Senior Medical Director, Drug Safety
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
- Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data
- Chair of the Safety Management Committee for designated product(s), responsible for identifying any emerging safety trends, defining the safety profile, and recommending safety actions based upon cumulative safety data
- In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries
- Support the clinical development team in the review of key documents, including protocol and ICFs
- Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators
- Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary
- Develop and prepare assessments of safety data, safety signals, and benefit/risk for internal senior management as well as external partner or regulatory authorities
- Assist in the authoring of aggregate reports
Requirements
- Medical Degree
- 10 years of drug safety and pharmacovigilance experience (clinical trials safety experience in the biotechnology, pharmaceutical, drug safety contract service organization (CSO)) preferred
- Experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of 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
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 evaluationregulatory submissionsCTD documentsadverse event reportsDSUR preparationsafety data analysisclinical trials safetysafety label updates
Soft skills
leadershipcollaborationcommunicationmanagementorganizational skillsanalytical skillsproblem-solvingattention to detailstrategic thinkinginterpersonal skills
Certifications
Medical Degree