BridgeBio

Compliance

• 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.
• Shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners.

Associate Director – Regulatory Advertising and Promotion

Clinical Research

• Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
• Manage external vendors and contract research organizations, may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)
• Prepare/Review/Approve study documents such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
• Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.
• Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
• Negotiate and manage vendor work agreements and site contracts

Senior Clinical Trial Manager

Director

• Leads the statistical and statistical programming efforts for medical publications, scientific congresses, and external collaborations
• Guides statistical design and analysis for investigator-initiated research and collaborative studies
• Provides statistical input to strategic planning of publication strategy plans
• Develops and maintains Supplemental SAPs
• Provides guidance to Medical Affairs team on all aspects of statistical activities to ensure methodological rigor
• Works collaboratively with Medical Affairs, Project Management, Translational Medicine, and other staff to meet scientific communication timelines
• Provides feedback to the Medical Affairs team regarding what is and is not possible with available data and partners with the team to brainstorm creative, scientifically sound approaches to address key questions
• Interacts with the team to prospectively plan publication strategies for future congresses and manuscript generation efforts
• Works with the team to develop idea-generating analyses, including ad hoc and exploratory data analyses (EDA), to inform scientific insights and evidence-generation opportunities
• Serves as the primary point of contact for Medical Affairs requests and collaborates closely with Clinical Biostatistics and Statistical Programming leads on relevant protocols
• Assists, as needed, with Health Economics and Outcomes Research (HEOR) and real-world evidence (RWE) evidence-generation requests

Biostatistics Director – Medical Affairs

• Lead the development and strategic deployment of HEOR evidence, economic models and resources to support US payer and health system engagement, including training and partnership with Market Access, Field Medical, and Sales Leadership
• Gather IDN and payer insights around evidence requirements to ensure differentiation of BridgeBio therapies
• Provide strategic input into HEOR real world evidence, study design and execution to ensure relevance for US population health decision-making
• Lead development of AMCP Dossiers, Budget Impact Models and other economic tools to support the commercialization of BridgeBio therapies
• Lead external collaborations with KOLs and Centers of Excellence to drive evidence generation, publications, and credibility with payer and health system leadership
• Conduct HEOR advisory boards and market research as needed to understand evolving evidence requirements and gaps for payers and IDNs in assigned therapeutic areas
• Collaborate with Head of HEOR and Market Access colleagues in ICER assessments and responses related to assigned

US Director of Health Economics Outcomes Research – Population Health

Account Manager

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer targets.
• Will demonstrate subject matter expertise concerning scientific and clinical information for Encaleret.
• Will take a customer-centric approach and engage customers in clinically relevant discussions utilizing approved materials.
• Will effectively analyze sales and targeting 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.
• Will exhibit compliant partnership 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.
• Develop and implement a dynamic territory business plan by analyzing the ADH1 market in their territory to drive business. Develops, nurtures and maintains professional relationships with targeted HCP’s including physicians, medical staff, and key personnel and multi-disciplinary staff.
• 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 BridgeBio. Present a professional image and represent the company, products and people with integrity and respect.
• Ensures that all activities are following applicable regulations, compliance and Pharma guidelines.

Endocrine Account Manager

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer targets.
• Will demonstrate subject matter expertise concerning scientific and clinical information for Encaleret.
• Will take a customer-centric approach and engage customers in clinically relevant discussions utilizing approved materials.
• Will effectively analyze sales and targeting 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
• Will exhibit compliant partnership 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
• Develop and implement a dynamic territory business plan by analyzing the ADH1 market in their territory to drive business. Develops, nurtures and maintains professional relationships with targeted HCP’s including physicians, medical staff, and key personnel and multi-disciplinary staff
• 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 BridgeBio. Present a professional image and represent the company, products and people with integrity and respect.
• Ensures that all activities are following applicable regulations, compliance and Pharma guidelines

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer targets.
• Will demonstrate subject matter expertise concerning scientific and clinical information for Encaleret.
• Will take a customer-centric approach and engage customers in clinically relevant discussions utilizing approved materials.
• Will effectively analyze sales and targeting 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.
• Will exhibit compliant partnership 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.
• Develop and implement a dynamic territory business plan by analyzing the ADH1 market in their territory to drive business. Develops, nurtures and maintains professional relationships with targeted HCP’s including physicians, medical staff, and key personnel and multi-disciplinary staff.
• 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 BridgeBio. Present a professional image and represent the company, products and people with integrity and respect.
• Ensures that all activities are following applicable regulations, compliance and Pharma guidelines

• Meeting and/or exceeding sales goals in an assigned territory by developing, implementing, and executing an integrated territory business plan encompassing key customer targets.
• Will demonstrate subject matter expertise concerning scientific and clinical information for Encaleret.
• Will take a customer-centric approach and engage customers in clinically relevant discussions utilizing approved materials.
• Will effectively analyze sales and targeting 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
• Will exhibit compliant partnership 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
• Develop and implement a dynamic territory business plan by analyzing the ADH1 market in their territory to drive business. Develops, nurtures and maintains professional relationships with targeted HCP’s including physicians, medical staff, and key personnel and multi-disciplinary staff
• 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 BridgeBio. Present a professional image and represent the company, products and people with integrity and respect.
• Ensures that all activities are following applicable regulations, compliance and Pharma guidelines.