The Role
The AssociateDirector, Sterility Assurance / Environmental Monitoring (EM) is a senior technical role fully dedicated to the MTC-E facility. This individual is accountable for the design, implementation, and oversight of the site's Contamination Control Strategy (CCS) and Environmental Monitoring (EM) program, ensuring execution is aligned with regulatory expectations, operational needs, and best practices in aseptic manufacturing.
This is a high-impact, hands-on role requiring regular presence on the manufacturing floor to observe, audit, and address behaviors, aseptic techniques, and process execution. The AssociateDirector partners closely with Manufacturing, MS&T, Facilities, QC, and Engineering, integrating sterility assurance into all layers of operations. This leader must be technically expert, data-driven, and proactive in identifying risks and driving continuous improvement across the site.
Here's What You'll Do
Contamination Control Strategy & Sterility Assurance
Contribute to the Contamination Control Strategy (CCS) for MTC-E, ensuring alignment with Annex 1, FDA aseptic guidance, and internal quality expectations.
Ensure risk-based, practical integration of CCS into isolator usage, cleanroom design, gowning, material/personnel flow, and environmental control.
Environmental Monitoring Program - Oversight, Trending & RCA
Lead key EM program lifecycle for MTC-E: sampling strategy, zoning, drawing management, alert/action levels, and trend reporting.
Guide EM-related root cause investigations, excursion management, and system improvements.
Present EM performance and risk trends to site leadership and drive data-based decision making.
Ownership of Quality System Records
Own and author sterility assurance-related Quality System documentation, including:
Change controls for EM, CCS, or aseptic practices
Risk assessments for sterility-impacting changes or contamination events
CAPAs tied to EM deviations, audit findings, or trend analysis
Ensure records are timely, scientifically justified, and aligned with site and global quality systems.
Audit Readiness & Regulatory Engagement
Serve as a critical leader in audit preparation, defense, and follow-up, including internal, client, and regulatory inspections.
Act as SME for CCS, EM, aseptic execution, isolator operations, and media fills.
Lead or support drafting of inspection responses and implementation of remediation strategies.
Presence in Critical Manufacturing Activities
Be actively present during key operations, including:
Media fills
Sterile filtration and aseptic filling operations
Isolator decontamination and validation events
Facility or process qualifications impacting sterility or EM
Support real-time issue resolution and verify proper execution of validated practices.
Behavioral Oversight & Coaching
Conduct routine floor audits to assess aseptic behaviors, gowning, EM technique, and adherence to contamination controls.
Coach floor personnel and partner with QA to reinforce expectations and elevate sterile execution culture.
Support aseptic training and certification programs site-wide.
Cross-Functional Integration & 24/7 Support
Partner closely with with Operations, Facilities, MS&T, QC, Engineering, and Supply Chain to proactively manage sterility assurance across all activities.
Be available 24/7 to respond to contamination events, EM alerts, and operational escalations requiring sterility input.
Here's What You'll Need (Basic Qualifications)
Education: Bachelor's degree in Microbiology, Life Sciences, Pharmacy, or related field (Master's or Ph.D. preferred).
Experience:
8+ years in sterile pharmaceutical manufacturing, aseptic processing, or sterility assurance roles
Deep expertise in isolator-based manufacturing, EM programs, contamination control, media fills, and aseptic filling operations
Direct involvement in regulatory inspections, root cause investigations, and Quality System document ownership
Here's What You'll Bring to the Table (Preferred Qualifications)
Must be on-site daily and available 24/7 per business needs for escalations and critical event support.
Strong understanding of aseptic manufacturing, campaign operations, and support service dependencies.
Excellent communication skills; able to translate complex plans into clear, actionable instructions.
Ability to hold stakeholders accountable, influence without authority, and drive alignment across multiple teams.
Highly organized, detail-oriented, and committed to maintaining a compliant, safe, and efficient production schedule.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NB1
-
$142.5k-256.5k yearly Auto-Apply 12d ago
Looking for a job?
Let Zippia find it for you.
Senior Director, Global Medical Affairs, Oncology
Moderna 4.8
Associate director job at Moderna
The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases.
As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.
Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide.
Moderna is seeking a Global Medical Director to lead medical affairs strategy across our Oncology portfolio, spanning early development through commercialization. This role offers a unique opportunity to influence the direction of mRNA oncology programs from a scientific and strategic perspective, with a strong emphasis on external engagement, data generation, and cross-functional alignment. As a key member of the global Medical Affairs team, you will be responsible for integrated evidence planning, medical governance leadership, and driving scientific thought leadership worldwide. The role will interface extensively with regulatory, clinical, commercial, and external stakeholders to ensure the success of Moderna's oncology assets. This is a high-impact position suited for a strategic thinker, scientific storyteller, and matrix leader with a passion for innovation in oncology. The successful candidate will report to the VP, Head of Medical Affairs Oncology.
Here's What You'll Do
Your key responsibilities will be:
Owning and leading the global medical strategy across Moderna's oncology portfolio, ensuring seamless integration from early development to lifecycle management.
Serving as final medical accountability for assigned oncology programs, including delivery of the integrated medical plan.
Driving medical leadership in governance bodies and cross-functional decision-making forums, ensuring alignment between development, regulatory, and commercial functions.
Leading the Development Integrated Evidence Team to build comprehensive data packages for regulators, payers, and other stakeholders.
