BridgeBio

Procurement

• The Sr. Manager of Clinical Outsourcing leads vendor outsourcing, negotiation, contracting, and vendor relationship management for assigned vendor categories and functions across specified BridgeBio affiliates within BridgeBio’s clinical development portfolio.
• This position will work closely with internal and external stakeholders to ensure the successful, cost-effective, and timely alignment on decision-making, approvals, and execution of contracts across BridgeBio programs and affiliates.
• S/he will be responsible for leading the request for information/proposal (RFI/RFP) processes and vendor selection for specific vendors and programs; analyzing bids, negotiating clinical development service provider contract business terms, reviewing and negotiating change orders and budgets; managing financial and contract approvals while consistently fostering an environment of collaboration and transparency between internal stakeholders and external business partners.
• This role will be responsible for but is not limited to managing ancillary clinical vendors including labs, specialty vendors, IRT, clinical technologies, and other supporting clinical trial vendors and will work across multiple affiliates.

Senior Manager, Clinical Outsourcing

Director

• Develop and execute the Central Europe Region market access priorities, including pricing, reimbursement, and launch sequence, aligned with global and regional frameworks
• Lead HTA and payer engagement strategy – with a strong focus on AMNOG, ensuring early, proactive dialogue with national and regional decision-makers to anticipate requirements and reduce access risk
• Own country value dossier strategy and adaptation: incl. comparator selection, evidence gaps, risk mitigation. Thereby ensuring high-quality, locally relevant submissions delivered on time and supporting favourable reimbursement outcomes
• Define and implement pricing strategy, including list price, net price corridors, and contracting principles, while protecting long-term value and portfolio optionality
• Coordinate cross-functionally with Medical Affairs, Commercial, Regulatory, and Finance to align evidence generation, access strategy, and launch readiness, as well as post-launch accounting of rebates and related accruals
• Develop, implement and maintain compliant incentive structures for buying groups in Germany
• Assess potential and advocate for cost coverage and tailored solutions for individual SHIs in Germany

Senior Director, Market Access, Europe Central Region

Compliance

• Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products
• Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management.
• Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests)
• Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.)
• Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

Executive Director, Regulatory CMC

Recruitment

• Partnering with leaders
• Shaping hiring strategies
• Contributing to meaningful growth

Talent Acquisition

General Counsel

• Provide day-to-day legal counsel to Sales, Marketing, Market Access/Payer, Medical Affairs, and Patient Advocacy teams on healthcare regulatory, compliance, and other legal matters
• Serve as a strategic partner and advisor to cross-functional teams on the design and execution of engagements with HCPs, HCOs, patients, patient organizations, payers, and consumers, including promotion, scientific exchange, services arrangements, sponsorships, grants, donations, and educational activities
• Participate as a core member of the Material Review Committee (MLR)
• Review third-party relationships and related contracts in partnership with business functions
• Provide counsel on healthcare compliance topics including Anti-Kickback Statute (AKS) and fraud and abuse considerations, and help identify/mitigate compliance risks

Commercial Counsel

• Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality
• Represents Data Management in study team meetings and facilitates cross-functional activities as the DM lead or DM point of contact for study
• Performs and/or Coordinates the ongoing data review activities, including identification, tracking and resolution of data issues
• Leads data management timelines and deliverables, including metric output, are detailed and communicated to the study team on a regular basis
• Participates in the oversight of external data reconciliation (e.g., IxRS, safety, central and specialty labs, patient reported outcomes, etc.)
• Participates in the oversight of data transfers and review/approval of documentation of Data Transfer Plans for study
• Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures documents are maintained throughout the duration of the study
• Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
• Coordinates the clinical data review listings, reporting of metrics, and adhoc requests · Contributes to the conduct of clinical data review and preparation for DMC, DSUR, Database Freeze, Database Lock and/or other data deliverables
• Participates in vendor selection, including RFPs and bid defense meetings, as applicable · Maintains a working knowledge of study protocols and any amendments

Associate Director, Clinical Data Management

• Provide leadership in creating and executing proactive regulatory strategies for product development, approval, and registration
• Apply knowledge of global quality/regulatory standards and guidelines to ensure requirements are met across programs
• Partner with internal senior leadership to align closely on cross-functional global regulatory plans and the company's short and long-term strategic objectives
• Take complete ownership of relevant regulatory submission deliverables
• Represent regulatory in senior management discussions and present strategies, recommendations, and risks accordingly
• Lead the specific Affiliate regulatory strategy team by managing, mentoring, and teaching capabilities
• Work at both high-level strategic and hands-on in leading an agile team
• Serve as key regulatory team member with responsibility for regulatory strategies and submissions lead asset
• Provide regulatory guidance and strategy for support of product development and registration strategies
• Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable) in compliance with all applicable regulatory requirements, and in alignment with corporate goals
• Provide leadership and oversight of the preparation of all critical global regulatory submissions (from pre-IND to post-marketing) to the FDA, EMA, and other international health authorities
• Act as the primary liaison with regulatory authorities
• Direct and assist internal staff and regulatory consultants, as required, to ensure compliance of drug development activities with all U.S. and international requirements
• Analyze and communicate current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape
• Support due diligence and partnering activities, as needed
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Senior Director, Regulatory Affairs

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
• Will take 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 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

Operations

• 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 protocols and informed consent forms (ICFs)
• Manage drug safety contract research organizations (CROs) for clinical programs to ensure compliance with expedited reporting requirements, on-time and scientifically sound DSUR preparation, and alignment with corporate goals and KPIs
• Assist in the medical review of adverse event reports; manage preparation and submission of expedited safety reports in compliance with global regulations, when necessary
• Develop and prepare assessments of safety data, safety signals, and benefit-risk evaluations for internal senior management as well as external partners and regulatory authorities
• Assist in the authoring of aggregate safety reports

Senior Director, Safety Scientist – Pharmacovigilance Operations

• Day-to-day activity oversight of commercial DP CMOs for small molecule solid-oral dose manufacturing and release of bulk DP, in collaboration with various CMC functions
• Holds teleconferences with CMO and suppliers; takes meeting minutes, tracks action items, creates workflows for complex and interdisciplinary CMC procedure and processes. Ensures delivery of DP batches on time and in full in accordance to supply plans
• Leads or supports documentation review and approval (MBRs, specs, methods), change controls and documentation for batch disposition
• Oversees investigations related to deviations and complaints, with proper evaluation of impact to product and processes. Manages the close out of the investigations in a timely manner with the proper root cause analysis and establishment of appropriate CAPAs
• Identifies and leads key process problem resolution activities and process improvement initiatives, resolves issues. Candidate must have technical (formulation/chemical engineering) background of small molecule tablet manufacturing on commercial, large scale production (process, equipment, analytical etc)
• Create and disseminate technical transfer information and documents required by CMOs for feasibility, transfer, validation and routine manufacturing
• Partner with CMC/QA/QC/RA CMC functions to develop and operate appropriate CMC procedures, ensure product meets established quality standards, adheres to established approved parameters filed in various regions. Works closely with supply chain group to design production schedules while maximizing production and cost efficiencies

Manager/Sr. Manager, Drug Product – Solid-Oral Dose Commercial Manufacturing Operations

• The Quality Operations Manager for ROW Product Distribution reports directly to the Senior Manager of Quality Assurance at BridgeBio Netherlands. This role is responsible for ensuring that distributed products consistently meet all applicable regulatory and internal standards throughout the entire distribution lifecycle.
• Key duties include overseeing quality from product release through customer delivery, evaluating distribution deviations and conducting investigations, and facilitating collaboration with suppliers and internal teams such as Quality Control, Manufacturing, Regulatory Affairs, and Supply Chain. The position demands exceptional analytical, organizational, and communication abilities.
• Manage batch release activities for distribution and communication of batch release schedules to key stakeholders.
• Ensure that required licenses at the distributors are available and current.
• Ensure Distributors are set-up in company’s approved list.
• Create, review and approve certificate of analysis applicable for specific markets.
• Ensure the quality and integrity of product during storage, transportation, and distribution.
• Ensure compliance with packaging requirements.
• Perform quality review and guide quality events (deviations, change requests, distributor notifications, etc.) as documented by contract distributors.
• Communicate distribution deficiencies/non-conformances to management and work with internal stakeholders and distributors to ensure timely resolution.
• Participate in the GDP/GMP qualification and audit of Distributors.
• Collaborate with the third-party logistics (3PL) providers to ensure they meet quality expectations.
• Participate in regulatory inspections at the Distributors as needed.
• Monitor Distributor performance using statistical analysis to report on key performance indicators (KPIs) and quality metrics to management.
• Participate as QA person-in-plant, internal, and external meetings.
• Write and review SOPs and quality assurance procedures.

