Medical Director Drug Safety

Scienta; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Scienta is seeking a Medical Director, Drug Safety to provide medical and scientific leadership for the safety profile of assigned products across the development lifecycle. Working with Clinical Development, Regulatory Affairs and Pharmacovigilance, this person will lead safety assessment, signal evaluation and benefit-risk activities while supporting key regulatory and clinical decisions.

The role requires an MD or equivalent, a minimum of three years of clinical practice, and experience as a

Qualifications

• MD or equivalent medical degree required.
• Minimum three years of clinical practice experience.
• Experience as PI or Co-Investigator on clinical trials.
• Experience in Drug Safety/Pharmacovigilance or Clinical Development preferred.
• Strong knowledge of signal detection and risk assessment.
• Familiarity with FDA, EU and ICH safety regulations.
• Excellent analytical, medical writing and communication skills.

Responsibilities

• Lead safety assessment and benefit-risk evaluation across development.
• Monitor safety data, signals, and literature.
• Provide medical safety input into trial design and endpoints.
• Lead cross-functional discussions on safety issues and risk management.
• Contribute to regulatory submissions and safety documents.
• Author or oversee DSURs, PSURs, and Risk Management Plans.
• Serve as medical safety expert for regulatory interactions.
• Collaborate with internal and external teams to standardize safety evaluation.

Skills

Pharmacovigilance

Safety signal detection

Medical writing

Cross-functional leadership

Clinical development

Regulatory submissions

Data interpretation

Education

MD or equivalent

Job description

The Medical Director, Drug Safety will provide medical and scientific leadership for the safety profile of assigned products across the development lifecycle. Working closely with Clinical Development, Regulatory Affairs and Pharmacovigilance, this individual will lead safety assessment, signal evaluation and benefit-risk activities while supporting key regulatory and clinical development decisions.

Key Responsibilities

• Lead ongoing assessment of product safety profiles and benefit-risk.
• Monitor and evaluate safety data, emerging signals and relevant literature.
• Provide medical safety input into clinical trial design, safety endpoints and interpretation of clinical data.
• Lead cross-functional discussions on significant safety issues and risk-management strategies.
• Provide safety input into regulatory submissions, Clinical Study Reports and market applications.
• Author or oversee key safety documents including DSURs, PSURs/PBRERs and Risk Management Plans.
• Serve as the medical safety expert for regulatory authority interactions.
• Partner with internal teams and external collaborators to ensure a consistent approach to safety evaluation and communication.

Qualifications

• Medical Degree (MD or equivalent) required.
• Minimum three years of clinical practice experience.
• Must have experience serving as a Principal Investigator (PI) or Co-Investigator on clinical trials.
• Experience in Drug Safety/Pharmacovigilance, Clinical Development or Clinical Research preferred.
• Strong knowledge of signal detection, benefit-risk assessment and pharmacovigilance processes.
• Understanding of FDA, EU and ICH safety regulations.
• Strong analytical, medical writing and communication skills.
• Ability to influence cross-functional teams and operate effectively in a fast-paced environment.