As a subject matter expert in Medical Affairs, the Senior Medical Director, UK, Ireland & Nordics will oversee all medical initiatives throughout the region and contribute to the development and implementation of global medical affairs strategies. They will provide support to internal colleagues and collaborate closely with the Global & European Medical Affairs teams to ensure high strategic and scientific standards by resolving medical issues and providing critical input in the development of medical documents (publications, external scientific communications, standard response letters, product materials, research ideas, internal training materials, etc.). The Medical Director, under the guidance of the VP of Medical Affairs Europe to whom s/he will be reporting (and dotted line to the UK leader), will ensure strategic partnerships with key external opinion leaders and academic institutions in the UK market, and represent Medical Affairs externally through presentations at advisory boards, key scientific meetings, and interactions with our key investigators.  In addition, the Medical Director will work cross-functionally with other colleagues to provide expertise on varied workstreams, including pre-launch and launch activities related to late-stage assets.

The role is hybrid twice per week in London office. 

Responsibilities

• Serves as an integral component of the Medical Affairs contribution to the regional launch of our late-stage cardiovascular clinical compounds, including:
• Implementation of the Country Plan of Action based on the Global and European Medical Affairs Plan,
• Execution of medical pre-launch and launch activities,
• Education of Cardiovascular HCPs (heart failure and hypertrophic cardiomyopathy) regarding the clinical profile of our CV compounds and their place in therapy
• Can speak to the mechanism of action of the compounds and their development, including Phase I-IV studies, at a detailed scientific level in a reactive conversation with key opinion leaders.
• Provide day‐to‐day medical guidance while working closely on joint projects with other members of the Medical Affairs team, the Countries leadership, other departments internally and our business partners.
• Projects may include scientific congress/conference strategy and planning, advisory boards, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects.
• Represent the company at Medical Congresses and ensure Medical Affairs coverage, including scientific session attendance and reporting, and information booth support.
• Represent the company in patient groups and associations.
• Provide scientific input into publication strategy and review abstracts and posters for presentation at scientific meetings and manuscripts for publication.
• Participate in appropriate cross‐functional and cross‐company Medical and Commercial teams in the UK to inform brand strategies and tactics and represent Medical Affairs.
• Liaise with Global & European Medical Affairs and R&D colleagues to develop and maintain timely and relevant product expertise for the region.
• Provide input into medical education, grant, and sponsorship review.
• Provide clinical and scientific support in responding to inquiries from healthcare professionals.
• Participate as medical reviewer in the Medical Review Committee and the Promotional Materials Review Committee
• Data Generation and Presentation
• Present data at company advisory board meetings and training programs
• Collaborate with R&D and HEOR in data generation projects to address identified medical data gaps for the UK
• Help identify and effectively interact with opinion leaders to engage in scientific exchange to meet the needs of patients and the medical community.
• Collaborate with Market Access and the HEOR function to define research strategy and design of studies, including the generation of real-world evidence and cost-effectiveness analyses.
• Provide support for and collaborate with the field medical teams in the region and support reactive material development to address healthcare professional inquiries.
• Upon initiation of a Phase 4 program, participate in the review and adjudication of investigator-sponsored study research proposals.

Qualifications

• MD/MBBS with strong Medical Affairs experience. Cardiovascular experience preferred, clinical experience desirable. Position will be filled at a Director level (i.e. Director, or Senior Director) commensurate with experience. 7 years of pharmaceutical industry experience preferred.
• Medical Affairs experience in the UK (with particular knowledge of the Country's market) with medicine approvals and peri-launch and launch activities. Ireland & Nordics experience is an advantage.
• Background in academic medicine, clinical research, and familiarity with study design, biostatistics and epidemiology desirable.
• Proven ability to work independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.
• Must be analytical and articulate in both oral and writing skills, possess excellent presentation skills, with a demonstrated ability to communicate well with others at varying professional levels.
• Familiarity with relevant regulatory authorization requirements and other key local authorities in the regional pharmaceutical industry.
• Ability to think broadly about scientific communications and the impact on medical content.
• Business fluent in English. Knowledge of other European languages are a plus.
• Proficiency with Microsoft Office
• Ability to travel within the UK, across Europe, and internationally (~35% of time)

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Job purpose

The role will provide structured assistance across document management, complaints handling, reporting, and general administrative activities. Securing this support will improve operational efficiency, strengthen compliance, and enable QA professionals to focus on high-value quality and oversight responsibilities. The Quality Department operates in a highly regulated environment with increasing demands related to documentation, customer assurance, and quality reporting. QA administrative workload has grown significantly, particularly in areas such as complaints management, CMO scorecard development, and compliance checks.