Acting as global medical lead in interactions with health authorities and payers, providing strategic input and medical representation.
Your responsibilities will also include:
Directing a cross-functional global medical matrix team (Scientific Communications, Field Medical, Patient Advocacy), ensuring timely execution of deliverables.
Leading global launch readiness for oncology assets, including medical training, evidence generation, scientific engagement, and narrative development.
Building partnerships with global, regional, and national thought leaders to shape best practices and influence health policy.
Developing and executing publication strategies, medical education initiatives, and real-world evidence programs to strengthen knowledge exchange.
Managing medical affairs budget and resource planning for assigned programs, aligning with broader franchise objectives.
Partnering with the VP, Oncology and cross-functional stakeholders to shape the long-term medical direction and investment strategy for the franchise.
The key Moderna Mindsets you'll need to succeed in the role:
We behave like owners. The solutions we're building go beyond any job description. In this highly autonomous role, you will take full ownership of the medical strategy for Moderna's oncology assets, driving high-quality execution and accountability across complex cross-functional landscapes.
We digitize everywhere possible using the power of code to maximize our impact on patients. This role offers the opportunity to engage with Moderna's digitally integrated ecosystem and leverage AI-powered data tools to support evidence generation, decision-making, and medical excellence.
Here's What You'll Need (Basic Qualifications)
MD or non-US equivalent, PharmD, or PhD with extensive oncology medical affairs leadership experience
Minimum of 15 years of experience in Medical Affairs, with a strong track record in global roles.
Demonstrated leadership of global launch planning and execution in oncology or immuno-oncology settings.
Deep expertise in oncology therapeutic area required
Strong strategic thinking and leadership skills in a global medical affairs role.
Experience in regulatory, scientific communication, and external stakeholder engagement.
Launch experience global and/or locally
Here's What You'll Bring to the Table (Preferred Qualifications)
melanoma and immunotherapy experience preferred.
Strong track record of KOL engagement, scientific communication, and external representation
Experience navigating strategic external collaborations and cross-company governance
Expertise in cross-functional team leadership, including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs
Strategic and operational mindset with excellent project leadership capabilities
Comfort managing cross-functional deliverables and owning timelines and outputs at a program level.
Exceptional communication skills with the ability to translate complex science into clear, impactful messaging
Ability to thrive in a fast-paced environment, balancing strategic leadership with hands-on execution
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The salary range for this role is $210,900.00 - $379,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
-
$210.9k-379.2k yearly Auto-Apply 14d ago
Associate Director - Operations NPI Business Partner
Amgen 4.8
Remote
Career CategoryProcurementJob 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.
AssociateDirector - Operations NPI Business Partner
What you will do
Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity, capable of shaping category-specific strategies with speed and precision.
In this vital role, you will serve as the Operations NPI Business Partner. You will be responsible for driving strategic alignment between Procurement and business stakeholders within verticals, sites, and categories. This role will play a critical part in shaping vertical-specific Procurement strategies, enabling business objectives, and delivering value through the end-to-end NPI project timeline from tech transfer to commercial readiness
Reporting to Procurement's Sr. Business Partner Lead for Operations, you will lead efforts to define partnering strategies, manage business planning and governance, and drive innovation and value realization across categories. The role will also focus on fostering collaboration, enabling company-wide initiatives, and leading change enablement to position Procurement as a strategic value driver for the business.
Roles & Responsibilities:
Align on key business and vertical-specific strategic priorities and needs (e.g., NPI, go-to-market strategies). Provide third-party market insights to shape business strategies and link business objectives to vertical Procurement strategies.
Scout the market for vertical-specific innovation opportunities across the external ecosystem. Introduce outside-in disruptions to influence and shape Procurement strategies for verticals.
Collaborate with Finance and cross-functional (engineering, R&D, manufacturing and quality) teams to drive pipeline value generation, realization, and recognition across verticals.
Track deliverables, risks and mitigation plans within verticals, and manage the overall prioritization, to achieve total value.
Provide Procurement expertise to enable business development, innovation realization, and other initiatives.
Drive adoption of Procurement and business critical initiatives across the ecosystem, including end users, suppliers, and strategic partners within verticals.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 3 years of business partnering, operations, G&A, technology, and/or related experience
Or
Master's degree and 5 years of business partnering, operations, G&A, technology, and/or related experience
Or
Bachelor's degree and 7 years of business partnering, operations, G&A, technology, and/or related experience
Or
Associate's degree and 12 years of business partnering, operations, G&A, technology, and/or related experience
Or
High school diploma / GED and 14 years of business partnering, operations, G&A, technology, and/or related experience
Preferred Qualifications:
Experience in developing and delivering Procurement strategies aligned with business objectives across verticals, sites, and categories.
Strong ability to segment stakeholders, create power maps, and define partnering strategies to influence and enable business strategies.
Expertise in market scouting for innovation opportunities and integrating external ecosystem insights into Procurement strategies.
Excellent communication and stakeholder management skills to align on strategic priorities and drive proactive pipeline management.
Analytical approach with a focus on performance and value management, including pipeline value generation, realization, and recognition.
Demonstrated ability to lead cross-functional initiatives, make category tradeoff decisions, and represent vertical mega-categories at strategic boards.
Experience in supporting company-wide initiatives, including business development, innovation realization, and merger integration.
Strong change enablement skills to drive adoption of Procurement and business strategic initiatives across ecosystems.
