At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Epidemiology
Job Category:
Scientific/Technology
All Job Posting Locations:
Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
We are searching for the best talent for our Associate Director, Benefit Risk/Patient Preference position, to be based in Titusville, NJ; Raritan, NJ; Horsham, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine/
Purpose: The Associate Director, Benefit-Risk / Patient Preference will be part of the Benefit-Risk Team within Global Epidemiology in Innovative Medicine and serve as an expert and consultant for benefit-risk methodology, patient preference studies an patient-focused drug development, collaborating with and supporting Johnson & Johnson colleagues in cross-functional teams across The Office of the Chief Medical Officer, R&D and the Global Commercial Strategy Organization.
You will be responsible for:
Leading structured benefit-risk assessments and patient preference studies including:
* Guiding clinical teams in benefit-risk assessment of products in development
* Leading preference studies to support products in development, including designing preference studies for internal advisory boards
* Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle
* Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents)
* Serving as an internal subject matter expert on these topics
Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development. Standard tools expected to be used in this role include:
* Benefit-risk frameworks
* Value trees
* Statistical analysis plans
* Effects tables
* Qualitative and quantitative preference methods
Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment.
Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings.
Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.
Qualifications / Requirements:
Education:
* Master's degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines.
Required:
* A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research
* Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development.
* Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
* Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.
* Experience presenting technical topics to clinical/medical audiences.
* Excellent communication (verbal and written) and interpersonal skills.
* The ability to collaborate with all levels in a cross-functional team environment.
* Strong problem-solving skills.
* Strong self-management skills with a focus on timely completion of competing deliverables.
Preferred:
* Experience with tabular and graphical displays of benefit-risk data.
* Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA).
* Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses).
* Basic understanding of epidemiology methods.
* Experience with writing statistical methods sections of study proposals or statistical analysis plans.
* Experience working with Health Authorities.
* Experience working in a regulated biomedical/life science product development environment.
* Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB).
* Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics.
Other:
* This position will require up to 20% domestic and international travel (up to 10% for individuals located at one of the New Jersey or Pennsylvania sites).
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Advanced Analytics, Critical Thinking, Data Privacy Standards, Disease Management, Emergency Planning, Environmental Health, Epidemiology, Financial Competence, Industry Analysis, Public Health, Public Health Surveillance, Researching, Research Proposals, Scientific Communications, Tactical Planning, Technical Credibility, Vendor Management
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Epidemiology
Job Category:
Scientific/Technology
All Job Posting Locations:
Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
We are searching for the best talent for our Associate Director, Benefit Risk/Patient Preference position, to be based in Titusville, NJ; Raritan, NJ; Horsham, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine/
Purpose: The Associate Director, Benefit-Risk / Patient Preference will be part of the Benefit-Risk Team within Global Epidemiology in Innovative Medicine and serve as an expert and consultant for benefit-risk methodology, patient preference studies an patient-focused drug development, collaborating with and supporting Johnson & Johnson colleagues in cross-functional teams across The Office of the Chief Medical Officer, R&D and the Global Commercial Strategy Organization.
You will be responsible for:
Leading structured benefit-risk assessments and patient preference studies including:
* Guiding clinical teams in benefit-risk assessment of products in development
* Leading preference studies to support products in development, including designing preference studies for internal advisory boards
* Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle
* Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents)
* Serving as an internal subject matter expert on these topics
Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development. Standard tools expected to be used in this role include:
* Benefit-risk frameworks
* Value trees
* Statistical analysis plans
* Effects tables
* Qualitative and quantitative preference methods
Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment.
Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings.
Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.
Qualifications / Requirements:
Education:
* Master's degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines.
Required:
* A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research
* Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development.
* Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
* Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.
* Experience presenting technical topics to clinical/medical audiences.
* Excellent communication (verbal and written) and interpersonal skills.
* The ability to collaborate with all levels in a cross-functional team environment.
* Strong problem-solving skills.
* Strong self-management skills with a focus on timely completion of competing deliverables.
Preferred:
* Experience with tabular and graphical displays of benefit-risk data.
* Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA).
* Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses).
* Basic understanding of epidemiology methods.
* Experience with writing statistical methods sections of study proposals or statistical analysis plans.
* Experience working with Health Authorities.
* Experience working in a regulated biomedical/life science product development environment.
* Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB).
* Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics.
Other:
* This position will require up to 20% domestic and international travel (up to 10% for individuals located at one of the New Jersey or Pennsylvania sites).
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Advanced Analytics, Critical Thinking, Data Privacy Standards, Disease Management, Emergency Planning, Environmental Health, Epidemiology, Financial Competence, Industry Analysis, Public Health, Public Health Surveillance, Researching, Research Proposals, Scientific Communications, Tactical Planning, Technical Credibility, Vendor Management
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$137k-235.8k yearly Auto-Apply 13d ago
Associate Vice President - Scientific Innovation Communications
Eli Lilly and Company 4.6
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Job Description
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Responsibilities
The Associate VicePresident - Discovery and Innovation Communications is responsible for developing and delivering global external communications to promote Lilly's scientific innovation story in support of Lilly's corporate narrative. This role will leverage strategic communications to enhance visibility and understanding of the company's commitment to discovering and advancing innovative medicines with external stakeholders working with Lilly's R&D leadership team.
Reporting to the Global Chief Communications Officer, this role will lead a team of strategic communicators within the Lilly Corporate Affairs department. The Advisor will strategically look across the work of the Therapeutic Area Communications leads and identify areas that cut across therapeutic areas. Where cross-TA narratives and themes emerge, this person will own and lead those integrated communications narratives.
Team Leadership
As a member of the Global Communications Leadership Team (GCLT), accountable for ensuring integration within Global Communications and continuous improvement across the function
Critical to the role's success will be close collaboration with counterparts in Content, Creative and Digital Channel communications, Enterprise communications, Public Affairs communications and BUCA communications.
Key Areas of Responsibility
Strategic Leadership & Cross-TA Integration
Strategically analyze the work across Therapeutic Area Communications leads to identify cross-cutting themes, narratives, and opportunities
Own and lead the development and execution of integrated communications narratives that span multiple therapeutic areas
Support the development and lead implementation of a comprehensive discovery and innovation communications strategy that drives home a critical component of the Lilly narrative, including scientific milestones and technology advancements
Executive Communications & Counsel
Serve as a trusted advisor to Chief Scientific Officer and other R&D executives while collaborating closely with colleagues across global communications to support an enterprise focus.
Team Leadership & Development
Coach and develop a team of communications professionals who will implement communications initiatives to support global communications objectives
Monitor the effectiveness of external suppliers of public relations activities
Basic Qualifications
Bachelor's Degree
Minimum of 10 years of diverse communications experience within corporate or public relations agency environments
Additional Skills/Preferences
Strong media relations and issues management
Pharmaceutical or healthcare experience and expertise
Experience managing teams and cross-company initiatives
Ability to identify patterns and connections across diverse therapeutic areas and synthesize cross-cutting narratives
Strategic thinking to connect dots across multiple TA communications strategies and identify enterprise-level stories
Ability to think strategically and broadly, focus on key priorities and translate strategy into action
Proven ability to effectively counsel senior management on communications strategies and ideas in verbal and written formats
Additional Information
Travel (domestic) is expected
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$232,500 - $341,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$232.5k-341k yearly Auto-Apply 7d ago
Associate Director - Cybersecurity Posture and Hygiene (Remote)
Abbvie 4.7
Mettawa, IL jobs
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at
**************
. Follow @abbvie on
X
,
Facebook
,
Instagram
,
YouTube
,
LinkedIn
and
Tik Tok
.
