Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine
Bristol-Myers Squibb
Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine
Job Description
Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs Prepares and delivers internal and external translational/biomarker presentations Maintains timelines for biomarker data related publication through interaction with Medical Communications and Publication team as needed Keeps up-to-date on relevant scientific/technical literature in order to applying external knowledge to internal research programs as appropriate and acts as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology Works with TM laboratory scientists and academic TLs to address nonclinical translational questions Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. PhD or MD/PhD in neuroscience with 7+ years of translational medicine experience 5+ years of late-stage clinical biomarker experience in biotech/pharma Recognized expertise in translational biomarkers in neuroscience space Deep training and education in Neuroscience required Experience in late-stage drug development and activities required for and related to clinical trial initiation, maintenance and completion Strong verbal and written communication skills Experience in interacting with CROs and TLs to manage projects and timelines Proven scientific/leadership expertise (working in teams, mentoring people, managing projects) Accountable for timelines and deliverables Prioritizes risks and implements contingency plans Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally as requested Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks. Ability to prioritize and manage time efficiently Accurate and detailed record keeping Excellent organizational skills
Key Responsibilities
- Design and implement program-specific late development biomarker/translational plans
- Aid in creation of clinical protocols, SAPs, SOWs, lab manual
- Interface with CRO for execution of services
- Determine appropriate assays and vendors for clinical biomarkers
- Manage outsourcing of biomarker assay development and validation
- Manage clinical biomarker data delivery and analysis and associated timelines
- Prepare and deliver internal and external translational/biomarker presentations
- Maintain timelines for biomarker data related publication
- Keep up-to-date on relevant scientific/technical literature and apply external knowledge to internal research programs
- Act as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
- Work with TM laboratory scientists and academic TLs to address nonclinical translational questions
- Participate in post-hoc biomarker analysis and publication efforts
- Support regulatory submissions and regulatory interactions as needed
Required Qualifications
- PhD or MD/PhD in neuroscience
- + years of translational medicine experience
- + years of late-stage clinical biomarker experience in biotech/pharma
- Recognized expertise in translational biomarkers in neuroscience space
- Deep training and education in Neuroscience
- Experience in late-stage drug development and activities related to clinical trial initiation, maintenance, and completion
Skills Required
- Strong verbal and written communication skills
- Experience in interacting with CROs and TLs to manage projects and timelines
- Proven scientific/leadership expertise including working in teams, mentoring people, and managing projects
- Accountability for timelines and deliverables
- Ability to prioritize risks and implement contingency plans
- Regular communication and preparation/delivery of presentations within the department, to governance and senior leadership bodies, and externally
- Recognition of cross-functional issues and communication within the larger organization
- Provision of expert guidance to multi-disciplinary teams and senior management
- Track record of delivering results, driving continuous improvements, and building effective cross-functional networks
- Ability to prioritize and manage time efficiently
- Accurate and detailed record keeping
- Excellent organizational skills
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Cambridge Crossing MA, United States
- Princeton NJ, United States
- San Diego CA, United States
Salary
Estimated Salary Rangemedium confidence
200,000 - 300,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong verbal and written communication skillsintermediate
- Experience in interacting with CROs and TLs to manage projects and timelinesintermediate
- Proven scientific/leadership expertise including working in teams, mentoring people, and managing projectsintermediate
- Accountability for timelines and deliverablesintermediate
- Ability to prioritize risks and implement contingency plansintermediate
- Regular communication and preparation/delivery of presentations within the department, to governance and senior leadership bodies, and externallyintermediate
- Recognition of cross-functional issues and communication within the larger organizationintermediate
- Provision of expert guidance to multi-disciplinary teams and senior managementintermediate
- Track record of delivering results, driving continuous improvements, and building effective cross-functional networksintermediate
- Ability to prioritize and manage time efficientlyintermediate
- Accurate and detailed record keepingintermediate
- Excellent organizational skillsintermediate
Required Qualifications
- PhD or MD/PhD in neuroscience (experience)
- + years of translational medicine experience (experience)
- + years of late-stage clinical biomarker experience in biotech/pharma (experience)
- Recognized expertise in translational biomarkers in neuroscience space (experience)
- Deep training and education in Neuroscience (experience)
- Experience in late-stage drug development and activities related to clinical trial initiation, maintenance, and completion (experience)
Responsibilities
- Design and implement program-specific late development biomarker/translational plans
- Aid in creation of clinical protocols, SAPs, SOWs, lab manual
- Interface with CRO for execution of services
- Determine appropriate assays and vendors for clinical biomarkers
- Manage outsourcing of biomarker assay development and validation
- Manage clinical biomarker data delivery and analysis and associated timelines
- Prepare and deliver internal and external translational/biomarker presentations
- Maintain timelines for biomarker data related publication
- Keep up-to-date on relevant scientific/technical literature and apply external knowledge to internal research programs
- Act as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
- Work with TM laboratory scientists and academic TLs to address nonclinical translational questions
- Participate in post-hoc biomarker analysis and publication efforts
- Support regulatory submissions and regulatory interactions as needed
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine @ Bristol-Myers Squibb.