Experience with analytical tools (Tableau, Power BI etc. )
Experience with Global Procurement e-Sourcing (Ariba, Coupa, Jaggaer, iValua, etc.) and CLM Tools (e.g., Workday Strategic Sourcing, Sirion 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 $161,681 to $187,820. 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
-
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 AssociateDirector, 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 AssociateDirector, 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 4d 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.
AssociateDirector, Congress Operations - US Remote
What you will do
The AssociateDirector, 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 AssociateDirector 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
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 AssociateDirector, 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 AssociateDirector, 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 AssociateDirector, 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 AssociateDirector, 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 AssociateDirector, 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 AssociateDirector, 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 4d ago
Associate Director, Site Engagement Strategy
Johnson & Johnson 4.7
Raritan, NJ jobs
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:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
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
We are searching for the best talent for an AssociateDirector, Site Engagement Strategy to be in Spring House, PA; Raritan, NJ; or Titusville, NJ.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Toronto, Canada - Requisition Number: R-052621
United States - Requisition Number: R-050504
Remember, whether you apply to one or all requisition numbers, your applications will be considered as a single submission.
Purpose:
As the AssociateDirector of Site Engagement within IHE&A, your role will be vital in helping to create engagement strategies that resonate with our sites to position JJIM as sponsor of choice. In collaboration with your peers and stakeholders across IHEA, DU and GCO, you will gather insights and work on key areas of opportunity to enhance site engagement. Converting insights into actions will be key to ensure we are building a best-in-class site engagement model.
Working closely with colleagues within IHE&A, as well as BGIA and the DUs, you will support the development of frameworks and processes that enable effective site engagement across our entire portfolio. Establishing and maintaining strong relationships with key stakeholders in these functions will be key to your success.
You will be responsible for:
* Collaborate closely with cross functional partners to support an integrated approach to site engagement, driving cohesion and maximizing effectiveness.
* Collaborate with the IHE&A innovation team to implement decentralized clinical trial (DCT) elements into scalable solutions for our study teams.
* Site insights management - support generation of insights (includes management of site advisory networks & survey governance), build processes, and support insight integration into different internal workflows.
* Support the development of tailored engagement approaches and tools for priority markets to optimize effectiveness.
* Lead and support the improvement of ways of working to streamline experience for our sites through cross-functional collaboration, initiative and project leadership.
* Work collaboratively with DUs and GCO countries to understand their needs in site engagement, in support of the global JJIM R&D portfolio.
* Adopt a client service mindset to ensure an integrated approach to engagement across IHE&A.
Qualifications / Requirements:
Education:
* Bachelor's degree is required, preferably in a scientific or health-related discipline
* An advanced degree is preferred
Required:
* Minimum 8 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO
* Strong track record in building site relationships.
* Strong drive and sense of urgency. Ability to work independently with strong influence skills.
* Possess sharp analytical skills and the ability to solve complex problems by identifying root cause and creating multi-faceted solutions.
* Entrepreneurial spirit. Ability to integrate new services into the organization, to demonstrate grit (mental toughness and courage) and to thrive in an ambiguous and complex environment.
* Excellent communication and negotiation skills, with a demonstrated ability to influence stakeholders across matrix organizations.
* Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of managing multiple projects.
* Up to 10% travel, defined by business need (Domestic/International)
Preferred:
* People management experience
The anticipated base pay range for this position in the US is $137,000 to $235,000.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
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 period 10 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: *********************************************
This job posting is anticipated to close on January 19, 2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
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:
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)).
For additional general information on Company benefits, please go to: - *********************************************
This position is eligible to participate in the Company's long-term incentive program.
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
$137k-235.8k yearly Auto-Apply 6d ago
Associate Director of North America Turnkey Projects (EPC)
Merck 4.6
Austin, TX jobs
Work Your Magic with us! Start your next chapter and join EMD Electronics.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
Everything we do in EMD Electronics is to help us deliver on our purpose of being the company behind the companies, advancing digital living. We are dedicated to being the trusted supplier of high-tech materials, services and specialty chemicals for the electronics, automotive and cosmetics industries. We foster a global collaborative organization made up of individuals who have the passion to win, obsess about the customer, are relentlessly curious and act with urgency. Together, we push the boundaries of science to make more possible for our customers.
Location:
The AssociateDirector for Turnkey Projects is a remote position that requires the candidate to be full-time at the customer jobsite (in North America) during the construction and commissioning phase of the project. During project planning, design stage, procurement stage, the role is primarily remote, with occasional travel to meet internal teams, suppliers, and vendors. There will be approximately 50% domestic and international travel to meet business needs, including staying at construction sites.
Your Role:
The role demands strong technical acumen, expert project management skills, and leadership in an environment where high-quality, efficient delivery is critical. The AssociateDirector for Turnkey Projects will be responsible for developing projects and managing project teams in the United States delivering specialty gases and chemical delivery systems in back pads, gas, and chemical buildings and subfabs for semiconductor manufacturing clients. The scope includes proposal work for new business opportunities, development of equipment modulization, leading and executing complex turnkey projects focused on engineering, procurement, construction, and commissioning. The successful candidate will work closely with Sales and Procurement while overseeing multiple project teams, including project managers, engineers, document control engineers, and a project administrator, to ensure projects meet scope, schedule, and budget targets while adhering to rigorous quality and safety standards.