Job Description
The Associate Director, Security Posture and Hygiene, plays a pivotal leadership role within our organization, steering the strategic direction, design, and implementation of our security posture and hygiene program. This role is at the forefront of enhancing our cybersecurity measures across a diverse and complex infrastructure landscape, including on-premise and cloud models. By continuously monitoring and remediating security control gaps and leveraging the
Center for Internet Security (CIS) Top 18 critical security controls
, this position aims to bolster our defenses by improving our hygiene of cybersecurity standards and practices.
This position can be based anywhere remotely/virtually anywhere in the U.S.
In this role, you will be responsible for:
Develop a comprehensive strategy for the security posture and hygiene program.
Assemble and manage a team dedicated to implementing, assessing, and maturing the CIS Top 18 critical controls and their associated safeguards.
Develop and execute strategies for continuous monitoring and improvement of security controls and configurations across enterprise systems.
Ensure the hygiene of security configurations by establishing and enforcing policies, procedures, and standards to prevent unauthorized access, data breaches, and other cyber threats.
Collaborate with IT, network, and other relevant departments to align security measures with organizational goals and compliance requirements.
Develop and maintain comprehensive documentation on security controls, assessments, incidents, and improvements.
Conduct regular assessments to determine the maturity of each security control, identifying areas for improvement and recommending enhancements.
Foster strong partnerships with technology and domain stakeholders to ensure seamless integration and compliance of security practices across the enterprise.
Stay abreast of the latest cybersecurity trends, threats, and technologies to adapt and evolve our security strategies accordingly.
Lead initiatives to educate and train team members and the wider organization on cybersecurity good practices and the importance of a forward-thinking security posture.
Ensure that all security programs and initiatives adhere to relevant laws, regulations, and policies, continuously updating practices to meet new standards.
Oversee daily operations, including targeted assessments, risk management, and response strategies, ensuring a high level of security and resilience against cyber threats.
Build collaborative relationships and partner effectively with business and technology senior leaders.
Maintain expert-level professional and technical knowledge in relevant domains
Building metrics and dashboards that will provide stakeholders with actionable insights into the security posture of technologies
Qualifications
Bachelors Degree and 9 years of experience OR Masters Degree and 8 years of experience OR PhD and 4 years of experience
Proven leadership in cybersecurity, with extensive experience in managing security posture and hygiene strategies within complex and diverse IT environments
Expert knowledge of operating systems, networking protocols, systems administration, X as a service, applications, and security technologies.
Expert knowledge and application of cybersecurity terminology, concepts, and the cyber threat landscape and attack vectors.
Deep understanding of risk management principles and the ability to integrate these into security practices.
Experience with the CIS Top 18 controls and familiarity with the CIS Controls Implementation Groups (IGs) methodology.
Demonstrated ability to innovate and adapt in response to a constantly changing environment.
Advanced critical thinking, problem solving, and analytical skills
Strong leadership and collaboration skills with business and technical groups.
Excellent written and verbal communication and listening skills, with the ability to effectively convey technical insights to technical and non-technical stakeholders.
Demonstrated ability to interface effectively with clients, IT management, and staff.
A sincere desire to learn, grow, and go beyond personal capabilities, staying abreast of the latest developments in the cybersecurity landscape .
Professional cybersecurity certifications (e.g., CISSP, CISM, CIS Controls, etc.) are highly desirable.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit
*************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
*************************************************************
$124k-161k yearly est. 16h ago
Associate Director - Cybersecurity Posture and Hygiene (Remote)
Abbvie 4.7
Mettawa, IL jobs
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Associate Director, Security Posture and Hygiene, plays a pivotal leadership role within our organization, steering the strategic direction, design, and implementation of our security posture and hygiene program. This role is at the forefront of enhancing our cybersecurity measures across a diverse and complex infrastructure landscape, including on-premise and cloud models. By continuously monitoring and remediating security control gaps and leveraging the Center for Internet Security (CIS) Top 18 critical security controls, this position aims to bolster our defenses by improving our hygiene of cybersecurity standards and practices.
This position can be based anywhere remotely/virtually anywhere in the U.S.
In this role, you will be responsible for:
Develop a comprehensive strategy for the security posture and hygiene program.
Assemble and manage a team dedicated to implementing, assessing, and maturing the CIS Top 18 critical controls and their associated safeguards.
Develop and execute strategies for continuous monitoring and improvement of security controls and configurations across enterprise systems.
Ensure the hygiene of security configurations by establishing and enforcing policies, procedures, and standards to prevent unauthorized access, data breaches, and other cyber threats.
Collaborate with IT, network, and other relevant departments to align security measures with organizational goals and compliance requirements.
Develop and maintain comprehensive documentation on security controls, assessments, incidents, and improvements.
Conduct regular assessments to determine the maturity of each security control, identifying areas for improvement and recommending enhancements.
Foster strong partnerships with technology and domain stakeholders to ensure seamless integration and compliance of security practices across the enterprise.
Stay abreast of the latest cybersecurity trends, threats, and technologies to adapt and evolve our security strategies accordingly.
Lead initiatives to educate and train team members and the wider organization on cybersecurity good practices and the importance of a forward-thinking security posture.
Ensure that all security programs and initiatives adhere to relevant laws, regulations, and policies, continuously updating practices to meet new standards.
Oversee daily operations, including targeted assessments, risk management, and response strategies, ensuring a high level of security and resilience against cyber threats.
Build collaborative relationships and partner effectively with business and technology senior leaders.
Maintain expert-level professional and technical knowledge in relevant domains
Building metrics and dashboards that will provide stakeholders with actionable insights into the security posture of technologies
Qualifications
Bachelors Degree and 9 years of experience OR Masters Degree and 8 years of experience OR PhD and 4 years of experience
Proven leadership in cybersecurity, with extensive experience in managing security posture and hygiene strategies within complex and diverse IT environments
Expert knowledge of operating systems, networking protocols, systems administration, X as a service, applications, and security technologies.
Expert knowledge and application of cybersecurity terminology, concepts, and the cyber threat landscape and attack vectors.
Deep understanding of risk management principles and the ability to integrate these into security practices.
Experience with the CIS Top 18 controls and familiarity with the CIS Controls Implementation Groups (IGs) methodology.
Demonstrated ability to innovate and adapt in response to a constantly changing environment.
Advanced critical thinking, problem solving, and analytical skills
Strong leadership and collaboration skills with business and technical groups.
Excellent written and verbal communication and listening skills, with the ability to effectively convey technical insights to technical and non-technical stakeholders.
Demonstrated ability to interface effectively with clients, IT management, and staff.
A sincere desire to learn, grow, and go beyond personal capabilities, staying abreast of the latest developments in the cybersecurity landscape .