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Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine
Bristol-Myers Squibb
Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine
Job Description
Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation of clinical protocols, SAPs, SOWs, lab manual, and interfacing with CRO for execution of services, in conjunction with Biospecimen Operations and Procurement. Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with Translational Sciences colleagues when applicable Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs Prepares and delivers internal and external translational/biomarker presentations Maintains timelines for biomarker data related publication through interaction with Medical Communications and Publication team as needed Keeps up-to-date on relevant scientific/technical literature in order to applying external knowledge to internal research programs as appropriate and acts as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology Works with TM laboratory scientists and academic TLs to address nonclinical translational questions Participates in post-hoc biomarker analysis and publication efforts Supports regulatory submissions and regulatory interactions as needed Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. PhD or MD/PhD in neuroscience with 7+ years of translational medicine experience 5+ years of late-stage clinical biomarker experience in biotech/pharma Recognized expertise in translational biomarkers in neuroscience space Deep training and education in Neuroscience required Experience in late-stage drug development and activities required for and related to clinical trial initiation, maintenance and completion Strong verbal and written communication skills Experience in interacting with CROs and TLs to manage projects and timelines Proven scientific/leadership expertise (working in teams, mentoring people, managing projects) Accountable for timelines and deliverables Prioritizes risks and implements contingency plans Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally as requested Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks. Ability to prioritize and manage time efficiently Accurate and detailed record keeping Excellent organizational skills
Key Responsibilities
- Design and implement program-specific late development biomarker/translational plans
- Aid in creation of clinical protocols, SAPs, SOWs, lab manual
- Interface with CRO for execution of services
- Determine appropriate assays and vendors for clinical biomarkers
- Manage outsourcing of biomarker assay development and validation
- Manage clinical biomarker data delivery and analysis and associated timelines
- Prepare and deliver internal and external translational/biomarker presentations
- Maintain timelines for biomarker data related publication
- Keep up-to-date on relevant scientific/technical literature and apply external knowledge to internal research programs
- Act as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
- Work with TM laboratory scientists and academic TLs to address nonclinical translational questions
- Participate in post-hoc biomarker analysis and publication efforts
- Support regulatory submissions and regulatory interactions as needed
Required Qualifications
- PhD or MD/PhD in neuroscience
- + years of translational medicine experience
- + years of late-stage clinical biomarker experience in biotech/pharma
- Recognized expertise in translational biomarkers in neuroscience space
- Deep training and education in Neuroscience
- Experience in late-stage drug development and activities related to clinical trial initiation, maintenance, and completion
Skills Required
- Strong verbal and written communication skills
- Experience in interacting with CROs and TLs to manage projects and timelines
- Proven scientific/leadership expertise including working in teams, mentoring people, and managing projects
- Accountability for timelines and deliverables
- Ability to prioritize risks and implement contingency plans
- Regular communication and preparation/delivery of presentations within the department, to governance and senior leadership bodies, and externally
- Recognition of cross-functional issues and communication within the larger organization
- Provision of expert guidance to multi-disciplinary teams and senior management
- Track record of delivering results, driving continuous improvements, and building effective cross-functional networks
- Ability to prioritize and manage time efficiently
- Accurate and detailed record keeping
- Excellent organizational skills
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Cambridge Crossing MA, United States
- Princeton NJ, United States
- San Diego CA, United States
Salary
Estimated Salary Rangemedium confidence
200,000 - 300,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong verbal and written communication skillsintermediate
- Experience in interacting with CROs and TLs to manage projects and timelinesintermediate
- Proven scientific/leadership expertise including working in teams, mentoring people, and managing projectsintermediate
- Accountability for timelines and deliverablesintermediate
- Ability to prioritize risks and implement contingency plansintermediate
- Regular communication and preparation/delivery of presentations within the department, to governance and senior leadership bodies, and externallyintermediate
- Recognition of cross-functional issues and communication within the larger organizationintermediate
- Provision of expert guidance to multi-disciplinary teams and senior managementintermediate
- Track record of delivering results, driving continuous improvements, and building effective cross-functional networksintermediate
- Ability to prioritize and manage time efficientlyintermediate
- Accurate and detailed record keepingintermediate
- Excellent organizational skillsintermediate
Required Qualifications
- PhD or MD/PhD in neuroscience (experience)
- + years of translational medicine experience (experience)
- + years of late-stage clinical biomarker experience in biotech/pharma (experience)
- Recognized expertise in translational biomarkers in neuroscience space (experience)
- Deep training and education in Neuroscience (experience)
- Experience in late-stage drug development and activities related to clinical trial initiation, maintenance, and completion (experience)
Responsibilities
- Design and implement program-specific late development biomarker/translational plans
- Aid in creation of clinical protocols, SAPs, SOWs, lab manual
- Interface with CRO for execution of services
- Determine appropriate assays and vendors for clinical biomarkers
- Manage outsourcing of biomarker assay development and validation
- Manage clinical biomarker data delivery and analysis and associated timelines
- Prepare and deliver internal and external translational/biomarker presentations
- Maintain timelines for biomarker data related publication
- Keep up-to-date on relevant scientific/technical literature and apply external knowledge to internal research programs
- Act as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
- Work with TM laboratory scientists and academic TLs to address nonclinical translational questions
- Participate in post-hoc biomarker analysis and publication efforts
- Support regulatory submissions and regulatory interactions as needed
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Associate Director, Neuroscience, Clinical Biomarker, Late Phases, Translational Medicine @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs