Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

We are seeking a highly capable and proactive Senior Finance Manager, EMEA to join our rapidly growing team in the EMEA Region. This is a critical new headcount addition that will be instrumental in stabilizing core financial controls and supporting a region expected to continue to grow its topline and investment.

Reporting to the EMEA Finance Director, the Senior Finance Manager will take ownership of essential operational and compliance duties. This role is ideal for a detail-oriented, commercially astute finance professional ready to thrive in a complex, fast-paced environment characterized by significant growth, multiple markets, new product launches (including gene therapies), and evolving partner deals.

Work Model:

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.
Or
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Perform detailed, day-to-day Opex tracking, variance analysis, and reporting, supporting OPEX and cost savings/productivity initiatives through transparent reporting and targeted analytics
• Provide proactive budget holder support to Commercial and Medical teams, ensuring strict adherence to budgets and financial policies
• Manage and control transactional volume related to increased headcount, vendor management, and travel/expense reporting
• Generate monthly and quarterly performance reports and review with regional, country, and department managers
• Maintain controllership of expenses, with focus on all OpEx lines directly controlled by the European entities
• Deliver monthly and quarterly results reporting, including variance analysis and corrective action plans, and recommend cost-saving initiatives to achieve financial targets
• Work closely with US-based teams to support procure-to-pay, payroll, management/statutory reporting, IT, HR, and other corporate processes
• Drive process improvement projects with corporate and regional functions to deliver cost and operational efficiencies across the region
• Support monthly and quarterly financial close processes, including preparation of accruals and detailed revenue reconciliation across multiple brands, countries, and partner deals
• Lead improvements in FP&A reporting, forecasting, and automation to enhance reliability, efficiency, and insight generation
• Act as the primary liaison for Global Accounting, Supply Chain, and Tax, supporting compliance and minimizing operational risk across the region
• Identify and implement improvements in core financial processes and utilize data analytics (Power BI, Excel) to deliver insights, scenario planning, and support senior stakeholder decision-making

Requirements:

• Minimum 5+ years of progressive experience in Finance (FP&A, Controlling, or Corporate Finance), in the biotech, pharmaceutical, or life sciences sector in a European context
• Master’s degree in finance, Accounting, Economics, or relevant field; professional qualification (CFA, ACA, ACCA, CIMA or equivalent) highly desirable
• Fluent English required; additional European language (e.g., German, French) a strong asset
• Demonstrable understanding of biotech business drivers, including revenue recognition for complex licensing/partner deals and product launch dynamics
• Strong proficiency in Opex tracking, financial analysis, and budget management
• Solid understanding of revenue recognition principles within pharmaceutical or life sciences environments
• Advanced Microsoft tools skills, including Excel and Power Query, with experience using ERP/financial planning systems and Power BI
• High attention to detail with a strong focus on compliance and financial control
• Proven ability to work cross-functionally and act as a liaison with global teams while building strong relationships
• Ability to manage high volumes of transactional activity while maintaining data integrity, alongside strong personal effectiveness (resilience, accountability, and self-motivation)

#LI-CK1 #LI-Remote

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

The legal work behind bringing medicines to patients is rarely one-dimensional. It spans commercial contracting, launch readiness, promotional review, digital channels, compliance, privacy, and the judgment to know when to move quickly and when to pause.

As Legal Counsel, International, reporting to the VP, Associate General Counsel, Legal International, you will serve as a hands-on legal business partner supporting pre-launch activities, commercial launch, and ongoing operations across Europe. You will advise a broad range of stakeholders, delivering practical, business-oriented guidance, managing risk thoughtfully, and helping the organization move with clarity, consistency, and speed.

This role is suited to a pragmatic lawyer who is excited by breadth, ownership, and the opportunity to help build scalable legal frameworks in a fast-moving biotech environment.

Responsibilities

Commercial Contracting & Day-to-Day Legal Support

• Draft, review, negotiate, and advise on a broad range of agreements, including supplier and vendor agreements, master services agreements, service agreements, NDAs/CDAs, technology and digital services contracts, and other ancillary commercial documents
• Provide day-to-day legal support across Commercial, Medical Affairs, Regulatory, Market Access, Finance and Supply Chain, on contractual and commercial, ensuring alignment with applicable laws, internal policies, and business objectives
• Advice on contract structuring, liability and risk allocation, and contract interpretation, and helping manage the full contracting lifecycle in partnership with business stakeholders

Commercial Launch, Marketing & Promotional Review

• Support launch readiness and ongoing commercial operations across relevant European markets by advising on pre-marketing activities, field force materials, promotional reviews, patient support initiatives and operational readiness questions
• Support EU MLR (Medical, Legal, Regulatory) review for Legal International, ensuring promotional and medical materials meet EU and national requirements, giving clear, enabling advice on claims, fair balance, substantiation, and appropriate risk mitigation
• Support the development and maintenance of EU-specific promotional review guidelines and support training of cross-functional stakeholders on compliant pre-marketing and promotion practices

Operational Excellence & Cross-Functional Partnership

• Partner closely with the global Compliance function to identify, assess, and manage regional compliance risks, including competition law, anti-bribery and anti-corruption, sanctions, and commercial governance, while supporting guidance and oversight on applicable industry codes and ethical standards across Europe
• Champion continuous improvement in legal operations, including the implementation and responsible use of modern legal tools, templates, playbooks, and AI-enabled solutions
• Contribute to legal training, knowledge sharing, and a culture of legal excellence across the wider Legal Department
• Handle additional legal projects and operational matters assigned

Where You'll Work

• This is an office role based and requires in-office collaboration 2-3x per week in our Zug Office
• Domestic and international travel is expected when required

Who You Are

• Swiss or EU qualified lawyer with 4–5 years of post-qualification experience in pharmaceutical or biotech, with meaningful exposure to commercial operations, product launch, and cross-functional legal support — at a law firm, a company, or both
• You have exposure to additional jurisdictions. MLR (Medical, Legal, Regulatory) review experience required
• You communicate with precision and confidence across all levels — whether advising a field team, sitting in an MLR, presenting to affiliate leadership, or escalating a complex matter to senior legal counsel. People always know where you stand and why
• You build real relationships with the teams you support — and those relationships are what make you effective
• You can work in a fast-paced dynamic work environment with efficient prioritization, responsiveness and focus (especially during periods of sustained pressure and often under tight deadlines). You are flexible and have a high tolerance for ambiguity
• You are fluent in English (working proficiency required); proficiency in an additional European language is preferred

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
  
  

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
  
  

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

#LI-Hybrid  #LI-YG1

The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

Reporting to the VP, GM, Midsized Markets, the Senior Director, Medical Affairs, Midsize Markets Europe, is the medical leader responsible for defining and executing the medical strategy for oncology products in our portfolio within Midsized markets. This role serves as the medical voice within the Midsized markets Leadership Team, ensuring scientific excellence, compliant medical engagement, and strong alignment between global strategy and local patient, physician, and healthcare system needs. This leader will ensure that Midsized markets medical considerations are embedded in the regional medical strategy and plans and will partner with the Midsized markets country managers and crossfunctional teams, as well as VP Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the Midsized markets medical team and working closely with the Global, Regional, Country Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical lead for Midsized Markets, accountable for medical strategy, execution, and impact across the RevMed portfolio.

• Serve as a core member of the Midsized Markets Leadership Team, contributing insights to medical and clinical development strategy, launch planning, and business decisions.

• Establish Midsized markets medical strategy across pre-launch, launch, and post-launch phases.

• Oversee all aspects of medical strategy and execution in Midsized markets.

• Cross-functionally align efforts seamlessly with access, regulatory, and commercial objectives while building and executing upon the medical plan.

• Collaborate effectively with regional and global teams by contributing to overall medical strategy, strongly partnering with local, regional and global clinical development and operations teams.

• Translate global medical and clinical strategies into relevant medical strategy.

• Represent the company as the senior medical expert within the local oncology and scientific community, acting as a spokesperson for Midsized markets.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions.

• Build strong relationships with national key opinion leaders, oncology networks, academic institutions, and scientific societies.

• Lead scientific exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level.

• Provide medical leadership on evidence generation activities including local studies, real-world evidence initiatives, and investigator-initiated research (where permitted).

• Ensure effective execution of publication plans and scientific communication activities.

• Lead medical launch readiness for oncology products, including training, scientific materials, and field medical engagement plans.

• Partner with Market Access and Commercial country and regional teams to support value communication and reimbursement-related interactions from a medical perspective, e.g. representing and defining evidence and value of innovation at oral HTA hearings.

• Support lifecycle management activities including new indications, label updates, and competitive positioning.

• Provide medical review and approval of non-promotional materials in accordance with local regulations and company policies.

• Help recruit country Medical teams, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the Midsized markets build-out.

• Foster a culture of scientific rigor, compliance, and collaboration.

• Ensure all medical activities comply with local regulations, national and EFPIA codes, and internal company policies.

• Represent Midsized markets Medical Affairs in company governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD or PhD).

• Strong background and experience in oncology required.

• 10+ years’ experience in Medical Affairs with a track record of country leadership.

• Experience with scientific data generation, clinical trial interpretation, and communication of complex data to diverse audiences.

• Proven value and benefit assessment experience, with deep understanding of midsized markets access, local healthcare systems and regulatory landscape.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Proven experience supporting oncology product launches in a European market.

• Experience in biotech.

• Excellent communication skills, both in person and virtual.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial environment.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environment.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.

• Willingness to travel nationally and internationally.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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The Opportunity:

The Senior Director, European Pricing & Market Access serves as the regional pricing leader and European pricing voice for Revolution Medicines. This incumbent will be a senior member of the European Market Access Leadership Team and acts as the dedicated European pricing strategist, providing rapid-response pricing scenario capability at product, indication, and portfolio level to support negotiations, pricing governance, and enterprise strategic planning.

The incumbent is accountable for maximizing European value realization while safeguarding long-term global price integrity across the RevMed portfolio. Operating at the intersection of regional execution and global pricing governance, this leader ensures European market dynamics, international reference pricing (IRP) implications, and health technology assessment (HTA) requirements are fully integrated into global pricing architecture and decision-making.

The Senior Director partners closely with Country Senior Directors, Market Access, as well as HEOR, Commercial, Regulatory, Finance, and Global Pricing colleagues, serving as the primary European interface to Global Pricing on all matters related to European pricing strategy. They will be based in Switzerland.

Key responsibilities:

• Deliver rapid European pricing scenario analyses to support pricing governance decisions, payer negotiations, and competitive response, with accountability for analytical rigor, strategic relevance, and executive decision-readiness.

• Own and maintain the European IRP simulation model, tracking basket compositions, referencing rules, revision timing, and exposure across 25+ markets.

• Develop European price corridor recommendations, floor prices, and launch sequencing strategies based on IRP dynamics, HTA timelines, and competitive context.

• Quantify the European revenue impact of proposed global pricing decisions and proactively shape recommendations to optimize regional and global value outcomes.

• Model pricing implications of indication expansions, including MFN/IRP effects on base business and cross-indication value trade-offs.

• Analyze portfolio pricing interdependencies and positioning implications across European markets.

• Balance long-term franchise value against individual product optimization, acting as a steward of portfolio-level value across current and future indications.

• Coordinate with Country Senior Directors, Market Access to provide pricing scenarios supporting live payer negotiations and guide strategic positioning during critical negotiation inflection points.

• Translate country-level pricing intelligence into European and global strategic insights.

• Support country teams with alternative pricing corridor scenarios when negotiations reach impasse.

• Provide leadership, mentorship, and strategic guidance to country and regional pricing colleagues, fostering consistent pricing excellence across European markets.

• Represent the European pricing perspective in global pricing governance forums and committees, serving as the accountable regional leader for European pricing inputs into enterprise decision-making.

• Partner with the Executive Director, Global Pricing on pricing methodology, tools, and governance frameworks.

• Provide European input into global price architecture, launch sequencing, and portfolio pricing decisions.

• Represent European Pricing & Market Access in relevant enterprise governance, portfolio, and risk management forums.

• Own and oversee the operational maintenance of the European pricing database as the single source of truth for list and net prices, including governance, audit trails, and documentation of price changes in alignment with global pricing standards and financial controls.

• Monitor competitor pricing moves, reimbursement decisions, and tender outcomes across European markets.

• Track European pricing policy changes, reforms, and implications of EU Joint Clinical Assessment (JCA) implementation.

• Maintain expert-level knowledge of IRP/MFN mechanics and HTA-driven pricing dynamics across key European markets.

• Translate external pricing and policy developments into forward-looking strategic implications for RevMed’s European and global pricing strategy.

Required Skills, Experience and Education:

• Bachelor’s degree required; advanced degree (MBA, MSc, PhD, PharmD) in health economics, finance, life sciences, or related field preferred.

• 12–15+ years of progressive experience in pharmaceutical or biotech pricing, market access, or health economics, including leadership across multiple European markets within a complex matrix organization.

• Deep expertise in European pricing and reimbursement environments, including MFN/IRP mechanics across major markets.

• Demonstrated experience with European HTA processes (e.g., NICE, G-BA, HAS, AIFA) and their pricing implications.

• Advanced analytical and financial modeling capabilities; experience with pricing intelligence platforms (e.g., IQVIA Pricentric, GlobalData).

• Proven ability to partner effectively with Finance to translate complex pricing agreements and commercial terms into accurate financial treatment, including oversight of gross-to-net revenue adjustments.

• Strong executive presence with demonstrated ability to influence senior and executive-level stakeholders.

• Experience operating in a fast-paced, entrepreneurial biotech environment.

• Oncology, rare disease, or specialty therapeutics experience preferred.

Preferred Skills:

• Experience building or scaling pricing capabilities in a pre-commercial or early-commercial biotech organization.

• Familiarity with EU Joint Clinical Assessment (JCA) regulation and Most Favoured Nation (MFN) and their impact on pricing strategy.

• Multilingual capability (German, French, or other European languages advantageous).

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. #LI-Remote #LI-LO1

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and the subject matter expert (SME) in Biostatistics within the Quantitative Sciences function, this position is to provide statistical leadership and support for EU access strategies, healthcare technology assessments and regulatory submissions. 

• Serve as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches in collaboration with global and regional crossfunctional teams.

• Partner with Regional and Local Market Access and HEOR functions to design and lead/oversee the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network meta-analyses, and RWE generation.

• Partner closely with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post-authorization commitments.

• Ensure statistical methodologies align with EU guidance (ICH, EMA guidelines, CHMP expectations). 

• Contribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions.

• Provide statistical expertise and support for regional study projects including study design, data analysis, and interpretation of results, to ensure high-quality and scientifically sound outcomes.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Drive and lead department initiatives, best practices, and guidelines.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics or related fields, a minimum of 10 years (for Ph.D.) and 15 years (for M.S.) of experience in the biotech/pharma industry as a statistician.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Advanced methodological and technical skills.

• Strong problem solving and critical thinking abilities.

• Proficiency in SAS and/or R.

Preferred Skills:

• Strong track record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as well as reimbursement dossier contributions in major European markets.

• Experience in engaging with European scientific advice/early payer.

• Deep understanding of evolving landscape of EMA, MHRA and Swissmedic, and the evolving landscape of joint clinical assessments (JCA) in Europe, in addition to European legislation requirements.

• Active participation in NDA/BLA filing through label negotiations advantageous.

• Hands-on experience in design and analysis of oncology trials.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. #DNI

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

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.

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.

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.