257 Clinical Safety jobs in the United States

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

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About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Clinical Safety Specialist. This is a remote role available in the continental USA.

Purpose: The Clinical Safety Specialist is responsible for implementing and executing clinical trial safety activities and responsibilities for the clinical research programs.

You will be responsible for:

• Management of safety related clinical trial activities for assigned studies including:
  • Ensure timely and accurate execution of all safety related processes (study-specific) per study Safety Management Plan (SMP) and applicable Charters
  • Conduct ongoing medical reviews of safety related events (e.g., AEs, DD/DMs) per study SMP
  • Manage safety related processes:
    • Develop, implementation and ongoing management of study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and Charters
    • Review of draft informed consent forms (templates and site specific)
    • Safety requests for and review of source documents
    • Issuing and resolving safety queries in the study database
    • Event reconciliation between EDC and Quality Assurance/Complaints
    • Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or overseeing third party management of committee activities per study SMP and associated Charters
  • Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements including collaboration with regulatory affairs and clinical operations or overseeing activities of third-party managing safety reporting.
  • Review applicable study reports and statistical outputs as needed
  • Other clinical trial safety activities as directed
• Support the review, implementation, and execution of standard operating procedures (SOPs)
• Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices

Qualifications:

• Bachelor’s Degree required, preferably in nursing. healthcare or life sciences
• Minimum of 5 years’ experience implementing safety processes or clinical research experience including management of safety events (medical devices preferred)
• Must have clinical research experience
• Experience managing and execution of processes for CEC and DSMB/DMC preferred
• Experience with complaint handling, quality & regulatory processes preferred
• Strong interpersonal skills and well-developed written and oral communication skills
• Effective analytical and problem-solving skills
• Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG /1,, ISO 14155, EU MDR 2017, and country-specific regulatory requirements
• Knowledge and proficient use of Microsoft Office Suite Applications (Word, Excel, Power Point, and Microsoft Project) and clinical trial databases (e.g., Medidata Rave, Argus)

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 internal employees contact AskGS to be directed to your accommodation resource.

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The anticipated base pay range for this position is :

Additional Description for Pay Transparency:

• Act as a mentor to Clinical Operations team members.
• Ensure the confidentiality of clinical trial participants and sponsors is respected.
• Continuously assess safety improvement opportunities and communicate to departmental management.
• Perform clinical trial activities including but not limited to safety assessments, Investigational Product (IP) administration and blood collection.
• Monitor, document and/or follow-up on participant adverse events.
• Maintain and advocate a high level of customer service, quality and safety within the department.
• May train employees on clinical trial activities associated to their jobs needs.
• Proactively communicate issues and/or problem resolutions to departmental supervisors and managers.

• Degree from accredited Licensed Practical Nurse or EMT.
• Related work experience preferred.
• Strong Communication Skills
• Customer service focused, able to work in fast-paced environment.

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs
• Telework when applicable

• Training & Development Programs
• Employee Referral Bonus Program

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Senior Research Scientist, Non-Clinical Safety & Toxicology

We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. As the Senior Research Scientist, Non-Clinical Safety & Toxicology you will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.

This role applies toxicology and immunology expertise to assess safety risks across the full product lifecycle, from early development through commercialization. Responsibilities include evaluating potential safety concerns related to product design, manufacturing changes, deviations, or consumer complaints that could impact animal safety or end-user health. The role involves preparing Product Safety Assessments (PSAs) for products in development, production, or on the market, and compiling medical and toxicological data to assess potential health risks for consumers and end users.

Your Responsibilities:

• Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro  and in vivo  safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens).

• Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals.

• Provide internal expert guidance, including expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.

• Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.

• Collaborate closely with colleagues in Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives for projects and products.

• Proactively participate in global, cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) within a matrix organization to drive project success.

• Maintain technical and professional expertise by staying current with scientific developments and sharing relevant insights and best practices within the organization.

What You Need to Succeed (Minimum Qualifications):

• Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master’s degree with at least 7 years of relevant experience.

• Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration.

• Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts.

What Will Give You a Competitive Edge (Preferred Qualifications):

• Board certification as a toxicologist (ERT, DABT, or equivalent).

• Immunological background, especially related to monoclonal antibodies and emerging platform technologies for indications like dermatology or pain.

• Deep understanding of US, European, and international veterinary drug development, as well as agribusiness practices for companion and farm animals.

• Strong working knowledge of GLP regulations and experience with in silico toxicity prediction tools.

• Ability to manage complex projects independently, with strong organizational and time management skills.

• Excellent written and verbal communication skills in English.

Additional Information:

• Travel: Up to 30% annually (domestic and international)

• Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Soon to be Indianapolis, Indiana NEW HQ October 2025)

Don’t meet every single requirement?   Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!  

Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)

• 8-week parental leave

• 9 Employee Resource Groups

• Annual bonus offering

• Flexible work arrangements

• Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

This position will be required to float between Waconia and Chaska.

This position is evening shift: 3:00pm-11:30pm

Purpose of Job

This position is responsible for continuous monitoring of the patient at the bedside to assure patient safety when the patient is a suicide risk or is at risk of harming themselves by pulling lines, falling, wandering, and other behaviors.

Job Functions

1. Remains at patient's bedside giving continuous observation and intervention under the direction of the RN.
2. Provides cares/interventions such as verbal redirection and orientation; hand holding; diversion activities such as imagery, storytelling, reading, game playing, towel folding, etc.; feeding and fluids; assisting to toilet, ambulate, and reposition; assisting patient to not pull on tubes, lines, etc.
3. Documents patient behaviors, cares, interventions, and patient response.
4. Performs other duties as assigned.
5. Accompanies patient and ensures patient safety during transportation, testing, and procedures occurring away from the patient's normal environment.
6. Performs room assessment regularly and after any visitations

Minimum Education/Work

• High school diploma or equivalent

Preferred Qualifications

• Direct patient care experience
• Nursing Assistant Certification Or EMT certification

Knowledge/Skills/Abilities

• Ability to meet and maintain the necessary background checks as aligned with position functions.
• Ability to communicate in the English language for effective written and verbal correspondence in order to complete job functions as mentioned above.
• Ability to accurately report to nurse any observed changes in the patient's behavior and/or condition
• Ability to respond appropriately to unpredictable situations and diverse patient populations

License/Certifications

• BLS certification within 60 days of employment

Physical Demands

Link to Employee Health Physical Demands

Compensation

Many factors are taken into consideration when determining compensation such as: the requirements of the position, experience, education, knowledge, and skills along with location and internal equity. Pay listed does not include any shift, weekend, or other differentials.

Benefits

Ridgeview strives to provide comprehensive and market competitive benefits to meet the needs of our employees and their families.

Click here to view the benefits available.

Southwestern Health Resources is looking for a highly skilled Program Manager. Is that you?

Work location: Southwestern Health Resources Headquarters , Hybrid: 1601 Lyndon B. Johnson Freeway, Farmers Branch, TX 75234.

Work environment: Patient Experience and Clinical Safety

Position Summary:

The Program Manager, Patient Experience & Clinical Safety, is a highly skilled professional responsible for managing and coordinating integrated patient experience and clinical safety initiatives across our clinically integrated network. This role primarily focuses on enhancing the patient's journey while incorporating essential clinical safety elements as they interrelate with and impact patient experience and overall quality performance. The Program Manager will focus on network-wide initiatives, collaborating across the clinically integrated network and its comprehensive care settings to synergize the patient's experience and journey, and influencing success through effective relationships with various leaders and counterparts. This position requires a blend of analytical skills, clinical understanding, and exceptional interpersonal abilities to drive measurable change within the healthcare environment. This role also encompasses providing functional guidance and oversight to assigned program personnel, ensuring the effective execution of program objectives and the enhancement of the patient journey.

Work hours:

• Full-time, 40 hours per week.

• Monday - Friday, Day shift.

• This is a Hybrid position: expectation to work onsite at least once per week.

• In-person attendance required at department meetings, provider and staff trainings and/or other department authorized activities, at the above-mentioned address or other locations as directed by the department management.

Organization Highlights

At Southwestern Health Resources (SWHR), we believe healthcare can be more integrated, accessible, and affordable for all. Our purpose is simple yet powerful: to build a better way to care, together. SWHR is a patient-centered, clinically integrated network that brings together academic and community clinicians, researchers, hospitals, and ambulatory facilities. We partner with physicians to drive a new model of value-based, high-quality, data-driven healthcare—serving everyone in the communities we touch. By combining the strengths of UT Southwestern Medical Center and Texas Health Resources, we've built the largest provider network in North Texas, giving our team members the opportunity to make a meaningful impact at scale. Healthcare in the U.S. is evolving rapidly, and SWHR is committed to leading that change—moving healthcare forward, together.

What You Will Do:

• Patient Experience Program Management: Manage and coordinate assigned multi-disciplinary, cross-departmental projects focused on enhancing patient experience across the network. This includes overseeing CAHPS, post-visit patient surveys, and other patient feedback programs, analyzing patient experience data trends, and developing provider education initiatives related to patient-centered communication and service excellence.

• Patient Feedback & Insights: Design, implement, and manage patient feedback mechanisms to gather insights and identify improvement opportunities.

• Patient Communication & Engagement: Lead efforts to enhance communication clarity and empathy and support the implementation of patient engagement strategies.

• Interrelated Clinical Safety Support: Support clinical safety initiatives that directly impact patient experience and quality outcomes, including assisting in the review of safety events, identifying contributing factors, and supporting the development and implementation of corrective actions.

• Documentation & Workflow Improvement: Collaborate with appropriate teams to identify and address clinical documentation gaps in the EHR (Electronic Health Record) that impact care quality, patient safety, and care gap closure, and support the implementation of EHR solutions aimed at improving patient care.

• Quality Improvement Project Execution: Execute and manage patient experience and related clinical safety improvement projects utilizing established quality improvement methodologies (e.g., Model for Improvement, Lean, Six Sigma, PDSA cycles), driving measurable improvements in outcomes.

• Data Analysis, Reporting & Benchmarking Support: Collaborate with analytics partners to establish, monitor, and report on key performance indicators (KPIs) for patient experience and relevant clinical safety metrics. Utilize benchmarking data to identify opportunities for improvement and prepare and present findings to leadership. This includes the ability to translate data confidently, defend its validity, and recommend actionable next steps.

• Value-Based Care Performance Insights: Provide subject matter expertise and insights to help inform discussions related to how patient experience impacts value-based care contract performance. Contribute to the development of ROI models for patient experience programs and educate internal and external stakeholders on the financial and quality impacts of experience performance.

• Network Synergy & Collaboration: Collaborate with leaders and counterparts across the network to synergize the patient experience and journey, motivating and influencing positive changes in diverse care settings.

• Program Personnel Guidance : Provide functional guidance, mentorship, and support to individuals assigned to support program initiatives, fostering their professional development and ensuring alignment with program goals.

• Work Coordination: Coordinate and oversee tasks for assigned program personnel, ensuring timely completion and adherence to program standards and objectives.

• Collaborative Support : Collaborate with contributing staff to address challenges, share best practices, and facilitate their growth in support of overall program success.

Education
Bachelor's Degree Healthcare Administration, Public Health, Nursing, or a related clinical or administrative field Required Or
Master's Degree Related field Preferred

Experience
5 Years Experience in healthcare delivery, with a strong focus on patient experience program management and/or quality improvement, including exposure to clinical safety principles. Required

Licenses and Certifications
Other CPXP - Certified Professional in Patient Experience Upon Hire Preferred And
CPPS - Certified Professional in Patient Safety Upon Hire Preferred
PMP - Project Management Professional Certification Upon Hire Preferred
SSLP - Six Sigma Lean Professional Upon Hire Preferred
SSGBC - Six Sigma Green Belt Certification Upon Hire Preferred

Skills

• Strong communication skills (verbal and written) needed to interact professionally and effectively in the work environment, including the ability to navigate difficult conversations successfully.
• Demonstrated self-awareness, accountability, and resilience, with the ability to calmly navigate challenging situations and take initiative to move forward.
• Strong analytical and problem-solving skills, with the ability to interpret data and identify trends related to patient experience and its impact on quality.
• Demonstrated ability and skills with project coordination and quality improvement tools, such as Microsoft Excel, or SharePoint.
• Excel lent organizational and time management skills, with the ability to adapt to changing priorities, manage numerous diverse projects simultaneously, and meet deadlines.
• Familiarity with quality improvement methodologies, such as Lean or PDSA.

