Senior Manager jobs at BioMarin

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Commercial Our Commercial organization leads our global sales and marketing strategies around the world. Our integrated team continues to solidify BioMarin's commercial presence in the United States and Europe and is rapidly growing in other regions, such as Latin America, the Middle East and Asia-Pacific. Summary Description BioMarin is seeking an experienced and strategic leader to serve as the Director, Global CRM Business Lead. This role is critical in shaping and executing the company's enterprise CRM strategy and roadmap, ensuring engagement alignment with customer experience (CX) goals, digital data strategy, and campaign needs. Reporting to the Senior Director, Digital Strategy and Capabilities, this individual will partner with Business Units, Commercial IT, Insights & Analytics and Performance & Planning teams to lead the CRM initiatives, innovation, processes and new ways of working for the global markets. The Director will drive business ownership of CRM capabilities, lead adoption and governance, and ensure seamless integration with omnichannel platforms to support therapeutic areas (Skeletal Conditions, Roctavian, and Enzyme Therapies). The position will optimize CRM systems to enhance both healthcare provider (HCP) and patient engagement through advanced segmentation, alerts or suggestions management, and closed-loop measurement, while aligning with global CRM standards. Key ResponsibilitiesStrategic Leadership: Define and lead the enterprise CRM strategy and roadmap, ensuring alignment with CX goals, digital data strategy, and campaign needs. Develop and implement a comprehensive CRM strategy that supports BioMarin's business objectives and enhances customer engagement. Define and prioritize CRM initiatives across Business Units and regions for efficient resource allocation and timely execution. Oversee the entire CRM lifecycle, from requirements gathering to deployment, ongoing optimization, and future enhancements. Business Unit Partnership & Alignment: Collaborate with therapeutic area leads, digital peers, and their respective teams to ensure the CRM system supports unique business needs. Act as a trusted advisor, guiding business units on leveraging CRM capabilities for customer engagement strategies. Ensure CRM functionalities are aligned with business unit goals to maximize impact on sales and marketing. CRM Tools Ownership & Omnichannel Integration: Lead business ownership of CRM tools (including Veeva, Salesforce, and other key life sciences CRM systems), driving adoption, governance, and integration with omnichannel engagement platforms. Ensure optimization of HCP and patient engagement via adaptation of segmentation, dynamic targeting, next-best-action logic, alerts / suggestions implementation, campaign tagging & attribution, and closed-loop measurement. Ensure activation of fit for purpose CRM capabilities for cross-functional team engagement, task and targets management IT Collaboration & Configuration: Partner with IT to define CRM business needs and ensure alignment with global Veeva/Salesforce standards. Implement technology and integration changes for cross-functional needs, system scalability, and stability. Collaborate on CRM upgrades, integrations, and new functionalities to meet evolving business requirements. Field Enablement & Usability: Optimize role-based CRM views, dashboards, and workflows to provide actionable information for field teams. Work with sales enablement to ensure field representatives have the tools needed for effective customer engagement. Identify opportunities to improve usability through streamlined workflows and enhanced system design. Data Analysis & Reporting: Monitor key CRM metrics and identify areas for system performance improvement. Analyze CRM data to extract insights that inform both strategic and operational decisions. Develop standardized reports to track performance and share insights with stakeholders. Stakeholder Management: Collaborate with cross-functional teams (sales, marketing, medical) to ensure seamless integration of CRM strategies across departments. Represent the value of the CRM system within the organization by communicating its impact on business outcomes to leadership teams. Address stakeholder concerns related to CRM systems or processes in a timely and effective manner. Drive field support frameworks & office hours for CRM user base QualificationsEducation: Bachelor's degree in Business Administration, Marketing, Information Systems, or a related field; MBA preferred. Experience: 10+ years of experience in CRM strategy development or management within the biotech/pharmaceutical industry or a similarly regulated environment. Proven experience working with Veeva, Salesforce (or similar platforms) at an enterprise level for configuration management and optimization. Experience with CRM configuration, management, and optimization, as well as integration with marketing automation tools (e.g., Salesforce Marketing Cloud, Marketo). Required Skills: Strong understanding of CRM systems (e.g., Veeva, Salesforce) and their integration with marketing automation tools (e.g., SFMC, Marketo). Strong understanding of pharma / life sciences CRM use cases, commercial workflows and customer types & lifecycle management Excellent analytical skills with the ability to turn data into actionable insights for strategic decision-making. Exceptional communication skills for collaborating across matrixed organizations with diverse stakeholders (Sales, Marketing, and IT). Demonstrated ability to lead cross-functional projects from concept through execution in a fast-paced environment. Strong advocate for efficiency tools such as Microsoft Copilot to make the most use of time. Preferred Skills: Familiarity with rare disease therapeutic areas or specialty pharma marketing practices. Experience managing complex system integrations or global Veeva & Salesforce implementations.Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Make a meaningful difference to patients around the world! Our Legal team works to protect our patients, team members, and innovations with the utmost diligence and care. You'll have the opportunity to work with a dedicated team and build lasting partnerships with stakeholders across our global organization. Your legal knowledge and contributions will help us ensure that we are supporting the needs and interests of the patients we serve. Work Schedule: Given the collaborative and complex nature of this work, this role is in person full time in Irvine, California with flexibility to work from home as needed. How you'll make an impact: The Senior Manager, Corporate Counsel, Commercial Contracts is responsible for the timely and thorough review, negotiation and counsel of a wide variety of commercial, IT and Software as a Service (“SaaS”) agreements. This role will be reporting directly to the Director, Corporate Counsel within the Law Department's Commercial group. The Senior Manager will collaborate with various teams across the Law Department including IP and Privacy, and will address legal issues across various business units and corporate functions, including Global Supply Chain and IT. Provide legal guidance to the company focused on artificial intelligence (AI), cybersecurity, and intellectual property issues while negotiating a broad range of IT agreements (e.g., data license agreements, software development agreements, hardware purchase agreements, service level agreements (SLAs), end-user license agreements (EULAs), maintenance and support agreements, SaaS and related cloud-based agreements) and commercial agreements (e.g., non-disclosure agreements (NDAs), master service agreements (MSAs), material transfer agreements (MTAs), and manufacturing supply agreements). Work directly with and advise key decision-makers in contract negotiations and other business arrangements, including identifying AI, cybersecurity, data privacy and intellectual property risks and proposing solutions to key business issues. Develop, manage and conduct training for internal clients and the Contract Management Team within Legal Department on legal review guidelines. Work on special projects and strategic initiatives, including Legal Department's efforts related to contract management and technology, such as AI applications and contract systems. What you'll need (required): J.D. degree from an ABA accredited law school with 4 years of legal experience at a law firm or in-house legal department. Relevant industry experience (e.g., medical device, pharmaceuticals, etc.) or in highly regulated environments What else we look for (preferred): Background in the medical device, pharmaceutical, or related healthcare industry Understand key issues around AI, cybersecurity, data privacy, and intellectual property rights. Excellent analytical, detail-oriented, organized and information seeking skills. Manage competing priorities in a fast-paced environment; set priorities for self and applicable team members. Ability to think strategically, analyze problems and present creative and practical legal business solutions; escalate issues to management as appropriate. Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives. Understanding of related aspects of legal processes and/or systems. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives. This is an exciting opportunity for an exceptional Clinical Scientist professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. How you'll make an impact: As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, Medical Affairs) is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical evaluations for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. This position can be an onsite or a hybrid role based at Edwards Lifesciences' corporate headquarters in Irvine, California, or can be a remote based role in the U.S. Contribute to strategy and planning of clinical science and medical writing deliverables. Lead clinical study design and clinical protocol development. Independently author complex documents including clinical study protocols (pre-market and post-market), clinical study reports, annual progress reports, post-approval study reports, clinical evaluation plans, clinical evaluation reports, post-market clinical follow-up plans and reports, and other scientific documents (as appropriate). Independently author complex regulatory responses. Perform systematic literature reviews from initiation to completion (develop search strategies, manage associated documentation, and prepare literature summaries). Independently review raw and summary clinical data for accuracy; resolve potential discrepancies. Interpret safety and effectiveness results from pre-market and post-market data sources; conduct systematic data appraisals to support overall benefit-risk assessments. Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting. Summarize key data from clinical studies and published literature and provide updates to internal and external stakeholders (as appropriate). Ensure documents comply with regulatory guidelines. May travel up to 15% to attend scientific conferences. What you'll need (Required): Bachelor's Degree in a related field with 10 years of related experience working in clinical science or medical/scientific writing; OR Master's degree in a related field with 8 years of related experience working in clinical science or medical/scientific writing; OR What else we look for (preferred): Doctorate degree (PhD, MD, PharmD) with 8 years of related experience working in clinical science or medical/scientific writing. Familiarity with the coronary interventional and/or structural heart environments and current treatment options or have other clinical and/or clinical trial experience. Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. Experience with FDA PMA applications. Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR, Japan PMDA, China NMPA) regulations. Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, statisticians, physicians, and support personnel. Excellent communication skills and experience influencing and guiding stakeholders. Recognized as an expert in own subject area with specialized depth within current or previous organization(s). Expert understanding of related aspects of clinical science and/or scientific/medical writing. Expert knowledge of regulatory requirements and study execution. Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously. Excellent oral and written communication skills. Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge. Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development. Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat. Strong analytical, problem-solving, and scientific writing skills. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients' lives. This is an exciting opportunity for an exceptional Clinical Scientist professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. How you'll make an impact: * As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, Medical Affairs) is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical evaluations for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. * This position can be an onsite or a hybrid role based at Edwards Lifesciences' corporate headquarters in Irvine, California, or can be a remote based role in the U.S. * Contribute to strategy and planning of clinical science and medical writing deliverables. * Lead clinical study design and clinical protocol development. * Independently author complex documents including clinical study protocols (pre-market and post-market), clinical study reports, annual progress reports, post-approval study reports, clinical evaluation plans, clinical evaluation reports, post-market clinical follow-up plans and reports, and other scientific documents (as appropriate). * Independently author complex regulatory responses. * Perform systematic literature reviews from initiation to completion (develop search strategies, manage associated documentation, and prepare literature summaries). * Independently review raw and summary clinical data for accuracy; resolve potential discrepancies. * Interpret safety and effectiveness results from pre-market and post-market data sources; conduct systematic data appraisals to support overall benefit-risk assessments. * Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting. * Summarize key data from clinical studies and published literature and provide updates to internal and external stakeholders (as appropriate). * Ensure documents comply with regulatory guidelines. * May travel up to 15% to attend scientific conferences. What you'll need (Required): * Bachelor's Degree in a related field with 10 years of related experience working in clinical science or medical/scientific writing; OR * Master's degree in a related field with 8 years of related experience working in clinical science or medical/scientific writing; OR What else we look for (preferred): * Doctorate degree (PhD, MD, PharmD) with 8 years of related experience working in clinical science or medical/scientific writing. * Familiarity with the coronary interventional and/or structural heart environments and current treatment options or have other clinical and/or clinical trial experience. * Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations. * Experience with FDA PMA applications. * Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR, Japan PMDA, China NMPA) regulations. * Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, statisticians, physicians, and support personnel. * Excellent communication skills and experience influencing and guiding stakeholders. * Recognized as an expert in own subject area with specialized depth within current or previous organization(s). * Expert understanding of related aspects of clinical science and/or scientific/medical writing. * Expert knowledge of regulatory requirements and study execution. * Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously. * Excellent oral and written communication skills. * Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge. * Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development. * Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat. * Strong analytical, problem-solving, and scientific writing skills. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manager of Corporate Strategy position is a unique career opportunity that could be your next step towards an exciting future. Drive Edwards' strategic advantage by transforming external signals-competitors, markets, technologies, policy-into timely, decision‑ready insights that inform enterprise strategy, portfolio bets, and ELT discussions. How you'll make an impact: + Run targeted primary and broad secondary competitive intelligence for the corporate strategy team + Stand up and iterate CI dashboards (e.g., Power BI/Tableau) and automated pipelines for news, trials, and KOL/patent data + Build and run an enterprise "early‑signal" system spanning competitors, pipeline moves, clinical data, regulatory milestones, pricing/reimbursement, M&A/partnerships, and adjacent tech. Stand up alerting, tagging, and impact triage so the right leaders see the right signal at the right time. (Newsletter + real‑time alerts model) + Maintain living competitive landscapes and scorecards; refresh pre‑ELT/Board cycles and major portfolio gates + Lead congress/earnings‑season coverage with fast, BLUF readouts and implications for Edwards + Create crisp, executive‑ready narratives (PowerPoint + live briefings) that translate complex dynamics into clear options and recommendations; tailor for ELT, BUs, regions, and functional partners + Collaborate across functions, regions, and BUs on Enterprise risks and opportunities + Other incidental duties What you'll need (Required): Bachelor's Degree or Equivalent in a scientific, technical, or quantitative field with 10 years of related work experience, or equivalent work experience based on Edwards criteria What else we look for (Preferred): + Master's Degree or equivalent plus 8 years of related work experience required and 5 years experience direct experience in strategy, management consulting, business development, or marketing and sales + Ability to synthesize complex information into a high-level strategic message, and to interpret internal/external business factors into recommendations and solutions + Demonstrated experience working with a range of professionals to help navigate through complex situations + Proficiency in PowerPoint/Excel; comfort with data tools (Power BI/Tableau; GenAI/Agentic AI models a plus) + Proven expertise in clinical and financial comprehension, and live presentations, with high attention to detail and