Position Overview:

Beam is seeking a highly motivated individual to join our Supply Chain team. The Supply Planning & Network leader will be responsible managing the global supply network performance by conducting risk-based inventory reviews and developing strategic options to address demand uncertainties and enhance network capabilities. He/she will be accountable to ensure uninterrupted supply of clinical and future commercial products via Beam’s S&OP process. This role will report to the Sr. Director of Global Supply Chain Planning and partner with TechOps, Clinical Ops, Commercial Patient Ops, Quality, Finance, and CMC teams to lead short-term integrated production planning and long-range strategic supply chain planning of Beam’s product portfolio. The role will be responsible for leading a global inventory management program to ensure critical material availability at Beam NC & CDMO mfg sites. The role will be integral to enhancing site planning and scheduling capabilities at Beam’s mfg site in Durham, NC and partnering with SAP business lead on further advancing technology capabilities. The ideal candidate will have a demonstrated track record of leading in a dynamic environment. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross functional relationships.

Responsibilities:

• Production & Capacity Planning: Develop and maintain a rolling 12–24-month master production schedule (MPS) aligned with demand forecasts and manufacturing constraints.
• External Network Collaboration: Lead planning and partner with key stakeholders to ensure supply continuity across the Contract Manufacturing Organizations (CMOs) and 3PLs.
• Sales & Operations Planning (S&OP): Drive the monthly S&OP cycle, including rough-cut capacity planning and scenario analysis. Partner cross-functionally to refine demand forecasts and execute supply network analysis to support both tactical and strategic goals.
• Inventory Optimization: Ensures appropriate inventory levels to minimize excess while preventing stockouts, specifically managing shelf-life/expiry for temperature-sensitive products like Critical Materials (pDNA, mRNA, gRNA, mAb, lipids), Drug Substance, and Bulk/Finished Drug Product.
• Clinical/Launch Readiness: Orchestrate supply for clinical trials or support new product introductions (NPI) and commercial launches.
• Risk Management: Proactively identify supply disruptions and develop mitigation strategies or business continuity plans.
• Process Improvement: Drive Global Supply Chain excellence through project management, process enhancement, and the deployment of digital tools that streamline business execution and strategic decision-making.
• Metrics: Leverage data-driven KPIs to track performance, ensuring accountability and optimizing the balance between operational efficiency and financial health.
• Systems: Optimize supply and inventory planning accuracy through utilization of SAP, driving improved stock maintenance and network visibility. Spearhead the design and execution of SAP enhancements, including Integrated Business Planning (IBP) and Jurisdictional Control (JC), to streamline end-to-end supply chain functions.
• Other duties as assigned.

Qualifications:

• BS/BA degree in Business, Science, Engineering or related field with 8-10+ years of experience in global supply chain from pharma, biotech or cell & gene therapy companies.
• Master's degree or MBA preferred.
• Prior drug development, manufacturing, and clinical operations experience is a plus.
• Final title/scope of role will be commensurate with experience.
• Passion for patients, collaborative and effective leader.
• Knowledge of practical implications of Sarbanes-Oxley controls.
• Knowledge of continuous improvement methodologies and tools.
• Strong organizational and facilitation skills, with high degree of customer focus.
• Expertise and track record in manufacturing and supply chain execution and oversight.
• Extensive experience in supply chain planning, SAP ERP system, capacity modeling, supply network strategy and optimization.
• Expertise and have a proven track record in supply chain risk management.
• Solid knowledge of regulatory requirements, regulatory guidance, including pharmaceutical GMPs and ICH guidance.
• Current on Biopharma supply chain, manufacturing technologies, supplier network, CMO network, performance and capacity.
• Possesses understanding and application of principles, concepts, practices, and standards for DS and DP manufacturing in the biopharma industry.
• Strong communication, negotiation, and interpersonal skills.
• Strong analytical skills and ability to clearly communicate at tactical and strategic level with team and Sr Management.
• Ability to work in a dynamic and challenging environment.
• Some travel may be required.
• Must be able to work onsite, not a remote role.

Position Overview:

The Regulatory Specialist will participate in the preparation of documentation packages for global regulatory submissions.

Primary Responsibilities:

• Able to prepare documentation packages for global regulatory submissions (including IND, CTA, Briefing Books, Scientific Advice, etc.) to the FDA and global regulatory agencies.
• Compiles documentation for submissions to FDA and global regulatory agencies.
• Support the development of regulatory strategies, risks and key issues in an evolving regulatory landscape.
• Support the develop regulatory processes and procedures of regulatory submissions.
• Develops and maintains collaborative partnerships with key internal and external stakeholders.
• Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts.