Professional cybersecurity certifications (e.g., CISSP, CISM, CIS Controls, etc.) are highly desirable.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit *************************************************************************
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
*************************************************************
$124k-161k yearly est. 8d ago
Sr. Director Clinical Development - Lilly Gene Therapy, Sensory
Eli Lilly and Company 4.6
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Role Overview
The Sr. Director, Clinical Development is an experienced clinical trialist who will be responsible for the clinical and scientific execution of global clinical programs. They will play a key role in strategy development and will ensure timely planning, implementation, management, and reporting of clinical studies and trials. The successful candidate will collaborate cross-functionally to support clinical programs and pipeline programs as needed and will provide insight into clinical development programs both externally and internally (e.g., Medical Affairs, Commercial, CROs, etc.). They will provide clinical / scientific support for training of clinical sites and CROs.
Responsibilities:
Lead the development of clinical strategies and plans for assigned programs and work with program teams to ensure integration of clinical strategies and plans into program targets and goals
Collaborate with cross-functional teams to support clinical programs and achieve organizational and corporate goals
Represent clinical development in program teams and cross-functional teams in decision making and problem solving, as well as development of Standard of Procedures (SOPs) and internal processes
Provide leadership, mentorship and guidance to clinical development team; manage direct reports as needed
Serves as the clinical / scientific representative for assigned clinical studies and trials; facilitate the clinical / scientific execution of clinical protocol(s) / programs (including interventional, non-interventional, validation, natural history, and registry trials / studies)
Supports the clinical operations team, including clinical trial manager, in achieving study deliverables, including adherence to budget and timelines, and developing study documents, including training materials, study procedures, and study plans
Supports the implementation and conduct of clinical studies and trials in all scientific aspects (e.g., scientific advisory committees, data safety monitoring boards, medical monitoring)
Reviews and evaluates emerging clinical trial data and oversees data interpretation; supports Communication teams in publication of data and development of materials (e.g., slide decks, posters, manuscripts, abstracts, etc.) based on clinical trial data
Supports authorship and review of clinical / regulatory documents (e.g., protocols, Investigator Brochures, clinical study reports, briefing packages, etc.); collaborates cross-functionally in planning regulatory strategy and communications
Serves as a clinical representative on internal and external teams; participates in development, review, and / or presentation of clinical data in internal and external meetings, as needed (e.g., DSMB, training, Investigator meetings, Board presentations, etc.)
Other duties as assigned or as business needs require
Basic Qualifications:
Master's degree or Advanced degree (ie., PharmD, PhD, etc.,) in the Life Sciences required.
A minimum of ten (10) years of pharmaceutical and/or clinical experience
Additional Skills / Preferences:
Prior pharma/biotech or academic experience in rare disease, otology, audiology, gene therapy, cellular therapy, and/or medical device a plus
Proven track record of successfully conducting / supporting global clinical trials and associated development activities
Comprehensive understanding of the drug development and approval process and clinical trial design
Strong interpersonal and leadership skills required
Strong analytical and problem-solving skills, including the ability to identify and evaluate the critical factors of obstacles or opportunities; given background, experience, and judgment, able to quickly understand potential causes and deliver effective solutions
Ability to plan and think strategically and critically; intellectually curious, willing to take ownership of the assigned clinical programs and support as needed other clinical / pipeline programs
Ability to critically evaluate and analyze scientific data and literature
Strong communication skills (written and verbal) including the ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required
Capable of representing Lilly Gene Therapy professionally with external global opinion leaders, investigators, vendors, regulatory agencies, and others
Ability to work effectively cross-functionally, and to serve as clinical resource within the company
Self-motivated and detail-oriented with ability to prioritize and handle multiple projects
Additional Information:
Travel may be up to 5%, including international travel
Location: USA Remote
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
**Job Function:**
Data Analytics & Computational Sciences
**Job Sub** **Function:**
Epidemiology
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
**Job Description:**
We are searching for the best talent for our **Associate Director, Benefit Risk/Patient Preference** position, to be based in Titusville, NJ; Raritan, NJ; Horsham, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine/
**Purpose:** The Associate Director, Benefit-Risk / Patient Preference will be part of the Benefit-Risk Team within Global Epidemiology in Innovative Medicine and serve as an expert and consultant for benefit-risk methodology, patient preference studies an patient-focused drug development, collaborating with and supporting Johnson & Johnson colleagues in cross-functional teams across The Office of the Chief Medical Officer, R&D and the Global Commercial Strategy Organization.
**You will be responsible for:**
Leading structured benefit-risk assessments and patient preference studies including:
+ Guiding clinical teams in benefit-risk assessment of products in development
+ Leading preference studies to support products in development, including designing preference studies for internal advisory boards
+ Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle
+ Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents)
+ Serving as an internal subject matter expert on these topics
Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development. Standard tools expected to be used in this role include:
+ Benefit-risk frameworks
+ Value trees
+ Statistical analysis plans
+ Effects tables
+ Qualitative and quantitative preference methods
Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment.
Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings.
Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.
**Qualifications / Requirements:**
**Education:**
+ Master's degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines.
**Required:**
+ A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research
+ Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development.
+ Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
+ Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.
+ Experience presenting technical topics to clinical/medical audiences.
+ Excellent communication (verbal and written) and interpersonal skills.
+ The ability to collaborate with all levels in a cross-functional team environment.
+ Strong problem-solving skills.
+ Strong self-management skills with a focus on timely completion of competing deliverables.
**Preferred:**
+ Experience with tabular and graphical displays of benefit-risk data.
+ Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA).
+ Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses).
+ Basic understanding of epidemiology methods.
+ Experience with writing statistical methods sections of study proposals or statistical analysis plans.
+ Experience working with Health Authorities.
+ Experience working in a regulated biomedical/life science product development environment.
+ Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB).
+ Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics.
**Other:**
+ This position will require up to 20% domestic and international travel (up to 10% for individuals located at one of the New Jersey or Pennsylvania sites).
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
**\#LI-Hybrid**
**Required Skills:**
**Preferred Skills:**
Advanced Analytics, Critical Thinking, Data Privacy Standards, Disease Management, Emergency Planning, Environmental Health, Epidemiology, Financial Competence, Industry Analysis, Public Health, Public Health Surveillance, Researching, Research Proposals, Scientific Communications, Tactical Planning, Technical Credibility, Vendor Management
**The anticipated base pay range for this position is :**
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Epidemiology
Job Category:
Scientific/Technology
All Job Posting Locations:
Cambridge, Massachusetts, United States of America, Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
We are searching for the best talent for our Associate Director, Benefit Risk/Patient Preference position, to be based in Titusville, NJ; Raritan, NJ; Horsham, PA or Cambridge, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine/
Purpose: The Associate Director, Benefit-Risk / Patient Preference will be part of the Benefit-Risk Team within Global Epidemiology in Innovative Medicine and serve as an expert and consultant for benefit-risk methodology, patient preference studies an patient-focused drug development, collaborating with and supporting Johnson & Johnson colleagues in cross-functional teams across The Office of the Chief Medical Officer, R&D and the Global Commercial Strategy Organization.
You will be responsible for:
Leading structured benefit-risk assessments and patient preference studies including:
* Guiding clinical teams in benefit-risk assessment of products in development
* Leading preference studies to support products in development, including designing preference studies for internal advisory boards
* Applying structured patient preference, benefit-risk and decision analysis methods throughout the development lifecycle
* Contributing as an author to internal and regulatory documents (e.g. statistical analysis plans, submission documents)
* Serving as an internal subject matter expert on these topics
Keeping up to date with guidance and policy produced by regulatory agencies and other critical organizations regarding methodologies for benefit-risk assessment, patient preference studies and patient-focused drug development. Standard tools expected to be used in this role include:
* Benefit-risk frameworks
* Value trees
* Statistical analysis plans
* Effects tables
* Qualitative and quantitative preference methods
Lead benefit-risk and preference studies for development strategy, dose selection, clinical trials, regulatory documents, health authority advisory committee meetings, safety decisions, treatment access and providing guidance on use of real-world evidence in benefit-risk assessment.
Assist with internal benefit-risk process development and training, developing novel means to communicate and display preference and benefit-risk information, participating in external benefit-risk methodology and policy activities, authoring publications on their research and presenting at internal/external meetings.
Work closely with members of the Global Epidemiology, Clinical and Global Medical Safety departments and collaborate with colleagues in cross-functional teams in performing these responsibilities.
Qualifications / Requirements:
Education:
* Master's degree in Decision Sciences, Health Economics, Epidemiology, Biostatistics, Public Health, or a related scientific discipline required; PhD or MD strongly preferred. MD applicants must also have a degree or certificate in one of these disciplines.
Required:
* A minimum of 5 years (3 year for PhD or MD) of hands-on experience in patient preference, benefit-risk, applied statistical or epidemiologic research
* Knowledge of current academic/regulatory/industry trends in structured benefit-risk, preference studies and patient-focused drug development.
* Experience using structured benefit-risk frameworks (e.g., FDA benefit-risk framework, BRAT, PrOACT-URL) and/or experience with patient preference studies (e.g., discrete choice experiments, best-worst scaling, threshold technique).
* Experience leading projects with multi-stakeholder teams (e.g., clinical, statistics, regulatory) on technical projects.
* Experience presenting technical topics to clinical/medical audiences.
* Excellent communication (verbal and written) and interpersonal skills.
* The ability to collaborate with all levels in a cross-functional team environment.
* Strong problem-solving skills.
* Strong self-management skills with a focus on timely completion of competing deliverables.
Preferred:
* Experience with tabular and graphical displays of benefit-risk data.
* Experience in quantitative benefit-risk assessment (e.g., multi-criteria decision analysis, SMAA).
* Experience with decision analysis (e.g., decision trees, strategy tables, sensitivity analyses).
* Basic understanding of epidemiology methods.
* Experience with writing statistical methods sections of study proposals or statistical analysis plans.
* Experience working with Health Authorities.
* Experience working in a regulated biomedical/life science product development environment.
* Experience with analytical or statistical tools (e.g., R, SAS, Stata, MATLAB).
* Publication record or evidence of scholarship in patient preference studies, benefit-risk assessment or related topics.
Other:
* This position will require up to 20% domestic and international travel (up to 10% for individuals located at one of the New Jersey or Pennsylvania sites).
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
Required Skills:
Preferred Skills:
Advanced Analytics, Critical Thinking, Data Privacy Standards, Disease Management, Emergency Planning, Environmental Health, Epidemiology, Financial Competence, Industry Analysis, Public Health, Public Health Surveillance, Researching, Research Proposals, Scientific Communications, Tactical Planning, Technical Credibility, Vendor Management
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$137k-235.8k yearly Auto-Apply 13d ago
Director, HEOR - Oncology
Eli Lilly and Company 4.6
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Oncology Medical Affairs team has an immediate opening for a Health Economics and Outcomes Research (HEOR) Scientist. The demand for high-quality economic and outcomes research (HEOR) and real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision-making continues to grow. Because of this heightened need, this team is seeking a talented individual who is energetic, creative, diverse, influential, and collaborative, to join the HEOR Oncology function and Team Lilly.
This HEOR scientist will be expected to provide strategic insight and leadership into the health outcomes (HO) evidence needs (e.g., health economics, access and reimbursement) for the Lilly Oncology portfolio, among other pipeline projects per the business' needs. This scientist's duties may range from developing and articulating product-value propositions, patient-reported outcomes strategies, real-world evidence generation, and differentiation strategies using HO research, depending on the individual assignment. This researcher will leverage their knowledge of health outcomes disciplines, therapeutic-area knowledge of disease states in the Lilly portfolio, comprehension of drug development and commercialization, and geographic market learning in this role. Research project ownership and execution is required.
Responsibilities:
Strategy
Drives sustained integration of HEOR from early-clinical development through commercialization
Develops and oversees HO research strategy for Lilly Oncology portfolio compounds.
Serves as a strategic partner on lead/core teams throughout development and/or commercialization lifecycles
Formulates and drives Patient-Focused Outcome, Real-World Evidence, and/or economic-value strategies for priority products and geographies.
Study Development and Execution
Executes bold high-impact science for products across the lifecycle, to influence and support evidence needs for Lilly products in support of improving patient outcomes.
Applies technical expertise (e.g., scope or depth in statistical analysis, economic modeling, clinical trials, PFO development, observational/epidemiologic research, and health technology or other value assessment) to execute HEOR.
Applies disease-state knowledge and research methods to solve HO issues associated with registration, pricing, reimbursement, and access initiatives.
Organizational Leadership and Influence
Communicates technical expertise with business acumen in a simple, succinct way.
Leads HO evidence planning and implementation in collaboration with cross-functional teams across the development and commercialization lifecycle.
Integrates and influences key business partners around HEOR prioritization, trade-offs, and recommendations to achieve strategic goals.
Provides consultation, input, and strategic direction about how to leverage HEOR to the enterprise
Triages business partners' requests with excellent prioritization and timeliness.
Information Dissemination
Communicates HO information to internal business partners, the scientific community, and customers, adapted for the audience and in a timely manner.
Leads research dissemination strategies and communication efforts including abstracts, posters, podium presentations, promotional materials, and manuscripts.
Plans for, aligns, and drives application of results/deliverables to increase the impact of HO work
Environmental Awareness
Maintains awareness of significant developments in disease states in the Lilly portfolio and HO field including current HO methodologies, HO applications, and other issues as appropriate for the position.
Anticipates and evaluates future market needs and trends for HO information within pertinent therapeutic area and geography of interest.
Monitors and influences internal and external environmental factors that shape and impact generation and use of HO research.
Project Management
Ensures HO projects meet timelines, budget, and scope by coordinating research efforts with cross-functional Lilly business partners and external collaborators as appropriate.
Basic Requirements:
Doctorate (PhD, MD), PharmD/MS degree with 10+ years' experience in creating, executing, and delivering outcomes strategies/projects, with at least 5 years' experience in therapeutic area expertise (preference to Oncology)
Additional Preferences:
Strong comprehension and excellent written and verbal communication skills.
Demonstrated ability to translate and disseminate complex scientific information in a clear and concise manner
Demonstrated ability to influence and collaborate within and across teams
Proven ability to be flexible with work assignments, deliver results with quality and speed, especially in an Oncology dynamic environment
Understanding of health care systems in at least one of US, Europe, and/or Asia
Understanding of and experience with health care delivery models and clinical research
Technical and analytic capabilities in one or more of the following areas: economic modeling, economic evaluation, cost-efficacy evaluation, patient-focused outcomes, real-world evidence, burden of disease, epidemiology, statistics, health care policy
Demonstrated ability to drive research agendas to completion and dissemination
Ability to think and act globally with a customer focus and a solution orientation
Additional Information:
Domestic and international travel may be necessary (approximately 25%)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$165,000 - $316,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
$165k-316.8k yearly Auto-Apply 6d ago
Senior Director, Head of Regulatory Intelligence
Johnson & Johnson 4.7
Vice president job at Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Legal & Compliance
Job Sub Function:
Enterprise Compliance
Job Category:
People Leader
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
Position Overview
We are seeking a strategic leader to establish and lead our new Regulatory Intelligence organization. The Sr. Director, Head of Regulatory Intelligence will set the strategic direction for the team, oversee the integration of regulatory insights into organizational decision-making, and represent the organization at the highest levels. This role is pivotal in shaping our regulatory intelligence strategy, setting key initiatives, and delivering actionable insights on emerging regulatory guidance and health authority enforcement trends.
