BridgeBio

Director

• Lead day-to-day clinical trial operational execution from start-up through close-out
• Oversee CROs, vendors, and site operations across potentially multiple studies
• Ensure alignment with protocols, GCP, SOPs, and regulatory requirements
• Drive quality, timelines, budget adherence, operational excellence, and inspection readiness
• Develop, implement, and train on SOPs
• Create monitoring and oversight processes to ensure GCP and regulatory compliance
• Advise management on risks, solutions, and operational strategies
• Build and maintain relationships with investigators and site staff
• Communicate with sites regarding study conduct, specimen tracking, and data review
• Manage CRO and vendor performance, site management activities, training, and operational guidance
• Conduct gap analyses, manage risks, and resolve issues proactively
• Partner with cross-functional teams on trial operations and supply chain planning for clinical and non-clinical trial materials
• Support audits and regulatory inspections
• Contribute to continuous improvement initiatives across Clinical Operations

Senior CTM/Associate Director, QED Alliance Support

Medical Director

• Lead clinical pharmacology and pharmacometrics strategies on cross-functional teams
• Oversee design and application of population PK, exposure–response, PK/PD, and PBPK models across clinical drug development programs, predominantly for small molecules
• Oversee external bioanalytical CROs
• Develop and implement clinical pharmacology and pharmacometrics strategies across all stages of clinical development, including pediatric programs
• Manage NCA, population PK, exposure–response, PK/PD, and PBPK modeling and simulation analyses to inform decision-making
• Support dose selection and clinical trial study design in pediatric populations
• Support global regulatory submissions and labeling
• Author and contribute to clinical pharmacology sections of regulatory documents, including IB, DSUR, briefing books, and NDA/MAA submissions
• Support interactions with global regulatory agencies
• Design clinical pharmacology studies and manage study execution and CROs/vendors
• Conduct PK data analyses and provide study-level oversight
• Author, review, and approve protocols, analysis plans, and reports
• Present results to internal teams and external stakeholders
• Contribute to scientific publications, abstracts, and conference presentations
• Communicate findings effectively to internal and external stakeholders

Senior Director, Clinical Pharmacology

Compliance

• Develop global CMC regulatory strategies with the manager and CMC subject-matter experts for the Eidos program
• Collaborate with cross-functional teams, including Regulatory International, to create and prepare CMC sections of global regulatory dossiers and marketing applications
• Help prepare and communicate timelines
• Plan and coordinate preparation of CMC sections
• Manage authoring, review, and approval workflows
• Provide regulatory strategy recommendations to the team
• Support Health Authority interactions, including coordinating meeting requests and briefing books
• Work with the team on strategy and responses to Health Authority CMC questions
• Support regulatory responses from triage through finalization
• Maintain current knowledge of global regulations, guidance, and standards for drug development and product registration
• Represent Regulatory Affairs CMC on interdisciplinary teams as needed
• Perform other duties as assigned
• Report to the Senior Director, Regulatory Affairs CMC

Associate Director, Regulatory Affairs – CMC

Sales

• Build the sales force and manage, motivate, and inspire teams from pre-launch through commercialization
• Lead launch readiness and post-approval sales force activities
• Achieve a successful commercial launch for Acoramidis with commercial and medical counterparts
• Hold the Regional Sales team accountable for sales performance targets
• Review Regional Sales team performance metrics with the Area Sales Director
• Ensure the team executes brand strategies and plans optimally across assigned geographies
• Collaborate with Marketing to create differentiated product messaging and execute regional marketing plans
• Establish, build, and maintain Key Opinion Leader relationships with Marketing and Medical Affairs
• Expand KOL and customer relationships to increase brand and company advocacy
• Communicate organizational vision and purpose
• Promote cross-organizational collaboration, transparency, and execution
• Resolve differing objectives within the Regional Sales Team
• Set ambitious team goals and identify opportunities to exceed performance targets
• Use quantitative and qualitative insights to drive business decisions
• Develop team skills through learning, coaching, and support

Regional Sales Director – Florida

• The posting template provides placeholders for the position mission and key objectives, but no actual duties
• The posting template provides placeholders for high-level responsibilities and day-to-day activities, but no actual responsibilities
• The posting identifies BridgeBio Pharma as a biopharmaceutical company that develops medicines for rare diseases and unmet patient needs

Director, Regulatory CMC

Manager

• Engage with families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset, infigratinib
• Educate families/care partners on access, affordability, and reimbursement processes
• Build family support program awareness and execute new product launch activities
• Collaborate with the Director of Family Access Managers and internal colleagues to align on patient services goals and brand strategies
• Provide personalized face-to-face or phone-based issue resolution for access and affordability hurdles
• Direct access support between consented families and hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Own relationships between ForgingBridges and consented patients
• Onboard and welcome new families to ForgingBridges
• Manage status changes and follow up with families, prescriber offices, and pharmacies
• Ensure ForgingBridges business rules are followed
• Control information and communications workflow with families
• Collaborate with Patient Advocacy and attend local, regional, and national advocacy meetings/events
• Facilitate and present in-person education for families/care partners
• Report compliant insights and findings to Brand Marketing and internal Commercial functions
• Handle protected health information according to BridgeBio policy
• Attend national sales meetings, conferences, and regional events as needed
• Develop and execute tactical plans supporting access imperatives and role metrics
• Provide strategic and tactical input for continuous improvement
• Complete assigned Market Access/Patient Support Services projects
• Travel 40-60% domestically across the US

