BridgeBio

Manager

• Review of analytical data for release, stability, and in-process testing at the contract manufacturing organizations in a timely manner
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results
• Follow up with the contract laboratories to correct any deficiencies/omissions in the provided test packages
• Submitting test packages to QA for their review and loading all data into the electronic storage program
• Review of analytical data related to reference standard qualification, method validation and method transfer activities
• Travel, when necessary, to analytical testing sites or other sites
• Able to communicate results both internally and externally through oral and written updates and formal reports as necessary
• Create or review BBio Standard Operating Procedures as it pertains to Quality Control or management of contract analytical laboratories

Quality Control Manager

Director

• Lead and design comparative effectiveness and health outcomes studies using real-world data (RWD), registries, claims databases, and clinical data sources
• Develop strategic evidence plans that address clinical, payer, and patient stakeholder needs
• Apply advanced study designs (e.g., propensity score matching, instrumental variables, target trial emulation) to generate credible, high-impact insights
• Collaborate cross-functionally with Clinical Development, Health Economics and Outcomes Research (HEOR), Market Access, and Data Science teams to align evidence strategies with organizational priorities
• Communicate findings in scientific forums, peer-reviewed publications, and internal stakeholder briefings
• Serve as a subject matter expert in comparative effectiveness research within Medical Affairs
• Represent the company in external collaborations, advisory boards, and industry working groups focused on RWE and methodological innovation
• Provide mentorship and scientific guidance to evidence scientists and cross-functional partners

Senior Director, Evidence Generation

QA Engineer

• Support Clinical functional areas in their management of Clinical Controlled Documents
• Design and develop Clinical Project-Specific Training Programs
• Champion Quality System Deviation and CAPA processing and support the Audit Program
• Drive strategy and execution of Clinical Controlled Document Management
• Own and manage Clinical Quality Assurance controlled documents in Veeva QualityDocs
• Develop, review, and approve documents for regulatory standards alignment
• Oversee document workflows and approval status in Veeva
• Collaborate on centralized Clinical document strategy with QED and cross-functional BBIO teams
• Design and manage project-specific training programs
• Serve as the primary Clinical QA lead for Quality System Deviations and CAPA processes
• Support mock inspections and identify potential compliance gaps
• Review audit reports and responses for completeness and quality
• Ensure timely and compliant documentation of audit reports and responses

Associate Director/Director, Clinical Quality Assurance

• Maintain and regularly update publication dashboards to track impact, metrics, status, timelines, and deliverables across the publication plan
• Prepare slide presentations and summarize key decisions for internal publication team meetings and scientific working groups
• Support the development of plain language summaries (PLS) for key scientific publications
• Liaise with internal and external authors, agencies, and vendors to ensure timely delivery and accuracy of publication outputs
• Manage cross-functional teams for publications planning, review, and medical trainings
• Lead medical congress planning in coordination with cross-functional stakeholders
• Manage medical presence logistics, cross-functional congress calendars, and insight capture/reporting tools
• Support the development of congress briefing materials and post-congress reports for internal dissemination
• Lead scientific content development and oversee writing projects (manuscripts, abstracts, posters, presentations, publication enhancers) from planning to submission
• Review tactics for messaging/lexicon alignment, scientific accuracy, appropriateness for audience, quality, and provide direction to medical communication agencies during development, and reviews
• Lead content development for the field medical affairs team in collaboration with the Field Medical Lead
• Partner with MSLs to drive medical training decks for all publications and FAQs for high-priority or critical publications

Associate Director, Medical Affairs

Operations

• Serve as a key point of contact for the field organization, communicating feedback and escalating issues to IT, business stakeholders, or vendors as needed
• Collaborate with cross-functional teams to manage field rosters, alignments, target lists, and sales allocations
• Track, process, and manage Commercial Fund Requests, including payments for displays, conferences, and grants
• Support cross-functional coordination and execution of sales operations activities, including Veeva CRM, reporting dashboards, fleet management, field credentialing programs, sponsorships, data warehouse processes, and master data management
• Partner with Commercial IT, Commercial Analytics, and external vendors to help maintain CRM, MDM, and data stewardship processes
• Support Sales Operations with ad hoc reporting requests to deliver actionable insights and inform decision-making

Senior Analyst, Sales Operations

Medical 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
• 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

• Responsible for statistical activities in support of Medical Affairs, including design, execution, interpretation, and communication of analyses that inform medical decision-making, health outcomes, and scientific exchange
• Contribute scientific and methodological expertise to support medical strategy, publications, and external engagements
• Interact with internal and external cross-functional study teams and support interactions with the medical community
• Manage CRO programmers and statisticians in preparing analysis files and performing statistical analyses; set expectations on deliverables and timelines and ensure accuracy and timeliness of deliverables
• Provide statistical input to medical publications, scientific congresses, and external collaborations
• Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management
• Ensure high-quality statistical deliverables that meet scientific and regulatory standards
• Partner with colleagues in Medical Affairs, HEOR, Clinical Development, and other cross-functional teams to align statistical activities
• Translate statistical concepts into clear insights for medical and scientific stakeholders
• Stay current with evolving statistical methods, data sources, and regulatory expectations related to real-world evidence