Key Responsibilities:
As the AssociateDirector of Turnkey Project Management Team in U.S., you will drive strategy execution, support team growth, manage resources, enhance communication, and align team success with organizational goals.
Obtain and maintain commercial general contractor licenses from the states' registrars of contractors. For bidding processes for new EPC (Engineering, Procurement, Construction) projects, analyze customer requirements (RFQ or RFP), review designs, estimate costs, plan schedules, and manage risks. It includes proposing technical solutions that meet customer needs, collaborating with suppliers to select optimal materials and services, and preparing bid documents. Review contract terms, provide competitive pricing, and evaluate project feasibility to secure successful awards. Additionally, manage legal and commercial risks during the bidding process and negotiate with clients to achieve the best outcomes. Interface with semiconductor clients and internal stakeholders to define project scopes, validate technical requirements, and provide strategic updates.
Oversee critical engineering deliverables across various disciplines, including process, mechanical, piping, electrical, instrumentation, and control engineering. Responsibilities include reviewing and managing Process Flow Diagrams (PFDs), Piping and Instrumentation Diagrams (P&IDs), Hazard and Operability Studies (HAZOPs), equipment specifications, plot and layout plans, piping isometrics, single line diagrams, Input/Output (I/O) lists, and logic diagrams. Facilitate design coordination among internal design engineers, subcontractors, vendors, and clients.
Develop procurement strategies leveraging professional network and working with procurement manager, coordinating with suppliers and vendors, mitigating risks, ensuring compliance with contractual and regulatory requirements, and fostering collaboration between procurement, engineering, and construction teams to secure timely delivery of materials and equipment critical to project success.
Oversee all aspects of construction activities on-site including coordinating with subcontractors, ensuring compliance with safety regulations, resolving on-site issues, and maintaining effective communication with stakeholders to achieve project objectives.
Lead cross-functional teams by mentoring and coordinating project managers, engineers, sales personnel, and support staff.
Oversee project budgets with forecast and actual cost, resource allocation, scheduling for timelines using Primavera P6 or MS Project, and risk mitigation efforts to ensure timely, on-budget delivery.
Ensure compliance with relevant engineering, quality, safety, and regulatory standards throughout project lifecycles.
Proactively identify project risks and implement corrective actions; maintain effective communication channels and reporting structures.
Champion continuous improvement initiatives by leveraging best practices and advanced project management methodologies.
Manage the development of the modularization of equipment such as gas room cabinets, mods, pods, and VMBs to enhance productivity, scalability, and cost-effectiveness. Develop and implement strategies for modular design, ensuring standardization and compatibility across systems. Collaborate with engineering, procurement, and construction teams to optimize designs for transport, assembly, and operation. Oversee the integration of modular units into existing workflows while maintaining quality, safety, and compliance standards. Identify opportunities to reduce project timelines and costs through modular solutions. Provide technical guidance, manage risks, and ensure alignment with project objectives and client requirements. Drive innovation and continuous improvement in modularization practices.
Who You Are
Minimum Qualifications:
Bachelor's degree in chemical engineering, mechanical engineering, electrical engineering, construction management, project management, or a related technical field along with 8+ years of experience in EPC project management within process heavy industries such as semiconductor, oil and gas, petrochemical, refinery, power plant, other plant engineering required.
In lieu of a degree, the candidate must have 12+ years of progressive experience in EPC project management, preferably within the semiconductor, oil and gas, petrochemical, refinery, power plant, or other plant engineering required.
Strong network of subcontractors and experience in contract negotiation with clients and subcontractors is essential.
Eligibility to clear background check required for licensing by states' registrars of contractors.
Preferred Qualifications:
Preconstruction, project management, engineering management, or design experience in EPC companies related to industrial or specialty gas, semiconductor, oil and gas, petrochemical, refinery, or power plant.
Demonstrates respect for individuals and fosters an inclusive work environment that values diversity. Possesses strong cultural awareness and the ability to collaborate effectively with global teams, ensuring mutual understanding and alignment across different perspectives and backgrounds.
Preference given to candidates with process, mechanical, piping, electrical and instrument engineering experience, specifically process engineering backgrounds.
Proven record of gaining market share by proposing value engineering and winning proposals in projects with intense competition.
Experience with preconstruction and proposal preparation of at least ten EPC projects worth more than $50M each.
Experience with project execution of at least three EPC projects worth more than $50M each.
Extensive experience collaborating with global teams across multiple time zones to achieve project goals and ensure seamless communication along with a proactive and diligent work ethic.
Certified Project Management Professional (PMP), MBA, or equivalent certification is strongly preferred.
Strong leadership, communication, and problem-solving skills with 10 years of experience in managing cross-functional teams.
Familiarity with industry-specific standards and technology related to semiconductor process support.
Pay range for this position: $177,200 - $265,800
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$177.2k-265.8k yearly 47d ago
Associate Director, Site Engagement Strategy
Johnson & Johnson 4.7
Spring House, PA jobs
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:
R&D Operations
Job Sub Function:
Clinical Trial Project Management
Job Category:
People Leader
All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:
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
We are searching for the best talent for an AssociateDirector, Site Engagement Strategy to be in Spring House, PA; Raritan, NJ; or Titusville, NJ.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Please note that this role is also available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Toronto, Canada - Requisition Number: R-052621
United States - Requisition Number: R-050504
Remember, whether you apply to one or all requisition numbers, your applications will be considered as a single submission.
