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Medical Safety Director Jobs (NOW HIRING)

CRISPR Therapeutics

$170 - $190/hr

Position Summary The Associate Director, Medical Safety is responsible for medical and clinical oversight of individual case safety reports (ICSRs), signal detection and evaluation, and benefit-risk ...

Argenx

Medical Safety Lead

The Medical Safety Lead provides strategic medical safety leadership, serving as the single point ... direct reporting lines) and managing complex matrix teams * Experience in clinical practice or in ...

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How much do medical safety director jobs pay per year?

As of Sep 5, 2026, the average yearly pay for medical safety director in the United States is $162,390.00, according to ZipRecruiter salary data. Most workers in this role earn between $100,000.00 and $207,000.00 per year, depending on experience, location, and employer.

What does a medical safety director do?

A Medical Safety Director is responsible for overseeing the safety of pharmaceutical products or medical devices throughout their lifecycle. They lead teams that monitor, assess, and manage risks related to patient safety, ensuring compliance with regulatory requirements. Their duties often include reviewing safety data, reporting adverse events, and implementing risk management strategies. Medical Safety Directors work closely with regulatory agencies, clinical teams, and other departments to protect patient well-being and improve product safety.

What are the key skills and qualifications needed to thrive as a medical safety director, and why are they important?

To thrive as a Medical Safety Director, you need extensive knowledge of pharmacovigilance, regulatory requirements, and clinical risk assessment, typically supported by a degree in medicine, pharmacy, or life sciences. Familiarity with safety databases (like Argus or ArisGlobal), signal detection tools, and relevant certifications (such as RAC or CCRA) is highly valued. Excellent leadership, analytical thinking, and effective communication are crucial soft skills for guiding teams and interacting with regulatory authorities. These competencies ensure patient safety, regulatory compliance, and successful management of medical product risks in the healthcare industry.

What are some common challenges faced by a medical safety director, and how can they be managed effectively?

Medical Safety Directors often navigate challenges such as rapidly evolving regulatory requirements, managing cross-functional safety teams, and responding to urgent safety signals. Effective management involves staying updated on global pharmacovigilance regulations, fostering strong communication across clinical, regulatory, and research teams, and implementing robust risk assessment processes. Proactive collaboration and continuous training are key to ensuring timely and accurate safety data reporting, which helps mitigate risks and maintain compliance.

What is the difference between Medical Safety Director vs Medical Safety Specialist?

AspectMedical Safety DirectorMedical Safety Specialist
CredentialsMedical degree, safety certifications, experience in drug safetyRelated certifications, such as pharmacovigilance training, with less managerial experience
Work EnvironmentOversees safety programs, manages teams, collaborates with regulatory agenciesSupports safety data collection, conducts analysis, assists in safety reporting
Employer & Industry UsagePharmaceutical companies, biotech firms, healthcare organizationsPharmaceutical companies, contract research organizations, healthcare settings

The Medical Safety Director typically holds a leadership role, overseeing safety strategies and teams, while the Medical Safety Specialist focuses on data analysis and safety reporting. Both roles require relevant safety certifications and industry experience, but the director has broader responsibilities and managerial duties.

Do medical safety directors get paid more?

Medical Safety Directors typically earn higher salaries compared to other safety or compliance roles due to their specialized expertise, leadership responsibilities, and often advanced certifications such as RAC or CSP. Their compensation varies based on experience, industry, and organization size, but they generally receive higher pay reflecting their critical role in ensuring patient and staff safety in healthcare settings.

How much does a Medical Safety Director make in the US?

A Medical Safety Director in the US typically earns between $150,000 and $200,000 annually, depending on experience, location, and the size of the organization. They often hold advanced certifications and have extensive knowledge of pharmacovigilance, risk management, and regulatory compliance.
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Medical Safety Director jobs near you
Infographic showing various Medical Safety Director job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 15% Part Time, and 6% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution, with an average salary of $162,390 per year, or $78.1 per hour.

Associate Director, Medical Safety

CRISPR Therapeutics

On-site

$170 - $190/hr

Other

Posted 15 days ago

Key responsibilities

  • Perform medical review of individual case safety reports (ICSRs), including causality assessment, seriousness classification, and expectedness determination.

  • Lead or contribute to signal detection activities, including signal prioritization, validation, and evaluation, and contribute to safety reports and benefit-risk assessments.

  • Oversee medical aspects of long-term follow-up safety surveillance and provide clinical input into vector-related safety monitoring.