Responsibilities

The Quality Associate support will initially provide approximately 20 hours per week of support across the following key areas

• Document Creation and Execution Support

• Preparation, formatting, and maintenance of QA documentation within Veeva
• Coordination of document lifecycle activities including review and version control
• Ensuring adherence to internal documentation standards

• Complaints Management Support

• Initiating and tracking of customer complaints
• Supporting data entry, documentation, and follow-up activities
• Assisting in maintaining audit-ready complaint records

• CMO Scorecard Development

• Supporting data collection and consolidation for CMO performance metrics
• Assisting in the preparation and formatting of scorecards and reports
• Maintaining consistency and accuracy in reporting outputs

• Distribution and Quality Disposition Support

• Coordinating distribution of quality-related documents and communications e.g. disposition returns
• Supporting quality disposition processes and maintaining executed record logs e.g Temperature excursions
• Facilitating communication between internal and external stakeholders as needed

• Bona Fide Customer Checks

• Conducting verification checks on customers
• Maintaining accurate and traceable records of compliance activities
• Supporting QA in meeting regulatory and internal compliance requirements

• General Administrative Support (Ad Hoc)

• Event and meeting organization
• Additional administrative duties as required

Qualifications

Required Qualifications

• Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline
• Approximately 5 years of hands-on experience in a life sciences Quality environment (biotech, pharmaceutical, medical device, or regulated healthcare industry)
• Demonstrated experience supporting Quality Assurance (QA) and Quality Management System (QMS) activities
• Strong working knowledge of GxP requirements (e.g., GMP, GDP) and regulated documentation practices
• Proven experience with document creation, formatting, execution, and lifecycle management within an electronic document management system (e.g., Veeva Vault or similar)
• Experience supporting complaints management processes, including documentation, tracking, and maintenance of audit-ready records
• High attention to detail with the ability to maintain accurate, compliant, and traceable records
• Strong organizational and time management skills, with the ability to manage multiple tasks and prioritize effectively in a part-time (approximately 20 hours/week) support role
• Excellent written and verbal communication skills, with the ability to interact professionally with internal and external stakeholders
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), particularly for data consolidation, tracking, and reporting
  
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Therapeutic Medical Scientist (Medical Science Liaison)

Reporting to the Senior Medical Director for Italy, the TMS is a scientific professional who serves as a key field-based scientific resource for healthcare providers, patients, industry partners and internal colleagues. This role will come with high visibility in our company including critical cross-functional relationships across Medical Affairs, Clinical Development / Operations, and Commercial. This role will focus on key opinion leaders and other HCP’s in the hypertrophic cardiomyopathy therapeutic area, but also support pipeline products in development.

Our passion is anchored in rigorous and diligent scientific and clinical approaches to the discovery and development of novel mechanism therapeutics. With gratitude for the commitments and convictions of our employees who are inspired by the courage of patients we aim to serve, we believe Cytokinetics will continue to be a pioneering, values-driven, sustainable, fully integrated biopharmaceutical company.

Role and Responsibilities:

• Identify national, regional, and local Key Opinion Leaders (KOLs) involved in the provision of cardiovascular care within institutional care centres and engage them in proactive and reactive scientific exchange
• Maintain and enhance existing scientific collaboration and professional relationships with hospital-based HCPs within a defined geography (physicians, genetic counselors, hospital teams, investigators, etc..) involved in the therapeutic management of patients with cardiac diseases to expand research, advisory, and educational partnership opportunities; identify areas of unmet medical need; and assure thoughtful exchange of current medical information related to products in development and therapeutic areas of importance
• Serve as a scientific expert at key medical and scientific conferences, clinical investigator meetings, internal meetings, and patient advocacy group meetings
• Maintain a high-level of scientific knowledge and understanding about disease state, underlying science, treatment guidelines, available treatment agents and options, as well as other relevant therapies under development
• Maintain a superior understanding of current trends in clinical research, competitive developments, patient care, and their impact on Cytokinetics’ medical strategies
• Ensure prompt intake and responses for medical information, requests for Medical Affairs support and PV.
• Work with Medical Affairs and other internal colleagues on initiatives including medical information, publications, medical education, grants, speaker training, and other educational programs both within the country and internationally
• Generate Field Medical Affairs plans to identify collaborative opportunities with KOL’s and institutions, review scientific program of relevant conferences, attend sessions, support exhibit booth operations, and contribute to a timely written conference report summarizing key information, activities, and competitive intelligence to colleagues
• Provide support to our clinical development programs by serving as a key point of contact for company-sponsored trial investigators, investigator-initiated research, and registries consistent with company objectives and regulations
• Support and collaborate with the Local Sales Team in alignment with the Medical Plan and local requirements
• Contribute to build up the Account Planning by providing to the local Sales Team the required medical insights
• Provide initial and ongoing disease and product training to internal and field personnel.
• Identify congresses and scientific national and international meetings that are interesting and relevant to attend. Review scientific program of relevant conferences, attend sessions, support exhibit booth operations, and contribute to a timely written conference report summarizing key information, activities, and competitive intelligence to colleagues
• Accurate and timely documentation of activities within applicable company databases and platforms

