28 jobs in Orchard Therapeutics
Global Medical Communications & Publications Director
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Senior Director, Medical Communications
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Reporting to : VP, Global Medical Affairs & Diagnostics
Location: London, UK
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.
Job SummarySenior Director, Medical Communications is a leadership role, responsible for developing, implementing and executing the strategy and key deliverables for Medical & Scientific Communications and Medical Publications, with oversight of Medical Information. This individual is an integral member of the global Medical Affairs Leadership Team (MALT), works in partnership with the broader Global Medical Affairs organization to develop and ensure pull-though of overall medical strategies for approved and investigational clinical programs, and manages direct reports. This role also ensures Medical Communications representation on internal cross-functional program strategy teams and contributes to the development of integrated program strategies. This position requires a professional with established personal and scientific credibility and self-awareness who works well in a collaborative cross-functional environment that includes Patient Advocacy, Diagnostics, Commercial, Regulatory, Clinical Development, Translational Research, Business Development, Corporate Communications and other functions within the broader organization.
Key Elements and Responsibilities- Collaborate with and contribute to the Medical Affairs Leadership Team (MALT) to develop overall Medical Affairs functional goals, objectives, strategy, and tactical plans aligned with the business and program goals in relation to medical/scientific communication
- Responsible and accountable for development and execution of Global Medical Communications strategy and key deliverables across multiple clinical programs at varying stages of clinical development (investigational and post-approval), including:
- Incorporating Disease State and autologous Hematopoietic Stem Cell Gene Therapy (HSC-GT) Product medical education for Healthcare Provider (HCPs) and other external stakeholders
- Supporting cross-functional efforts for Diagnostics / Newborn Screening (NBS), Market Access/ Reimbursement, and Clinical Development medical education
- Applying effective project management skills to ensure timely completion of high-quality deliverables within budget.
- Responsible and accountable for development and execution of Global Publications strategy and key deliverables, including:
- Overseeing the development and execution of Global Strategic Publications plans across translational research, investigational, and approved gene therapy programs in alignment with program and organizational goals
- Interfacing with external experts (i.e., clinical trial investigators, key opinion leaders (KOL), and other healthcare practitioners) and internal stakeholders (i.e., members of Clinical Sciences, Diagnostics, Biostatistics, Medical Affairs, Health Economics, Regulatory) for the planning, review, and approval of publications activities, including leading program-specific publication strategy teams
- Building and maintaining productive working relationships with alliance partners and external collaborators to ensure alignment on publications strategies, timelines, and deliverables and contribute to overall partnership success through proactive collaboration
- Ensure the timely delivery of high-quality and scientifically accurate publications aligned with the scientific narrative and medical strategy
- Overseeing budget and financial planning for publication projects
- Engage with key stakeholders to gather feedback and improve publication quality
- Overseeing third-party publications agencies or medical writers, including contract negotiation, and publications management system
- Overseeing publications development, review, and approval processes to ensure
- Compliance with Good Publication Practice (GPP) guidelines, ICMJE, and company policies and procedures
- Medical, clinical, and scientific data accuracy
- Publication relevance, objectivity, balance and alignment with product portfolio
- Collaboration with key internal and external stakeholders, including authors
- Review of company corporate communication materials as needed
- Leading the development of Medical/scientific content
- In support of Medical Communications activities (e.g., scientific trainings, advisory boards, medical booth assets, medical symposia content, field medical team resources)
- Ensuring all medical communication content is regularly updated, accurate, and readily available for external use
- Creation of cross-functionally aligned scientific communication platforms for disease state areas and drug products, including crafting of lexicon and scientific narrative and ensuring consistency of scientific narrative across Medical Affairs materials
- Oversight of Medical Information Strategy and plans
- Leadership of an efficient and productive Medical Communications team by fostering a team environment aligned with company values and culture as well as setting and maintaining team performance standards
- Drive Medical Communications team efforts to
- Align and work internally with other functional and cross-functional strategic partners globally (London office, as well as remote)
- Build and maintain collaborative partnerships with external thought leaders and represent the scientific communications function in key external meetings and congresses
- Other responsibilities as assigned
- Substantial and proven Medical Communications / Publications experience in the biotechnology / pharmaceutical industry
- Required to possess thorough understanding of and experience with:
- Medical Communications / Publications function, strategy development and execution, and team roles / responsibilities
- People manager role and responsibilities
- Government and industry guidelines, regulations, laws, etc., for appropriate scientific/medical exchange, communication, and compliance with customers
- Preferred experience with one or more key therapeutic areas:
- Medical Communications role within the context of clinical development, product launch and life-cycle management
- Rare disease and/or neurology/genetics (neurometabolic) therapeutic landscape
- Gene therapy and/or hematopoietic stem cell transplantation (HSCT)
- Medical Affairs Medical Excellence
- Skills and ability to:
- Develop internal relationships in a matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts
- Exhibit excellent leadership and strategic skills with the ability to influence decisions, both internally and externally
- Generate team results in a cross-functional setting
- Assimilate / interpret new information and inform the business
- Manage multiple projects simultaneously
- Work independently and lead teams in the execution of operational deliverables
- Identify departmental needs and partner with colleagues to proactively implement practical solutions
- Travel occasionally (10%) and sometimes overnight to meetings, trainings, conferences, programs, etc., as required
- Advanced Scientific / Healthcare Degree (PhD, PharmD, MD, NP, or similar)
- Fluency in both spoken and written English
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Senior HR Business Partner
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Location: London
Reporting to: SVP, Head of Human Resources
Job SummaryOrchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.
The Senior HR Business Partner (HRBP) is a critical strategic partner to C-level global functional leaders, providing expert advice, coaching and solutions across all aspects of the employee lifecycle. Reporting to the Head of HR, the HRBP will play a key role in shaping and importantly delivering people strategies that enhance organisational performance, capability and culture across a global, matrixed environment.
Key Elements and Responsibilities- Partner with senior, C-level executive leadership and global functional leaders to provide strategic HR guidance across all aspects of the employee lifecycle, including talent, performance, engagement and organisational effectiveness
- Build trusted relationships and coach leaders to enhance capability, leadership effectiveness and organisational performance
- Act as a strategic partner in hiring, working with leaders and Talent Acquisition to define workforce needs, guide selection decisions and ensure high-quality, timely hiring outcomes
- Drive annual talent management processes, including goal setting, talent and succession reviews, performance management and compensation planning in collaboration with Global Rewards
- Develop and implement business-aligned HR strategies that support organisational goals, growth and transformation
- Contribute to the development of the HR function by coaching team members and supporting the Head of HR in building organisational capability
- Ensure effective utilisation and continuous improvement of HR systems, promoting data accuracy and insight-driven decision making
- Lead employee relations matters, ensuring appropriate handling, resolution and risk mitigation
- Monitor external trends and best practices to inform HR strategy and continuous improvement
- Ensure compliance with applicable employment legislation, policies and procedures
- Significant global HR generalist experience, ideally within a complex, matrixed, international organisation
- Proven track record as an HRBP, influencing senior leaders to enhance organisational performance and drive change
- Strong business acumen, with the ability to influence executive and functional leadership on people-related matters in alignment with business priorities and performance outcomes
- Strong working knowledge of HR practices and employment frameworks across multiple geographies, with the ability to navigate regional nuances
- Demonstrated ability to build credible, trusted relationships and operate effectively at all organisational levels
- Skilled in coaching, influencing and constructively challenging leaders to enhance capability, engagement and performance
- Ability to translate business strategy into pragmatic, people-focused solutions and actions
- Strong analytical and problem-solving skills, with the ability to leverage data to inform decision-making
- Proficient in HR systems and technologies, with a focus on data integrity and continuous process improvement
- Highly organised with strong attention to detail and the ability to manage competing priorities
- Excellent communication skills, with the ability to convey complex information clearly and effectively
- Comfortable operating both strategically and hands-on in a fast-paced, evolving environment
- Experience within the biotechnology, biopharmaceutical or healthcare industry is preferred
Bachelor’s degree (or equivalent) required, preferably in Human Resources, Business Administration or a related field, with a recognised professional HR qualification (e.g. CIPD or equivalent)
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Senior Manager, Medical Communications — Gene Therapy
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Orchard Therapeutics, located in London, seeks a Senior Manager for Medical Communications to lead and execute the medical communications strategy for gene therapy programs. The role involves close collaboration with cross-functional teams to ensure high-quality communication and compliance in delivering medical information.
The successful candidate will possess an advanced degree in a life sciences discipline, strong project management skills, and a track record in medical communications within biotech or pharma.
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Senior Manager, Medical Communications
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Location: London, UK
Reporting to: Senior Director, Medical Communications
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England.
Job SummaryReporting to the Senior Director, Medical Communications, the Senior Manager, Medical Communications will be responsible for overseeing the processes for program-level planning and execution across medical communications, medical publications, and medical information activities for assigned gene therapy programs within the strategic framework set by the Global Medical Communications Leadership. The individual in this role will work in partnership with the broader Medical Affairs organisation, cross-functional partners, and external stakeholders, as appropriate, to support the development, and execution of Global Medical Communications and Publication Plans in alignment with program and organizational goals, and to ensure effective execution of medical information roles and responsibilities for supported clinical programs. The individual in this role will serve a critical role in the dissemination of Orchard-sponsored research and medical information, ensuring accuracy, high quality, and compliance. This position requires a professional with established personal and scientific credibility, self-awareness, and strong written and verbal communications skills, who works well in a collaborative, cross-functional environment that includes Clinical Development, Diagnostics, Pharmacovigilance, Patient Advocacy, Regulatory, Translational Research, Commercial, Corporate Communications and other functions and regional stakeholders within the broader organization.
Key Responsibilities Medical Communications Planning and Execution- Oversee the process for planning and implementation of the Global Medical Communications strategy across assigned investigational and approved gene therapy programs in alignment with program and organizational goals
- Translate complex clinical and scientific data into clear, balanced, and impactful deliverables for healthcare practitioners and other key stakeholders
- Lead the creation and review of medical communications content, including slide decks, infographics, FAQ documents, medical booth assets, ensuring all materials are regularly updated, accurate, and adhere to regulatory and compliance requirements
- Oversee the process for development and implementation of the Global Publications Plan across assigned investigational and approved gene therapy programs in alignment with program and organizational goals
- Oversee the planning and tactical execution of company-sponsored publication activities (i.e, abstracts, posters, oral presentations, manuscripts, and publications extenders, if applicable), including critical review of publications drafts, ensuring the development of high-quality, scientifically accurate, and timely publications
- Manage third-party publications agencies or medical writers
- Interface with external experts (i.e., clinical trial investigators, key opinion leaders, and other healthcare practitioners) and internal stakeholders for the planning, review, and approval of publications activities, including the management of Publication Steering Committees, if applicable
- Ensure all publications activities comply with Good Publication Practice (GPP) guidelines, ICMJE, and company policies and procedures
- Build and maintain productive working relationships with alliance partners and external collaborators to ensure alignment on publications priorities, timelines, and deliverables and contribute to overall partnership success through proactive collaboration
- Oversight of publications management system
- Participate in department initiatives and activities to optimize publications practices and processes and stay current on industry trends and standards related to scientific publications
- Management of Medical Inquiry systems, content, and responses, including
- Oversight of validated system for intake and documentation of medical inquiries
- Ensure effective inquiry intake, triage, timely responses, and documentation in alignment with regulatory requirements and company policies
- Partner with Pharmacovigilance to ensure appropriate adverse event and product complaint identification and reporting
- Partner with cross-functional colleagues to lead the creation and maintenance of standard response letters (SRLs), non-standard responses, and other medical information resources, ensuring timely updates based on new data, regulatory changes, and literature surveillance
- Develop and execute medical Information booth design and serve as Orchard Medical Affairs staff presence at clinical and scientific congresses
- Oversee systems and processes for documenting and evaluating managed access requests, including pre-approval access (compassionate use) requests
- Analyse Medical Information intake data to identify trends, insights, and education gaps, and share analytics reports with internal stakeholders
- Advanced degree (required: MSc, desirable: PhD, PharmD, MD) in a life sciences discipline required.
