Medical Director, Head of Pharmacovigilance

About ML Bio Solutions & BridgeBio Pharma

ML Bio Solutions, an affiliate of BridgeBio Pharma, is a biotechnology company founded by the McColl and Lockwood families after a family member was diagnosed with the condition. ML Bio is developing BBP-418, potentially the first oral treatment for patients with LGMD2I.

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, Boston, New York, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at https://mlbiosolutions.com/ | https://bridgebio.com

Location:

This position is based at any office location (remote)

Who You Are:

The Medical Director of Pharmacovigilance serves as the product safety leader for BBP-418. This pharmacovigilance expert will identify and evaluate potential safety signals and drive risk management activities to enable patients and healthcare providers' safe and effective use of ML Bio products.

Reporting directly to the Chief Medical Officer, the Medical Director will work cross-functionally to develop strong relationships with key stakeholders within Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, CRO partners, and others to support ongoing clinical trials and lifecycle of BBP-418.

Responsibilities:

• Serve as a product safety expert and primary point of contact for BBP-418 for both internal & external stakeholders
• Represent PV in project teams and study teams, and provide expert medical and safety knowledge regarding safety issues
• Collaborate closely with clinical development, clinical operations, and regulatory affairs, medical affairs teams to ensure alignment with risk management plans and collection of safety data
• Review and provide analysis for study-related documents, including IB, ICF, and safety management plans
• Perform/provide oversight for medical review of ICSRs from all sources for assigned product
• Help develop and lead benefit/risk assessment and risk management strategies in collaboration with VP Pharmacovigilance
• Evaluate safety data, provide input on signal detection activities, and continuously assess the benefit/risk ratio and design and implementation of risk management & mitigation activities; prepare presentations and present data at quarterly signal detection meetings
• Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)
• Participate in production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties, as applicable
• Represent PV and participate in labeling committees as required (prepare, evaluate & review material to be present with Safety Risk Management)
• Responsible for medical coding (AEs, ConMeds, Medical History, etc.) review of clinical trial data in conjunction with clinical development
• Responsible for collaboration & review of protocols, ICFs, CSRs, IB, narratives, etc. & providing feedback to medical writers in a timely manner
• Collaborate with Clinical Operations, Clinical Development, Regulatory, Quality & Compliance for inspection readiness
• Support Medical Affairs and responsible for review of medical Info letters, other similar outward communication
• Contribute to the development, review, and update of Drug Safety/Pharmacovigilance SOPs, drug safety processes, Safety Data Exchange Agreements and other safety-related tasks to support the development of the department infrastructure and business needs
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 towards 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

• M.D., Pharm.D., or educational equivalent is required. U.S. Licensure and Board Certification are preferred
• Minimum two (2) years seeing patients in either clinical practice or relevant setting; minimum (1-2 years as Associate Medical Director)/(3 to 5 years as Director) years in Pharmacovigilance & Drug Safety
• Rare disease experience is a plus
• Experience filing NDA/MAA is a plus
• Excellent medical knowledge and experience applying medical knowledge to the interpretation of individual case review, as well as aggregate data
• Excellent medical writing skills and previous experience reviewing and/or contributing to PBRERs, DSURs, PADERs, and other safety surveillance reports
• Experience in Argus (or similar) safety database preferred; experience with Medidata/InForm preferred; experience using Spotfire is a plus
• Excellent oral and written communication skills and presentation skills
• Demonstrate flexibility, open-mindedness, adaptability, and act nimbly in a fast-paced small company environment
• Ability to operate with some/minimal direction
• Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues
• Experience working in a team environment, including supporting other team members when necessary; promoting collegiality and teamwork among peers

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. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• 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
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels seen, valued, and heard
#Li-Remote

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.