When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement... read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life‑changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we’ll ask “why not?” and help reengineer the future of biopharma.
Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR‑CM).
What You’ll Do
The Sr. Medical Director, Drug Safety, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.
- 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
Responsibilities
Support the clinical development team in the review of key documents, including protocol and ICFsManage 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 indicatorsAssist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessaryDevelop and prepare assessments of safety data, safety signals, and benefit / risk for internal senior management as well as external partner or regulatory authoritiesAssist in the authoring of aggregate reportsWhere You’ll Work
This is a U.S.-based remote role that will generally require three visits per year, or as needed visits to our San Francisco Office.
Who You Are
Medical DegreeRequires 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 two years of oversight management experience (line management or CSO management)Extensive 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 updatesExperience in both clinical development and post‑marketing safetyExperience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviewsDemonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on‑time DSUR preparationExperience in drug safety audits and agency inspectionsIntimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelinesProven ability to collaborate successfully with clinical trial teams, including data management, clinical sciences, medical monitors, clinical operations, biostats, regulatory, medical writing, and QAExperience in managing all clinical safety aspects of product quality defect investigations and assessmentsManagement of compliance deviations and formulation of CAPAsFamiliar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)Must be able and willing to travel periodically for face‑to‑face engagements with regulatory authorities, and occasional on‑site meetings (if based remotely)Rewarding Those Who Make the Mission Possible
We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
Market leading compensation401K with 100% employer match on first 3% & 50% on the next 2%Employee stock purchase programReferral program with $2,500 award for hired referralsComprehensive health care with 100% premiums covered - no cost to you and dependentsMental 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 workUnlimited flexible paid time off - take the time that you needPaid parental leave - 4 months for birthing parents & 2 months for non‑birthing parentsFlex spending accounts & company‑provided group term life & disabilitySubsidized lunch via Forkable on days worked from our officeSkill Development & Career Paths
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobilityWe provide career pathing through regular feedback, continuous education and professional development programs via Learning, LifeLabs, Spring Health & BetterUp CoachingWe celebrate strong performance with financial rewards, peer‑to‑peer recognition, and growth opportunitiesAt BridgeBio, we strive to provide a market‑competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits.
Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.
$310,000 - $340,000 USD
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