Sr. Medical Director

BridgeBio Pharma

5d•$325,000 - $370,000•Hybrid

About The Position

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. You are an experienced safety physician who will support the clinical development and postmarketing safety strategy for your assigned products, working closely with internal and external stakeholders. You will be responsible for all aspects of safety evaluation and risk management for your assigned products. This role requires a keen ability to work collaboratively, adapt and find solutions to complex problems, and drive results.

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

Responsibilities

The Sr. Medical Director is 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

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
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 mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities