About BridgeBio Pharma, Inc. 

BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for three therapies and continue to advance promising science from academia into meaningful treatments for patients worldwide. 

Who We Are 

BridgeBio is a global biotechnology company with our Global Headquarters located in San Francisco, USA, and our International HQ located in Zug, Switzerland. Since establishing our European presence in 2021, we’ve been building empowered, high-performing teams across countries — with experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth. 

At BridgeBio, you’ll find an energetic and collaborative culture where pragmatism meets bold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world. 

To learn more about our story and company culture, visit us at https://bridgebio.com

What You'll Do

In this role, you will report to the VP, Head of Medical Affairs, International and partner closely with the Director, Commercial Excellence, International. You will be responsible for establishing and optimizing Medical Affairs operations and processes, including medical information, while facilitating and coordinating medical planning activities across the organization. You will lead the implementation and continuous improvement of systems such as medical CRM and contribute to excellence in scientific engagement. As a central member of the Medical Affairs organization, you will play a key role in supporting the successful launch of new therapies in rare genetic diseases, working cross-functionally to ensure aligned, efficient, and high-quality execution of medical strategies.

Responsibilities

• Develop and deliver comprehensive onboarding and continuous learning curricula 
• Contribute to annual medical planning across brands 
• Contribute to successful medical launches by building a close partnership with the Commercial Excellence counterpart
• Manage and oversee multiple projects, including medical launch readiness and annual medical planning across brands, to drive consistency and efficiency across the medical organization
• Identify and recommend opportunities for process improvement and innovation in both medical excellence and operations within the Intl Medical Affairs organisation 
• Establish and maintain systems and dashboards as relevant for reporting key execution indicators and outcomes of medical activities
• Collaborate cross-functionally to generate insights and shape strategy using data analytics, demonstrating the value and impact of Medical to the business
• Lead and support core medical processes across brands, including publications and medical congresses and symposia
• Support the management and tracking of the medical budget

Medical Operations & systems  

• Establish and implement medical information processes and systems
• Establish and lead the international Medical, Legal, and Regulatory (MLR) review process in collaboration with Legal and Regulatory teams
• Lead the implementation of a medical CRM, as applicable, for the International Medical organization

The above job description documents the general nature and level of work but is not intended to be an exhaustive list of activities, duties, and responsibilities required of job incumbents. Therefore, job incumbents are expected to perform all other duties as assigned or required, as training and experience allow. 

Where You'll Work

• This is an office role based and requires in-office collaboration 2-3x per week in our Zug Office. No relocation is offered
• Travel (20-30%) may be required to represent the company at medical conferences, key events and meetings 

Who You Are

• Medical degree or Bachelor’s degree in a scientific discipline (advanced degree preferred)
• Extensive experience in the pharmaceutical industry (10+ years), with a solid understanding of drug development and clinical research
• Experience in rare diseases is an advantage
• Excellent verbal and written communication and presentation skills, with experience developing and implementing effective communication and engagement plans
• Strong expertise in systems, platforms, and methodologies, including the generation of associated reports
• Proven experience in establishing and managing medical processes, such as medical information, annual medical planning, and implementation of new systems and innovative ways of working
• Collaborative, team-oriented mindset with the ability to operate effectively in a fast-paced environment
• Demonstrated ability to manage multiple projects and competing priorities with a strong sense of urgency

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.  

• Market leading compensation 
• Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
• We provide career development through regular feedback, continuous education and professional development programs
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities
  
  

Ihre Aufgaben

• Rohrleitungsplanung in 2D und 3D über sämtliche Phasen von der Machbarkeit bis zur Übergabe für Prozess-, Forschungs- und Produktionsanlagen für unsere Kunden aus den Bereichen Biotech, Pharma und Chemie
• Unterstützung des Projektteams mit entsprechenden Unterlagen: Grundrisse, Schnitte, Isometrien, 3D Modelle und Visualisierungen
• Übernahme der Schnittstellenfunktion zwischen einzelnen Gewerken, Erstellung entsprechender Koordinationsmodelle und Koordination der Fachgewerkarbeiten
• Erstellen Massenauszügen sowie Stück- und Bestelllisten
• Weiterentwicklung der Modellierer-Standards (Projektfamilien, Templates, Strukturen) sowie Sicherstellung des kontinuierlichen Verbesserungsprozess innerhalb deiner Kompetenzfelder

Ihr Profil

• Abgeschlossene Ausbildung einer technischen Fachrichtung
• Weiterbildung (FH/HF) von Vorteil
• Anwenderkenntnisse in der Software Autodesk Revit, Aveva E3D, Autodesk Navisworks Manage, Revizto, AutoCAD oder die Bereitschaft diese zu erlernen
• 5+ Jahre Erfahrungen in Life Science Projekten sind von Vorteil
• 3-5 Jahre Erfahrung in der Koordination verschiedener Gewerke
• Sehr gutes Vorstellungsvermögen, flexible und kommunikative Persönlichkeit
• Selbständige und teamorientierte Arbeitsweise
• Sprachkenntnisse: Deutsch min. Level C2, Englisch min. Level B2

Über BakerHicks

Seit 1957 sind wir Vorreiter in den Bereichen Design, Engineering und Projektmanagement. Von der Beratung bis hin zum Bau und der Compliance unterstützen unsere multidisziplinären Design- und Ingenieurteams Unternehmen auf der ganzen Welt dabei, ihre Projekte auf die effizienteste, kostengünstigste und nachhaltigste Weise zu realisieren.

Benefits

• Überstunden voll kompensierbar
• Flexible Arbeitszeiten im Rahmen eines Gleitzeitmodells mit Blockzeiten
• Europäische Projekteinsätze möglich
• Rabattangebote im Stücki Center Basel
• Umfassende Spesenregelung zur Aufwandserstattung
• Mitarbeiter werben Mitarbeiter
• 2 verschiedene Pensionskassenlösungen (jährlich wechselbar)
• U-Abo für Pendler
• Flache Hierarchien
• Homeoffice
• Höchster Standard für Arbeitssicherheit
• 25 Urlaubstage
• Volle Lohnzahlung im Krankheitsfall bis zum 30. Tag
• Weltweite Reiseversicherung
• UVG-Zusatzversicherung
• Zuschuss für Velopendler
• Teilzeitarbeit möglich
• Möglichkeit zu unbezahltem Urlaub

Diversität & Inklusion

Bei BakerHicks ist es uns wichtig, dass wir ein Umfeld schaffen, in dem sich alle zugehörig fühlen. Als Unternehmen sind wir in der glücklichen Lage, mit einem vielfältigen Team von Menschen mit den unterschiedlichsten Hintergründen und Erfahrungen zusammenzuarbeiten. Alle von uns sollten respektvolles und positives Verhalten erwarten können, das uns anspornt. Um sicherzustellen, dass wir immer ein offenes Ohr haben und ständig dazulernen, haben wir ein Team zusammengestellt, das uns dabei hilft, unsere Strategien für Diversität und Inklusion zu steuern.

Über BakerHicks

Seit 1957 sind wir Vorreiter in den Bereichen Design, Engineering und Projektmanagement. Von der Beratung bis hin zum Bau und der Compliance unterstützen unsere multidisziplinären Design- und Ingenieurteams Unternehmen auf der ganzen Welt dabei, ihre Projekte auf die effizienteste, kostengünstigste und nachhaltigste Weise zu realisieren.

Benefits

• Überstunden voll kompensierbar
• Flexible Arbeitszeiten im Rahmen eines Gleitzeitmodells mit Blockzeiten
• Europäische Projekteinsätze möglich
• Rabattangebote im Stücki Center Basel
• Umfassende Spesenregelung zur Aufwandserstattung
• Mitarbeiter werben Mitarbeiter
• 2 verschiedene Pensionskassenlösungen (jährlich wechselbar)
• U-Abo für Pendler
• Flache Hierarchien
• Homeoffice
• Höchster Standard für Arbeitssicherheit
• 25 Urlaubstage
• Volle Lohnzahlung im Krankheitsfall bis zum 30. Tag
• Weltweite Reiseversicherung
• UVG-Zusatzversicherung
• Zuschuss für Velopendler
• Teilzeitarbeit möglich
• Möglichkeit zu unbezahltem Urlaub

Reisetätigkeit

Die Laufzeit unserer Projekte liegt meist zwischen 6 und 24 Monaten. Abhängig von Projekt und Projektphase ist der Einsatzort hauptsächlich der Projektstandort beim Kunden, wobei Mobiles Arbeiten von Zuhause in Absprache mit der Projektleitung teilweise möglich ist. Bei BakerHicks hat man so die Möglichkeit immer wieder bei unterschiedlichen Kunden mit unterschiedlichen Technologien zu arbeiten. Man lernt neue Städte kennen und ist dennoch am Wochenende immer zuhause.

Diversität & Inklusion

Bei BakerHicks ist es uns wichtig, dass wir ein Umfeld schaffen, in dem sich alle zugehörig fühlen. Als Unternehmen sind wir in der glücklichen Lage, mit einem vielfältigen Team von Menschen mit den unterschiedlichsten Hintergründen und Erfahrungen zusammenzuarbeiten. Alle von uns sollten respektvolles und positives Verhalten erwarten können, das uns anspornt. Um sicherzustellen, dass wir immer ein offenes Ohr haben und ständig dazulernen, haben wir ein Team zusammengestellt, das uns dabei hilft, unsere Strategien für Diversität und Inklusion zu steuern.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

Reporting to the Executive Director, Regulatory Affairs - CMC, the Director of Regulatory Affairs-CMC is responsible for leading regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international regulatory submission strategies.

Responsibilities

• Formulate CMC regulatory strategies, without supervisor oversight, based on current regulatory intelligence.
• Collaborates with cross-functional project teams and external business partners to develop CMC regulatory strategies and identify regulatory risks; represents the department in cross-functional project teams.
• Identifies the required documentation and any content, quality and timeline issues for global submissions and manages the delivery of approved technical documents in accordance with project timelines.
• Manages the preparation, authoring and maintenance of regulatory submission documents pertaining to CMC data for global clinical trial and marketing applications, as well as post-marketing variations. May require technical regulatory authoring of submission package components.
• Supports the evaluation of manufacturing changes for the potential impact on products.
• Provides expert review of CMC documentation supporting regulatory submissions and communications.
• Coordinates preparation of responses to queries from regulatory authorities, particularly focused on CMC. May require technical regulatory authoring to support responses to queries.
• Maintains knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs.
• Ensures conformance to commitments made with various regulatory agencies (e.g., IND/CTA commitments) for assigned programs.
• Provides regulatory advice to other functional areas.
• May participate in regulatory due diligence activities.

Relationships

• Build and maintain collaborative relationships with internal/external business partners to achieve project regulatory goals.
• Develops and maintains collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines.
• Develop and manage relationships with external vendors and regulatory health authorities.
• Coordinates activities for meetings and conferences with FDA, EMA, and other regulatory authorities
• Collaborate with regulatory colleagues to provide CMC expertise as needed.

Management

• This is an Individual Contributor position; however, there is the possibility for supervising consultants/contractors and/or interns.
• Develops and implements regulatory operating guidelines and common work practices/strategies within the team.

Qualifications

• 10 - 12+ years of related work experience (Director candidates will typically bring 12+ years; Associate level candidates may be considered with 10+ years and strong potential), including 8+ years in Regulatory Affairs CMC in the Biotech/Pharmaceutical industry; experience in small molecule drug development required; experience in the cardiovascular therapeutic area is a plus
• Proven experience serving as a primary RA-CMC contact to Health Authorities, with full strategic responsibility.
• Bachelor’s degree is required, preferably in chemistry or a closely related field; advanced degree is a plus.
• Advanced degree is preferred.
• Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
• Solid working knowledge of core processes associated with discovery, development, and manufacturing of small molecules.
• Experience with eCTD requirements and electronic submissions
• Experience with international regulatory submissions and processes is a strong plus.
• Ability to work effectively across teams, functions and with outside partners.
• Excellent oral and written communication skills
• Excellent organizational skills and attention to detail

#LI-HYBRID

Summary:

The Manager, Supply Chain Management is responsible for day‑to‑day operational execution of supply chain activities supporting Vaxcyte’s clinical, GMP, PPQ, and commercial readiness programs. This role focuses on tactical planning, execution, tracking, and issue resolution across materials, logistics, and external partners, ensuring smooth and compliant operations in support of manufacturing campaigns.

The role works closely with the Associate Director, Supply Chain, who retains end‑to‑end strategic ownership across programs, while the Manager, Supply Chain Management ensures disciplined execution, follow‑through, and operational stability.

Essential Functions:

Operational Supply Chain Execution

• Execute approved supply chain strategies and plans across GMP, PPQ, and clinical/commercial readiness activities.
• Manage day‑to‑day material planning, ordering, and tracking to ensure on‑time availability aligned with manufacturing schedules.
• Support execution of supply activities across multiple programs, with a focus on operational readiness and delivery.
• Manage and coordinate Critical Raw Materials and Customer‑Supplied Materials provided to Lonza.

Materials, Logistics & Vendor Coordination

• Coordinate shipments and storage with the Logistics Team.
• Track material movements, inventories, and material status, proactively escalating risks or delays, particularly for Critical Raw Materials.
• Act as the primary operational interface between Supply Chain and Procurement / Buyer, ensuring alignment between ordered materials, delivery timelines, and campaign execution needs.

