Director, Safety Scientist

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Director of Safety Scientist to lead safety signal management and risk assessment for oncology biopharma compounds. You will collaborate with Product Safety Leads and cross‑functional teams to review safety data, author safety sections of regulatory documents, and support global pharmacovigilance activities.

The role emphasizes regulatory interactions, health hazard evaluations, and safety governance, with minimal travel.

Qualifications

• Pharmacovigilance or safety science experience required, 8+ years.
• MD/PhD/PharmD with clinical training preferred; MD with clinical experience a plus.
• Strong proficiency with safety databases, MedDRA, and data analysis tools.

Responsibilities

• Lead safety signal detection and evaluation in oncology programs.
• Assess safety data and prepare safety communications for internal and regulatory use.
• Support regulatory submissions (INDs, NDAs) and DSURs; participate in governance meetings.

Skills

Safety signal management

Pharmacovigilance

Regulatory interactions

Data analysis

Cross-functional collaboration

Education

PharmD/MD/PhD or equivalent with 8+ years

Tools

Argus

MedDRA

Spotfire

PowerBI

Job description

Role: Director, Safety Scientist, supporting clinical safety assessments for biopharma compounds, primarily in oncology or cancer-related areas.

Responsibilities include leading safety signal detection and evaluation, assessing safety data, preparing safety communications, and supporting regulatory submissions such as INDs, NDAs, and safety reports (e.g., DSURs, PBRERs). The role involves collaboration with Product Safety Leads, Safety Scientists, and cross-functional teams, with a focus on pharmacovigilance, risk assessment, and regulatory interactions. The position also supports clinical trial safety monitoring, safety data review, and health hazard evaluations. It requires applying scientific expertise to safety signal management, authoring safety sections of regulatory documents, and leading safety governance meetings. The role may involve managing direct reports and influencing internal/external stakeholders, including regulatory agencies.

Qualifications:

PharmD, NP, RN, or PhD in medical or biological sciences with 8+ years of experience in safety science, clinical development, or pharmacovigilance; MD plus clinical training and 4+ years clinical experience is preferred. Skills include advanced proficiency with safety databases (Argus), MedDRA, signal management tools, and data analysis software (Spotfire, PowerBI). Experience in global regulatory requirements, pharmacovigilance principles, and medical safety assessments is essential.

Travel is minimal (<10%), and the work setup is not explicitly specified but likely global and matrix-based. High-value specifics include a focus on oncology, biologics, and regulatory safety oversight.