Senior Medical Director
BridgeBio
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $325,000 - $370,000 per year
Job Level
About the role
- Responsible for the overall safety evaluation and risk management of assigned products, including both internal and external engagement with key collaborators
- In collaboration with internal and external stakeholders establish the safety strategy for the clinical development and postmarketing safety for the assigned products, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries
- Preparation for the Safety Management Committee and other internal or external committees for the designated product(s)
- Manage medical aspects of aggregate data analysis, presentation of safety analyses internally and to regulatory agencies as required, scientifically sound DSUR/PSUR preparation, and contribution to the contract service organizations oversight
- Medical review of adverse event reports, manage preparation and submission of drug safety expedited reporting in compliance with regulations
- Compliance with project timelines, and inspection readiness
Requirements
- Medical Degree
- At least 12 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO) with at least three years of oversight management experience (line management or CSO management)
- Extensive experience with all aspects of safety signal evaluation, including data review and analysis, collaboration with cross-functional team members and senior management, authoring required regulatory correspondence, and safety label updates
- Experience in both clinical development and post-marketing safety
- Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews
- Demonstrated ability to successfully manage drug safety team or drug safety CSO for a postmarketing program with responsibilities for expedited reporting, on-time PBRER preparation
- Experience in drug safety audits and global agency inspections
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
drug safetypharmacovigilancesafety signal evaluationdata reviewregulatory submissionsexpedited reportingPBRER preparationadverse event reportingaggregate data analysisDSUR/PSUR preparation
Soft skills
collaborationmanagementcommunicationleadershiporganizational skillsstakeholder engagementpresentation skillsstrategic planningproblem-solvinginspection readiness
Certifications
Medical Degree