output + Excellent problem-solving, organizational, analytical and critical thinking skills + Recognized as an expert in own area with specialized depth and breadth of expertise within area of work in the organization + Expert understanding and interpretation of complicated market dynamics with the ability to identify and quantify market potential, and build business case with both business and financial analysis skills + Expert understanding of related aspects of processes and/or systems + Ability to listen to stakeholders, discover unmet needs, develop strong rapport with audience, and be customer-focused + Strict attention to detail + Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization + Ability to manage competing priorities in a fast paced environment + Ability to represent leadership on projects on sections of projects within a specific area interfacing with project managers and cross-functional teams + Ability to consult in project setting + Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Drive Scientific Impact at the Forefront of Innovation. Patients are at the heart of everything we do. As a key member of our Medical Affairs team, you will drive the strategic direction of our Transcatheter Heart Valve (THV) evidence generation and dissemination efforts-shaping the future of structural heart disease treatment through science, collaboration, and innovation. Your work will directly influence how life-saving data is created, shared, understood, and applied across the global medical community. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will make an impact by: Transforming Lives. Advancing Science. Leading with Purpose. Leading Strategy & Execution: Spearheading the planning and operations of the THV Podium & Publication (PnP) Committee, aligning cross-functional teams to deliver high-impact scientific projects. Delivering Executive Insights: Developing compelling, executive-level presentations and reports that simplify complexity and drive actionable outcomes for senior leadership. Driving Evidence Planning: Collaborating with internal and external stakeholders to shape and execute a robust evidence generation roadmap that supports the overall THV business strategy. Championing Investigator-Initiated Studies (IIS): Contributing to the IIS program by aligning research priorities with business strategy; serving as a thought partner to investigators and providing input to study designs, abstracts, and manuscripts. Fostering Scientific Collaboration: Building and strengthening relationships with leading physicians, researchers, and thought leaders to advance shared goals in structural heart diseases. Elevating Scientific Presence: Anticipating key data releases and ensuring strategic visibility at global congresses and podiums. Supporting the Medical Affairs Team: Performing other duties as assigned by leadership. What you'll need (Required): Bachelor's Degree in related field Plus 10 years of related work experience Advanced degree (e.g., Masters, PhD, MD) in related field Plus 8 years of related experience Ability to travel up to 10% (Domestic) This role is posted as Hybrid in Irvine, CA, but we are open to considering highly qualified candidates for a remote U.S. arrangement, provided they can meet the travel requirement: up to 30% domestic travel, including regular visits to our Irvine headquarters. What else we look for (Preferred): Holding an advanced degree (e.g., Master's, PhD, MD) in a related field Thinking strategically with strong analytical and problem-solving capabilities Demonstrating excellent Microsoft PowerPoint skills Showing proven project management expertise and proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams, CoPilot) Possessing working knowledge of clinical research methodologies and statistical principles Exhibiting exceptional communication and relationship-building skills Maintaining strict attention to detail and excellent follow-up Adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries to self and others, as well as protecting the environment and preventing pollution within your span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Make a meaningful difference to patients around the world. Our talented people are central to the future of Edwards Lifesciences, which is why our Human Resources teams help design, guide, and deliver inspiring experiences for our people. With a fundamental understanding of how to build a supportive community and organizational capability, you'll deliver solutions to attract and retain talent. Your work will enable our teams to thrive as they help patients live healthier and more productive lives. Edwards is looking for a Senior Manager of Organizational Effectiveness (OE) to join our Organizational Effectiveness team. Our Organizational Effectiveness team is a tight knit internal consulting team responsible for running multiple strategic projects across different Business Units, regions, and functions at Edwards Lifesciences. This is an exciting opportunity to have a significant impact to a wide variety of functional areas within our multibillion-dollar global organization. Our ideal candidate possesses a management consulting background with proven experiences in leading a cross-functional teams to deliver strategic projects that are high-profile and fast. This role will partner with Executive Leadership, HR Leaders, and business stakeholders to address the people and organization factors as Edwards scales for growth. This position will be on-site located at our Irvine headquarters. How you'll make an impact: Deliver key strategic talent and org imperatives and/or OE initiatives Collaborate with key partners to the develop Edwards-wide org & talent strategies and imperatives to enable business objectives over the 7-year strategy horizon Consult on enterprise wide, high impact business initiatives, with focus on the people and organizational impact to ensure ROI on significant initiatives Partner with the business & HR leaders to build Talent & Org Strategies and capability plans to enable Edwards for rapid growth Plan and direct initiatives including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives Direct initiatives with overall responsibility of planning, staffing, managing priorities, recommending, and implementing changes to methods through several managers Continue to build out and elevate Edwards Org Change Management capability, advocate “change management” knowledge and capabilities into the organization Develop a robust talent development and succession planning in alignment with functional growth strategies across the global organizational effectiveness team Direct responsibility for assessing and building organizational effectiveness capabilities within direct team, global HR organization, and across the EW organization What you'll need (Required): Bachelor's degree in engineering, Computer Science or other related technical areas and 10 years direct experience in Organizational Effectiveness (e.g., OE/Workforce Planning/ or organizational design strategy, including business case analysis and communications) or equivalent work experience based on Edwards criteria Or a Master's degree in engineering, Computer Science or other related technical areas and 8 years of experience or equivalent work experience based on Edwards criteria Occasional travel, up to 30% annually, may be required to support business needs What else we look for (Preferred): Strong technical/science-based backgrounds that foster systems thinking, or management consulting experience with strong facilitation and problem-solving skills Expert Business understanding of organizational effectiveness Excellent presentation and facilitation skill Excellent problem-solving, organizational, analytical and critical thinking skills Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills with ability to drive achievement of objectives Proven success in managing two or more concurrent projects and initiatives Recognized as an expert in one area (e.g., Organizational Design, OCM, Workforce Planning) with specialized depth within the organization Expert knowledge and understanding of EW policies, procedures, and requirements as it relates to organizational effectiveness Excellent leadership and influencing skills Ability to manage internal and external confidential information with utmost discretion Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast paced environment Ability to represent leadership on projects within a specific area interfacing with project managers and team Ability to consult in project setting within specific area Provide leadership to outsourcing partners on a task level Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $136,000 to $190,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Position Summary: This role centers on managing and expanding Edwards's annual congress strategy, driving impactful business initiatives across marketing, sales, and product development. You will be the leader that oversees congress strategy, planning, and execution, vendor relationships, contract negotiation, promotional strategies, and fiscal management. Candidates should bring extensive experience in sales, marketing, or healthcare, along with strong project management, communication, and event planning expertise. With opportunities to lead cross-functional teams and shape Edwards's brand