BridgeBio

Medical Director

• 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

Senior Medical Director

Communications

• Advance and execute the publication plan for acoramidis clinical data, ensuring alignment with medical strategic objectives and compliance with industry best practices (e.g., GPP, ICMJE, PRISMA, CONSORT, etc)
• Lead the timely development, review, and submission of scientific publications, including manuscripts, abstracts, posters, presentations, and plain language summaries
• Collaborate closely with internal cross-functional teams, external authors, and agency partners to develop high-quality, high-impact scientific publications
• Drive the development of medical communication strategies and materials to support medical affairs team and cross-functional partners, including internal training and publication extenders
• Maintain updated Scientific Communication Platform and other internal resources
• Manage agency partners and budget for scientific communications and publication activities, optimizing resource allocation for maximum impact

Senior Director, Publications & Scientific Communications

• 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

Senior Medical Director, Drug Safety

Director

• 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
• Facilitate 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

Senior Director, Scientist

• The Associate Director/Director, Patient Advocacy, LGMD is responsible for leading global patient advocacy strategy and execution for Limb-Girdle Muscular Dystrophy (LGMD).
• This role builds and sustains compliant, long-term relationships with LGMD patient advocacy organizations, community leaders, and patient representatives, with a focus on understanding lived experience and translating patient insights into meaningful organizational action.
• Serving as a central liaison across BridgeBio, the Associate Director partners closely with Medical Affairs, Communications, Marketing, Clinical Development, Legal, and Compliance to ensure patient perspectives are appropriately reflected in education, engagement, and outreach activities.
• This role contributes to cross-functional planning by elevating patient and caregiver needs, identifying unmet gaps, and supporting alignment between advocacy initiatives and program objectives.
• Through external engagement and internal collaboration, the Associate Director/Director, Patient Advocacy, LGMD reinforces BridgeBio’s commitment to putting patients first by ensuring advocacy efforts are thoughtful, strategic, and integrated throughout the development lifecycle of LGMD programs.

Associate Director – Patient Advocacy, LGMD

• Develop, operationalize, and execute a national field medical strategy aligned to Calcilytix Medical Affairs objectives and program priorities
• Lead field medical launch readiness planning, including field tool development, scientific narrative alignment, and readiness for congress and other high-impact external engagement
• Provide leadership to the field-based Medical Affairs organization, including recruiting, onboarding, coaching, mentoring, and performance development
• Define expectations and quality standards for field excellence (engagement planning, documentation, insight quality, congress execution, and stakeholder follow-through)
• Build and maintain strategic relationships with national and regional endocrinology key opinion leaders (KOLs), investigators, academic centers, specialty clinics, and other influential stakeholders
• Ensure delivery of high-quality, compliant scientific exchange with healthcare providers and external stakeholders, including disease biology, emerging clinical data, trial activity, unmet need, and the Calcilytix pipeline
• Support Calcilytix-sponsored and investigator-initiated research (IIR), including site identification, feasibility input, investigator engagement, and appropriate clinical/scientific support

Senior Director, National Head – Field Medical Affairs

Supply Chain

• The Logistics Coordinator will report directly to the Head of Ex-US Supply Chain and will work remotely from the Netherlands.
• This role will be responsible for creating purchase orders and managing material movements between RSM, API, Bulk & Finished Good sites; mainly located within the European time zone.
• Close collaboration required with Global Procurement & Logistics, located in the Pacific Time zone, to ensure alignment on global processes and transport scheduling expectations.
• The Logistics Coordinator will be collaborating with external partners such as Contract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs), Couriers and Third Party Logistics Providers (3PLs) to prepare shipping documents and shipping schedules.

Logistics Coordinator

Operations

• Play a key cross-functional role supporting the development, coordination, and execution of strategic medical initiatives across medical affairs
• Serve as a core liaison between external vendors/stakeholders, field medical teams, and internal stakeholders
• Drive medical insights and execution excellence to support the organization’s strategic goals
• Design and manage the Medical Affairs Group’s Operational infrastructure
• Support other key medical affairs activities, such as driving all grants, IITs, and sponsorships
• Be the medical member of the medical/regulatory/legal (MRL) review committee
• Provide project management support to the Medical Affairs organization in alignment with its objectives and strategies
• Own, manage, oversee and update the library of MSL training material, standard response letters, medical presentation material, contracts, publications and other materials
• Manage and own provide operational and functional aspects of congresses, advisory boards, complex meeting planning and execution
• Ensure that timelines, initiatives and resources align with Home Office Medical Affairs and Field MSL objectives
• Develop and maintain a calendar of meetings across programs, including congress and internal meetings
• Liaise with HCPs, and Legal and Contracts teams by submitting and tracking Medical Affairs contracts for timely submission and full execution
• Coordinate the development of Standard Operating Procedures (SOPs) and compliance updates on an as needed basis
• Lead and drive medical affairs in identifying potential investigators and research projects, grants, investigator-sponsored trials (IITs), sponsored study site identification etc.