Senior Director, Safety Science & Risk

Parabilis Medicines; Cambridge (MA); On-site; USD 255,000 - 300,000; Full time

Job summary

Parabilis Medicines in Cambridge, MA is seeking a Senior Director, Safety Scientist to lead safety surveillance and risk management across our clinical portfolio.

You will drive signal detection, safety analyses, SSPs, SARs, and regulatory interactions while partnering with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to influence pivotal program decisions in a fast-paced biotech environment.

Qualifications

• Advanced degree in Life Sciences, Pharmacy, Nursing, or Medicine.
• 12+ years in pharmacovigilance, drug safety, or safety science.
• Experience supporting clinical stage development programs.
• Experience authoring SSPs, SARs, dRMPs, DCSI, IBs, DSURs, protocols, and ICFs.
• Experience with regulatory interactions and global health authorities.
• Knowledge of FDA/EMA/ICH requirements.

Responsibilities

• Lead safety science activities for assigned development programs.
• Author and maintain Safety Surveillance Plans (SSPs) for Parabilis development assets.
• Perform signal detection and signal management activities, including maintenance of the signal tracker.
• Contribute to literature surveillance to identify, evaluate, and communicate potential safety signals.
• Perform MedDRA SMQ and Preferred Term searches for adverse events of clinical interest to support ongoing safety monitoring.
• Partner with internal stakeholders to leverage visualization tools (e.g., Spotfire) to support safety signal detection and analysis.
• Author Signal Analysis Reports (SARs) for validated signals and support risk characterization and mitigation strategies.
• Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings, including signal validation and follow-up reviews.
• Develop scientific materials for safety-focused advisory boards and Key Opinion Leader (KOL) meetings.
• Author and maintain Development Risk Management Plans (dRMPs) and Development Core Safety Information (DCSI) for Parabilis development assets.
• Contribute safety expertise to Investigator's Brochures, clinical protocols, informed consent forms, DSURs, and other regulatory documents.
• Contribute to PV dashboards and ensure timely communication of relevant safety science information.
• Author and update Safety Science SOPs, work instructions, and signal/risk management procedures.
• Support safety-related responses to health authorities, IRBs/ECs, and Clinical Trial Applications (CTAs).
• Collaborate cross-functionally to integrate safety insights into clinical development strategy, regulatory submissions, and key program decisions while driving continuous improvement in safety science processes.

Skills

Safety surveillance

Signal detection

Safety risk management

Cross-functional collaboration

AI tools in work

Education

Advanced degree in Life Sciences, Pharmacy, Nursing, or Medicine (PharmD, Ph.D.)

Tools

Safety databases

MedDRA coding

SMQ searches

Spotfire

Job description

Parabilis Medicines in Cambridge, MA is seeking a Senior Director, Safety Scientist to lead safety surveillance and risk management across our clinical portfolio.

You will drive signal detection, safety analyses, SSPs, SARs, and regulatory interactions while partnering with Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations to influence pivotal program decisions in a fast-paced biotech environment.