BridgeBio

Operations

• Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards.
• Establish TMF governance across the clinical development program by monitoring TMF health, quality metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership.
• Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans.
• Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely document filing, issue resolution, and consistent execution of TMF processes.
• Provide strategic oversight of CRO-managed TMF activities through performance metrics, governance meetings, quality reviews, issue escalation, and continuous improvement initiatives.
• Lead TMF inspection readiness activities, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up.
• Identify TMF compliance risks and quality trends, develop mitigation strategies, and drive corrective and preventive actions to maintain a state of continuous inspection readiness.
• Serve as the TMF Subject Matter Expert by providing strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives.
• Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program.
• Foster a culture of TMF excellence through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF quality and efficiency

Associate Director, TMF Operations Lead

General Counsel

• Support the build of technology and infrastructure for the Legal and Compliance team
• Manage the implementation and maintenance of the legal technology stack
• Define use cases and workflows that don't yet exist
• Analyze contracting data and usage patterns to identify inefficiencies

Legal Operations Sr. Manager – Associate Director

Account Manager

• Develop and execute a dynamic territory business plan targeting geneticists, pediatric endocrinologists, orthopedic specialists, pediatricians, and multi-disciplinary skeletal dysplasia clinic teams to meet and exceed sales goals.
• Demonstrate deep expertise in Infigratinib, achondroplasia, and the broader skeletal dysplasia landscape; engage HCPs in clinically relevant, compliant discussions.
• Use sales and target data to identify growth opportunities and address territory challenges proactively.
• Anticipates potential business challenges, adjusts priorities as needed, demonstrates flexibility, and develops solutions to address challenges.
• Partners compliantly with Field Medical Directors, Field Reimbursement Managers, Family Account Managers, and the HUB to maximize customer and family satisfaction.
• Build and maintain relationships with KOLs in partnership with Marketing and Medical Affairs to expand advocacy for Infigratinib and BridgeBio.
• Operate with an “One Bridge” mindset—collaborating across the organization to execute company initiatives and represent BridgeBio with integrity.
• Maintains an exceptional level of proficiency in selling skills, clinical, market and product knowledge and the business environment of the territory.
• Ensure all activities comply with applicable regulations, company policies, and Pharma guidelines.

Skeletal Dysplasia Account Manager

Sales

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer target
• Will demonstrate subject matter expertise concerning scientific and clinical information for Acoramidis
• Takes a customer centric-approach and engage customers in clinically relevant discussion utilizing approved materials
• Will effectively analyze sales data to identify opportunities for business growth or areas of concern in their territory
• Be responsible for territory business planning and execution of key company initiatives
• Will adhere to company guidelines and demonstrate honesty, integrity, trust, respect, and accountability and perform all responsibilities in accordance with company policies and procedures and applicable state and federal rules and regulations
• Compliantly partners with Medical Science Liaisons, Field Reimbursement, Patient Access, HUB, Marketing and other key cross-functional team members to develop strategies to ensure a high level of customer satisfaction
• Develop and implement a dynamic territory business plan by analyzing the business, competitive landscape and territory market to drive business. Develops, nurtures and maintains professional relationships with targeted KOLs including physicians, medical staff, and key hospital personnel and multi-disciplinary center staff
• Navigates the hospital formulary process and develops and implements strategies to ensure successful product positioning and availability
• Anticipates potential business challenges, adjusts priorities as needed, demonstrates flexibility, and develops solutions to address challenges
• Maintains an exceptional level of proficiency in selling skills, clinical, market and product knowledge and the business environment of the territory
• Collaborates with peers and company personnel to ensure corporate objectives and initiatives are achieved
• Effectively plans and organizes schedule to ensure maximum efficiency and use of time to accomplish goals and objectives
• Acts as an ambassador on behalf of the company. Presents a professional image and represents the company, products and people with integrity and respect
• Completes tasks and projects assigned by Sales Leadership
• Ensures that all activities are following applicable regulations, compliance and Pharma guidelines