presence, this role is ideal for accomplished professionals ready to make a meaningful contribution in a dynamic environment. How you will make an impact: Develop and manage the annual congress strategy; identify global and regional business initiatives and how to effectively impact through congress strategies; includes marketing, brand, sales, product and new business development initiatives. Identify new congress opportunities Develop congress objectives and strategies to ensure business goals are met at each congress; brand awareness, product messaging, education, networking, market research Initiate process development and improvements; identify new vendor opportunities; develop relationships to maximize Edwards benefits in execution Negotiate higher volume and complex contracts Create successful congress promotional sponsorship strategies and communication plans to maximize Edwards brand presence and exposure to the customer Lead cross functional teams to successful results Lead annual fiscal planning; annual budget preparation, forecasting, analysis, reporting; drive strategies to forecast optimal capex vs. opex spending Other incidental duties and some travel *This is an on-site position based in Irvine, CA What you will need (required): Bachelor's Degree and a minimum of 10 years of related work experience or equivalent work experience based on Edwards criteria Required or Master's Degree or equivalent and minimum 8 years of related experience working in sales, marketing, or healthcare industry or equivalent work experience based on Edwards criteria Required What else we look for (preferred): Certified Meeting Professional (CMP) or Certified Meeting Professional healthcare subspecialty (CMP-HC) Preferred Proven successful project management skills Proven expertise in Microsoft Office Suite and Project Management applications Experience with Cvent Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Recognized as an expert in own area with specialized depth within the organization Expert understanding of related aspects of marketing concepts and principles Expert knowledge and understanding of policies, procedures, and guidelines relevant to strategic event planning Expert knowledge and understanding expertise in event management strategies: speaker management, content development, attendee/invite strategies Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast-paced environment Represents leadership on projects within a specific area working closely with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management Consult in project setting within specific marketing area Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. **You will make an impact by...** + Collaborating with internal and external stakeholders to execute strategic initiatives, gather insights, and share scientific knowledge with healthcare providers and societies, driving toward an elevated standard of care and improving access to innovative, life-saving technologies. + Driving strategic initiatives as a key facilitator, thought leader, and internal project manager. + Executing societal sponsorship engagements through strong relationships with society leaders and ideations. + Expanding and strengthening relationships with healthcare providers while exploring collaborations. + Planning key advisory board activities with subject matter experts. + Supporting integrated evidence planning to ensure alignment with strategic focus areas. + Managing needs assessment, planning, development, and approval of select scientific materials. + Driving conference planning, including conversations with healthcare providers and societies. + Building executive presentations and clearly communicating strategic initiatives and insights. + Developing and expanding internal cross-functional relationships to drive toward collective goals. + Handling incidental duties. **What you'll need (Required):** + Bachelor's Degree plus 10 years of related work experience in life sciences Or + Master's Degree or equivalent plus 8 years of related experience in life sciences + Able to travel domestically up to 30%, including conferences and meetings at the Edwards main campus in Irvine, California. **What else we look for (Preferred):** + Excellent written and verbal communication skills, and interpersonal relationship skills, including consultative and relationship management skills + Organized and efficient project management skills with proven expertise in Microsoft Office Suite, including PowerPoint, Word, Excel, Teams, and CoPilot + Strategic thinker with strong problem-solving, critical thinking, and investigative abilities, including ability to review, distill, and communicate key information clearly + Proactive connector skilled at engagement with healthcare providers and professional societal leaders + Confident collaborator able to interact with senior internal and external stakeholders on assigned projects + Ability to thrive in a team environment with cross-functional collaborators + Substantial knowledge and understanding of medical affairs policies, procedures, and guidelines, including medical-legal review policies and procedures + Well-versed in healthcare provider policies and regulations + Highly knowledgeable in regulatory, compliance, and AdvaMed requirements Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Drive Scientific Impact at the Forefront of Innovation. Patients are at the heart of everything we do. As a key member of our Medical Affairs team, you will drive the strategic direction of our Transcatheter Heart Valve (THV) evidence generation and dissemination efforts-shaping the future of structural heart disease treatment through science, collaboration, and innovation. Your work will directly influence how life-saving data is created, shared, understood, and applied across the global medical community. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. **You will make an impact by:** + Transforming Lives. Advancing Science. Leading with Purpose. + Leading Strategy & Execution: Spearheading the planning and operations of the THV Podium & Publication (PnP) Committee, aligning cross-functional teams to deliver high-impact scientific projects. + Delivering Executive Insights: Developing compelling, executive-level presentations and reports that simplify complexity and drive actionable outcomes for senior leadership. + Driving Evidence Planning: Collaborating with internal and external stakeholders to shape and execute a robust evidence generation roadmap that supports the overall THV business strategy. + Championing Investigator-Initiated Studies (IIS): Contributing to the IIS program by aligning research priorities with business strategy; serving as a thought partner to investigators and providing input to study designs, abstracts, and manuscripts. + Fostering Scientific Collaboration: Building and strengthening relationships with leading physicians, researchers, and thought leaders to advance shared goals in structural heart diseases. + Elevating Scientific Presence: Anticipating key data releases and ensuring strategic visibility at global congresses and podiums. + Supporting the Medical Affairs Team: Performing other duties as assigned by leadership. **What you'll need (Required):** + Bachelor's Degree in related field Plus 10 years of related work experience + Advanced degree (e.g., Masters, PhD, MD) in related field Plus 8 years of related experience + Ability to travel up to 10% (Domestic) + This role is posted as Hybrid in Irvine, CA, but we are open to considering highly qualified candidates for a remote U.S. arrangement, provided they can meet the travel requirement: up to 30% domestic travel, including regular visits to our Irvine headquarters. **What else we look for (Preferred):** + Holding an advanced degree (e.g., Master's, PhD, MD) in a related field + Thinking strategically with strong analytical and problem-solving capabilities + Demonstrating excellent Microsoft PowerPoint skills + Showing proven project management expertise and proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams, CoPilot) + Possessing working knowledge of clinical research methodologies and statistical principles + Exhibiting exceptional communication and relationship-building skills + Maintaining strict attention to detail and excellent follow-up + Adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries to self and others, as well as protecting the environment and preventing pollution within your span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will make an impact by... * Collaborating with internal and external stakeholders to execute strategic initiatives, gather insights, and share scientific knowledge with healthcare providers and societies, driving toward an elevated standard of care and improving access to innovative, life-saving technologies. * Driving strategic initiatives as a key facilitator, thought leader, and internal project manager. * Executing societal sponsorship engagements through strong relationships with society leaders and ideations. * Expanding and strengthening relationships with healthcare providers while exploring collaborations. * Planning key advisory board activities with subject matter experts. * Supporting integrated evidence planning to ensure alignment with strategic focus areas. * Managing needs assessment, planning, development, and approval of select scientific