Key Responsibilities
Set strategic direction and priorities for the Regulatory Intelligence team to ensure alignment with organizational goals.
Represent the organization at the executive level, overseeing the integration of intelligence into internal decision-making processes.
Coordinate cross-sector intelligence and external engagement strategies to foster collaboration and influence.
Prepare concise, actionable executive briefings on emerging regulatory themes, health authority enforcement, and industry trends.
Lead a high-performing team, fostering a culture of innovation, collaboration, and continuous improvement.
Conduct advocacy for key initiatives in close coordination with Innovative Medicine and MedTech sectors.
Build and maintain relationships with global health authorities and key external stakeholders.
Qualifications
Proven experience in building and leading a regulatory intelligence organization within a complex, global organization.
Previous experience as a compliance leader or inspector at a global health authority (e.g., U.S. FDA, MHRA, etc.) is highly preferred.
Previous experience with developing platforms for regulatory intelligence (e.g. AI-driven analytics) is highly preferred.
Deep understanding of global regulatory environments, including agencies like FDA, EMA, MHRA, etc.
Demonstrated ability to develop and execute strategic initiatives at the executive level.
Strong expertise in regulatory compliance strategy, policy development, health authority enforcement trends, and industry trends.
Exceptional communication skills with the ability to prepare and deliver clear, concise executive briefings.
Proven leadership skills, with experience in building high-performing teams and fostering cross-sector collaboration.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Audit and Compliance Trends, Audit Findings and Recommendations, Compliance Management, Compliance Policies, Confidentiality, Controls Compliance, Corporate Investigations, Developing Others, Inclusive Leadership, Leadership, Legal Function, Legal Services, Policy Development, Risk Compliance, Risk Management Framework, Tactical Planning
The anticipated base pay range for this position is :
$178,000.00 - $307,050.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
For additional general information on Company benefits, please go to: - *********************************************
$178k-307.1k yearly Auto-Apply 20d ago
2. Senior Director - GS Finance Transformation (Signifi/Transact)
Johnson & Johnson 4.7
Vice president job at Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Finance
Job Sub Function:
Accounting
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
We are searching for the best talent for our Senior Director - GS Finance Transformation (Signifi/Transact) role located in New Brunswick, NJ.
Senior Director, GS Finance Transformation will lead a multi-year transformation program to evolve Finance capabilities across people, process, and technology. This role will define and execute strategic roadmaps, drive program and project management excellence, and deliver end-to-end integration of finance processes through standardized operations, digital solutions and optimization. The incumbent will champion and shape organizational design for success, lead large global teams, and ensure sustainable operating models while fostering a culture of innovation, collaboration, and continuous improvement.
Specific GS Finance Program/ Project Scope (Signifi Transact) The leader will modernize our end-to-end Finance digital capabilities by shaping/deploying Transact and boundary systems, standardizing our core business processes and enabling our integrated data strategy through a single ERP instance. The leader is also responsible for GS Finance Master Data Management Team (FMDM), responsible for Finance Master Data Strategy and execution as Finance continues to build integrated standard end-to-end data, system and process transformation through S4 ERP. This role will drive program strategy development and execution and will provide oversight and coordination with and across workstream leads with a strong focus on end-to-end integration, employee experience, value realization, continuous improvement, and development of sustainable operating mode/run state Technology and Process solutions. This role will also partner closely with the GS Finance operations to ensure consistency of processes and approach in the GS Finance function. Close/integrated partnership with the FS&T organization will be critical to driving success of the program.
Additional responsibilities:
Strategic Leadership & Execution
• Define and implement transformation strategy aligned with enterprise priorities and finance vision.
• Shape organizational design to optimize people, process, and technology for long-term success.
• Establish governance structures ensuring accountability, transparency, and value realization.
• Program & Project Management
• Lead large-scale, complex transformation programs, ensuring delivery against scope, timeline, and budget.
• Drive stage-gate readiness, risk mitigation, and dependency management across global workstreams.
• Mobilize resources and oversee program financials, ensuring alignment with business plans and targets.
Change & Transformation Management
• Champion change adoption and capability building across regions.
• Partner with enabling functions (Change Management, Communications, HR, L&D) to drive stakeholder engagement and cultural alignment.
• Provide integrated impact assessments and readiness criteria for deployment.
• Stakeholder & Executive Engagement
• Serve as primary liaison to Global Finance Leadership Team and senior executives.
• Influence decision-making at all organizational levels through data-driven insights and strategic storytelling.
• Build strong partnerships across Finance, Technology, and cross-functional teams globally.
Talent & Team Leadership
• Lead and inspire large, diverse global teams, fostering a high-performance culture.
• Drive talent strategy, succession planning, and capability development for future-ready finance organizations.
• Promote a Credo-based culture of collaboration, transparency, and continuous improvement.
Qualifications:
Required Minimum Education: Bachelor's degree in Finance, Accounting, Business, or related field is required. (Master's/MBA or CPA preferred).
Required Years of Related Experience:
15+ years total with a strong foundation in accounting, comptrollership and transformation program management required.
Previous GS Finance experience and successful track record preferred.
Proven track record in leading large-scale global transformation initiatives
Demonstrated leadership experience, including the ability to inspire, motivate, and empower teams.
Ability to influence and shape senior level business decisions effectively.
Strong understanding of systems landscape is preferred.
Ability to interact effectively in an international matrix environment, demonstrating strong communication and interpersonal skills across cultures and organizational levels.
Proven track record in influencing and leading peers and business partners, as well as interacting with senior management.
Excellent communication skills, including presentations, listening, and written communication.
Position is based in New Brunswick, New Jersey, with up to 10% domestic and international travel required.
The expected base pay range for this position is $173,000-$299,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
â–ª Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). â–ª This position is eligible to participate in the Company's long-term incentive program.
â–ª Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$178,000.00 - $307,050.00
Additional Description for Pay Transparency:
$178k-307.1k yearly Auto-Apply 3d ago
Associate Director, Market Access Training
Gilead Sciences 4.5
Remote
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Associate Director, Market Access Training at Gilead you will ...
As Associate Director, Market Access Training, you'll report to the Senior Director of Commercial Learning and Development. You'll lead the design, implementation, and sustainment of training programs for our Market Access business unit, focusing on Oncology and Liver teams. Your work will prepare and execute future launch training aligned with market access and reimbursement strategy. This role evolves with our business needs and offers flexibility-remote work with travel (25-30%) or headquarters-based with less travel (10-15%).
Key responsibilities:
· Lead Training Initiatives: Design, deliver, and implement engaging training for market access field and internal teams, including new hire programs.
· Drive Launch Success: Plan and execute training for Oncology and Liver product launches.
· Support New Talent: Enhance onboarding and continuous learning for new hires and transfers.
· Collaborate Cross-Functionally: Work with Medical Affairs, Market Access Strategy, Field Teams, Therapeutic Area Training, and Compliance/Legal to ensure accuracy and alignment.
· Innovate Learning: Partner with vendors and experts to create curricula using adult learning principles and innovative tools, including AI-driven technologies.
· Measure Impact: Monitor training effectiveness and adapt programs to meet evolving business needs.
· Manage Resources: Oversee training budgets and ensure alignment with key initiatives.
· Foster Collaboration: Coordinate project timelines, drive stakeholder engagement, and build consensus across teams
Basic Qualifications:
BS or BA degree with 10+ years of related experience in training and sales management, including 3+ years of Field Sales management experience, and 2+ years of experience in commercial training or health education.
Preferred Qualifications:
4+ years in market access (access, reimbursement, or distribution)
4+ years in training and development; launch training in biotech/pharma preferred
Deep understanding of Oncology and Liver/Rare Disease
Experience as Regional Trainer, Commercial Learning & Development, or similar
Strong communication, facilitation, and instructional design skills
Proficiency in Microsoft Office (Word, Teams, PowerPoint, Outlook, Copilot)
Self-motivated, organized, and able to manage multiple projects and vendors
Skilled in building consensus and leading collaboration
Strong problem solving, decision making and analytical skills
Experience with AI-driven learning tools
Ability to foster an inclusive, learning-focused culture aligned with Gilead's values.
People Leader Accountabilities:
•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the
way they manage their teams.
•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current
performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and
realize their purpose.
•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding
them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is: $177,905.00 - $230,230.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
$177.9k-230.2k yearly Auto-Apply 6d ago
Advocacy Relations Senior Manager - Rare Disease
Amgen 4.8
Remote
Career CategoryCorporate ServicesJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Advocacy Relations Senior Manager - Rare Disease
What you will do
Let's do this. Let's change the world. In this vital role you will primarily drive patient advocacy efforts in the Immunoglobulin G4-related disease (IgG4-RD) and ANCA Associated Vasculitis communities.
Serve as a key contributor to Amgen's U.S. Advocacy strategy and execution for IgG4-RD Disease and ANCA Associated Vasculitis, including strategic programming, awareness month activations, patient events and national and/or local engagement opportunities with the advocacy community.
Serves as primary relationship manager to IgG4-RD Disease and ANCA Associated Vasculitis related patient groups, cultivating high-trust, compliant, partnerships based on shared goals in awareness, education, and access.
Collaborates cross-functionally with medical, marketing, government affairs and alliance management, and communication teams to drive critical insights and amplify patient voices in shaping access and reimbursement strategies.
Represents Amgen in relevant coalitions and forums to elevate the patient community's voice and needs.
Drives high-quality initiatives and shared goals to empower patients to take a more active role in treatment decision-making with their HCPs.
Lead identification and support of patients and caregivers in sharing their experiences, ensuring these stories inform external and internal initiatives.
Proactively identify emerging trends, issues, and community needs related to rheumatology, gastroenterology and nephrology ecosystems, and formulate timely, collaborative responses.
Support awareness, education, and empowerment efforts across the patient and caregiver communities.
Translate patient and caregiver insights into actionable strategies that inform cross-functional decisions, advancing patient-centered approaches across the product lifecycle.
Create and execute collaboration plans with advocacy groups on mutually aligned goals, including public health and clinical education campaigns.
Organize patient feedback mechanisms to ensure ongoing alignment with advocacy and overall business priorities.
Travel up to 40% as needed, to engage in internal meetings, advocacy meetings, and conferences.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The patient advocacy professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of patient advocacy experience
Or
Master's degree and 4 years of patient advocacy experience
Or
Bachelor's degree and 6 years of patient advocacy experience
Or
Associate's degree and 10 years of patient advocacy experience
Or
High school diploma / GED and 12 years of patient advocacy experience.
Preferred Qualifications:
Previous experience developing and leading patient advocacy engagement strategies for rare, rheumatic and sever inflammatory conditions.
Previous academic/CRO/pharmaceutical/biotech experience; rare disease experience a plus
Experience building community in an emerging disease state that lacks robust patient support.
Contribute to the development of the patient advocacy strategic plan that is aligned with the company philosophy on patient advocacy engagement.
Experience working with community-based organizations, a plus.
Experience working with multiple projects, priorities and managing multiple internal and external partners.
Must have strong planning, project management, communication, and organization skills. Flexibility to work in a fluid, fast-paced environment with multiple demands with initiative and independence required.
Strong ability to collaborate across multiple internal and external partners.
Team and cross functional orientation.
Self-starter demeanor.
Strong interpersonal skills.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
154,865.00 USD - 182,086.00 USD
$122k-163k yearly est. Auto-Apply 6d ago
Cardiovascular Advocacy Relations Senior Manager
Amgen 4.8
Remote
Career CategoryCorporate ServicesJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Cardiovascular Advocacy Relations Senior Manager
Let's do this. Let's change the world. In this vital role you will be responsible for managing relationships with advocacy groups and other external stakeholders. They may lead campaigns, communicate with advocates, and work to build and maintain relationships that support the company's goals.
The following are key responsibilities and elements of the role:
Energizes the advocacy community to drive towards Amgen's 2030 ambition to reduce CV events by 50%
Drives high-quality sponsorships that measurably address known barriers to LDL testing and treatment
Coordinate Amgen's engagement strategies with stakeholders at Congresses
Empowers patient groups to advocate for patients to receive guideline appropriate cholesterol testing and treatment
Mobilizes patient groups to advocate for equitable patient access to appropriate PCSK9 treatment
Supports existing and new long term, substantive relationships with patient groups, professional associations and other key stakeholders based on values of trust, respect and transparency
Supports the implementation of the advocacy relations strategy for Amgen's cardiometabolic portfolio
Works cross-functionally as a strong partner and collaborator with global and US teams including Marketing, Medical, Value and Access, Policy and Corporate Communications
Nimbly aligns advocacy strategic plans with internal functions to ensure One Amgen voice and priorities are incorporated into engagement plans
Facilitates connections between patient advocacy groups with appropriate internal subject experts, including but not limited to Global and US Medical, US Business Units, Global Product Teams, Government Affairs, Healthcare Policy, Clinical Development, Health Economics/Outcomes Research, Value & Access, and Corporate Communications
Identifies and understands the drivers behind the official positions, priorities, and networks of influence of key patient and professional associations and advocacy groups to advise Amgen's business strategies
Incorporates simple and transparent systems for patient advocacy groups to understand Amgen's partnership and funding requirements
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The advocacy professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of advocacy, policy, marketing, or medical experience
Or
Master's degree and 4 years of advocacy, policy, marketing, or medical experience
Or
Bachelor's degree and 6 years of advocacy, policy, marketing, or medical experience
Or
Associate's degree and 10 years of advocacy, policy, marketing, or medical experience
Or
High school diploma / GED and 12 years of advocacy, policy, marketing, or medical experience
Preferred Qualifications:
5+ years of experience with patient advocacy groups and/or professional (medical) associations.
3+ years of experience working for global pharmaceutical companies as a liaison with patient advocacy groups and/or professional associations.
