Sr. Medical Director, Drug Safety & Pharmacovigilance

BridgeBio; United States; Remote; USD 120,000 - 220,000; Full time

Job summary

An established industry player in biopharmaceuticals is seeking a Senior Medical Director to lead drug safety and pharmacovigilance efforts. This pivotal role involves overseeing safety strategies, managing risk assessments, and collaborating with cross-functional teams to ensure compliance and safety of innovative treatments. The ideal candidate will possess a Medical Degree and extensive experience in drug safety, demonstrating a commitment to patient welfare and scientific excellence. Join a dynamic team dedicated to transforming genetic disease treatment and making a meaningful impact on patients' lives.

Benefits

Flexible PTO

Robust compensation package

Access to learning resources

Rapid career advancement

Commitment to Diversity, Equity & Inclusion

Qualifications

• 12+ years of drug safety and pharmacovigilance experience required.
• Extensive experience with safety signal evaluation and regulatory submissions.

Responsibilities

• Lead postmarketing safety strategy and risk management for assigned products.
• Oversee safety data review and collaboration with regulatory authorities.

Skills

Drug Safety

Pharmacovigilance

Clinical Trials Safety

Regulatory Submissions

Data Review and Analysis

Collaboration

Risk Management

Education

Medical Degree

Tools

Argus

ArisG

VeevaSafety

Microsoft Office Suite

Job description

Sr. Medical Director, Drug Safety & Pharmacovigilance

Remote - United States

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a commercial stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Attruby (acoramdis) is an orally administered small molecule designed to stabilize TTR, a best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.

An experienced safety physician who will lead the postmarketing safety strategy for your assigned products, working closely with highly motivated colleagues eager to bring safe, new treatments to patients. This role requires a keen ability to work collaboratively, adapt and find solutions to complex problems, and drive results. You will be responsible for comprehensive oversight and strategic oversight of core safety information and local labeling, postmarketing safety data review, benefit-risk assessment, and risk management, and be a subject matter expert during agency inspections.

Responsibilities

The Sr. Medical Director 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 contract service organizations and partners that provide safety data.
• Chair of the Safety Management Committee for the designated product(s), responsible for identifying emerging safety trends, defining the safety profile, and recommending safety actions based on cumulative safety data.
• In collaboration with regulatory, clinical development, medical affairs, and business partners, establish the safety strategy for postmarketing safety, core safety information, local labeling, safety reporting, benefit-risk evaluation, risk management, engagement with regulatory authorities, and authoring of responses to inquiries.
• Participate in publication preparation and medical information material review.
• Manage medical aspects of aggregate data analysis, presentation of medical analyses internally and to regulatory agencies as required, expedited case analyses, scientifically sound PBRER preparation, and ensure the signal management and risk management functions of the contract service organizations 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.
• Develop and present assessments of safety data, safety signals, benefits, and risks for internal senior management as well as external partner or regulatory authorities.
• Assist in the authoring of aggregate reports.
• Accountable for partner liaison aspects of signal management and risk management (GVP Modules).
• Supports ad hoc safety review meetings, including all internal and external stakeholders, with compliance with signal evaluation timelines, and maintains audit trail as inspection ready at all times.
• When requested, work with other BridgeBio Affiliates to provide strategic input and work on assigned non-product/compound-related projects.

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards.
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset.
• Truth Seekers, who are detailed, rational, and humble problem solvers.
• Individuals Who Inspire Excellence in themselves and those around them.
• High-quality executors, who execute against goals and milestones with quality, precision, and speed.

Education, Experience & Skills Requirements

• Medical Degree.
• Requires 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.
• Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines.
• Proven ability to collaborate successfully with postmarketing teams, including medical affairs, biostats, regulatory, medical writing, and QA.
• Experience in managing all postmarketing safety aspects of product quality defect investigations and assessments.
• Management of compliance deviations and formulations of CAPAs.
• Familiar with clinical trial safety database use and CIOMS II and PBRER 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).

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients.
• A place where you own the vision – both for your program and your own career path.
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.
• Access to learning and development resources to help you get in the best professional shape of your life.
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
• Flexible PTO.
• Rapid career advancement for strong performers.
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time.
• Commitment to Diversity, Equity & Inclusion.