New · posted Oct 31
Vertex Pharmaceuticals · Biotechnology
Patient Safety Senior Medical Director
- Boston, MA
- Hybrid
- Full-time
- Director
The role
The Patient Safety Senior Medical Director will provide leadership for all safety and risk management activities for assigned products, pre- and/or post-approval. This role will lead Risk Management activities, pre-, peri- and post-approval (as applicable) for assigned compound(s) and will provide relatively autonomous leadership of periodic (aggregate) safety report, signaling, labelling and DST activities for assigned compounds, as well as participate in individual case medical review. This role will lead representation, as safety lead, on clinical teams/programs, regulatory filings and submissions and other intra and/or inter-departmental activities and initiatives, including process/SOP development, audits and inspections.
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 make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
What you need
- MD, DO or equivalent ex-US medical degree
- Typically requires 7 years of experience, or the equivalent combination of education and experience
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Knowledge and Skills
- Solid knowledge of GCP, ICH and Global regulations
- Strong knowledge of current Benefit-Risk principles
- Ability to multi-task
- Solid written and oral communication skills to communicate highly complex ideas and interact/negotiate with senior leaders
- Solid independent judgment and decision-making skills, including the identification and communication of relevant safety-related issues or concerns to GPS Management in an appropriate and timely manner
- Sound ability to communicate effectively in a matrix environment
- Advanced knowledge of General Medicine
- Advanced experience in the evaluation and interpretation of data
- Advanced experience in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents
What you'll do
- Represents department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert input regarding safety matters and issues.
- Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed, demonstrating solid judgment.
- Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Participates in the analysis of safety data from on-going and completed clinical trials and its presentation in Clinical Study Reports.
- Provides strategic leadership in the content for periodic reports (DSUR, PSUR) for assigned products.
- Reviews and provides medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charters.
- Provides leadership in pre-, peri- and post-approval Risk Management activities and deliverables, including dRMP, RMPs and product safety labeling, as well as key regulatory engagements, such as Advisory Committee meetings, EU Pre-submission meetings, and Pre-NDA meetings
- Participates in departmental development activities including SOP and Work Instructions development.
- Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective through leadership of Product Teams.
- Provides timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources.
- As directed by a Disease-area Safety Head, perform due diligence from the perspective of Global Patient Safety for potential in-licensed compounds.
- Provides Global Patient Safety function in Partner /Affiliate agreements and interactions, as needed.
- As directed by a Disease-area Safety Head, serve as Chair of one or more Disease-area Safety Team(s) for assigned products, assuming primary responsibility for the conduct and deliverables of the Teams.
- Participates in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with Vertex signal detection practices.
- Other activities as needed or as requested by GPS Management
Pay and benefits
$276,000 – $414,000 a year
Employer provided$276,000 - $414,000
Annual bonus
Annual equity awards
Medical, dental and vision benefits
Generous paid time off
Student loan repayment and educational assistance
401(k)
Where you'll work
Boston, MAHybridOpen in Maps (opens in a new tab)
More jobs in Boston, MAWorking conditions
Flex Designation
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
From the posting
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation.
Equal opportunity, accessibility and legal noticesVertex Pharmaceuticals's statements, word for word
Disclosure Statement
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Vertex 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, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 33% above the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Director roles in Massachusetts24 roles publishing pay
Director roles in the US69 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $276,000 | — | $414,000 |
| Massachusetts (middle half) | $217,500 | $229,000 | $281,000 |
| All US (middle half) | $213,500 | $260,000 | $281,000 |
This role: Vertex Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 113 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Vertex's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Documentation and SOPs8
- Clinical trial conduct5
- GMP and compliance2
- Regulatory submissions2
- Quality systems and risk2
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Vertex on Regulatory Jobs
- 46
- Open roles
- 46
- Distinct roles
- 2
- Locations
By discipline
- Clinical20 43%
- Quality15 33%
- Regulatory11 24%
By level
- Director39 85%
- Manager5 11%
- VP & Executive1 2%
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Patient Safety Senior Medical Director at Vertex
Open until filled. $276K–$414K a year, employer provided.