Associate Director, Biostatistics

Bookkeeper

• Responsible for payroll processing to ensure accurate and timely payment of wages to employees
• Handle payroll activities, coordinate the payroll system, and ensure compliance with federal, state, and local regulations for the USA population
• Review employee/payroll records in ADP Workforce Now including new hires and terminations, compensation changes, banking profile, tax profile or other miscellaneous changes
• Manage 401k contribution files and funding via Fidelity
• Process employee's HSA/FSA contributions to vendors
• Manage completion of timesheet entry and approval for non-exempt employees
• Manage wage garnishments and other involuntary court-ordered payments
• Work closely with HR/Benefits groups pertaining to payroll input
• Monitor and update tax rates in ADP and partner with ADP for new state/local tax registrations
• Answer employee questions related to payroll matters
• Participate in system implementation initiatives including gathering requirements, attending system demos, testing, developing desktop procedures, and training
• Maintain strong internal controls and documentation over the payroll function in compliance with SOX requirements
• Work with internal/external auditors on audit requests
• Prepare payroll and various accrual accounting entries and reconciliations
• Other duties and special projects, as assigned

Senior Payroll Analyst

• Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements
• Establish and maintain business relationships with CROs and CMOs for process validation and commercial supply requirements
• Lead late-stage drug substance process finalization, validation, and commercial-scale manufacturing
• Identify and lead key process problem resolution activities and process improvement initiatives
• Work closely with Quality Assurance to develop and operate appropriate CMC procedures and ensure product meets established quality standards
• Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods
• Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD and contribute to regulatory control strategy
• Support a culture of continuous improvement and high-performance teamwork

Senior Scientist/Associate Director, Drug Substance Development and Manufacturing

Supply Chain

• Manage a global team of supply chain professionals responsible for clinical and commercial end-to-end supply chain
• Manage all aspects of commercial supply chain, including Drug Substance and Drug Product CMOs, Packaging and Labeling with CPOs, and Finished Good receiving, storage and distribution at 3PLs
• Coordinate logistics of material transfer for clinical and commercial drug substance, drug product and components to/from international CMOs/CPOs, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
• Own the global Sales & Operations Planning (S&OP) process for all commercial products, coordinating demand planning, finance and communicating final supply plans to global partners
• Own and actively manage the commercial supply plan, commercial inventory (in process and finished goods), shelf life and expiration management
• Own and manage all serialization activities for commercial products globally
• Manage clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
• Provide clinical demand signals and translate total demand into a forecast based on clinical protocols or study overviews
• Prepare clinical supply plans including determination of supply overage amounts; monitor inventory and provide regular inventory updates to project teams
• Monitor clinical drug expiry/retest dating; initiate inventory release and re-supply; serve as the unblinded inventory manager
• Manage domestic and international distribution and logistics for clinical programs, including importing/exporting clinical supplies and developing distribution instructions with clinical supply vendors
• Support budget activities, including managing supplier contracts, PO generation and invoicing approvals for clinical and commercial purchases
• Work collaboratively with QA to manage batch release, final release, temperature excursions and support investigations of deviations
• Liaise with CMC and clinical operations and evaluate new CMOs/CPOs for commercial supply chain
• Work with Global Trade & Distribution and global Finance teams to manage global 3PLs, ensuring finished good inventory management, distribution, logistics, sales and revenue reporting
• Generate and maintain global SOPs in Veeva QMS and ensure compliance with industry standards
• Develop and maintain strong cross-functional collaboration with CMC, Clinical Operations, Market Access, Finance, Quality, and Regulatory Affairs

VP, Supply Chain

Project Manager

• Develop, implement, and manage regulatory strategies to support global submissions, product approvals, and lifecycle management, ensuring alignment with company objectives and regulatory requirements
• Monitor and interpret global regulatory guidelines and policies to ensure company compliance
• Oversee the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, MAAs, and other regional filings
• Manage timeline preparation for CMC, Clinical, and Nonclinical Modules, ensuring successful and timely global marketing application submissions
• Track submission deliverables, manage workflows, and provide support for regulatory submissions by coordinating with team members
• Collaborate with cross-functional teams to align regulatory activities with overall project goals, providing hands-on contributions when necessary
• Lead program activities, including creating and managing reports, dashboards, and scorecards, and conduct risk assessments to keep projects on track
• Communicate program status and escalate risks to stakeholders, ensuring smooth coordination of activities and resolution of issues with cross-functional partners
• Provide Overall PM support, including leading or co-leading meeting series with cross-functional teams, developing and managing timelines, tracking action items, and preparing for meetings and interactions with international regulatory agencies
• Ensure effective communication and collaboration between internal teams and external consultants, aligning regulatory strategies and submission requirements with project milestones
• Provide regulatory support for internal and external audits, ensuring readiness and compliance