  Supervision
  This position manages people

  ADA Requirements
  Working Indoors 67% or more

  Physical Demands
  Sedentary

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position: Manager, Business Analyst, In-Vivo & Non-Clinical Safety Product Team, Research BI&T

Location: Cambridge, MA

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Overview: The Business Analyst in the In-Vivo & Non-Clinical Safety Product Team will play a key role in bridging the gap between scientific research needs and IT solutions, specifically focusing on In-Vivo & Non-Clinical Safety Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN). This is a hands-on role where the successful candidate will work closely with researchers, lab personnel, and IT teams to gather requirements, design solutions, and ensure the effective implementation and support of LIMS and ELN applications.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Desired Candidate Characteristics:

• Strong commitment to a career in technology with a passion for healthcare.

• Proven experience with LIMS and ELN systems.

• Degree in Biological or Chemical sciences with prior research experience.

• Knowledge of l In-Vivo & Non-Clinical Safety laboratory experimental processes and data management.

• Technical knowledge and support experience for LIMS and ELN systems in biotech/pharma research labs.

• Experience in business analysis and conducting training on LIMS and ELN platforms.

• Ability to work collaboratively with scientists, IT colleagues, vendors, and contractors.

• Demonstrated ability to work across a matrixed organizational model.

• Strong understanding of business needs and commitment to delivering the best user experience.

• Excellent communication skills.

• Agility to learn new tools and processes.

Key Responsibilities:

• Requirements Gathering: Collaborate with researchers, lab personnel, and other stakeholders to understand and document their needs and requirements for LIMS and ELN applications.

• Solution Design: Work with IT and software development teams to design and propose solutions that meet the identified requirements, ensuring alignment with best practices and regulatory standards.

• Support: Support end users with configuration, customization, and deployment of LIMS and ELN systems. Provide support during implementation phases to ensure smooth transitions and minimal disruption to lab operations.

• Manage Jira boards, create user stories and specifications for developers and testers. Support end users in use of LIMS, ELN, and other scientific applications and troubleshooting user issues. Conduct structured training in use of LIMS, ELN, and other scientific applications.

Qualifications:

• Education: Degree in Life Sciences, Information Technology, Computer Science, or a related field.

• Experience: Minimum 3 years of experience as a Business Analyst, preferably in a life sciences research or laboratory environment. Experience with LIMS and ELN systems is highly desirable.

• Technical Skills: Proficiency in LIMS and ELN applications, as well as familiarity with database management, data integration, and software development lifecycle (SDLC) methodologies.

• Analytical Skills: Strong analytical and problem-solving skills, with the ability to translate complex scientific requirements into technical solutions.

• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact with both technical and non-technical stakeholders.

• LIMS/ELN Implementation: Experience in leading rollouts of LIMS/ELN platforms to large user groups.

• Regulatory Knowledge: Understanding of regulatory requirements and quality standards in the life sciences industry, such as GxP, FDA, and ISO standards.

Preferred Qualifications:

• Experience with LIMS and ELN platforms (e.g. Genedata, Dotmatics, Revvity, Sapio, Benchling, etc.).

• Certification in Business Analysis (e.g., CBAP, CCBA) or Project Management (e.g., PMP).

• Familiarity with data analytics and reporting tools.

Why You Should Apply:

Around the world, we are passionate about impacting the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments, and ongoing support in their roles. Applicants can request accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Bristol-Myers Squibb Company is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Cambridge Crossing: $118,650 - $143,778

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R

Updated: :50:10.876 UTC

Location: Cambridge Crossing-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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 no-style="text-align:left;">Job Function:

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Job Description:

Johnson & Johnson is recruiting for a Director, Clinical Translational Safety Lead to be located in Spring House, PA; Horsham, PA; Raritan, NJ; or Titusville, NJ.