Sensitivity to diverse groups of people both internal and external with the ability to manage many different opinions and perspectives, including tolerance for ambiguity.
Demonstrated reputation internally and externally as a well-respected, dynamic team-player.
Empathic and hardworking individual with the ability to build meaningful connections with stakeholders.
Previous experience leading the development of professional medical society and patient advocacy strategies for pharmaceutical organizations.
Previous experience as relationship manager for professional medical associations and patient advocacy groups.
Demonstrated understanding of key external and internal trends affecting patient and consumer engagement; solid understanding and experience in new forms of patient/consumer interactions such as social media and patient online communities.
Previous experience communicating the value of innovation and addressing access barriers to care.
Previous experience communicating complex health policy access issues to patient advocates
Demonstrated ability to adapt relationship style to external partner's preferences and comfort levels
Previous experience in government affairs.
Outstanding verbal and written communications skills and an ability to adapt one's approach to a challenge, as well as excellent interpersonal skills.
Ability to assimilate complex medical knowledge and communicate to non-medical audiences.
Capable of handling shifting priorities in a constantly evolving environment.
Understands the pharma/biotech business model, regulatory process & compliance guidelines.
Experience with product (drug) launches.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
154,865.00 USD - 182,086.00 USD
$122k-163k yearly est. Auto-Apply 12d ago
Regulatory Writing Sr Mgr
Amgen 4.8
Remote
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Regulatory Writing Senior ManagerLive
What you will do
Let's do this. Let's change the world. In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include:
Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of directly related experience
OR
Master's degree and 6 years of directly related experience
OR
Bachelor's degree and 8 years of directly related experience
OR
Associate's degree and 10 years of directly related experience
Or
High school diploma / GED and 12 years of directly related experience
Preferred Qualifications:
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
152,684.00 USD - 193,308.00 USD
$122k-163k yearly est. Auto-Apply 20d ago
Health Policy & Reimbursement Executive Director
Amgen 4.8
Remote
Career CategoryGovernment AffairsJob Description
At Amgen, if you feel like you are a part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you will do
Let's do this. Let's change the world. In this vital role the Health Policy & Reimbursement Executive Director will lead development and implementation of reimbursement strategies for federal (US) payer issues across multiple therapeutic areas and the company's biosimilar portfolio. He/she will work cross-functionally to help identify and resolve barriers to entry for pipeline products/ therapies and provide broad reimbursement-related advice for inline products, including mitigation strategies in response to proposals that would negatively affect access of Amgen therapies for patients. In addition, he/she will manage broader health policy efforts including reviewing and analyzing complex policy proposals including regulatory proposals and legislative text, and promptly and concisely communicating impact of these proposals to key internal audiences (government affairs, commercial, regulatory, clinical, and senior executives). This position requires intense collaboration with government affairs staff to ensure alignment of strategy, talking points and messaging to constituents (elected officials/leaders, agencies, third parties, etc.). Further, the successful candidate will play a key role in health policy engagement with major trade associations on corporate policy priorities which include Amgen specific priorities as well as industry-wide priorities including, but not limited to, Federal drug pricing policy. In partnership with trades or independently, he/she may also conduct research and integrate clinical, market and payer data to inform engagement on reimbursement objectives. The Health Policy Executive Director will regularly update via written and oral communications to senior executives and other key partners on various reimbursement and US health policy topics.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree & 6 years of health policy or reimbursement experience OR
Master's degree & 10 years of health policy or reimbursement experience OR
Bachelor's degree & 12 years of health policy or reimbursement experience AND
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
Experience with Congressional Budget Office style modelling, cost estimates, and analyses
Experience/relationships with key agencies including HHS, CMS, and CBO
Deep understanding of Federal (US) and/or commercial payer environment including areas of (1) healthcare product and service coverage, coding, and reimbursement, (2) health policy, and (3) Federal (US) Executive and Legislative Branch healthcare policy-setting authorities, processes, and responsible parties
Broad and deep experience in federal health policy issues - specifically Medicare, Medicaid, and national health programs/reform
Deep understanding of US biosimilars marketplace and its history/evolution
Experience reviewing clinical literature, including disease state information and target product profiles to understand implications of payer actions and develop submissions for Federal programs like Medicare
Demonstrated communication skills including both interpersonal skills to foster collaboration and oral/written presentation skills/comfort level speaking to senior executives
Comfort with CBO style modeling and cost estimates/analysis including strong quantitative skills-including translating complex data and information into succinct 1-pagers and presentations
Product commercialization experience desirable (direct or consultant)
Experience in Amgen therapeutic areas preferred (health policy or product)
Experience in multi-stakeholder groups (trade associations or disease-specific groups)
People management experience preferred
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The annual base salary range for this opportunity in the U.S. is $281,425 to $325,550. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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, including remote work arrangements, where possible
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship for this role is not guaranteed.
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Salary Range
281,425.00 USD - 325,550.00 USD
$281.4k-325.6k yearly Auto-Apply 25d ago
Sr Director- Reinforcement Learning
Amgen 4.8
Remote
Career CategoryInformation SystemsJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Sr. Director- Reinforcement Learning
What you will do
Responsibilities
Define enterprise RL roadmaps, landmarks, and success metrics; drive early hands-on prototypesas the capability matures .
Architect simulation environments, reward structures, and training loops for scientific andoperational RL use cases.
Lead algorithmic innovation and technical decisions across model-based RL, policy gradientmethods, and actor-critic architectures .
Advance RL for scientific domains such as protein design, docking, and structural modeling;expand RL beyond R&D into Manufacturing, Supply Chain, and Commercial applications .
Oversee data pipelines, curation, and feature engineering supporting RL experimentation and multi-modal model training.
Guide RL pilots from proof-of-concept through production deployment, ensuring ML Ops rigor-versioning, automated testing, monitoring, and continuous training .
Partner deeply with biology, engineering, platform teams, product teams, and enterprise AI groupsto integrate RL into existing workflows and systems.
Mentor and develop talent; drive innovation, safety, and scientific/engineeringexcellence.
Evaluate emerging research, open-source frameworks, and frontier methods (e.g., multi-agent RL,RLHF, simulation-based optimization) for enterprise adoption .
Communicate outcomes, technical decisions, and implications to leadership and key stakeholders.
Qualifications
Basic Qualifications
Doctorate degree and 5 years of Artificial Intelligence/ Machine Learning experience
OR
Master's degree and 8 years of Artificial Intelligence/ Machine Learning experience
OR
Bachelor's degree and 10 years of Artificial Intelligence/ Machine Learning experience
PhD or equivalent experience in ML, RL, or related fields.10+ years AI/ML;
5+ years reinforcement learning leadership.
Preferred Qualifications
Proficient Python, PyTorch/TensorFlow, distributed training.
Contributions to AlphaFold-like or large-scale scientific AI.
Publications at NeurIPS, ICML, or ICLR.
Biotech, pharma, or healthcare domain exposure.
Familiarity with GxP, HIPAA, or FDA guidance.
Experience leading AI Centers of Excellence.
Patents or open-source RL contributions.
Prior collaborations with academia or top AI labs
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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, including remote and hybrid work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
-
$191k-262k yearly est. Auto-Apply 16d ago
Medical Senior Director - Early Clinical Development - Inflammation
Amgen 4.8
Remote
Career CategoryClinical DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Medical Senior Director - Early Clinical Development
What you will do
Let's do this. Let's change the world. Amgen Early Development is looking for a strong scientific leader in Early Clinical Development. In this vital role you will be responsible for providing scientific and medical direction and leadership for pre-clinical/early clinical programs for Amgen's Inflammation/General Medicine Early Development pipeline. This Early Development Leader will develop strategy for and oversee the early phase clinical development of therapeutic candidates from first-in-man studies through proof of concept and translational projects as part of the initial drug development strategy.
Provide clinical and biological insights into the strategy for Inflammation/General Medicine programs and specifically how to best support that strategy within Early Development studies
Mentor Medical Directors/Early Development Leaders to ensure best practices for study design and execution in support of overarching strategy for early assets
Partner with colleagues in Research, Precision Medicine, Global Development as well as other functions across the organization to ensure alignment of goals and effective advancement of early programs
Participate in evaluation of business development opportunities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Clinical Development Medical professional we seek is a leader with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
AND
5 years of clinical research and/or basic science research experience
AND
5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
MD, PhD with clinical training/expertise in a relevant clinical subspecialty
5 years of clinical trial /drug development experience in Inflammation/General medicine areas with the majority of that experience within an industry setting
strong understanding of the biology of the relevant diseases
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
326,210.00 USD - 377,034.00 USD
$191k-262k yearly est. Auto-Apply 16d ago
Associate Director, Congress Operations
Amgen 4.8
Remote
Career CategoryMarketingJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Associate Director, Congress Operations - US Remote
What you will do
The Associate Director, Congress Operations is responsible for leading the operational center of excellence within the Amgen Congress Team (ACT). This role ensures the delivery of consistent, complaint, and cost-efficient execution of Tier 1 and Tier 2 congresses globally, overseeing vendor performance, budget governance, logistics, HCP engagement services, and operational standards.
This leader partners closely with the Associate Director of Congress Planning & Execution to align operational support with TA needs and business priorities while delivering a One Amgen experience to internal and external stakeholders.
Operational Strategy & Oversight
Define and oversee operational models for booth build and design, OL engagement, logistics management, and vendor partnership for all ACT-led congresses.
Develop and enhance standardized operating procedures, documentation, and reporting tools/dashboards across the ACT function (e.g., CCDs, CAF reporting, post-congress metrics, SLAs).
Ensure global consistency and regional adaptability in vendor engagement models, compliance workflows, and attendee services.
Vendor Management & Quality Assurance
Lead the performance management of key vendor partners across booth builds (Access TCA, Ignition), OL engagement (Proske), and logistics (Maritz, BCD).
Govern all scopes of work (SOWs), budget forecasting, invoice, and service-level agreements (SLAs) related to congress operations.
Oversee executional quality across vendor deliverables, including booth design, setup, compliance submissions, and onsite support.
HCP Logistics & OL Engagement
Direct the end-to-end logistics processes including housing, registration, badge coordination, ancillary meetings, and pre-congress attendee communications.
Manage the operational support of OL engagement scheduling, rooming, and metrics tracking for all ACT-supported congresses, partnering with the Engagement team leads.
Budget & Compliance Governance
Serve as operational budget steward for all congress activities led by ACT, maintaining controls across all logistics, OL, and booth spend categories.
Ensure compliance with internal processes (CAF, C3, Veeva) and external regulations (PhRMA, EFPIA, local country requirements) across operational workflows.
Team Leadership & Development
Lead a team of Senior Managers and Senior Associates supporting functional operations across US and OUS congress execution.
Foster a high-performance culture focused on operational excellence, team development, cross-functional collaboration, and innovation.
Partner with the ACT Leadership Team to build scalable systems, tools, and training that enhance team capability and future-readiness.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.
Basic Qualifications:
Doctorate degree and 3 years of experience in event operations, logistics, or vendor management within the pharmaceutical, biotech, or healthcare sector.
Or
Master's degree and 5 years of experience in event operations, logistics, or vendor management within the pharmaceutical, biotech, or healthcare sector.
Or
Bachelor's degree and 7 years of experience in event operations, logistics, or vendor management within the pharmaceutical, biotech, or healthcare sector.
Or
Associate's degree and 12 years of experience in event operations, logistics, or vendor management within the pharmaceutical, biotech, or healthcare sector.
Or
High school diploma / GED and 14 years of experience in event operations, logistics, or vendor management within the pharmaceutical, biotech, or healthcare sector. experience
Preferred Qualifications:
Advanced degree (MBA, CMP, PMP, or CEM).
Proven experience managing congress or event operations at a global scale.
Expertise in booth production, HCP engagement logistics, and pharmaceutical compliance requirements.
Familiarity with Amgen's therapeutic areas and internal systems (Smartsheet, SharePoint, SAP, Veeva).
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
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, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
180,851.00 USD - 217,817.00 USD
$130k-169k yearly est. Auto-Apply 21d ago
R0047580 Director, Pharmacometrics
Gilead Sciences 4.5
Remote
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
You will lead quantitative analyses in the Oncology, Inflammation and Virology Therapeutic Areas of Gilead Sciences, Inc.. These analyses will include all stages of drug development from first-in human through Phase IV clinical trials. You will be responsible for the conduct as well as interpretation and reporting of the analyses, and support of regulatory filings. You will champion model-informed drug development (MIDD) across drug discovery and development and serve as a subject matter expert for modeling and simulation to cross-functional partners.
Responsibilities:Leading quantitative and innovative strategies within clinical pharmacology to impact MIDD during the life cycle of the program Evaluate and apply state-of-the-art quantitative pharmacology approaches for clinical pharmacology decision-making and for global regulatory submissions, including INDs, IBs, NDAs, BLAs, MAAs, and pediatric plans in collaboration with key stakeholders.Evaluate and apply strategy and content as appropriate.Guide dose regimen/optimization strategies in partnership with other therapeutic area leads and clinical pharmacology leads to enable data-driven decisions Develop high-quality modeling and simulation strategy and content: author/review/approve modeling and simulation analysis plans and outputs, interpretation, and presentation of key findings to regulators and to stakeholders as needed.Ensure adherence to agreed timelines and budgets to ensure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.Develop and present training within and outside the department as needed Basic Requirements:PhD or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 8+ years' relevant pharmacometrics research or development experience ORMasters or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 10+ years' relevant pharmacometrics research or development experience ORBachelors or equivalent degree in engineering, pharmaceutical sciences, pharmacology, or related discipline with 12+ years' relevant pharmacometrics research or development experience.
Preferred Requirements:Significant experience working on, with, and leading cross-functional project/program teams in life sciences.Extensive experience in pharmacometrics leading and authoring modeling and simulation plans and having responsibility for the scientific execution of related analyses across Phase I - IV studies.Demonstrated excellence in effectively managing multiple pharmacometrics analyses deliverables and priorities through matrix management and leadership.Relevant experience in the Oncology, Virology, and/or Inflammation Therapeutic Areas.Proficiency in mathematics Demonstrated ability to be a fast learner.Demonstrated ability to be flexible and adaptable to change Recognized for sustained scientific excellence.Extensive knowledge of quantitative analyses as well as the physiological/pharmacological aspects of drugs.Strong communication and organizational skills.Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams and executives.When needed, ability to travel.
The salary range for this position is: $205,615.00 - $266,090.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.