In addition to above, for Senior Therapeutic Medical Scientist:

• Mentor, train and support other Therapeutic Medical Scientists
• Provide scientific training on key relevant data to Key Account Managers and other business colleagues as required
• Provide strategic input and execute region-specific plans to achieve KOL engagement goals and Medical Affairs departmental goals
• Pursue projects independently with a high degree of quality and timely execution
• Contribute to / lead Congress Planning activities
• Maintain a complete awareness of and understanding about current “real world” clinical practices, HEOR drivers, and emerging trends in treatments/medicine
• Establish relationships with key executive leadership colleagues across Cytokinetics and connect external parties with appropriate leadership team members

Qualifications

• Advanced clinical or scientific degree (BSc, MSc, BPharm, MPharm, PhD, BM BS or equivalent) preferred
• Minimum of 2-5 years of MSL experience for Snr. MSL.  Experience in cardiovascular therapy area and / or hypertrophic cardiomyopathy is preferable. Experience in heart failure is beneficial but not required. Final position level will be determined based on overall experience
• Must be analytical and articulate in both oral and written communications, possess excellent presentation skills, with a demonstrated ability to communicate well with external stakeholders and all internal levels of the organization
• Must possess knowledge of the Medical Science Liaison roles and responsibilities and understand compliance within the ABPI Code Standards, AIFA and Farmaindustria rules & regulations for Interactions with Italian Healthcare Providers and all other company policies, rules and regulations
• Comply with all credentialing requirements for any healthcare institution which is part of the Medical Science plan, including, among other things, routine background checks, medical testing or proof of immunisations, training on facility policies, and adherence to confidentiality and/or other agreements
• Proficiency with Microsoft Office and web-based applications
• A valid Driver’s License and good driving record are required
• Ability to travel both domestically (~30%-50%) and internationally on occasion (TBD)
  
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We are seeking an experienced Director of Quality Assurance, Alliance Management to join our growing global organization. As Cytokinetics expands through strategic in-licensing partnerships with regional market leaders, this role will be critical in ensuring that all quality and compliance aspects of these partnerships are effectively established and maintained.

This position will lead and coordinate Quality Assurance activities across partner relationships, ensuring alignment with global regulatory requirements and internal standards. The successful candidate will act as a key liaison between Cytokinetics and its partners, supporting both the onboarding of new alliances and the ongoing management of established collaborations.

The role reports to the Head of Quality Assurance Operations and works closely with Alliance Management, Technical Operations, Regulatory CMC, and other cross-functional teams.

Key Responsibilities

• Serve as a core member of the QA Operations team and Point of Contact (POC), coordinating quality requirements arising from partnership activities, in partnership with alliance management teams
• Lead and manage all Quality Assurance activities related to the onboarding of new partners
• Develop scalable frameworks, models, and processes for partner onboarding and QA integration
• Act as the lead for partner-related Quality Assurance audits
• Develop standards for Quality Agreements supporting in-licensing partnerships in collaboration with Quality Compliance
• Review and approve (as applicable) change controls, deviations, investigations, procedures, and CAPAs related to partner supply
• Participate in Quality Management Review meetings, providing input on partnership-related quality topics
• Collaborate with Quality Systems and Compliance to ensure the QMS meets market-specific regulatory requirements associated with partnerships
• Ensure timely and effective resolution of quality issues related to product supply for partners
• Conduct risk assessments and implement appropriate controls when onboarding new partners
• Partner with Technical Operations, Regulatory CMC, and other functions to ensure GMP compliance across new markets and partnerships
• Support review of Product Quality Reviews (PQRs) as part of partner oversight
• Represent the QA function in cross-functional and external meetings, making decisions within scope of responsibility
• Promote a culture of quality, compliance, and continuous improvement across the organization
• Identify and lead initiatives to enhance quality systems, processes, and practices

Qualifications & Experience

• Bachelor’s degree (BSc) or higher in a relevant scientific discipline
• Minimum of 10 years’ experience in pharmaceutical or biopharmaceutical manufacturing and quality functions
• Strong knowledge of global cGMP regulations and emerging regulatory trends
• Experience in a biopharma or pharmaceutical start-up environment,
• Preference for experience hosting regulatory inspections and/or partner/client audits
• Demonstrated ability to influence and collaborate effectively across all organizational levels
• Experience working with external partners, alliances, or contract organizations
• Strong ability to work independently, demonstrating initiative and sound judgment
• Excellent organizational skills with the ability to manage multiple priorities effectively
• Strong written and verbal communication skills
• Proficiency in Microsoft Office applications
• Fluency in English; additional language(s) are an advantage
• Willingness to travel up to 15% annually
  
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Cytokinetics is dedicated to upholding the highest standards of excellence to bring potential medicines to patients to improve outcomes and quality of life. We are looking for Regulatory Affairs professionals who bring a strategic mindset and a deep understanding of the regulatory environment. As a member of the team, you will play a crucial role in ensuring our processes meet regulatory requirements while maintaining high standards of compliance.

Cytokinetics is seeking an experienced Director, Regulatory Affairs Europe to join the Regulatory Affairs team in Europe. He/she will provide leadership in developing and executing best in class regulatory strategies for assigned programs in the European region. The Director will lead regulatory activities related to the submission of Marketing Authorization Applications of assigned Cytokinetics products in Europe  as well as implementation of post-marketing requirements.

The Director, Regulatory Affairs Europe will work closely with the Global Regulatory Lead and be a member of the Global Regulatory Team. He/she will work cross-functionally including with Clinical Research, Medical Affairs, Drug Safety, Quality, Market Access and with country operations to ensure all regional and local regulatory requirements are met.  

The Director will also maintain awareness of the regulatory environment and communicate the impact of changes on business and product development programs.

This position offers a temporary contract till end of the year, with possibility of extension. The work set up is hybrid, with 2-3 days per week in our centrally located Zug office, and the rest of the time from home.

Responsibilities

• Develop a robust European strategy for specific products aligning with the Global regulatory strategy and cross functionally identify the best strategy that will lead to European approval.
• Contribute and independently execute the filing plans for Europe in line with corporate, regional and local business objectives.
• Ensure high-quality regulatory submissions are made on time and meet Cytokinetics requirements.
• Collaborate with the Regulatory Study Lead to review and provide strategic input/advice to EU CTR submissions and/or queries.
• As part of the Global Regulatory Team (GRT), provide direction and expertise on regional and local regulatory mechanisms to optimize product development
• Provide strategic and operational contributions to EMA/national agencies interactions and their preparation
• Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Cytokinetics products and discuss their implications with business.
• Oversees regulatory-related launch and post-marketing activities in the EU:
• Provides regulatory input to market access strategy and HTA plans and submissions in the EU
• Ensures all post-marketing requirements and maintenance activities are met.
• Work closely with the Quality department on relevant regulatory procedures applicable to the European region

Qualifications

• Seasoned professional with a minimum of 10 years of relevant experience with a solid expertise and knowledge of the applicable European regulatory regulations, directives and guidelines.
• Bachelor of Science in a scientific discipline, Pharm D (/Pharmacist) or PhD preferred. Fluency in English, and any other key EU market languages are an advantage.
• Proven track record of directly leading Marketing Authorization Applications through EMA centralized procedure and national agencies (including Switzerland and UK). Experience in international markets is advantageous.
• Strong experience leading or participating in regulatory agency interactions.
• Solid foundation in science obtained through academics and business experience.
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Strong interpersonal capabilities and ability to build and maintain networks.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.

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Job purpose

As the Associate Director, External Manufacturing and Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within Manufacturing and External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Director, External Supply Operations.

