Associate Director, Safety Scientist

Bicara Therapeutics

. Perform cumulative safety data reviews across trials or indications to assess safety profiles and identify emerging risks or trends .

Posted 4/29/2026full-timeBoston • Massachusetts • 🇺🇸 United StatesSenior💰 $230,000 - $233,000 per yearWebsite

About the role

Key responsibilities & impact

Perform cumulative safety data reviews across trials or indications to assess safety profiles and identify emerging risks or trends
Responsible for review of aggregate safety data and signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
Collaborate with Safety Physicians to review and align on safety data conclusions for informed decision-making regarding assigned program(s)
Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to applicable health authorities
Provide input into regulatory submissions (e.g., BLA, Module 2.7.4/2.5) and respond to Health Authority queries with scientifically sound responses
Contribute or be the primary safety contact person for clinical trial-related documents including Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Statistical Analysis Plans (SAPs), and eCRF setup
Mentor new team members by providing training on core safety processes and fostering their development within the organization
Act as Subject Matter Expert during audits and inspections for key safety processes such as Safety Surveillance and aggregate report generation
Lead the safety governance meetings and develop meeting materials (agenda, minutes, slide preparation)
Additional activities as assigned at the discretion of the hiring manager

Requirements

What you’ll need

Advanced degree (PharmD, PhD, MD, or MS) in a life sciences discipline, or equivalent scientific background is required.
4+ years of experience in pharmacovigilance or clinical development within a pharmaceutical or biotechnology company.
Familiarity with global pharmacovigilance regulations (FDA, EMA, ICH, CIOMS) and safety databases (e.g., Argus, ArisGlobal).
Expertise with Microsoft Word, PowerPoint, SharePoint and Excel
Excellent written and verbal communication skills, with a track record of high-quality safety document contributions.
Ability to collaborate effectively across functions, drive timelines, and maintain compliance standards.

Benefits

Comp & perks

health insurance
dental coverage
vision coverage
short term and long term incentives
cash bonus
equity incentive opportunities
comprehensive benefits and wellness package

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

safety data reviewsignal detectionsignal investigationaggregate safety reportsregulatory submissionssafety surveillanceclinical trial documentationsafety governancepharmacovigilanceclinical development

Soft Skills

collaborationmentoringcommunicationdecision-makingtrainingleadershiporganizational skillsattention to detailproblem-solvingtime management

Certifications

PharmDPhDMDMS