materials. * Driving conference planning, including conversations with healthcare providers and societies. * Building executive presentations and clearly communicating strategic initiatives and insights. * Developing and expanding internal cross-functional relationships to drive toward collective goals. * Handling incidental duties. What you'll need (Required): * Bachelor's Degree plus 10 years of related work experience in life sciences Or * Master's Degree or equivalent plus 8 years of related experience in life sciences * Able to travel domestically up to 30%, including conferences and meetings at the Edwards main campus in Irvine, California. What else we look for (Preferred): * Excellent written and verbal communication skills, and interpersonal relationship skills, including consultative and relationship management skills * Organized and efficient project management skills with proven expertise in Microsoft Office Suite, including PowerPoint, Word, Excel, Teams, and CoPilot * Strategic thinker with strong problem-solving, critical thinking, and investigative abilities, including ability to review, distill, and communicate key information clearly * Proactive connector skilled at engagement with healthcare providers and professional societal leaders * Confident collaborator able to interact with senior internal and external stakeholders on assigned projects * Ability to thrive in a team environment with cross-functional collaborators * Substantial knowledge and understanding of medical affairs policies, procedures, and guidelines, including medical-legal review policies and procedures * Well-versed in healthcare provider policies and regulations * Highly knowledgeable in regulatory, compliance, and AdvaMed requirements Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manager of Corporate Strategy position is a unique career opportunity that could be your next step towards an exciting future. Drive Edwards' strategic advantage by transforming external signals-competitors, markets, technologies, policy-into timely, decision‑ready insights that inform enterprise strategy, portfolio bets, and ELT discussions. How you'll make an impact: Run targeted primary and broad secondary competitive intelligence for the corporate strategy team Stand up and iterate CI dashboards (e.g., Power BI/Tableau) and automated pipelines for news, trials, and KOL/patent data Build and run an enterprise “early‑signal” system spanning competitors, pipeline moves, clinical data, regulatory milestones, pricing/reimbursement, M&A/partnerships, and adjacent tech. Stand up alerting, tagging, and impact triage so the right leaders see the right signal at the right time. (Newsletter + real‑time alerts model) Maintain living competitive landscapes and scorecards; refresh pre‑ELT/Board cycles and major portfolio gates Lead congress/earnings‑season coverage with fast, BLUF readouts and implications for Edwards Create crisp, executive‑ready narratives (PowerPoint + live briefings) that translate complex dynamics into clear options and recommendations; tailor for ELT, BUs, regions, and functional partners Collaborate across functions, regions, and BUs on Enterprise risks and opportunities Other incidental duties What you'll need (Required): Bachelor's Degree or Equivalent in a scientific, technical, or quantitative field with 10 years of related work experience, or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree or equivalent plus 8 years of related work experience required and 5 years experience direct experience in strategy, management consulting, business development, or marketing and sales Ability to synthesize complex information into a high-level strategic message, and to interpret internal/external business factors into recommendations and solutions Demonstrated experience working with a range of professionals to help navigate through complex situations Proficiency in PowerPoint/Excel; comfort with data tools (Power BI/Tableau; GenAI/Agentic AI models a plus) Proven expertise in clinical and financial comprehension, and live presentations, with high attention to detail and output Excellent problem-solving, organizational, analytical and critical thinking skills Recognized as an expert in own area with specialized depth and breadth of expertise within area of work in the organization Expert understanding and interpretation of complicated market dynamics with the ability to identify and quantify market potential, and build business case with both business and financial analysis skills Expert understanding of related aspects of processes and/or systems Ability to listen to stakeholders, discover unmet needs, develop strong rapport with audience, and be customer-focused Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast paced environment Ability to represent leadership on projects on sections of projects within a specific area interfacing with project managers and cross-functional teams Ability to consult in project setting Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Drive Scientific Impact at the Forefront of Innovation. Patients are at the heart of everything we do. As a key member of our Medical Affairs team, you will drive the strategic direction of our Transcatheter Heart Valve (THV) evidence generation and dissemination efforts-shaping the future of structural heart disease treatment through science, collaboration, and innovation. Your work will directly influence how life-saving data is created, shared, understood, and applied across the global medical community. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. **You will make an impact by:** + Transforming Lives. Advancing Science. Leading with Purpose. + Leading Strategy & Execution: Spearheading the planning and operations of the THV Podium & Publication (PnP) Committee, aligning cross-functional teams to deliver high-impact scientific projects. + Delivering Executive Insights: Developing compelling, executive-level presentations and reports that simplify complexity and drive actionable outcomes for senior leadership. + Driving Evidence Planning: Collaborating with internal and external stakeholders to shape and execute a robust evidence generation roadmap that supports the overall THV business strategy. + Championing Investigator-Initiated Studies (IIS): Contributing to the IIS program by aligning research priorities with business strategy; serving as a thought partner to investigators and providing input to study designs, abstracts, and manuscripts. + Fostering Scientific Collaboration: Building and strengthening relationships with leading physicians, researchers, and thought leaders to advance shared goals in structural heart diseases. + Elevating Scientific Presence: Anticipating key data releases and ensuring strategic visibility at global congresses and podiums. + Supporting the Medical Affairs Team: Performing other duties as assigned by leadership. **What you'll need (Required):** + Bachelor's Degree in related field Plus 10 years of related work experience + Advanced degree (e.g., Masters, PhD, MD) in related field Plus 8 years of related experience + Ability to travel up to 10% (Domestic) + This role is posted as Hybrid in Irvine, CA, but we are open to considering highly qualified candidates for a remote U.S. arrangement, provided they can meet the travel requirement: up to 30% domestic travel, including regular visits to our Irvine headquarters. **What else we look for (Preferred):** + Holding an advanced degree (e.g., Master's, PhD, MD) in a related field + Thinking strategically with strong analytical and problem-solving capabilities + Demonstrating excellent Microsoft PowerPoint skills + Showing proven project management expertise and proficiency in Microsoft Office Suite (PowerPoint, Excel, Word, Teams, CoPilot) + Possessing working knowledge of clinical research methodologies and statistical principles + Exhibiting exceptional communication and relationship-building skills + Maintaining strict attention to detail and excellent follow-up + Adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking adequate control measures to prevent injuries to self and others, as well as protecting the environment and preventing pollution within your span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society. The Opportunity Our Data, Analytics, and AI team (DDA) empowers business partners to make impactful decisions with data and AI/ML. We unify understanding of patient experience and outcomes by integrating insights into digital platforms, creating scalable solutions. As a trusted advisor, you'll drive measurable impact within a collaborative and innovative culture.. The Sr. Manager, Data Strategy & Acquisition is responsible for developing a comprehensive strategy to build a differentiated data ecosystem that delivers maximum business impact. This role also oversees the integrity and effectiveness of data acquisition processes. It involves leading the strategic planning and execution of data acquisition initiatives and collaborating with cross-functional stakeholders to define standards, priorities, and a roadmap for strategic data acquisition. Define and evolve CMG's data strategy and roadmap, aligning with business needs and data products. Develop and refine data acquisition strategies across CMG, ensuring consistency with business objectives and overall data strategy. Architect and execute end-to-end data acquisition, including assessment, ingestion, and integration, for all CMG business domains. Advise CMG and product leadership on data acquisition risks, opportunities, and priorities, including third-party contracts and governance. Oversee strategic vendor relationships, negotiating data agreements and ensuring compliance with governance policies. Manage and coordinate an offshore team, and develop/implement data acquisition frameworks to ensure data quality and optimize workflows. Define KPIs, monitor implementation, and stay informed on emerging data trends to drive continuous improvement and innovation. Who You Are Bachelor's degree in Data Science, Information Systems, Business Analytics, Computer Science, or a related field. 