Family Access Manager, Skeletal Dysplasia

• Engage families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset
• Educate families/care partners on access, affordability, reimbursement processes, and family support programs
• Execute new product launch activities supporting infigratinib
• Collaborate with the Director of Family Access Managers and internal colleagues to align patient services goals and brand strategies
• Provide family-facing access and affordability support
• Ensure a positive patient journey compliantly through BridgeBio stakeholder collaboration
• Evaluate and implement family access opportunities within a specific geographic area
• Provide personalized issue resolution by phone or face-to-face
• Direct access support among consented families, hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Own relationships between ForgingBridges and consented patients
• Onboard and welcome new families to ForgingBridges
• Manage ForgingBridges status changes and follow up with families, prescriber offices, and pharmacies
• Control information and communications workflows with families
• Collaborate with Patient Advocacy and attend local, regional, and national advocacy meetings/events
• Facilitate and present in-person family/care-partner education
• Report compliant insights and findings to Brand Marketing and other Commercial functions
• Handle protected health information according to BridgeBio policy
• Attend national sales meetings, conferences, and regional events as needed
• Develop and execute tactical plans supporting access imperatives and role metrics
• Provide strategic and tactical input for continuous improvement
• Perform designated Market Access/Patient Support Services projects
• Additional responsibilities may be assigned

• Engage families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset
• Educate families/care partners on access, affordability, and reimbursement processes
• Build family support program awareness and execute new product launch activities
• Collaborate with the Director of Family Access Managers and internal colleagues on patient services goals and brand strategies
• Provide families/care partner-facing access and affordability support for infigratinib
• Ensure a positive patient journey through compliant collaboration with BridgeBio stakeholders
• Lead evaluation and implementation of family access opportunities within a geographic area
• Provide personalized issue resolution by phone or face-to-face
• Direct access support among consented families, hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Own relationships between ForgingBridges and consented patients
• Onboard and welcome families to ForgingBridges
• Manage status changes and follow up with families, prescriber offices, and pharmacies
• Ensure ForgingBridges business rules are followed
• Control information and communications workflow with families
• Collaborate with Patient Advocacy and attend local, regional, and national advocacy meetings/events
• Facilitate and present in-person education for families/care partners
• Report compliant insights and findings to Brand Marketing and other Commercial functions
• Handle protected health information according to BridgeBio policy
• Attend national sales meetings, conferences, and regional events as needed
• Complete assigned Market Access/Patient Support Services projects
• Provide strategic and tactical input for continuous improvement
• Develop and execute tactical plans supporting access imperatives and role metrics
• Travel 40-60% domestically across the US

• Engage families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset
• Educate families/care partners and build awareness of the ForgingBridges family support program
• Execute new product launch activities and align patient services goals with brand strategies
• Collaborate with Legal, Compliance, Sales, Marketing, Commercial Analytics, Commercial IT, Training, Pharmacovigilance, Market Access, and Patient Advocacy teams
• Provide personalized face-to-face or phone-based access and affordability issue resolution
• Direct access support between consented families and hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Own relationships between ForgingBridges and consented patients; onboard and welcome new families
• Manage program status changes and follow up with families, prescriber offices, and pharmacies
• Ensure support-program business rules and protected health information policies are followed
• Control information and communications workflow with families
• Attend local, regional, national advocacy meetings/events, sales meetings, conferences, and regional events as needed
• Report compliant insights and findings to Brand Marketing and other Commercial functions
• Develop and execute tactical plans supporting Market Access/Patient Support Services performance metrics
• Provide strategic and tactical input for continuous improvement and complete designated projects
• Travel 40–60% domestically across the US

• Engage families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset
• Educate families/care partners on access, affordability, and reimbursement processes
• Build family support program awareness and execute new product launch activities for infigratinib
• Collaborate with the Director of Family Access Managers and internal colleagues on patient services goals and brand strategies
• Provide personalized access and affordability issue resolution by phone or face-to-face
• Direct access support between consented families and hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Own relationships between ForgingBridges and consented patients; onboard new families
• Manage status changes and follow up with families, prescriber offices, and pharmacies
• Ensure ForgingBridges business rules are followed and control information workflows
• Collaborate with Patient Advocacy on engagements and attend advocacy meetings and events
• Facilitate in-person education for families/care partners
• Report compliant insights and findings to Brand Marketing and Commercial functions
• Handle protected health information according to BridgeBio policy
• Attend national sales meetings, conferences, and regional events as needed
• Develop and execute tactical plans supporting Market Access/Patient Support Services metrics
• Provide strategic and tactical input for continuous improvement
• Travel 40-60% domestically across the US

• Engage with families/care partners on access, affordability, and reimbursement processes for BridgeBio’s commercialized skeletal dysplasia asset
• Educate families/care partners on access, affordability, and reimbursement processes
• Build family support program awareness and execute new product launch activities
• Collaborate with the Director of Family Access Managers and internal colleagues on patient services goals and brand strategies
• Provide family-facing access and affordability support for infigratinib
• Ensure a compliant, positive patient journey with BridgeBio stakeholders
• Evaluate and implement family access opportunities within a specific geographic area
• Resolve access and affordability issues by phone or face-to-face
• Direct access support among consented families, hubs, pharmacies, prescriber offices, and support organizations
• Coordinate missing-information follow-ups with the hub partner
• Manage relationships between ForgingBridges and consented patients
• Onboard new families to ForgingBridges and manage program status changes
• Control information and communications workflows with families
• Collaborate with Patient Advocacy and attend advocacy meetings and events
• Facilitate in-person education for families/care partners
• Report compliant insights and findings to Brand Marketing and Commercial functions
• Handle protected health information according to BridgeBio policy
• Attend national sales meetings, conferences, and regional events as needed
• Develop and execute tactical access plans and role metrics
• Provide strategic and tactical input for continuous improvement
• Perform additional assigned responsibilities
• Report to the Director of Family Access Managers