Purpose:
As the AssociateDirector of Site Engagement within IHE&A, your role will be vital in helping to create engagement strategies that resonate with our sites to position JJIM as sponsor of choice. In collaboration with your peers and stakeholders across IHEA, DU and GCO, you will gather insights and work on key areas of opportunity to enhance site engagement. Converting insights into actions will be key to ensure we are building a best-in-class site engagement model.
Working closely with colleagues within IHE&A, as well as BGIA and the DUs, you will support the development of frameworks and processes that enable effective site engagement across our entire portfolio. Establishing and maintaining strong relationships with key stakeholders in these functions will be key to your success.
You will be responsible for:
* Collaborate closely with cross functional partners to support an integrated approach to site engagement, driving cohesion and maximizing effectiveness.
* Collaborate with the IHE&A innovation team to implement decentralized clinical trial (DCT) elements into scalable solutions for our study teams.
* Site insights management - support generation of insights (includes management of site advisory networks & survey governance), build processes, and support insight integration into different internal workflows.
* Support the development of tailored engagement approaches and tools for priority markets to optimize effectiveness.
* Lead and support the improvement of ways of working to streamline experience for our sites through cross-functional collaboration, initiative and project leadership.
* Work collaboratively with DUs and GCO countries to understand their needs in site engagement, in support of the global JJIM R&D portfolio.
* Adopt a client service mindset to ensure an integrated approach to engagement across IHE&A.
Qualifications / Requirements:
Education:
* Bachelor's degree is required, preferably in a scientific or health-related discipline
* An advanced degree is preferred
Required:
* Minimum 8 years of relevant experience in clinical trial execution with a pharmaceutical company and/or a CRO
* Strong track record in building site relationships.
* Strong drive and sense of urgency. Ability to work independently with strong influence skills.
* Possess sharp analytical skills and the ability to solve complex problems by identifying root cause and creating multi-faceted solutions.
* Entrepreneurial spirit. Ability to integrate new services into the organization, to demonstrate grit (mental toughness and courage) and to thrive in an ambiguous and complex environment.
* Excellent communication and negotiation skills, with a demonstrated ability to influence stakeholders across matrix organizations.
* Strong planning and tracking skills, customer focused, well organized, detail oriented and capable of managing multiple projects.
* Up to 10% travel, defined by business need (Domestic/International)
Preferred:
* People management experience
The anticipated base pay range for this position in the US is $137,000 to $235,000.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
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 period 10 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: *********************************************
This job posting is anticipated to close on January 19, 2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.
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:
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)).
For additional general information on Company benefits, please go to: - *********************************************
This position is eligible to participate in the Company's long-term incentive program.
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
$137k-235.8k yearly Auto-Apply 6d ago
Associate Director, Clinical Site Agreements and Budgets (remote)
Merck 4.6
Billerica, MA jobs
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
This position will have strategic responsibility for a global Start-up Solution Unit Lead focused on Clinical Site Agreements (CSA).
You operate in a matrixed environment supporting the review and execution of agreements with the Institutions and Investigators involved in our Clinical Trials.
You will be responsible to review and manage legal and budget escalations related to different type of agreements, collaborating with internal and external stakeholders across multiple Countries with the final goal to support contract execution and the delivery of the site activation strategy as per best-in-class benchmarks.
Additional responsibilities will include leading, developing and updating negotiating parameter guidance documents at Country and Site level; approving Fair Market Value (FMV) assessments and performing CDA customization across the portfolio, leading discussion with Legal where required.
Who You Are
Minimum Qualifications:
Medical or Life Sciences degree or equivalent qualifications
At least 10 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment
Understanding of the overall clinical development paradigm, especially around clinical study operations and have global or regional experience.
Has 5 or more years of experience in contract and budget negotiation
Experience in oversight of external service providers, preferred
Location: Remote, Boston MA or east coast preferred
Pay range for this position: $125,000 - $187,400. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$125k-187.4k yearly 39d ago
Associate Director, Thought Leader Liaison - Neuroscience - Northeast
J&J Family of Companies 4.7
Boston, MA jobs
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:**
Medical Affairs Group
**Job Sub** **Function:**
Professional Medical Education
**Job Category:**
Professional
**All Job Posting Locations:**
Boston, Massachusetts, United States of America, Connecticut (Any City), Maine (Any City), Massachusetts (Any City), New Hampshire (Any City), New Haven, Connecticut, United States, Portland, Maine, United States, Portsmouth, New Hampshire, United States, Providence, Rhode Island, United States of America, Rhode Island (Any City)
**:**
We are recruiting for an AssociateDirector, Thought Leader Liaison - Neuroscience to support the Northeast (CT, MA, ME, NH, RI) region. This is a field-based position, with preference for the candidate to be in a major metropolitan market with easy access to a national airport.
This is a field based role available in Connecticut, Massachusetts, Maine, New Hampshire and Rhode Island. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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 *******************/ .
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
The AssociateDirector, Thought Leader Liaison -Neuroscience, will be responsible for leading the CAPLYTA Key Opinion Leader (KOL) engagement strategy, as well as contributing significantly to the overall KOL strategy across the Neuroscience franchise in close collaboration with the brand team. This territory includes CT, MA, ME, NH, and RI.
_Job Responsibilities_
+ Lead the development and execution of Regional KOL engagement strategy, marketing education strategy and faculty development. This includes oversight of regional peer to peer marketing plans, health care compliance training for faculty, and other related activities as needed.