Therapeutic Sales Specialist – Louisiana/Mississippi

Medical Director

• Recruiting, training, developing, and managing a team of high-performing MSLs
• Fostering a team culture of accountability and develop a proactive approach to growing skillsets
• Provide strategic direction for MSL development and execution of comprehensive territory medical plans that align with medical objectives
• Ensure high quality presentations and interactions through quantitative and qualitative MSL data tracking
• Be instrumental in internal training and communication. Knowledge sharing, including KOL and site profiling, and education both internally and externally will be a crucial area of responsibility
• Developing relationships with various healthcare professionals and providing them with credible, fair, balanced, scientific information about product development, research activities, and therapy(s)
• Be a significant source of balanced medical information for HCPs and will be skilled in issues management and addressing unsolicited questions about safety and potential off-label use of products based on available scientific data
• Expected to become and lead teams to become a therapeutic area and product expert. This will be evidenced by regular review of relevant literature and participation in scientific congresses and conferences, including therapeutic area training sessions, to establish and maintain an up-to-date knowledge base
• Assist in identifying potential investigators and research projects. This may include assistance with the investigator-sponsored trial process, sponsored study site identification, recruitment strategies, and collaboration with clinical operations

Senior Director, Regional Field Medical Science Liaison, West

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer targets
• Demonstrating subject matter expertise concerning scientific and clinical information for Acoramidis
• Taking a customer centric-approach and engaging customers in clinically relevant discussions utilizing approved materials
• Effectively analyzing sales data to identify opportunities for business growth or areas of concern in their territory
• Being responsible for territory business planning and execution of key company initiatives
• Adhering to company guidelines and demonstrating honesty, integrity, trust, respect, and accountability while performing all responsibilities in accordance with company policies and procedures and applicable state and federal rules and regulations
• Compliantly partnering with Medical Science Liaisons, Field Reimbursement, Patient Access, HUB, and other key cross-functional team members to develop strategies to ensure a high level of customer satisfaction
• Developing and implementing a dynamic territory business plan by analyzing the business, competitive landscape, and territory market to drive business, maintaining professional relationships with targeted KOLs including physicians, medical staff, and hospital personnel
• Navigating the hospital formulary process and developing and implementing strategies to ensure successful product positioning and availability
• Anticipating potential business challenges, adjusting priorities as needed, and developing solutions to address challenges
• Maintaining an exceptional level of proficiency in selling skills, clinical, market and product knowledge, and the business environment of the territory
• Collaborating with peers and company personnel to ensure corporate objectives and initiatives are achieved
• Effectively planning and organizing schedule to ensure maximum efficiency and use of time to accomplish goals and objectives
• Acting as an ambassador on behalf of the company, presenting a professional image and representing the company, products, and people with integrity and respect
• Completing tasks and projects assigned by Sales Leadership
• Ensuring that all activities are following applicable regulations, compliance, and Pharma guidelines

Therapeutic Sales Specialist

Director

• Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
• Provide proactive guidance on promotional strategy, claims development, and risk positioning.
• Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
• Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
• Assess regulatory risk and recommend clear, practical mitigation strategies.
• Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).
• Ensure materials are accurate, balanced, and supported by substantial evidence.
• Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.
• Support advisory boards, speaker programs, and field training materials as needed.
• Contribute to development and refinement of internal SOPs and review processes.
• Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.
• Anticipate labeling implications for promotional planning, especially during launch readiness.
• Support development of core claims documents and messaging frameworks.
• Monitor FDA enforcement actions and emerging trends.
• Support responses to OPDP inquiries or regulatory questions related to promotional materials.
• Contribute to inspection readiness activities related to promotional review processes.

Regulatory Affairs Director

• Provide strategic regulatory leadership for promotional materials and external communications across assigned programs or brands.
• Ensure that all promotional activities are compliant with FDA regulations, industry guidance, and company policy.
• Help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners.

Associate Director, TMF Operations Lead

Legal Operations Sr. Manager – Associate Director

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager

Therapeutic Sales Specialist – Louisiana/Mississippi

Senior Director, Regional Field Medical Science Liaison, West

Therapeutic Sales Specialist

Regulatory Affairs Director

Regulatory Affairs Associate Director

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager

Skeletal Dysplasia Account Manager