5 years of experience in data acquisition, data strategy, data governance, or related roles. Demonstrated success defining and implementing data acquisition policies, practices, and operations while balancing business agility and compliance. Working knowledge of FAIR data principles and big data technologies. Preferred Advanced degree or equivalent experience (e.g., MBA or related graduate-level qualification). Experience working in cross-functional teams within commercial, medical, and market access functions. Experience leading large-scale data acquisition projects and initiatives. Proficiency in agile methodologies for data acquisition processes. Strong stakeholder management and cross-functional collaboration skills across analytics, business, and IT. Excellent problem-solving, communication, and change management abilities, including driving experimentation and optimization. Strong knowledge of big data/database technologies (SQL, relational/non-relational, cloud platforms like AWS, GCP, Azure). Expertise in key pharma and healthcare data sources/vendors (IQVIA, claims, Veeva, SFDC, EHR), coupled with strong budget management and adaptability in ambiguous environments. This position is based in South San Francisco, CA and offers a hybrid schedule working 3 days per week in the office. Relocation Assistance is not available for this posting. The expected salary range for this position based on the primary location in California is $150,700 - $279,900. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. US Medical, part of Genentech, is passionate about delivering on Our Promise to improve the lives of patients. We foster a culture of inclusivity, integrity, and creativity while boldly pursuing answers to the world's most complex health challenges. To achieve this, Genentech has identified establishing world-class digital medical capabilities as a key priority. The Opportunity We're looking for a Strategy and Insights Enablement Lead to digitally transform our medical organization. This role is key to driving strategy and insights generation using digital and AI tools. You'll act as the bridge between business needs and product development, defining feature roadmaps and leading crucial change management efforts for adoption. Success requires close collaboration with USM and CMG partners to align on a shared vision, evolve our systems architecture, and integrate cutting-edge medical analytics to inform USM strategy. Key Responsibilities Strategic Insights & Data Leadership Lead the execution of US Medical's insights strategy, generating actionable insights from diverse sources, and spearhead a transformative digital insights strategy to pinpoint and address care gaps within therapeutic areas. This includes collaborating with stakeholders, leading the productization of the Medical Care Gaps Insights tool, and championing the innovative use of enterprise-wide data, digital tools, and AI to elevate the customer experience and inform USM strategy. Advance Field Medical Insights by implementing a Comprehensive Insights Engine, an end-to-end module enabling dynamic capture of field insights and facilitating efficient, near real-time aggregation, analysis, and reporting. This system will embed AI-generated customized Next Best Actions (NBA) to empower Field Medical in identifying untapped experts, emerging trends, and unmet needs, and inform strategic decisions. Product & Process Enablement Leadership for Strategy and Insights Define clear business needs, prioritize features, and partner with Product Owners on roadmap development and execution, while also conducting thorough reviews and validations of products pre-launch to ensure operational readiness and strategic alignment. Collaborate with stakeholders to design and seamlessly integrate tools into end-to-end medical workflows, lead essential process changes to foster adoption, and inform the overall medical data strategy and governance, ensuring compliant handling of medical data and overseeing the progressive evolution of priority USM insights systems architecture. Execution Excellence Demonstrate cross-functional leadership by influencing and integrating diverse teams without direct authority, and create customer-centric programs and solutions that meaningfully engage customers. Exhibit advanced proficiency in uniting, motivating, evaluating, guiding, and driving teams towards exceptional execution performance against digital insights plans, and provide exceptional leadership in planning and executing projects to address USM's data and information needs, while continuously tracking and optimizing the performance of digital insights initiatives. Who you are Qualifications & Experience Master's or advanced degree. 10+ years of experience in the healthcare industry In-depth understanding of US clinical workflows Expertise in managing and applying healthcare data (RWD, RWE, claims, EHR). Strong knowledge of AI/ML for insights and process automation, along with familiarity with digital health technology (CRM) and data privacy regulations (HIPAA) Preferred Qualifications & Experience A medical degree or prior experience in Medical Affairs is a strong plus. Location & Travel Requirements This position is based in South San Francisco, CA, and offers a hybrid schedule working in the office three days per week. Occasional travel may be required. The expected salary range for this position based on the primary location of South San Francisco, CA is $182,100 - 338,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. Sr. Manager/Associate Director, Quantitative Science SummaryThe Quantitative Science team at BioMarin performs statistics and data science across research and development and beyond.As the Senior Manager or Associate Director of Quantitative Science, you will assume the role of a statistician/data scientist and play a pivotal role in supporting different functional areas. This influential and self-sufficient position will make significant contributions to drug discovery, nonclinical research, preclinical research, experimental medicine, biomarker development, clinical development, post-approval/medical areas, real-world data/real-world evidence (RWD/RWE), genomics, business development, and manufacturing.Your primary responsibility will be to ensure excellence in the design, analysis, interpretation, and communication of data. Additionally, you will actively engage with counterparts to foster collaboration and champion the use of quantitative thinking.The ideal candidate must demonstrate the following qualifications: Broad subject matter expertise in statistics and data science with hands-on experience in application in diverse areas Proficiency in statistics, advanced data science, and programming Ability to develop fit-for-purpose statistical methodologies and software tools is a plus Exceptional communication/interpersonal skills Responsibilities Perform statistical experimental design, analysis, interpretation, and reporting, including for example Estimate sample size and aid in study design including conducting simulations Conceptualize solutions to unique challenges and develop analysis methods and analysis programs accordingly Explore and develop the use of artificial intelligence (AI) and machine learning (ML) Write statistical analysis reports and give presentations Develop statistical applications that enable researchers to analyze repetitive experiments Conduct outreach to internal functions, establishing collaborations and providing education to identify opportunities to apply statistics and data science that positively impact the business Provide guidance and direction to junior staff on the team Education & Experience:M.S. in Biostatistics, Statistics, Data Science, or similar field required.Ph.D. in Biostatistics, Statistics, Data Science, or similar field preferred.Minimum QualificationsYears of experience in pharmaceutical and/or biotech industry: A minimum of 5 (PhD) or 7 (Master's) for associate director; A minimum of 2 (PhD) or 4 (Master's) for senior manager.Preferred Qualifications:Overall: Basic broad knowledge of the research, development, and associated areas in the pharmaceutical/biotechnology field Broad knowledge of statistical methods and ability to solve problems creatively and pragmatically Scientific curiosity and ability to learn Exceptional consultative, conversational, written communication, presenting, collaborative, teaching, and interpersonal skills Adaptability and ability to thrive in a dynamic, diverse, and matrixed environment Statistics and data science: Hands-on knowledge of statistical methods applicable across research and development such as time-to-event analyses, analysis of covariance, mixed models for repeated measures, categorical data approaches, Bayesian methods, simulation approaches, artificial intelligence (AI) and machine learning (ML), graphical methods, etc. Hands-on knowledge of study design and sample size calculation Strong programming skills in at least two of SAS, R, or Python Software tool development: Proficiency in or demonstrated ability to learn developing specifications and designing analysis modules to automate analysis, visualization, and reporting of standardized experiments; proficiency in documenting and supporting such systems Supervisory: Demonstrated ability to lead, motivate, and mentor both internal and contract staff. Effective review and evaluation skills for documents drafted by staff. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

We advance science so that we all have more time with the people we love. The Senior/ Principal Business Manager will serve as a strategic advisor and thought partner to senior leadership within the gRED Translational Medicine organization. This individual will play a critical role in driving cross-functional alignment, enabling business planning and operational excellence, and ensuring the successful execution of strategic priorities. The role requires strong business acumen, systems thinking, and the ability to influence and partner across multiple levels and functions. The Business Manager also enables leadership team effectiveness by shaping agendas, connecting strategic dots, and anticipating organizational needs. With a strong grasp of the enterprise landscape, the Senior Business Manager proactively connects strategic priorities to execution, facilitates sound decision-making, and identifies opportunities to strengthen how the organization operates, collaborates, and delivers impact. The Opportunity: As a valuable member on the Translational Medicine team you will be: Serving as a strategic thought partner to senior functional leaders (Director and Vice President level), providing insights and driving aligned decision-making in support of organizational goals. Leading short- and long-term business planning efforts, including annual planning cycles, resource allocation, budget forecasting, and functional goal setting. Driving leadership team operating rhythm, ensuring effective prioritization, focus, and delivery on strategic objectives. Anticipating emerging needs, risks, and opportunities across the organization and proactively frames options for leadership consideration. Facilitating effective leadership and project team operations-designing and executing agendas, preparing briefing materials, and ensuring clarity of decisions, follow-ups, and outcomes. Connecting the dots across initiatives and stakeholders, identifying interdependencies and proactively addressing risks and opportunities. Synthesizing data and perspectives to support informed decision-making, including preparing pre-reads, strategic recommendations, and decision frameworks for leadership discussions. Driving planning and execution of strategic initiatives and change efforts that support the function's success and alignment with gRED and enterprise priorities. Advising on and contributes to solutions for complex challenges, offering structure, process, and creative thinking to move initiatives forward. Supporting key people and culture activities-such as functional offsites, recognition programs, and engagement initiatives-helping to foster a high-performance, inclusive, and purpose-driven environment. Acting as a connector across teams, promoting collaboration, shared accountability, and alignment toward common goals. Supporting communication strategies to ensure transparency, clarity, and engagement across stakeholders and organizational levels. Bringing a strong enterprise mindset, continuously linking functional goals to broader strategic context and organizational objectives. Who You Are A skilled communicator with strong written, verbal, and presentation abilities-able to synthesize and convey complex information clearly and effectively to diverse audiences. Highly organized, with exceptional program and project management capabilities. Trusted relationship builder who fosters collaboration, psychological safety, and transparency across teams and leadership levels. Agile and resourceful in navigating ambiguity and shifting priorities, with a proactive and solutions-oriented mindset. Adept at identifying process improvements and delivering business impact through operational excellence. Demonstrated experience in business management disciplines such as: Strategic planning Organizational development Project and portfolio management Business process improvement Change management Internal communications and engagement Proven success leading cross-functional initiatives in complex matrixed environments. Background in clinical development, drug development, or translational research is preferred. Strong understanding of enterprise functions, organizational dynamics, and business operations. Formal degree preferred; equivalent training and experience will be considered. Additional training or certification (e.g., PMP, Six Sigma, Design Thinking, Agile) is a plus. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of California for Senior Business Manager is $144,000- $267,400 and Principal Business Manager is $156,500-$290,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #TM Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

At Roche/Genentech, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and making medicines more convenient and accessible to patients while investing in our planet to reduce the carbon footprint. We are fearless in both decision and action. That is why we come to work each day. Who We Are Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche's groundbreaking therapies to millions of patients worldwide. PT is involved in producing every Roche medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche medicines in all disease areas and dosage forms. Pharma Technical Development (PTD) is an integral part of this mission. As an organization of over 2,500 people globally, PTD is responsible for developing the manufacturing processes, products, analytical methods, and Chemistry, Manufacturing & Controls (CMC) strategies to deliver all new products in Roche's pipeline. This work encompasses the full range of development functions, including biologics, synthetic molecules, devices, clinical supply chain management, and project and portfolio management. PTD applies leading technical expertise to design, develop, supply, and register clinical-stage products globally, reliably delivering the pipeline and supporting commercial manufacturing operations. We excel through innovation, collaboration, dedication, and mutual respect, continuously improving what we do to ensure Roche's supply of quality products to patients. We commit ourselves to scientific rigor, technical excellence, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. The Opportunity The Global Head of Project and Portfolio Management will provide strategic and operational leadership for Chemistry, Manufacturing & Controls (CMC) across the R&D organization. You will define and drive the global CMC development portfolio and strategy, ensuring alignment with corporate priorities, scientific innovation, and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders (CMC leaders) responsible for delivering high-quality, timely CMC packages to advance the pipeline from early development through commercialization. Key Responsibilities CMC Strategy & Leadership * Establish and lead the global CMC development strategy in alignment with One Pharma Strategy and R&D Excellence objectives. * Anticipate and integrate industry, regulatory, and scientific trends into CMC approaches and portfolio decisions. * Provide scientific, technical, and business leadership to guide critical CMC development programs. Portfolio Management & Execution * Develop, enhance, and oversee CMC portfolio governance, prioritization, and decision-making processes effectively such as Late Stage Technical Development Committee (LSTDC). * Ensure timely and efficient delivery of CMC packages supporting IND, CTA, IMA/BLA/NDA, and global submissions. * Drive portfolio insight and performance analytics to optimize resource allocation and execution. * Lead the creation and use of standard systems, tools, and processes to enable analysis and management of the technical development portfolio (e.g. 100 people years, RDE DevGo to EIH goal). Project & Program Leadership * Manage CMC strategies, risks, and overall project execution to efficiently deliver robust manufacturing processes and materials within requested timelines and budget * Partner with R&D, regulatory, quality, clinical, and commercial & PT stakeholders to ensure seamless development collaborations and execution. * Champion a culture of operational excellence, accountability, and proactive risk identification and mitigation. Team Leadership & Talent Development * Lead, inspire, and develop a team of technical development leaders (TDLs) delivering the projects by working with functions such as drug substance, drug product, analytical development & quality control, device and delivery, regulatory CMC, manufacturing sciences, and clinical and commercial manufacturing sites. Act as a