CDMO & External Partner Support

• Support operational interfaces with CDMOs, primarily Lonza.
• Participate in recurring Lonza‑related forums (e.g. VIBEX, MINT material ordering, allocation, and operational alignment meetings).
• Follow up on action items, timelines, and required documentation to enable smooth execution.
• Support deviation‑related activities by coordinating information flow between Supply Chain, Quality, and Operations.

Tracking, Reporting & Documentation

• Maintain operational trackers, dashboards, and status updates related to materials, shipments, and readiness.
• Own the accuracy and maintenance of campaign progression data, including OMP‑related tracking, ensuring consistency across Supply Chain, Manufacturing, and Lonza‑reported data.
• Support preparation of weekly and recurring campaign updates by providing validated execution‑level data.

Issue Resolution & Continuous Improvement

• Act as a first line of response for operational issues related to materials, logistics, and execution.
• Escalate issues with clear data, options, and recommendations to the Associate Director.
• Identify opportunities to improve execution efficiency, tracking, and operational robustness.

Requirements: 

Bachelor’s degree in Supply Chain, Operations, Engineering, Life Sciences, or a related field with 7+ years of experience in Supply Chain Operations, Manufacturing Support, or a related role. Other combinations of education and/or experience may be considered.

• Experience working in a regulated biotech, pharmaceutical, or life sciences environment.
• Strong ability to work in a cross‑functional, matrix organization.
• Hands‑on experience with material planning, logistics coordination, and operational execution.
• Strong analytical, organizational, and follow‑through skills.
• Proficiency with ERP systems, SharePoint, and MS Office tools.
• Fluent in English.
• Fluency in German highly preferred; other European languages an advantage.

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Purpose/Summary: The Clinical Operations Lead owns program delivery & operational CRO/vendors oversight oof one or more development programs.

The Clinical Operations Lead has hands-on accountability and responsibilities in overseeing clinical trials execution within the program(s), especially the oversight of the trials/Program CRO, consultants and contractors to secure excellence in the delivery of their services to meet the trial milestones while adhering to quality, timeline, and budget. Leads by example with strong partnering and communication capabilities.

Key responsibilities:

• Takes a lead role in managing clinical program(s) and collaborating globally and across departments such as clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety, etc.
• Supports creation and maintenance of the clinical development plan in collaboration with the Clinical Development Lead by providing input on operational aspects of the program and trials, including, but not limited to, budget, timelines, and vendors.
• Oversees CTT performance, including metrics, milestones and compliance with relevant regulatory standards, including ICH‑GCP, protocol requirements and company procedures.
• Collaborates with the Global Clinical Trial Managers (gCTM) and functions in the following activities, among others:
  • Support decision-making in the selection of study
  • oversight of CROs, vendors, consultants and contractors, including negotiation of Scope of work (SOW), ensuring delivery against contracted SOW, budgets, performance management and issue
  • Development and management of program timelines, budgets and
  • Oversight of trial subject retention
• Constantly scans for possible risks and implementation of mitigations; while identifying best practices and opportunities for trial efficiencies and opportunities for enhanced quality.
• Leads by example, onboarding, coaching, and mentoring other Development Operations team members, , fostering a team culture of ownership, engagement, and continuous improvement, ensuring recognition of team successes.
• Provides immediate supervision and line management to one or more employees, , including employee development, company goal setting, and performance management processes.
• Contributes to strategic vision and long-term plans of Development
• Supports in determining the best utilization and prioritization of resources, and the optimal organization of infrastructure and staff, leveraging experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, etc.).
• Identifies and eliminates any impediments that obstruct or distract the team from delivering value; report and escalate issues, concerns, and roadblocks to management as needed.
• Regularly interacts with senior management on matters concerning functional areas and/or vendors.
• Contributes with the development and implementation of policies and standard operating procedures (SOPs) to be used in Development Operations
• Other duties as assigned

Prerequisite Education, Experience, & Skills:

• A highly motivated and results-oriented leader with a Bachelor’s degree and 14 years of pharmaceutical/Biotech clinical development and operations experience.
• Broad experience in global level clinical trial management, and knowledge of principles and practices of Program and Project Management. 
• Significant experience managing all aspects of activities in Phase I-IV trials, oversight of CROs and vendors at global level.
• Advantageous to have rare disease trial experience.
• Proven ability to effectively manage a large team comprised of permanent employees, consultants, contractors and oversight/partnering with CROs and teams within their varying levels.
• Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
• Strong proficiency in GCP/ICH, U.S. drug development process and regulatory expectations related to global clinical trials execution .
• Excellent interpersonal, oral, and written communication skills.
• Ability to drive high-level decision-making, think strategically, and take initiative in the face of incomplete information
• Able to motivate teams to do their best work through active collaboration, healthy debate, and continued learning.