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 Summary:

As a Clinical Translational Safety Lead within the Preclinical Sciences and Translational Safety team (PSTS), you will play an important role in guiding the strategy for mechanistic de-risking and understanding of safety signals that arise in pre-clinical and clinical development within a robust and multi-modality portfolio covering multiple therapeutic areas (oncology, immunology, neurosciences, ophthalmology, others). You will be part of the Translational Safety leadership team, working in a global organization of motivated and passionate scientists with expertise in toxicology, safety pharmacology, pathobiology, DMPK and bioanalysis. The individual contributor role (reporting to the Executive Director, Global Translational Safety) requires a well-rounded physician scientist with an investigative mind and a track record of excellent communication and collaboration in cross-functional, complex, and fast-paced, highly matrixed environments. This role requires a deep understanding of systems and pathway biology, mechanistic pathobiology and biochemistry, and the ability to “translate” pathologic and clinical findings into disease phenotypes. 

The Clinical Translational Safety Lead will build strong partnerships with Translational Research, Global Medical Safety and Clinical Pharmacology and will work in collaboration with key stakeholders in investigative toxicology, pathobiology, safety pharmacology and other pre-clinical sciences to set investigative pre-clinical strategy and bridge knowledge between pre-clinical and clinical disciplines to advance new medicines into the clinic. You will contribute to our discovery programs by providing expert interpretation and contextualization of competitive intelligence around clinical safety data in collaboration with medical safety officers, translational leads and compound development team leaders. This role is responsible for establishing a robust translational safety assessment framework, ensuring that clinical insights are translated back into discovery to inform and optimize our preclinical safety models and ultimately improve the safety profiles of future therapies.

What’s in it for you:

If you have a creative scientific, translational and strategic mindset and you thrive on (1) identifying opportunities for (cross disciplinary) project impact, (2) raising the scientific bar of our discipline and (3) challenging/defending scientific and/or strategic project views to senior management and senior governance bodies, this will be an excellent opportunity to (1) further grow you career, (2) significantly impact drug discovery and development and (3) ultimately to help patients.

In addition, our R&D culture of being courageous in science and unwavering in execution and of being one team that CARES for each other enables us to navigate uncertainty, seize opportunities, and lead where medicine is going.

Key Responsibilities:

• Develop and maintain strong collaborative partnerships with key stakeholders including Global Medical Safety, Clinical Development, Medical Affairs, Translational Research and other related functions to formulate investigative and mechanistic frameworks to understand safety signals arising in our clinical programs.

• Serve/Act as a key point of contact for PSTS on the initiative of creating “a translational safety community of practice” between Global Medical Safety and PSTS.

• Provide expert consultation on translational safety issues and evaluate safety packages in competitive intelligence assessments for target or modality de-risking

• Contribute expertise to support development of advanced in vitro models (3D, organoids, micro physiologic systems) and integrated AI/ML foundational models as we invest in R&D innovation in collaboration with laboratory experts and in silico modelers

• Translate pathologic findings and biochemical/genetic pathways into disease phenotypes to enhance our understanding of data generated in the pre-clinical studies and to help contextualize risks and mitigation strategies in our first-in-human studies

• Lead efforts to integrate clinical safety data back into preclinical models (reverse translation), improving predictive accuracy and addressing potential safety risks early in development.

• Provide mentorship toward our PSTS goal to develop future, outstanding preclinical science experts and through creating and upholding a culture of engagement, scientific rigor, inclusion, program impact and innovation

Some Key Qualifications:

• Medical education (MD) and advanced degree (PhD, MS) in investigative medical sciences such pathology, radiology, nephrology, internal medicine, oncology, rheumatology, or similar.

• Deep understanding of systems and pathway biology, and ability to translate pathologic and laboratory findings into disease phenotypes and actionable follow up experiments or mitigation strategies.

• 5+ years of experience in clinical research, medical safety, medical affairs, translational research, investigative toxicology, or related roles within the area of drug discovery and development. Phase I clinical trial and clinical PoC experience preferred.

• Excellent analytical and critical thinking skills, with a focus on innovative approaches to mechanistic approaches and reverse translation in safety science.

• Able to communicate effectively and with confidence to senior management and R&D leaders. Experience in a broad range of therapeutic modalities is a plus.

The anticipated base pay range for this position is $194,000 to $334,650.

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.

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• Employees and/or eligible dependents may be 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.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

  • Vacation – up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found via the following link:

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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.

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