Responsibilities

• Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues
• Ensure timely and effective execution of all manufacturing and supply plans at assigned CMO’s
• Develop and manage production processes to support operational execution, including BOM’s, specifications, CAPA’s, change controls, master data, and artwork. Familiarity with ERP/MRP systems
• Support logistics, transportation and import/export activities
• Act as the manufacturing and supply chain representative for review and approval of documentation including but not limited to batch records, BOM’s, specifications, artwork, and change control
• Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls
• Play a key role in supporting selection and onboarding of new CMOs, technical transfers, operationalizing product supply and site establishment
• Manage and track inventory, perform inventory reconciliations, and support month end close process.
• Issue purchase orders, and track invoices and budgets
• Maintain production schedules and track batch record execution in coordination with Quality
• Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation
• Proven risk management acumen with a continuous improvement mindset
• Where necessary, provide input to the manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
• Build and maintain strong partnerships and provide effective communication with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded
• Responsible for scheduling and maintaining routine business operations meetings with CMO’s
• Support Regulatory submissions and CMC as required

Qualifications

Education & Core Experience

• BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired
• 10+ years’ combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry
• cGMP career experience embedded in a pharmaceutical manufacturing plant is essential – with first-hand knowledge of plant operations, with the insight to assess performance, and diagnose issues directly at the source
• Technical background with knowledge of engineering and pharmaceutical manufacturing processes in small molecules is required, and experience in DS/API production is desirable
• Excellent problem-solving skills, with the ability to address complex challenges under time pressure
• Demonstrated expertise in risk management, with a history of successfully implementing risk mitigation strategies
• Hands-on investigations/RCA (OOS/OOT/deviations) and continuous improvement at external sites
• The ability to function in a fast-paced, high-growth, entrepreneurial environment
• Ability to travel domestically and internationally ~25%
• Position requires a strong working knowledge and understanding of both regional and international regulations by government agencies affecting the pharmaceutical industry (CFR's, EU GMP, ICH)
• Timely and effective communication across multiple audiences, both verbally and in writing
  
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Job purpose

We are seeking a Director of Packaging & Artwork Management to lead the strategy, systems, and execution of artwork lifecycle management. Reporting to the VP of External Manufacturing, this role will build inspection-ready, scalable, and fit-for-purpose artwork capabilities, with a strong emphasis on Global market requirements. This role is accountable for establishing end-to-end artwork management, including system selection and validation, intake and workflow design, lifecycle processes, and regulatory alignment. The leader will operate in a fast-paced, resource-constrained environment, balancing compliance, speed, and efficiency while supporting global commercialization.

Responsibilities

Artwork Strategy & Systems

• Define and implement a scalable global artwork strategy aligned to company growth.
• Lead selection, validation, and deployment of Artwork Management Systems (AMS), including:
• Ensure systems are GxP-compliant, right-sized, and integrated with Regulatory, Quality, and ERP platforms as appropriate.

Intake, Triage & Workflow Management

• Establish a centralized intake and prioritization model for artwork requests across products and markets.
• Implement governance and prioritization frameworks (launches, lifecycle changes, safety updates).
• Deploy tracking tools and dashboards to provide visibility into timelines, risks, and bottlenecks.
• Align artwork demand with regulatory submissions and manufacturing schedules.

Artwork Lifecycle Management

• Design and implement end-to-end processes (creation, review, approval, change control).
• Enable efficient cross-functional workflows that minimize cycle time while ensuring compliance.
• Establish version control, audit trails, and documentation to support inspection readiness.
• Oversee mock-ups and concept artwork for regulatory and internal use.

Safety & Time-Critical Labeling Updates

• Build lean, rapid-response processes for safety-driven labeling updates.
• Ensure accelerated execution while maintaining full compliance.
• Coordinate with Regulatory, Pharmacovigilance, and Manufacturing to support timely multi-country implementation.

Packaging & External Manufacturing Integration

• Partner with External Manufacturing and CMOs to ensure artwork is production-ready.
• Align artwork processes with packaging operations, supply timelines, and launch readiness.
• Provide oversight to artwork vendors and packaging partners to ensure quality and consistency.

Compliance, Quality & Continuous Improvement

• Establish and maintain GMP-compliant SOPs, policies, and workflows.
• Ensure all activities are inspection-ready and aligned with global expectations.
• Drive improvements in cycle time, right-first-time performance, and process simplicity.

Leadership & Performance Management

• Act as the artwork and labeling SME across Regulatory, Quality, Supply Chain, and Commercial.
• Define and track KPIs (cycle time, approval timelines, right-first-time, on-time delivery).
• Manage budget and vendors with a focus on cost-effective, scalable solutions.

