatives to reduce/mitigate risks due to metabolism
Collaborate with scientists across our PKDM scientific community
Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, to impact project progression and decision-making
Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
Building close relationships with partner functions

Senior Clinical Research Associate II - FSP

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Turkey

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 5 years relevant experience in clinical research site monitoring (preferably 3 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Senior Clinical Research Associate

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

Argentina

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Global clinical trial experience
Must be fluent in English and in the native language(s) of the country they will work in
Significant travel (60-80%) within area is required. May require some international travel and some weekend travel
Valid driver’s license and passport required
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
Demonstrated knowledge of global and local regulatory requirements
Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)

Job Responsibility

Oversight of Monitoring Responsibilities and Study Conduct
Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

What we offer

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Clinical Scientist Associate Director - Late Development, Oncology

In this role, the Clinical Scientist Associate Director supports late-phase clin...

Location

Portugal , Lisbon

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 3 years of life sciences/healthcare experience
Master’s degree and 5 years of life sciences/healthcare experience
Bachelor’s degree and 7 years of life sciences/healthcare experience
3 years of pharmaceutical clinical drug development experience
Demonstrated experience contributing to clinical trial process improvements within a therapeutic area or study team environment
Industry or academic experience supporting early or late-phase drug development within a relevant therapeutic area or disease indication
Strong communication and presentation skills in English
Experience supporting the design, monitoring, and implementation of clinical trials in compliance with Good Clinical Practice standards and applicable regulatory requirements
Working knowledge of study data readout activities, including data cleaning, database lock, data extraction, and generation of clinical data outputs
Experience contributing to regulatory submission documents and supporting clinical regulatory responses for health authority interactions under guidance

Job Responsibility

Support set up and execution of late phase clinical trials with a focus on data quality
Assist in authoring clinical protocols, Investigators Brochures and other regulatory documents ensuring consistency and clarity
Provide input into & implementation of data management plan, CRF design, and data review oversight
Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission
Assists Development Lead and Medical Sciences Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
Anticipate and actively manage problems across a broad spectrum of cross-functional teams
Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents
Support appropriate training, recruitment, and development requirements for matrix team resources

What we offer

Vast opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

Department Program Specialist I

Provides executive high-level administrative support to the Associate Director o...

Location

United States of America , Rochester

Salary:

23.06 - 32.29 USD / Hour

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent combination of education and experience required
5 years of relevant experience preferred
Strong organizational and time-management skills required
Excellent communication and interpersonal skills, especially regarding high-level sensitive information required
Ability to work collaboratively in a team environment required
Advanced knowledge of the medical center, Wilmot and departmental activities required
Basic proficiency with Microsoft Office Suite and social media platforms required
Strong project management skills, with the ability to manage multiple tasks simultaneously preferred
Proficiency with data analysis tools and software preferred
High-level proofreading/editing skills with attention to grammar, punctuation, spelling, etc. preferred

Job Responsibility

Provides executive high-level administrative support to the Associate Director of Wilmot Cancer Institute for Population Science, Co-Director of the URCC NCORP Research Base, and Director of the URMC PEAK Human Performance Clinical Science Program, and Director of the Wilmot RENEW Program
Helps with direct oversight of Wilmot Cancer Institute operations related to Population Science and the Cancer Prevention and Control Program, as well as the RENEW Clinical Exercise Oncology Program
Helps with direct oversight of operations of the URCC NCORP Research Base and PEAK Human Performance Clinical Science Program
Organizes calendars, schedules events and meetings, and manages commitments prioritizing and delegating as appropriate
Oversee email group lists for various groups
Oversee, submit, and ensure compliance with NIHMS and MyNCBI to ensure publications are compliant with federal regulations
Plan, execute and provide high level meeting support for meetings, compiling data, preparing reports, agenda, and distribution and monitoring of action items and follow-up communications
Assists with grants, proposals, and progress reports
Helps with oversite of financials, compliance forms, and financial sign offs
Procurement card holder

Fulltime

Medical Laboratory Scientist

Baptist Health is looking to add a Medical Laboratory Scientist II at Baptist Me...

Location

United States , Jacksonville

Salary:

Not provided

Baptist Health (Florida)

Expiration Date

Until further notice

Requirements

Associate's Degree
Less than 1 year Medical Technologist Experience
Licensed Medical Technologist Required Or Licensed Clinical Laboratory Technician Required
Medical Laboratory Scientist or Medical Laboratory Technician (2-3 years preferred)
Experience working in a laboratory setting
Candidates licensed prior to 1997 are not required to have certification per the State of Florida Licensure rules
Eligible candidates must not have been employed with Baptist Health within the last 12 months

Job Responsibility

Maintain expertise and perform technical, specimen collection/processing, LIS, general department, and clerical functions in laboratory areas where applicable
Maintain records of performance as defined in the SOP manuals
Supervised by Director and Section Supervisors
can perform all responsibilities without on-site supervision
Can supervise MLTs as General Supervisor and serve as Charge Technologist in the absence of other lab supervisors or MTs
May instruct new employees and students

Parttime

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Clinical Scientist Associate Director

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