- Proven and relevant experience in medical affairs, medical communications, or publications within biotech, pharma, or medical communications agencies
- Track record of overseeing medical communications and/or publication planning and execution in a collaborative, fast-paced environment
- Strong understanding of regulatory and compliance requirements (i.e., GPP, ICMJE)
- Demonstrated project management and vendor oversight experience
- Demonstrated stakeholder management, including success working collaboratively in cross-functional settings
- Strong interpersonal skills including verbal and written communication and ability to establish and maintain a positive and efficient collaborative working relationships with internal stakeholders, including remote team members
- Ability to handle multiple tasks in parallel in a fast-paced environment; ability to plan, prioritize and respond effectively to program/activities changes
- Strong attention to detail and excellent organizational and documentation skills
- Problem-solving mindsetUnderstanding of activities related to the planning, conduct, and analysis of clinical trials
- Familiarity with medical information systems and inquiry management platforms
- General interest in a broad range of medical communications activities
- Experience in rare diseases and/or gene therapies is a plus
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Senior Director, GMP Facilities Engineering (Gene Therapy)
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Orchard Therapeutics is searching for a Senior Director of Facilities Engineering based in London. This pivotal role involves leading the design, build, and operational readiness of a new GMP gene therapy manufacturing suite, alongside managing a multidisciplinary team.
The ideal candidate will have substantial experience in facilities engineering in GMP environments, with expertise in regulatory compliance and project leadership. Provide strategic oversight for laboratory and corporate operations.
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Global HRBP: Strategic Partner to C-Level Leaders
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Orchard Therapeutics, a biotechnology gene therapy company, is seeking a Senior HR Business Partner (HRBP) to strategically guide C-level executive leaders. This role involves providing expert HR advice across all employee lifecycle aspects, influencing policies to enhance organisational performance and culture.
The ideal candidate will hold a Bachelor’s degree and possess significant HRBP experience in complex environments. The position offers a great opportunity to contribute to a fast-paced and evolving company culture in London.
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Senior Director, Facilities Engineering
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Location : London, Hammersmith
Reporting to : Chief Technical Officer
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.
Job SummaryThe Senior Director, Facilities Engineering will spearhead the design, build, commissioning, qualification, handover and operational readiness of our new clinical-stage GMP gene therapy manufacturing suite, while also providing strategic leadership to the facilities and laboratory operations team. This is a high-impact role at the heart of our growth as a gene therapy company, requiring deep expertise in GMP-compliant facility engineering, strong project leadership, and the ability to manage and develop a multidisciplinary facilities team.
Key Responsibilities GMP Manufacturing Suite — Design, Build & Commissioning- Lead end-to-end design and construction of the clinical GMP gene therapy manufacturing suite, acting as the primary internal owner and technical authority throughout the project lifecycle.
- Partner with architects, specialist contractors, mechanical and electrical (M&E) engineers, and validation consultants to deliver GMP-compliant facilities on time and within budget.
- Oversee development of engineering and qualification deliverables for all critical systems, including URS input, design reviews, commissioning, qualification and validation documentation, and activities required to support handover and maintenance of the qualified state.
- Ensure the facility design meets applicable regulatory requirements including EU GMP Annex 1, MHRA guidelines, EMA guidance, and other relevant international standards.
- Manage the installation, commissioning, qualification support and handover of HVAC, cleanroom classifications, pressure differentials, environmental monitoring systems, utilities, and building management systems (e.g. BMS/SCADA).
- Oversee contractor qualification, performance, and compliance throughout design and build phases.
- Lead installation, commissioning, qualification, and a successful handover into routine GMP operation in collaboration with QA and Manufacturing, ensuring maintenance strategy, asset care, calibration, vendor support, spare parts, alarm response, and engineering ownership are established for run-state operation.
- Provide engineering leadership and technical input to the site Contamination Control Strategy, including cleanroom zoning, HVAC strategy, pressure cascades, barrier infrastructure, environmental monitoring infrastructure, and other facility design decisions relevant to sterility assurance and contamination control.
- Establish and own the ongoing maintenance program for GMP manufacturing suite infrastructure, including preventative, corrective, and planned maintenance of all critical systems and equipment, supporting GMP compliance and maintenance of the qualified/validated state.
- Ensure continuous facility compliance through robust change control, deviation management, and CAPA processes in partnership with Quality Assurance.
- Maintain all facility-related SOPs, logbooks, and controlled documentation in line with GMP requirements.
- Serve as the primary point of contact for regulatory inspections and audits relating to facility infrastructure and engineering systems.
- Own the engineering response to environmental monitoring and facility system excursions, including EMS, HVAC, alarms, and infrastructure-related investigations, in partnership with EM programme management.
- Develop and oversee the continuous improvement of the facility through optimization and feedback from the manufacturing team.
- Provide senior oversight and strategic direction for all corporate office and laboratory facilities operations, working through the Facilities & Laboratory Operations Manager and Health & Safety Manager to ensure consistently high standards across the estate.
- Set the strategic framework for health, safety, and environmental compliance across all managed buildings; hold senior accountability for regulatory standards while the Health & Safety Manager leads day-to-day implementation and risk management.
- Own the strategic vendor and estates relationships, including contract governance and service performance frameworks; support the Facilities & Laboratory Operations Manager in ensuring service quality and value for money across all providers.
- Lead capital projects for office and laboratory spaces, including fit-out, refurbishment, and relocation programmes, ensuring alignment with business needs, budget, and regulatory requirements.
- Ensure integration between the GMP manufacturing programme and broader estate operations, so that lessons learned, standards, and compliance practices are appropriately shared across the facilities function.
- Line manage and develop the facilities and engineering team, fostering a high-performance, safety-first culture.
- Set clear objectives, conduct performance reviews, and support professional development across the team.
- Manage the facilities and engineering budget, including forecasting, procurement, invoicing oversight, and financial reporting, ensuring expenditure aligns with business priorities and cost controls.
- Represent the Engineering & Facilities function at senior leadership level, providing regular updates on project progress, operational performance, and compliance status.
- Champion continuous improvement initiatives across all facility operations.
- Proven experience in a facilities, engineering and/or technical operations role within a GMP-regulated pharmaceutical, biotech, or cell & gene therapy environment.
- Proven track record of leading GMP facility design and build projects, from concept through to commissioning and regulatory approval.
- In-depth knowledge of GMP regulatory frameworks including EU GMP Annex 1, MHRA, and EMA requirements.
- Demonstrated experience managing cleanroom facilities, HVAC systems, environmental monitoring, and critical utilities.
- Solid experience in facility qualification (DQ/IQ/OQ/PQ) and validation documentation.
- Experience leading, managing, and developing teams in a fast-paced, regulated environment.
- Strong project management skills with experience managing multiple workstreams and external contractors simultaneously.
- Experience managing facilities budgets and working within financial governance frameworks.
- Deep technical knowledge of GMP engineering systems: HVAC, cleanrooms, utilities, BMS, and environmental monitoring.
- Strong understanding of UK/EU health, safety, and environmental legislation applicable to laboratory and manufacturing environments.
- Excellent leadership and interpersonal skills with the ability to influence across all levels of the organisation.
- Highly organised and the capability to manage complex, concurrent workstreams and competing priorities.
- Clear and confident communicator — able to convey technical information effectively to non-technical stakeholders.
- Collaborative approach with a customer-service mindset; able to build strong relationships with internal stakeholders and external partners.
- Analytical and solutions-focused, with strong aptitude for problem-solving under pressure.
- Proficiency with facilities management and project management tools; familiarity with BMS/SCADA systems advantageous.
- In-depth knowledge of GMP regulatory frameworks including EU GMP Annex 1, MHRA, EMA and FDA requirements.
- Working knowledge of sterility assurance / contamination control principles relevant to facility design and operation.
- Degree in Engineering (Mechanical, Electrical, Chemical, or Biomedical), Life Sciences, or a closely related discipline; relevant professional qualifications (e.g., CIBSE, IWFM, IChemE) highly desirable.
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
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Global VP, Clinical Operations & Data Management
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Orchard Therapeutics is seeking a Vice President of Clinical Operations and Data Management in London to provide strategic leadership over global clinical trials. The role focuses on ensuring compliance and advancing clinical development strategies.
The ideal candidate should have a strong background in clinical operations leadership, management of CROs, and regulatory expertise. This position offers an exciting opportunity to lead high-performing teams in a fast-paced environment.
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VP, Clinical Operations and Data Management
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Reporting to: Chief Medical Officer
Location: London
Job SummaryThe Vice President of Clinical Operations and Data Management (CODM) provides strategic leadership for the planning, execution, and oversight of global clinical trials. This role is accountable for delivering high-quality, compliant, patient-focused studies on time and within budget, while advancing the organization’s clinical development strategy and supporting global regulatory and commercialization objectives.
Key Elements and Responsibilities- Provide strategic and operational leadership for clinical operations and data management across programs, from study start-up through close-out, in compliance with ICH-GCP.
- Ensure the quality, integrity, and inspection-readiness of all clinical and data management activities globally.
- Drive cross-functional collaboration to deliver clinical trials on time and within budget.
- Lead planning, execution, and reporting of clinical studies, ensuring alignment on timelines, deliverables, and resources.
- Act as the primary escalation point for critical study and vendor issues.
- Oversee study budgets, timelines, resources, and financial tracking.
- Partner with Clinical Science, Biostatistics, and external vendors to ensure seamless delivery of:
- Clinical documentation
- Data management activities
- Ensure effective coordination of regulatory submissions (e.g., IRB/ethics committees, local authorities).
- Oversee data management strategy and execution, including database design, build, maintenance, and database lock activities, in alignment with biostatistics.
- Ensure robust data integrity, accurate record-keeping, and compliant archiving practices.
- Provide oversight of clinical sites, academic partners, and vendors (e.g., CROs, labs) to ensure performance, quality, and compliance.
- Build and maintain strong relationships with investigators and key opinion leaders.
- Lead, develop, and mentor high-performing teams.
- Ensure delivery of high-quality study documentation to meet program timelines.
- Extensive experience in clinical operations leadership within biotech/pharma.
- Strong clinical project and program management expertise.
- Proven track record managing CROs and external vendors.
- Solid understanding of global regulatory requirements (ICH-GCP).
- Experience managing budgets and resource planning.
- Strong problem‑solving skills with the ability to operate strategically and tactically.
- Excellent leadership, communication, and stakeholder management skills.
- Ability to thrive in a fast‑paced, evolving biotech environment.
- Experience in rare/orphan diseases and/or academic collaborations is a plus.
- Bachelor’s degree in Life Sciences required.
- Advanced degree (MS, PhD, or equivalent) preferred.
- Substantial experience leading Clinical Operations and Data Management teams.
- Experience in rare disease; gene and cell therapy experience is a plus.
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