coach for teams. * Recruit, retain, and develop high-potential talents for the Technical Development Leaders (TDLs) and Project Managers. Foster a high-performing, collaborative, and inclusive culture. * Build organizational capabilities to meet evolving portfolio and industry needs. Leadership Team Contribution * As a member of the PTD leadership team, contribute to the team's high performance, foster cross-functional thinking, and work collaboratively to set priorities for the global organization. Stakeholder Engagement and Communication * Ensure a strong connection to key stakeholders within the broader global project team system (e.g., Lifecycle Teams, gRED & pRED project Teams). * Partner with R&D, regulatory, quality, commercial stakeholders, and Roche Partnering to ensure seamless development transitions and alignment. * Enable open and timely communication with senior management regarding CMC issues and resolutions. Facilitate project status reports, governance committee briefings, and project updates to management. Who You Are * Advanced degree (Ph.D. preferred) in chemistry, biology, engineering, pharmaceutical sciences, or related discipline. * Extensive years of progressive and inspiring leadership in CMC development, manufacturing sciences, or related R&D functions, with proven success and a long track record. * Deep knowledge of global regulatory requirements, product development processes, and CMC and/or product lifecycle management. * Demonstrated ability to grasp the changing and dynamic external environment to shape strategy, manage complex portfolios, and deliver across early and late-stage development. * Exceptional leadership capabilities, excellent communication-, and influencing skills in effective engagement with leaders and stakeholders across R&D and PT. Ability to positively influence colleagues and key decision-makers. * Strong business acumen and collaboration skills, with the ability to balance scientific, operational, and strategic priorities in a global organization. * Experience in team leader development, project portfolio management, and developing business processes and tools to support a global team system. * 15-20% international travel required. Leadership Competencies * Strategic and innovative thinker with a global mindset. * Strong decision-making and problem-solving skills in complex, fast-paced environments. * Track record of building and leading high-performing, inclusive teams, passionate about talent development. * Highly collaborative, able to influence and align across all levels, internal stakeholders, and external partners. * Commitment to quality, compliance, and patient-centric innovation. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

** **_At Roche/Genentech, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and making medicines more convenient and accessible to patients while investing in our planet to reduce the carbon footprint. We are fearless in both decision and action. That is why we come to work each day._** **Who We Are** Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche's groundbreaking therapies to millions of patients worldwide. PT is involved in producing every Roche medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche medicines in all disease areas and dosage forms. Pharma Technical Development (PTD) is an integral part of this mission. As an organization of over 2,500 people globally, PTD is responsible for developing the manufacturing processes, products, analytical methods, and Chemistry, Manufacturing & Controls (CMC) strategies to deliver all new products in Roche's pipeline. This work encompasses the full range of development functions, including biologics, synthetic molecules, devices, clinical supply chain management, and project and portfolio management. PTD applies leading technical expertise to design, develop, supply, and register clinical-stage products globally, reliably delivering the pipeline and supporting commercial manufacturing operations. We excel through innovation, collaboration, dedication, and mutual respect, continuously improving what we do to ensure Roche's supply of quality products to patients. We commit ourselves to scientific rigor, technical excellence, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. **The Opportunity** The Global Head of Project and Portfolio Management will provide strategic and operational leadership for Chemistry, Manufacturing & Controls (CMC) across the R&D organization. You will define and drive the global CMC development portfolio and strategy, ensuring alignment with corporate priorities, scientific innovation, and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders (CMC leaders) responsible for delivering high-quality, timely CMC packages to advance the pipeline from early development through commercialization. **Key Responsibilities** **CMC Strategy & Leadership** + Establish and lead the global CMC development strategy in alignment with One Pharma Strategy and R&D Excellence objectives. + Anticipate and integrate industry, regulatory, and scientific trends into CMC approaches and portfolio decisions. + Provide scientific, technical, and business leadership to guide critical CMC development programs. **Portfolio Management & Execution** + Develop, enhance, and oversee CMC portfolio governance, prioritization, and decision-making processes effectively such as Late Stage Technical Development Committee (LSTDC). + Ensure timely and efficient delivery of CMC packages supporting IND, CTA, IMA/BLA/NDA, and global submissions. + Drive portfolio insight and performance analytics to optimize resource allocation and execution. + Lead the creation and use of standard systems, tools, and processes to enable analysis and management of the technical development portfolio (e.g. 100 people years, RDE DevGo to EIH goal). **Project & Program Leadership** + Manage CMC strategies, risks, and overall project execution to efficiently deliver robust manufacturing processes and materials within requested timelines and budget + Partner with R&D, regulatory, quality, clinical, and commercial & PT stakeholders to ensure seamless development collaborations and execution. + Champion a culture of operational excellence, accountability, and proactive risk identification and mitigation. **Team Leadership & Talent Development** + Lead, inspire, and develop a team of technical development leaders (TDLs) delivering the projects by working with functions such as drug substance, drug product, analytical development & quality control, device and delivery, regulatory CMC, manufacturing sciences, and clinical and commercial manufacturing sites. Act as a coach for teams. + Recruit, retain, and develop high-potential talents for the Technical Development Leaders (TDLs) and Project Managers. Foster a high-performing, collaborative, and inclusive culture. + Build organizational capabilities to meet evolving portfolio and industry needs. **Leadership Team Contribution** + As a member of the PTD leadership team, contribute to the team's high performance, foster cross-functional thinking, and work collaboratively to set priorities for the global organization. **Stakeholder Engagement and Communication** + Ensure a strong connection to key stakeholders within the broader global project team system (e.g., Lifecycle Teams, gRED & pRED project Teams). + Partner with R&D, regulatory, quality, commercial stakeholders, and Roche Partnering to ensure seamless development transitions and alignment. + Enable open and timely communication with senior management regarding CMC issues and resolutions. Facilitate project status reports, governance committee briefings, and project updates to management. **Who You Are** + Advanced degree (Ph.D. preferred) in chemistry, biology, engineering, pharmaceutical sciences, or related discipline. + Extensive years of progressive and inspiring leadership in CMC development, manufacturing sciences, or related R&D functions, with proven success and a long track record. + Deep knowledge of global regulatory requirements, product development processes, and CMC and/or product lifecycle management. + Demonstrated ability to grasp the changing and dynamic external environment to shape strategy, manage complex portfolios, and deliver across early and late-stage development. + Exceptional leadership capabilities, excellent communication-, and influencing skills in effective engagement with leaders and stakeholders across R&D and PT. Ability to positively influence colleagues and key decision-makers. + Strong business acumen and collaboration skills, with the ability to balance scientific, operational, and strategic priorities in a global organization. + Experience in team leader development, project portfolio management, and developing business processes and tools to support a global team system. + 15-20% international travel required. **Leadership Competencies** + Strategic and innovative thinker with a global mindset. + Strong decision-making and problem-solving skills in complex, fast-paced environments. + Track record of building and leading high-performing, inclusive teams, passionate about talent development. + Highly collaborative, able to influence and align across all levels, internal stakeholders, and external partners. + Commitment to quality, compliance, and patient-centric innovation. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .