Director, Patient Safety Physician – Cardio Renal Metabolic

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the proactive strategy for patient safety and benefit-risk assessment for assigned investigational compounds during early clinical development.

• Provide medical safety oversight for first-in-human, dose-escalation, proof-of-concept, and other clinical trials.

• Review protocols, investigator brochures, safety monitoring plans, and clinical study reports.

• Integrate clinical, nonclinical, translational, epidemiologic, and external evidence to identify, characterize, and communicate emerging safety concerns.

• Collaborate with cross-functional development teams to establish risk management and risk minimization strategies.

• Contribute to program governance, regulatory interactions, and evidence-based go/no-go decision-making.

• Supervise ongoing safety surveillance, signal evaluation, and aggregate safety assessments.

• Provide medically sound input for regulatory documents, including DSURs.

• Represent Experimental Medicine Patient Safety in both internal and external discussions.

• Communicate the evolving safety profile to senior management and regulators.

• Lead matrix teams or strategic safety initiatives as assigned.

⛳️ Requirements

• MD or DO degree from an accredited institution in the US or an equivalent international qualification.

• Completion of an ophthalmology residency is strongly preferred.

• An active or inactive medical license is strongly preferred.

• Over 5 years of relevant experience, including clinical practice, research, or work in the pharmaceutical industry.

• At least 2 years of experience in pharmaceutical safety, clinical development, or a closely related area.

• Strong medical-scientific judgment.

• Ability to synthesize complex clinical, nonclinical, and translational data into clear benefit-risk conclusions and recommendations.

• Knowledge of global pharmacovigilance and clinical development safety requirements, including safety surveillance, signal management, aggregate reporting, and regulatory compliance in major markets.

• Excellent leadership, executive presence, and communication skills.

• Experience in influencing cross-functional teams within a global matrix environment.

• People leadership experience is preferred.

• A patient-first, highly ethical, and accountable mindset.

• Initiative to tackle ambiguity and take ownership of tasks.

• Willingness to attend key meetings in person as required.

• Must be legally authorized to work in the United States without restrictions.

• Must be willing to undergo a drug test and post-offer physical examination if required.

• Must be 18 years of age or older.

🏝️ Benefits

• Role-specific discretionary bonus eligibility.

• Relocation assistance may be offered.

• Additional compensation elements may be available.

• Health and wellbeing support.

• Opportunities for meaningful work and support for work-life balance.

• Mobility and networking opportunities.

• Competitive compensation and benefits packages.

• Opportunities for international collaboration.