Medical Director, Senior Patient Safety Physician

Regulatory Toolkit; Cambridge (MA); Hybrid; USD 250,000 - 375,000; Full time

Benefits offered by this job

401(k) plan

Health benefits (medical, dental, and视

Paid vacation and holidays

Overtime pay

Short-term incentive bonus

Job summary

Regulatory Jobs is seeking an experienced Medical Director, Senior Safety Physician to lead clinical safety strategy and risk management across product lifecycles. You will influence safety decisions within cross-functional teams and ensure robust safety communications to stakeholders.

The role involves global regulatory safety deliverables, collaboration with Regulatory Affairs, Medical Affairs and Safety Science, and mentorship to safety professionals in a hybrid on-site setting in Boston.

Qualifications

• Significant clinical safety/pharmacovigilance experience in pharma/biotech.
• Strong knowledge of benefit-risk assessment and regulatory PV requirements.
• Experience preparing or reviewing global regulatory safety documents.
• Proven ability to influence and lead within a matrix environment.

Responsibilities

• Lead the clinical safety strategy for assigned products and programs.
• Oversee safety surveillance, signal detection, and risk management activities.
• Prepare regulatory safety deliverables and contribute to submissions.
• Present safety assessments to governance committees and senior stakeholders.
• Foster cross-functional collaboration and mentorship within safety teams.

Skills

Clinical safety experience

Pharmacovigilance expertise

Benefit-risk assessment

Regulatory safety knowledge

Matrix leadership

Medical communication

Education

Medical Degree (MD, MBBS, or equivalent)

Job description

Location: Kendal Square, Boston

Hybrid: 3 days a week on site

Medical Director, Senior Safety Physician

We are seeking an experienced physician to provide medical leadership for clinical safety and benefit-risk management across the lifecycle of assigned products and development programs. This role is accountable for shaping and executing safety strategy, evaluating emerging safety data, and ensuring the effective communication of safety information to internal and external stakeholders.

Working within a global, cross-functional environment, you will collaborate with experts across Clinical Development, Regulatory Affairs, Epidemiology, Safety Science, Risk Management, and Medical Affairs to protect patient safety and support the successful development and commercialization of innovative medicines.

Key Responsibilities

Clinical Safety Leadership

• Lead the clinical safety strategy for assigned products and programs.
• Drive medical evaluation of safety data and benefit-risk assessments.
• Provide expert input into risk identification, characterization, and mitigation activities.
• Influence safety-related decisions within project teams and governance forums.

Safety Surveillance and Risk Management

• Provide medical oversight of signal detection, safety surveillance, and risk evaluation activities.
• Lead interpretation of safety data from clinical trials, post-marketing experience, literature, and other relevant sources.
• Contribute to risk management planning and the development of appropriate risk minimization strategies.
• Ensure alignment of safety strategy with development and lifecycle objectives.

Regulatory Safety and Governance

• Lead and review key regulatory safety deliverables, including DSURs, PBRERs, PADERs, safety responses, and other global submissions.
• Support major regulatory submissions and interactions with health authorities.
• Present safety assessments and recommendations to governance committees and senior stakeholders.

Cross-Functional Leadership

• Serve as the Patient Safety representative in clinical project teams.
• Build effective partnerships across Clinical Development, Regulatory Affairs, Safety Science, Medical Affairs, and other key functions.
• Support due diligence, licensing, and business development activities when required.
• Mentor colleagues and contribute to a culture of scientific excellence, collaboration, and continuous improvement.

Essential Requirements

• Medical Degree (MD, MBBS, or equivalent).
• Clinical practice experience following medical qualification.
• Significant experience in Clinical Safety/Pharmacovigilance within the pharmaceutical or biotechnology industry.
• Strong knowledge of benefit-risk assessment, risk management, signal detection, and global pharmacovigilance regulations.
• Experience preparing or reviewing global regulatory safety documents and submissions.
• Proven ability to influence and lead within a matrix environment.

Preferred Qualifications

• Advanced training in Pharmaceutical Medicine or a related discipline.
• Experience across multiple therapeutic areas and stages of product development.
• Experience mentoring or leading safety professionals.

What Success Looks Like

• Sound medical judgement and strategic thinking.
• Strong collaboration and stakeholder management skills.
• Ability to communicate complex safety information clearly and effectively.
• Passion for advancing patient safety and delivering medicines responsibly.

The annual base pay (or hourly rate of compensation) for this position ranges from $249,827 - $374,740 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

15-Oct-2026

Closing Date

14-Dec-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.