Job description

Job Description:

Company Overview Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

Position Summary

The Associate Director, Medical Safety is responsible for medical and clinical oversight of individual case safety reports (ICSRs), signal detection and evaluation, and benefit-risk assessment for the company's cell and gene therapy (CGT) / CRISPR-based product portfolio. This role provides medical judgment across the case processing lifecycle — causality assessment, seriousness and expectedness determination, and narrative review — with particular attention to the safety considerations unique to gene-edited and vector-based therapeutics, including insertional oncogenesis, secondary malignancy, engraftment failure, and long-term follow-up (LTFU) surveillance. The role sits at the intersection of clinical medicine, regulatory pharmacovigilance, and CGT-specific scientific expertise, and is expected to represent PV medical safety perspectives cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Manufacturing/Quality.

ResponsibilitiesCase Safety & Medical Review
  • Perform medical review of ICSRs including causality assessment, seriousness classification, and expectedness determination against the current Investigator's Brochure / labeling
  • Provide clinical input on complex or ambiguous cases, particularly those involving secondary malignancy (e.g., MDS), graft failure, delayed engraftment, prolonged cytopenia, or replication‑competent lentivirus (RCL) findings
  • Review and approve case narratives for medical accuracy and completeness prior to submission
  • Serve as a medical escalation point for Unanticipated Problems / Emerging Safety Issues (UPESI) identified during case review
Signal Detection & Benefit‑Risk
  • Lead or contribute to signal detection activities per GVP Module IX, including signal prioritization, validation, and evaluation
  • Apply disproportionality analysis methods (PRR, ROR, EBGM) and benchmark observed events against real‑world cohort data where applicable, particularly for oncologic and hematologic safety signals
  • Contribute medical safety content to aggregate safety reports (DSURs, PBRERs/PSURs) and benefit‑risk assessments
  • Support the Safety Management Team / Safety Review Committee with medically‑grounded risk characterization and mitigation recommendations
CGT‑Specific Safety Oversight
  • Maintain current expertise in gene editing modalities (CRISPR/Cas9, base/prime editing, HDR/NHEJ repair pathways) and their associated safety considerations, including off‑target editing and founder mosaicism
  • Oversee medical aspects of long‑term follow‑up (LTFU) safety surveillance, including delayed‑onset AEs and integration site analysis follow‑up where applicable
  • Provide clinical input into vector‑related safety monitoring (e.g., vector shedding, immunogenicity) in coordination with Clinical and CMC/Manufacturing teams
Process, Compliance & Cross‑Functional Collaboration
  • Contribute to and maintain PV SOPs relevant to medical safety review, signal management, and UPESI handling
  • Support inspection readiness and participate in internal audits and health authority inspections as a medical safety subject matter expert
  • Partner with Regulatory Affairs on safety‑related regulatory submissions and health authority queries (FDA, EMA, PMDA/MHLW, NMPA/CDE)
  • Provide medical safety training to case processing staff, clinical operations, and investigator sites as needed
  • Mentor and provide medical guidance to junior case processing and safety staff, as applicable to team structure
Minimum Qualifications

MD, DO, PharmD, or equivalent advanced clinical degree; Minimum 6+ years of pharmacovigilance, drug safety, or clinical safety experience, including direct ICSR medical review and causality assessment Working knowledge of global PV regulations and frameworks (GVP Modules, FDA safety reporting requirements, ICH E2 guidelines) Demonstrated experience with signal detection methodology and aggregate safety report contribution (DSUR, PBRER/PSUR) Strong written and verbal communication skills, with demonstrated ability to produce clear, medically sound case narratives and safety assessments

Preferred Qualifications
  • Prior experience in cell and gene therapy, CAR‑T, or gene editing/CRISPR therapeutics safety oversight is nice to have
  • Familiarity with CAR‑T‑specific toxicity grading (CRS/ICANS per ASTCT consensus criteria)
  • Experience with long‑term follow‑up (LTFU) safety programs for gene therapy products
  • Board certification in a relevant clinical specialty (e.g., hematology/oncology, internal medicine)
  • Experience presenting to or supporting Data Safety Monitoring Boards (DSMBs) or Safety Review Committees
  • Familiarity with safety database platforms (Argus, ArisGlobal, Veeva Vault Safety)
  • Standard office environment; occasional travel (domestic/international) for audits, inspections, or scientific conferences (estimated 5–10%) May require availability outside standard business hours for urgent safety escalations (e.g., serious AESI review, expedited reporting deadlines)
Competencies
  • Collaborative – Openness, One Team
  • Undaunted – Fearless, Can‑do attitude
  • Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
  • Entrepreneurial Spirit – Proactive. Ownership mindset.
Working Environment

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in‑person interactions. Our employees work at least three days on‑site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross‑functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on‑site.

Base Pay

Associate Director, Medical Safety: Base pay range of $170,000 to $190,000+ bonus, equity and benefits

Equal Employment Opportunity

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research‑stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize‑winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly‑owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

To view our Privacy Statement, please click the following link: http://www.crisprtx.com/about-us/privacy-policy

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