+ Serve as a key member of the CAPLYTA Brand team by providing local market insights and feedback to craft future strategies for the Neuroscience franchise in close collaboration with sales leaders, key business partners, and medical teams to elevate brand advocacy.
+ Build trusting relationships with academic and community KOLs, and other key partners to achieve above-brand priorities.
+ Maintain pulse on regional trends and closely coordinate regional marketing education and engagement plans with cross functional partners to ensure heightened KOL and customer engagement strategies that are fully aligned to the Brand strategic imperatives.
+ Partner with coordinated analytics team to better understand regional variations in treatment patterns to advise peer to peer and insight program placement.
+ Attend conferences and serve as onsite host for product theatres
+ Facilitate, participate, and attend advisory boards where appropriate
+ Coordinate executive engagements with KOLs and commercial leadership
+ Closely supervise the regional marketing budget and provide continuous feedback on business planning.
+ Assist in crafting future innovative educational platforms including national and regional recommendations to tailor our education to local needs and creating innovative solutions in further engaging KOL's at all regional and national medical congresses.
+ Leadership of the overall neuroscience strategy inclusive of mapping, framework development, innovative engagement planning for current brands and future launches, inclusive of marketing operations for KOL strategy and planning including agency management, champion materials through CAC, Totality, MRC.
_Job Requirements_
+ BA/BS Degree Required; advanced degree preferred.
+ Minimum 6 years of experience in marketing, key account management, medical, sales leadership, sales training, or field sales engaging with KOLs/Influential HCPs and professional healthcare organizations.
+ Deep understanding and experience working cross functionally with various key internal & external partners with a strong ability to innovate, collaborate and deliver results with desired outcomes.
+ Demonstrated understanding of key industry trends and ability to develop strategies to stay ahead of the competition and improve patient outcomes.
+ Demonstrated ability to build and manage relevant and lasting customer relationships with strong focus on patient impact and outstanding customer centricity.
+ Travel can be up to 65%; this includes internal meetings, advisory boards, medical meetings, congresses, and select program attendance.
+ A Valid Driver's license issued in the United States.
**Preferred:**
+ Minimum 5 years of experience in neuroscience.
+ Previous cross-functional industry experience in pharma or biotech engaging with KOLs and professional healthcare associations is preferred.
+ Deep medical/scientific knowledge/experience with a firm understanding of the psychiatry marketplace is preferred.
+ Experience leading through change and transformation, product launches, and exceptional communication and leadership skills is preferred.
+ Complete all company and job-related training as assigned within the required timelines.
+ Must be able to perform all essential functions of the position, with or without reasonable accommodation.
+ Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
\#NeuroTLLBuild
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._**
**Required Skills:**
**Preferred Skills:**
Brand Marketing, Channel Partner Enablement, Digital Strategy, Global Market, Learning Materials Development, Medical Affairs, Medical Communications, Mentorship, Organizing, Process Improvements, Program Management, Sales Enablement, Sales Presentations, Strategic Sales Planning, Strategic Thinking, Technical Credibility, Training People
**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 39d ago
Associate Director, Thought Leader Liaison - Neuroscience - Northeast
Johnson & Johnson 4.7
Boston, MA jobs
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:
Medical Affairs Group
Job Sub Function:
Professional Medical Education
Job Category:
Professional
All Job Posting Locations:
Boston, Massachusetts, United States of America, Connecticut (Any City), Maine (Any City), Massachusetts (Any City), New Hampshire (Any City), New Haven, Connecticut, United States, Portland, Maine, United States, Portsmouth, New Hampshire, United States, Providence, Rhode Island, United States of America, Rhode Island (Any City)
:
We are recruiting for an AssociateDirector, Thought Leader Liaison - Neuroscience to support the Northeast (CT, MA, ME, NH, RI) region. This is a field-based position, with preference for the candidate to be in a major metropolitan market with easy access to a national airport.
This is a field based role available in Connecticut, Massachusetts, Maine, New Hampshire and Rhode Island. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.
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 *******************/.
Johnson & Johnson has entered into an agreement to acquire Intra-Cellular Therapies, Inc, a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With a differentiated commercialized therapy and promising clinical-stage pipeline that complements our current areas of focus, this acquisition brings us one step closer to achieving our ambition of becoming the #1 neuroscience company worldwide.
The AssociateDirector, Thought Leader Liaison -Neuroscience, will be responsible for leading the CAPLYTA Key Opinion Leader (KOL) engagement strategy, as well as contributing significantly to the overall KOL strategy across the Neuroscience franchise in close collaboration with the brand team. This territory includes CT, MA, ME, NH, and RI.
Job Responsibilities
* Lead the development and execution of Regional KOL engagement strategy, marketing education strategy and faculty development. This includes oversight of regional peer to peer marketing plans, health care compliance training for faculty, and other related activities as needed.
* Serve as a key member of the CAPLYTA Brand team by providing local market insights and feedback to craft future strategies for the Neuroscience franchise in close collaboration with sales leaders, key business partners, and medical teams to elevate brand advocacy.
* Build trusting relationships with academic and community KOLs, and other key partners to achieve above-brand priorities.
* Maintain pulse on regional trends and closely coordinate regional marketing education and engagement plans with cross functional partners to ensure heightened KOL and customer engagement strategies that are fully aligned to the Brand strategic imperatives.