Qualifications

Required Experience

• Bachelor’s degree preferred
• 10+ years in pharmaceutical packaging, labeling, and artwork management within a GxP environment
• Demonstrated experience building artwork intake, triage, and tracking processes in fast-paced environments
• Track record of success implementing end-to-end artwork lifecycle management
• Proven success in managing time-critical labeling and safety updates and selecting and deploying validated AMS platforms

Leadership Capabilities

• Proven ability to build scalable processes from the ground up
• Strong stakeholder management and decision-making skills
• Ability to simplify complexity and drive execution in resource-constrained settings
  
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Job purpose

As a Manager, External Manufacturing and Supply Operations, you are responsible for the end-to-end technical and operational oversight of external manufacturing and supply activities across a network of Contract Manufacturing Organizations (CMOs). This role sits at the core of Manufacturing and External Supply Operations and requires a strong technical foundation, the ability to manage multiple concurrent priorities, and to operate effectively in a fast-paced, ambiguous environment.

This position places particular emphasis on batch record review and approval, process oversight, and technical decision-making, ensuring that manufacturing activities are executed in full compliance with cGMP standards and aligned with global supply requirements.

You will collaborate cross-functionally with Quality Assurance, Technical Operations, Regulatory Affairs, and Supply Chain to ensure robust, compliant, and reliable supply for both clinical and commercial products. You will report to the Director, External Supply Operations.

Responsibilities

• Build and maintain strong, technically credible relationships with external CMOs and internal cross-functional stakeholders
• Provide hands-on technical oversight of manufacturing operations at CMOs, ensuring adherence to validated processes, regulatory expectations, and internal standards
• Own and lead the review and approval of batch records, ensuring accuracy, completeness, and compliance with cGMP and product specifications
• Act as the technical authority for batch disposition readiness and support, identifying and resolving issues that may impact product quality or release timelines
• Ensure prompt execution of manufacturing and supply plans, proactively identifying risks and implementing mitigation strategies
• Drive investigation and resolution of deviations, OOS/OOT events, and product complaints, including leading or supporting root cause analysis (RCA) and CAPA development
• Provide technical input and oversight for change controls, ensuring appropriate impact assessments and alignment with regulatory filings and process validation state
• Develop and support deep understanding of manufacturing processes (API, Drug Product, and Packaging) to enable effective troubleshooting and continuous improvement
• Review and approve technical documentation, including but not limited to:
  
  
  • Batch manufacturing and packaging records
  • Specifications and master data
  • Validation protocols and reports (IQ/OQ/PQ)
  • Stability protocols and reports
  • Change controls and deviations
    
    
• Support process validation and ongoing process verification, ensuring continued state of control at CMOs
• Play a key role in technology transfers, process scale-up, and site onboarding, ensuring technical robustness and successful execution
• Partner with Quality and CMO teams to monitor batch execution in real time, ensuring proactive issue identification and resolution
• Ensure effective management of BOMs, master data, and ERP/MRP systems to support accurate production planning and execution
• Lead or participate in routine governance and operational meetings with CMOs, driving accountability and performance improvements
• Support regulatory submissions and CMC activities, ensuring technical accuracy and consistency with manufacturing processes
• Maintain oversight of inventory, production schedules, and supply continuity, ensuring alignment with demand and minimizing supply risk
• Drive a continuous improvement culture, identifying opportunities to enhance process robustness, reduce deviations, and improve right-first-time performance

Qualifications

Education & Core Experience

• BS/BA Degree in Life Sciences, Engineering, or related discipline desirable
• 10+ years’ experience across pharmaceutical manufacturing, technical operations, or external supply in a regulated environment
• Strong cGMP manufacturing experience within a pharmaceutical plant environment, with direct exposure to shop-floor operations and batch execution
• Demonstrated expertise in batch record review and approval, with a deep understanding of critical process parameters, in-process controls, and data integrity
• Proven experience working with external CMOs, providing technical oversight and driving performance in outsourced manufacturing environments
• Strong technical knowledge across Drug Product, API, and Packaging operations, with the ability to troubleshoot complex manufacturing issues
• Hands-on experience in deviation management, investigations (OOS/OOT), and CAPA implementation
• Solid understanding of process validation, lifecycle management, and continued process verification
• Experience supporting or leading technology transfers and process scale-up activities
• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH, EU GMP)
• Experience with ERP/MRP systems and manufacturing data structures (BOMs, master data)
• Proven ability to apply risk management principles and make sound technical decisions under pressure
• Excellent communication skills, with the ability to clearly articulate complex technical issues to diverse stakeholders
• Ability to operate effectively in a fast-paced, high-growth environment, managing multiple priorities simultaneously
• Willingness to travel (~25%) to support CMO oversight and on-site technical activities
  
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As part of the Commercial organization, this role plays a key role in driving the marketing strategy and execution for innovative cardiovascular therapies across France & Benelux. Reporting to the Head of Commercial France & Benelux, the position combines strategic contribution with strong operational leadership to support successful product launches and sustainable brand growth.

The role works in close partnership with cross-functional teams including Medical Affairs, Regulatory, Market Access, and Sales, as well as with Global and Regional Marketing counterparts. The incumbent contributes to the adaptation and evolution of brand strategy, ensures effective omnichannel execution, and supports business performance while maintaining full compliance with internal and external requirements.

Key Responsibilities

• Lead the development, adaptation, and delivery of local marketing strategies and plans in alignment with global and regional brand frameworks.
• Contribute to the evolution of brand positioning, value propositions, and lifecycle priorities by integrating local market insights, competitive intelligence, and customer needs.
• Build and steer comprehensive pre-launch, launch and post-launch plans, ensuring cross-functional alignment, planning and execution readiness.
• Translate scientific and clinical data into clear, compelling, and differentiated customer narratives.
• Drive omnichannel engagement initiatives to effectively engage healthcare professionals through digital platforms, congresses, and face-to-face interactions.
• Partner with Sales leadership to support field force enablement, including training on brand strategy, campaigns, and tools.
• Lead market research activities and competitive analysis to inform both tactical decisions and forward-looking planning.
• Act as a key partner to Medical Affairs, Regulatory, Market Access, and Sales teams to ensure integrated, compliant brand execution.
• Serve as a primary interface with Global and Regional Marketing teams, providing local market input and contributing to broader strategic discussions.
• Manage relationships with external agencies, media partners, and event organizers to ensure high-quality delivery aligned with brand objectives.
• Plan and oversee the company’s participation in national and regional congresses, symposia, and educational initiatives.
• Own and manage marketing budgets and financial processes in line with strategic and operational priorities.
• Monitor brand performance, launch progress, and key business risks, providing regular updates to local and EU stakeholders.
• Ensure compliance with company SOPs, promotional codes, and applicable regulations, while supporting continuous improvement of marketing processes and ways of working.
• Provide leadership and direction to marketing resources and extended cross-functional contributors to drive accountability and performance.
• Contribute to the definition of operational priorities and resourcing to support business objectives.
• Support the development of marketing capabilities, best practices, and cross-functional collaboration within the affiliate.

Qualifications & Experience

• Bachelor’s degree in science, pharmacy, or medical science; an advanced degree in marketing, business administration, or a related field is preferred.
• Significant experience in pharmaceutical marketing, omnichannel strategy, or related commercial roles, including leadership of country-level launches.
• Experience in cardiovascular and/or specialty products, ideally within competitive or innovative therapeutic areas.
• Strong scientific acumen with the ability to translate complex clinical data into impactful marketing strategies.
• Solid understanding of laws, regulations, and codes governing communication with healthcare professionals.
• Demonstrated project management experience with strong planning, prioritization, and cross-functional coordination skills.
• Experience working with external agencies and partners (digital, media, events, congresses).
• Excellent interpersonal, communication, and presentation skills.
• Fluency in French and English.

Key Competencies

• Strategic and analytical thinking combined with a hands-on, execution-oriented approach.
• Strong leadership presence with the ability to influence and collaborate across functions and levels.
• Ability to operate effectively in complex and evolving environments.
• High level of organizational rigor and ability to manage multiple priorities.
• Clear and concise communication skills, with the ability to convey complex information effectively.
  
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At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

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

Responsibilities

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

Relationships

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

Management

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

Qualifications

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

#LI-HYBRID

We are currently seeking a Senior Manager, Supply Chain and Technical Project Management in our Global Supply Chain & Technical Operations department. 

This position is integral to the advancement of Cytokinetics’ growing portfolio of drug candidates and technology programs and will coordinate cross-functionally to ensure project deliverables are met on-time, on-budget, and with a high degree of quality.

Reporting to the Director of Portfolio Management within Global Supply Chain & Technical Operations, this role will be responsible for the creation, and management of timelines, and deliverables to support the technical development, validation, and commercialization of drug substances, formulated drug product and packaging using Cytokinetics internal resources and an external network of providers. 