Manager, Quality Operations, ROW Distribution

• Develop and implement the global Medical Information strategy for encaleret and infigratinib, aligned with overall Medical Affairs and program objectives
• Serve as the subject matter expert and functional lead for Medical Information across both assets
• Oversee development, review, and maintenance of Medical Information materials, including core response documents, FAQs, and standard response letters
• Ensure scientific accuracy, medical rigor, and consistency of content and ensure Medical Information activities comply with applicable regulations, company policies, and industry standards
• Partner with Clinical and Translational teams to ensure incorporation of the latest data and insights
• Establish and oversee SOPs, workflows, and quality controls for intake, response, documentation, and reporting of Medical Information inquiries
• Partner closely with Pharmacovigilance to ensure appropriate adverse event and product complaint reporting
• Manage external Medical Information vendors, including scope definition, training, quality oversight, and performance metrics
• Oversee intake and response to unsolicited medical inquiries from healthcare professionals, patients, and other stakeholders
• Collaborate with Field Medical, Publications, Commercial, and Patient Advocacy teams to ensure aligned scientific messaging and seamless stakeholder experience
• Provide Medical Information insights and monitor inquiry trends to inform medical strategy, evidence generation, and educational initiatives

Director, Medical Information – Skeletal and Endocrinology

• Develop and own the endocrinology scientific communications platform, including core narrative, lexicon, scientific messaging, and visual frameworks across disease state and asset-level content
• Translate complex clinical and translational science into clear, compelling, and compliant scientific communications tailored to diverse audiences
• Ensure consistency and alignment of scientific messaging across Medical Affairs, publications, congresses, and educational initiatives
• Develop and oversee the integrated publication strategy and tactical publication plan for endocrinology programs
• Lead execution of manuscripts, abstracts, posters, and presentations in collaboration with key internal teams including Clinical Development and Global Value and Health Economics, as well as with key opinion leaders
• Manage publication vendors and ensure high-quality, timely delivery aligned with clinical and regulatory milestones
• Lead development of scientific content for Field Medical, including slide decks, training materials, FAQs, and reactive resources
• Oversee creation of congress materials, symposia content, booth messaging, digital educational tools, and external scientific presentations
• Partner closely with Clinical Development, Regulatory, Global Value and Health Economics, and Commercial teams to align scientific communication strategy and execution
• Support KOL engagement, advisory boards, and external scientific collaborations as needed
• Represent BridgeBio at key scientific congresses and meetings, as appropriate

Associate Director, Scientific Strategy – Publications

Executive Assistant

• Provide administrative support to VP and multiple Sr. Leaders
• Calendar, meeting, and event management to coordinate internal and external meetings/events; Assist with food orders, meeting needs, and proactively manage calendar requests and conflicts
• Support internal communications (e.g., team announcements, recognition, internal updates)
• Interview preparation, such as providing resumes and appropriate materials in a timely manner ahead of meetings and interviews
• Manage all travel (flight, hotel, car) arrangements for domestic and international travel
• Expense management duties, which include submitting expense reports and receipts in a timely manner
• Contract Assistance and Liaison: Assist with obtaining Legal approval and routing contracts for signatures (via Docusign), managing electronic storage (in Gatekeeper), and tracking contract progress to ensure timely execution
• Purchase Order Requisitions: Manage purchase order requisitions and invoice reconciliation (via Coupa)
• Support new hires by adding them to distribution lists, scheduling onboarding meetings, granting building access, and serving as their main contact
• Provide onboarding support for new vendors and agencies when needed, ensuring they have the proper access and documents/enablement required to get them up and running
• Project work as necessary to support each team’s goals including work cross functionally with other EA’s, HR, Marketing, Clinical Development, etc.
• Identify opportunities to streamline administrative and project processes for improved efficiency

Medical Director

• Support development and execution of the United States Medical Affairs strategy for encaleret in ADH1 and chronic hypoparathyroidism, and support Medical Affairs launch readiness and lifecycle planning, serving as an internal medical expert with scientific rigor and patient focused decision making
• Lead integrated evidence generation planning and manage execution, including real world evidence generation, Phase 4 studies, registries, investigator initiated research support, and data integration activities
• Lead an omnichannel Health Care Professional engagement strategy, integrating field and digital scientific exchange to gather insights and inform internal Medical Affairs programs
• Build and sustain strategic relationships with key opinion leaders, investigators, and external stakeholders across endocrinology, nephrology, and related specialties, and lead advisory board and expert panel planning and execution
• Partner with Clinical Development to support ongoing and planned clinical trials and contribute to scientific data disclosure and publication strategy development in collaboration with Scientific Communications
• Provide medical leadership for peer to peer scientific exchange and external education programs, including scientific presentations and representation at scientific congresses, clinical meetings, and external forums
• Serve as medical reviewer and approver for medical, commercial, and patient advocacy materials, and support patient finding initiatives and Field Medical strategy and training in partnership with cross functional stakeholders, ensuring compliance with applicable regulations and internal Medical Affairs policies