* Partner with coordinated analytics team to better understand regional variations in treatment patterns to advise peer to peer and insight program placement.
* Attend conferences and serve as onsite host for product theatres
* Facilitate, participate, and attend advisory boards where appropriate
* Coordinate executive engagements with KOLs and commercial leadership
* Closely supervise the regional marketing budget and provide continuous feedback on business planning.
* Assist in crafting future innovative educational platforms including national and regional recommendations to tailor our education to local needs and creating innovative solutions in further engaging KOL's at all regional and national medical congresses.
* Leadership of the overall neuroscience strategy inclusive of mapping, framework development, innovative engagement planning for current brands and future launches, inclusive of marketing operations for KOL strategy and planning including agency management, champion materials through CAC, Totality, MRC.
Job Requirements
* BA/BS Degree Required; advanced degree preferred.
* Minimum 6 years of experience in marketing, key account management, medical, sales leadership, sales training, or field sales engaging with KOLs/Influential HCPs and professional healthcare organizations.
* Deep understanding and experience working cross functionally with various key internal & external partners with a strong ability to innovate, collaborate and deliver results with desired outcomes.
* Demonstrated understanding of key industry trends and ability to develop strategies to stay ahead of the competition and improve patient outcomes.
* Demonstrated ability to build and manage relevant and lasting customer relationships with strong focus on patient impact and outstanding customer centricity.
* Travel can be up to 65%; this includes internal meetings, advisory boards, medical meetings, congresses, and select program attendance.
* A Valid Driver's license issued in the United States.
Preferred:
* Minimum 5 years of experience in neuroscience.
* Previous cross-functional industry experience in pharma or biotech engaging with KOLs and professional healthcare associations is preferred.
* Deep medical/scientific knowledge/experience with a firm understanding of the psychiatry marketplace is preferred.
* Experience leading through change and transformation, product launches, and exceptional communication and leadership skills is preferred.
* Complete all company and job-related training as assigned within the required timelines.
* Must be able to perform all essential functions of the position, with or without reasonable accommodation.
* Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
#NeuroTLLBuild
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.
Required Skills:
Preferred Skills:
Brand Marketing, Channel Partner Enablement, Digital Strategy, Global Market, Learning Materials Development, Medical Affairs, Medical Communications, Mentorship, Organizing, Process Improvements, Program Management, Sales Enablement, Sales Presentations, Strategic Sales Planning, Strategic Thinking, Technical Credibility, Training People
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 39d 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.
.
Salary Range
-
$191k-262k yearly est. Auto-Apply 7d ago
Associate Director Inspection Management (GCP)
Regeneron Pharmaceuticals 4.9
Uxbridge, MA jobs
The AssociateDirector, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials.
In this role, a typical day might include the following:
Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
* Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
* Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection.
* Assisting with the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
* Identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
* Ensuring the preparation, management and conduct of inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits working with GDQA team to identify and mitigate risks to clinical programs.
* Serving as the back room lead/co-lead or front room co-lead, responsible for explaining, managing,and ensuring the execution of all activities, including managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection conducted worldwide.
* Responsible for managing the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
* Responsible for managing inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow-up activities alongside other GDQIM colleagues, cross-functional stakeholders, and process owners.
* Ensuring and managing the development, collection, reporting and analysis of inspection-related quality data, trends, and metrics.
This role may be for you if have:
* Advanced knowledge, understanding and application of GCP, and/or GVP
guidelines including the management of significant/complex quality issues
and compliance activities.
* Extensive experience with participating in, and supporting, Regulatory
Agency Inspections of Investigator Sites, Sponsors and Clinical Research
Organizations (CROs) in a GxP environment, including inspection
preparation, facilitation, and follow-up.
* Effective management of interpersonal relationships, stakeholder
engagement, and collaborations.
* Demonstrated ability to interface and collaborate effectively with other
Managers and Directors within, and external to, the organization.
* Extensive experience in providing training and presenting information on
key quality and regulatory compliance information.
To be considered for this opportunity we are looking for:
Bachelor's degree with a minimum of 10 years of relevant
healthcare/pharmaceutical industry experience.
* Experience working in either a quality/compliance role (e.g., Quality
Management, Quality Assurance etc.), or in a Clinical Development role
with expertise and/or transferable skills related to Good Clinical Practice
(GCP), and/or Good Pharmacovigilance Practice (GVP).
* Experience in training, supervising, line management, mentoring and
development of staff, and leading a small team
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
$138k-181k yearly est. Auto-Apply 1d ago
Associate Director, Clinical Trial Lead (on-site Billerica MA)
Merck 4.6
Billerica, MA jobs
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your role
Manages multiple studies, projects, and work streams with
high complexity, risk, impact and reach, typically Ph III and registrational/sourcing models.
Demonstrates skills in successfully leading large-sized global project teams in a matrix organization and directs, influences and motivate stakeholders from closely related areas and beyond, creating a positive working climate.
Leads the development of the clinical trial strategy while accountable for successful project execution and delivery of clinical operational budget, timelines and quality standards agreed upon by Governance Committees.
As a core member of the Clinical Operations Team and leader of the Clinical Trial Team, aligns clinical trial team with organizational goals, Clinical Operations Team, and/or Global Program Strategy Team.
Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to operational and organizational challenges in a holistic manner to mitigate risks.
Exhibits Subject Matter Expert level understanding of multiple functions and functional processes. Familiar with and considers overall company strategy.
Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical functional teams or projects.
Ensure all study management activities will be completed in accordance with SOPs/WI, local regulatory guidance including ICH-GCP; audit leadership- interviewee & responses.
Contribute to non-study -related initiatives in addition to study assignments. Provide reports to senior management, including updates and timelines independently.
Demonstrates creativity and innovation to support projects from a strategic perspective, able to predict the result of action in advance and achieve goals.
Who you are
At least 10 or more years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 7 years of in-depth experience in clinical trial management including managerial responsibility. Advanced degree desirable (MPH, MS, MA, MBA, PharmD); PM cPMP) desirable.
Proven experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing study activities, from startup through final study report.
Experience in multiple Therapeutic Areas (oncology and immunology preferred)
Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Required and experience in own discipline and beyond which may also require good market and competitor knowledge.
Strong leadership competencies and influencing skills.
Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
Growing expertise in drug development, including some knowledge of interfaces and interdependencies of clinical development with other nonclinical & pharmaceutical development, regulatory, commercial/marketing)
Location: On-site Billerica MA
Pay range for this position: $130,700 - $196,000. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
$130.7k-196k yearly 47d ago
Senior Director, Quantitative Pharmacology
Regeneron Pharmaceuticals 4.9
Cambridge, MA jobs
We are looking for a Senior Group Director in Quantitative Pharmacology. This individual will be responsible for managing a team functioning in one or more therapeutic focus area. In this capacity the SGD is accountable for the successful and timely completion of QP related activities, encompassing a broad array of deliverables in support of Drug Safety and Pharmacometrics. The successful applicant will support a range of assets from Early Clinical Development through submission and beyond.
This position can be based in our Tarrytown, NY, Warren, NJ or Cambridge, MA offices.
A day in the life of a Senior Group Director may look like:
* Managing and mentoring a broad spectrum of individual contributing scientists.
* Providing technical guidance and mentoring of colleagues within the function and across the organization.
* Performance management and assessment of staff and providing guidance and training to enable their success.
* Utilizing a mastery level of PK/PD knowledge and strategic leadership skills, effectively developing and implementing strategic analyses in support of research and development projects.
* Taking accountability for the PK/PD evaluation of a portfolio of products or projects, and/or highly complex projects that are wide in scope.
* Identifying opportunity for process and procedural improvements, product or service improvements.
* Solving unique and complex problems that have a broad impact on the business.
This may be the right role for you, if you:
* Can inspire and lead colleagues to deliver PMx and company goals.
* Want the ability to make a significant impact on the organization and external groups, and can influence and effect change.
* Enjoy making contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
* Understand long-term career opportunities and can guide other QP staff on potential directions.
In order to be considered qualified for this role, you must have:
* 10+ years of industry experience (with a Ph.D.) or 12+ years (with an M.S.), focusing on modeling and simulation, PK/PD (pharmacokinetics/pharmacodynamics), systems pharmacology, and quantitative drug development strategies.
* Hands on usage of a broad range of quantitative tools and systems is required, as is a strong publication record in the field.
* A proven ability to display excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly.
* Strong collaborative skills and effective at building alliances across functions, as well as the ability to effectively influence colleagues and multi-disciplinary project teams.
* The ability to handle all types of projects and leverage higher level staff for technical input and brainstorming to implement solutions for complex projects.
* Proven experience interacting with regulatory agencies without supervision, and within the company to develop regulatory strategy.
#REGNQPCP
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$238,400.00 - $397,300.00
$238.4k-397.3k yearly Auto-Apply 1d ago
Director, Program Operations Leader- Internal Medicine
Regeneron Pharmaceuticals 4.9
Cambridge, MA jobs
For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence.
In a typical day, you will:
* Be responsible for the overall success of the clinical study team(s) within a program(s)
* Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested
* Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
* Oversee clinical study timelines within a clinical program(s)
* Provide input and operational insight into Clinical Study Concepts (CSC)
* Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
* Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM
* Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
* Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
* Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
* Act as point of contact for clinical program and study level escalation
* Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress
* Provide proactive creation and implementation of risk mitigation strategies
* Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges
* Drives the strategy and oversight for vendor selection and management within a clinical program(s)
* Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts
* May require up to 25% travel
To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations.
#hematology
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$202,000.00 - $336,600.00
$202k-336.6k yearly Auto-Apply 1d ago
Director, Program Operations Leader - Early Phase Clinical Trials
Regeneron Pharmaceuticals 4.9
Uxbridge, MA jobs
For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. The Director Program Operations Leader (POL) is responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to
the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The Dir POL is a member of the
Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department
initiatives. The Dir POL is responsible for line management of clinical trial management staff, including responsibility for staff recruitment, development, coaching, mentoring, and performance management.
In a typical day, you will:
* Be responsible for the overall success of the clinical study team(s) within a program(s)
* Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level
updates to stakeholders as requested
* Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
* Oversee clinical study timelines within a clinical program(s)
* Provide input and operational insight into Clinical Study Concepts (CSC)
* Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best
practices within CTM
* Oversee clinical study budgets within a program: ensures review, presentation and approval of initial
study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
* Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s).
* Drives decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation
* Be responsible for direct supervision of CTM staff. Line management responsibilities include: work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.
To be considered, you must possess:
A Bachelor's degree and minimum of 12 years relevant in-house sponsor-side industry experience, 8 years within clinical operations.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$0.00 - $0.00