Responsibilities

• Provide project management support at any stage of the drug development lifecycle (e.g., early to late-stage development, market authorization, or post-launch phases)
• Develop charters, integrated schedules, deliverable lists, status updates, resource requests and related communications for assigned projects and programs
• Maintain a positive, results-oriented work environment by building partnerships, modeling collaboration and communicating in an open, balanced and objective manner to enable a high-performing team
• Proactively monitor timelines, KPIs, critical path, and resources for assigned projects using appropriate tools, project management principles and practices to deliver project objectives
• Work cross-functionally to coordinate interdependencies with other projects. Resolve and/or escalate conflicts and issues to remove barriers to project success
• Leverage risk management tools and techniques to proactively identify, mitigate and manage risks throughout the project lifecycle to avoid deviations to the project goals and objectives
• Engage sponsors, functional senior leadership, and key stakeholders in regular and meaningful project communications (dashboards, reports, metrics, etc.) to ensure delivery of expected business outcomes
• Lead and/or support continuous improvement of processes and tools
• 10-20% Travel, as necessary according to project needs

Qualifications

• BA/BS in Scientific, Technical, Engineering or Business discipline (advanced degree preferred)
• A minimum of 10 years total work experience, with at least 5 or more years relevant experience in project management within the life sciences (pharmaceutical / biotech / medical device) industry
• Sound technical knowledge in one or more of the following categories: Chemical Development, Formulation Development, Clinical, Manufacturing, Analytical, Packaging, Serialization, Planning, or Logistics (small molecule drug development is a plus)
• Outstanding project management, planning, organization, prioritization, and time management skills
• Ability to adapt to changing situations, and effectively manage multiple projects and priorities
• Ability to think creatively in order to provide non-standard solutions
• Strong partnering skills – ability to thoughtfully cultivate strong and highly effective working relationships with internal and/or external customers and stakeholders
• Strong influencing, organizational and interpersonal skills – consistently achieves targeted results without authority by leveraging expertise, business knowledge, and partnerships
• Project Management Professional (PMP) Certification preferred
• Six Sigma or other Operational Excellence related certifications is a plus
  
  #LI-HYBRID

As Associate Director, Sourcing & Supplier Relationship Management, you will play a critical role in ensuring the suppliers and partners we work with meet our high standards for quality, innovation, and patient impact. This role plays a critical part in the comprehensive lifecycle of Cytokinetics relations with partners and suppliers supporting Global Supply Chain & Technical Operations. This role requires strong strategic thinking, broad industry experience and excellent relationship development and management skills. This role will support our Sourcing and Network Strategy pillar, a key component of our Global Supply Chain & Technical Operations strategy.  This role will support our Manufacturing and Lab Services Supplier Strategy, marketplace assessments of supplier capabilities from early development thru post approval Commercialization, supplier due diligence through Request for Information (RFI) and Requests for Proposals (RPF). These due diligence activities will lead to collaborative supplier selection, contract negotiations, operationalization of the relationship and ultimately management of supplier performance against the contract. This role will be a key partner to CMC and Technical Operations, External Manufacturing and Supply Operations, Enterprise Risk Management, Supply Planning and Partner Pillar activities, and the Supply Chain Center of Excellence in Dublin Ireland. This role requires demonstrated business acumen, influencing skills, strategic thinking, relationship building and collaboration behaviors.

Responsibilities

Strategic Supplier Management

• Develop and execute sourcing and network strategies that align with Global Supply Chain & Technical Operations goals.
• Serve as the primary commercial point of contact for assigned CMOs, Labs and critical suppliers.
• Conduct marketplace assessments, supplier segmentation, and due diligence (RFIs/RFPs).
• Collaborate with Enterprise Risk Management to identify and mitigate supplier sourcing risks.

Contracting & Negotiations

• Lead supplier selection, contract negotiations, and agreement development in partnership with Legal, Finance, Procurement, and Quality.
• Support External Supply team with contract setup, budget planning, and tracking.

Performance & Risk Management

• Monitor supplier performance using standard KPIs and ensure compliance with contractual and regulatory requirements.
• Support supplier audits and develop business continuity and risk management processes.
• Identify opportunities to improve supplier value, cost, quality, and service.

Collaboration & Leadership

• Partner with CMC, Technical Operations, Supply Planning, and global teams in Dublin, Ireland.
• Represent Supply Chain Sourcing on cross-functional teams for complex projects.

Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or related field (advanced degree a plus).
• 10+ years of experience in Life Sciences, Engineering, Business, or Supply Chain, preferably within Biotech/Pharma.
• Strong understanding of product development, GMP manufacturing, and related regulations (cGMP, GCP, CFRs, Part 11, FDA/EMA Guidelines).
• Proven expertise in manufacturing cost benchmarks and pricing strategies for small molecule manufacturing.
• Demonstrated success in supplier relationship management, contract negotiation, and strategic sourcing.
• Strong communication, collaboration, and influencing skills.
• ERP systems experience, preferably Oracle
• Ability to travel domestically and internationally (15–20%).

#LI-HYBRID

Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do –all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer