Senior Medical Director, Product Safety Physician Lead

Location: Fully remote within the United States; occasional travel of less than 10% is expected.

Salary: $298,200–$368,200 annual base salary, plus eligibility for an annual bonus, discretionary equity awards, and an Employee Stock Purchase Plan.

Company

hirify.global uses an AI-powered matching process to connect candidates with partner-company opportunities and manages the initial application review.

What you will do

• Lead product safety and integrated global safety interpretation for multiple, complex, or strategically important developmental programs.
• Oversee benefit-risk assessments, safety surveillance, signal identification, issue management, and escalation throughout the product lifecycle.
• Chair safety management meetings and represent product safety perspectives to senior governance bodies, regulatory agencies, and monitoring committees.
• Provide medical review and guidance for serious adverse events, aggregate safety analyses, clinical trial safety plans, labeling, and regulatory submissions.
• Collaborate with Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, Epidemiology, and other functions on development and commercialization strategy.
• Mentor Safety Physicians and Safety Scientists while supporting process improvement, inspection readiness, standards, and organizational capability development.

Requirements

• MD or internationally recognized equivalent with an accredited residency.
• At least 6 years of pharmaceutical or biotechnology industry experience, including 4+ years of Phase 1 and Phase 2 safety experience.
• Previous experience as a Product Safety Physician with responsibility for developmental product safety and risk management.
• Strong knowledge of global pharmacovigilance requirements, safety regulations, ICH standards, clinical trial safety, regulatory submissions, labeling, and DSURs.
• Advanced knowledge of MedDRA, intermediate experience with safety databases, and advanced proficiency in Excel, PowerPoint, and Word.
• Strong analytical, communication, leadership, mentoring, influencing, and cross-functional stakeholder-management skills.

Nice to have

• Oncology experience, particularly in pre-approval development.
• Accredited fellowship and at least one year of clinical patient experience in a relevant therapeutic specialty.
• Familiarity with Spotfire and other data-mining or exploratory analysis tools.

Culture & Benefits

• Fully remote work within the United States with occasional travel below 10%.
• Medical, dental, and vision insurance, plus life insurance coverage.
• 401(k), FSA, HSA, paid time off, and wellness programs.
• Annual bonus eligibility for non-commercial roles, discretionary equity awards, and an Employee Stock Purchase Plan.
• Opportunity to influence global product development, safety governance, and regulatory strategy for therapies addressing serious diseases.
• Leadership and mentoring opportunities within a multidisciplinary, patient-safety-focused environment.

Hiring process

• Applications are reviewed through an AI-powered matching process.
• Shortlisted candidates are shared with the hiring partner, which manages interviews, assessments, and final next steps.