What Jobs are available for Director Safety Physician 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:

• Manage and conduct comprehensive pharmacovigilance activities, including the collection, assessment, and reporting of adverse events (AEs) and serious adverse events (SAEs).
• Ensure compliance with all relevant global regulatory requirements for pharmacovigilance (e.g., FDA, EMA).
• Contribute to the development and maintenance of safety databases and ensure data integrity.
• Review and interpret clinical trial data and post-marketing surveillance data to identify potential safety signals.
• Prepare safety reports, including Periodic Benefit-Risk Evaluation Reports (PBRERs) and DSURs.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, medical affairs, and R&D, on safety-related matters.
• Participate in the development of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS).
• Communicate safety information effectively to internal stakeholders, healthcare professionals, and regulatory authorities.
• Stay updated on the latest scientific literature, regulatory guidelines, and best practices in pharmacovigilance.
• Mentor and train junior pharmacists or safety associates as needed.

Job Description

Company introduction:

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.  

We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area.

We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways.

Job Overview:

The Senior Director, Clinical Safety and Pharmacovigilance plays a key leadership role in driving our patient safety and shaping risk management strategies across global clinical development. This position offers the opportunity to champion pharmacovigilance excellence, proactively manage safety signals, and steer impactful medical monitoring in an innovative, science-led environment.

Location: Remote on the East Coast, United States or hybrid in our NYC office.

Reports to: Vice President, Clinical Safety and Pharmacovigilance.

Roles and responsibilities
(Include but are not limited to):

• Serve as drug safety SME for Compass clinical development programs and as primary Sponsors medical contact or medical monitor for assigned Phase 1-3 studies
• Lead safety activities, benefit-risk strategies, and safety signal management for assigned studies and compounds
• Oversee aggregate safety review documents, safety labelling, and safety sections of clinical trial documents and regulatory filings, ensuring compliance with global regulations
• Oversee and manage vendors/CROs supporting Safety/PV functions
• Identify, evaluate, and manage safety signals through comprehensive data analysis author safety signal assessments and aggregate reports
• Prepare, coordinate, and submit safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities ensure ongoing compliance with local and international regulations
• Develop, maintain, and provide training on SOPs, PV processes, and procedures in accordance with Good Pharmacovigilance Practices (GVP)
• Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop effective risk minimization strategies
• Manage and develop PV scientists and mentor/supervise colleagues as positive change agents
• Represent Compass at Health Authority inspections, DMC meetings, and provide input to R&D publication strategy
• Maintain thorough and accurate documentation of safety data, supporting timely and quality submissions and presentations
• Ensure all responsibilities are performed efficiently, accurately, and cost-effectively in line with current global regulatory and quality standards
• Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process
• Promote collegiality and teamwork among peers

Candidate Profile:

• MD/DO/MBBS required with considerable experience in the pharmaceutical industry, predominantly in the drug safety/medical monitoring function track record of successful product launch
• Extensive industry experience in CNS, ideally psychiatry
• Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes
• Experience/in-depth understanding of clinical trial/drug development from a regulatory perspective
• Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively
• Proven ability to work effectively on a team in a collaborative environment
• Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety

【For NYC】Compensation Description (annually):

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.

【Base salary per annum】:

$260,000—$320,000 USD

Benefits & Compensation:

For an overview of our benefits package and compensation information, please visit "Working at Compass".

Reasonable accommodation

We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.

UK applicants

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

US applicants

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

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