Qualifications, Knowledge and Skills:

• Minimum BA/BS degree in a scientific/engineering discipline.
• Cell and gene experience preferred.
• 6+ years’ experience in the biotech industry.
• 8-10+ years’ experience in Regulatory CMC, or related experience (e.g., manufacturing, analytical, quality assurance) as a strong dossier preparation contributor for IND/CTA/MF and BLA/MAA submissions.
• Comprehensive knowledge of regulatory (FDA. EMA, and ICH) guidelines; with a demonstrated ability to articulate and apply these principles to regulatory CMC strategies for novel products.
• Diverse experience including drugs, biologics, devices and international filings preferred.
• Strong experience with CTD format and content regulatory filings.
• Excellent organizational, written/oral communication, and time management skills; ability to communicate complex issues in a succinct and logical manner; strong listening skills.
• Experience with related CMC disciplines (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders; flexibility in responding to changing priorities and/or unexpected events.
• Demonstrates independence of ideas and contributes to the development and execution of the group’s activities.
• Exercises sound judgment to determine appropriate action of tasks.

Position Overview:

The Manager/Senior Manager, Regulatory — Advertising, Labeling, and Promotion (ALP) is responsible for leading U.S. promotional regulatory strategy and supporting ex-U.S. needs across our gene editing portfolio. This role reports to the Director of Regulatory Labeling and serves as a key member of the Promotional Review Committee (PRC/MLR). The position ensures compliant, compelling, and scientifically accurate communications consistent with core labeling and regulatory requirements.

Responsibilities:

• Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling.
• Manage the lifecycle of core and regional labeling documents including updates, reviews, approvals, and submissions.
• Ensure claims are truthful, non-misleading, balanced, and aligned with approved labeling and scientific evidence.
• Prepare and submit FDA Form 2253 filings; maintain records and track OPDP correspondence in conjunction with regulatory operations.
• Ensure alignment with promotional materials with CCDS, USPI/PI, IFU, and patient labeling.
• Monitor FDA OPDP/CBER guidance's, enforcement trends, and evolving U.S. regulations; educate internal teams.
• Support development of SOPs, governance documents, training programs, and inspection readiness activities.
• Advise cross-functional partners on scientific substantiation, evidence gaps, and claims strategy.
• Review digital and social media content for compliance with fair balance, risk proximity, and evolving digital standards.

Qualifications:

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• 8+ years (Manager) 10+ years (Senior Manager) experience in Regulatory Advertising & Promotion.
• Strong understanding of FDA promotional regulations (FD&C Act, 21 CFR 202.1, OPDP/OC, CBER/CDER).
• Hands-on PRC/MLR experience and 2253 submission experience required.
• Excellent communication, cross-functional collaboration, and regulatory judgment.

Position Overview:

The Vice President, Compliance is a strategic leader responsible for designing, implementing, and continuously improving the company’s Corporate Compliance Program to oversee promotional materials, field training, and HCP/patient programs. As an objective advisor, the Vice President, Compliance ensures the organization operates with integrity and in compliance with all applicable laws, regulations, and internal policies. Reporting to the Chief Legal Officer, the Vice President, Compliance partners with executive leadership, the legal and compliance function, the Audit Committee of the Board of Directors, and employees at all levels to foster a culture of ethical conduct and accountability.

Beam is transitioning to a commercial stage company, and this position plays a critical role in developing a culture of compliance.  Additionally, ex vivo cell therapy and in vivo gene therapy have unique commercial and operational needs that require a strategic leader to collaborate with commercial, medical, and manufacturing to build a commercial process that delivers for patients compliantly.

Key Responsibilities:

• Develop, execute, and evolve a comprehensive compliance strategy and program focusing on healthcare compliance and aligning with business objectives and legal requirements that meets the unique needs of cell and gene therapy.
• Provide proactive strategic advice to the business to help drive commercial success and ensure compliance with applicable laws and company policies, including federal and state anti-kickback and false claims laws; U.S. and other country anticorruption laws; the federal Food, Drug and Cosmetic Act; and federal and state transparency laws.
• Serve as Chair of the Beam Compliance Committee and as Data Privacy Officer.
• Provide regular updates on the Compliance Program to executive leadership and the Audit Committee of the Board of Directors.
• Review business strategy plans and business development opportunities for compliance risks and advise the business on how to mitigate those risks.
• Develop and maintain trusting relationships with key client groups, such as commercial and clinical, and serve as a trusted and strategic advisor and resource.
• Act as a compliance champion to reinforce a culture of integrity and raise awareness of compliance as a collective responsibility of all company personnel.
• Champion open communication by ensuring employees feel empowered to raise concerns without fear of retaliation.
• Oversee ongoing education initiatives to enhance understanding of the Code of Business Conduct & Ethics, Beam policies and procedures, and emerging compliance risks, and seeking opportunities for continuous learning across the organization.
• Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics. Identify gaps and support the design and tracking of corrective actions to strengthen compliance controls.
• Manage and conduct compliance investigations, working with internal business partners to identify appropriate corrective and preventive actions.
• Stay ahead of regulatory and industry code changes and industry and enforcement trends impacting compliance areas and proactively advise leadership on potential impacts and necessary adaptations.
• Serve as a trusted advisor to the Board of Directors, Chief Legal Officer, executive leadership team, and other functions, providing actionable guidance on compliance matters and risk mitigation.
• Engage with outside counsel, regulatory agencies, and industry groups to understand and benchmark the best practices and ensure the compliance regime meets or exceeds industry standards.

Qualifications:

• Bachelor’s degree required, Juris Doctorate or advanced degree a plus.
• Cell and gene therapy experience a must.
• Relevant experience (typically 7 years or more, or equivalent combination of education, training, and experience) with a deep understanding of compliance issues confronting the pharmaceutical/biotech industry.
• Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.
• Demonstrated effectiveness operating in complex organizational and regulatory environments and experience with Code implementation (PhRMA, EFPIA, IFPMA)
• Demonstrated knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical industry including sales and marketing, OIG and other industry guidance documents, regulations on the promotion of marketed products, clinical trial regulations, patient privacy and issues arising under the False Claims Act, anti-bribery/anti-corruption laws, and other related laws.
• Business focused and solution oriented.
• Excellent written, oral and presentation skills.
• Proven ability to work with all levels of management.
• Strong problem-solving and analytical skills.
• Self-motivated and able to perform role independently, with a minimum level of supervision.
• Demonstrated ability to partner effectively with others in addressing complex issues.
• Strong influencing skills and sound business judgment.
• Ability to appropriately prioritize issues.
• Outstanding attention to detail.

Position Overview:

Beam is looking for a Senior Manager/Associate Director of statistical programming to join our growing Statistical Programming team in the Biometrics department. This individual will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam’s clinical programs. In this role, you will work with the head of statistical programming and the head of biometrics to develop statistical programming strategies, SAS programming infrastructure as well as department standards, applications and processes. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Responsibilities:

• Lead and manage statistical programming activities on clinical studies and oversee CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions.
• Review and validate SDTM, ADaM analysis datasets and TFLs created by CROs.
• Work collaboratively and communicate effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions.
• Manage creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources.
• Manage the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R.
• Oversee and manage the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
• Partner with Statisticians and other members of the clinical study team, perform ad hoc analysis.
• Review SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents by CROs and provide expert feedback from functional perspective.
• Assist the Head of Statistical Programming in reviewing bid proposals, monitoring and tracking budgets for outsourced activities.
• Assist the Head of Statistical Programming to develop and implement programming processes, programming standards and SOPs.
• Develop SAS programming infrastructure and programming processes to improve data deliverables and ad hoc analyses quality and efficiency.
• Build and mentor a team of programmers as needed to support Beam clinical trials and drug development pipelines.

Qualifications:

• MS or higher degree in Statistics, Mathematics, or related scientific Discipline.
• At least 12 years Pharmaceutical/Biotech programming experience.
• Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies.
• NDA or BLA submission experience is required.
• Excellent organizational skills and ability to prioritize tasks.
• Excellent communication and interpersonal skills.
• Experience managing CROs and other data vendors.
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance.
• Experience with R-Shiny or Python is a plus.

Position Overview:

Reporting to the Senior Director, Clinical Data Management, the Associate Director / Director, Clinical Data Management will serve as the dedicated data management lead for our Liver franchise. Initially supporting a single study within the program, this individual will grow with the franchise as it expands to include additional studies within the same program and, ultimately, other programs across the franchise portfolio.

This role offers a unique blend of hands-on study oversight and strategic leadership, making it an ideal opportunity for a candidate who thrives at the intersection of execution and innovation, in a fast‑paced biotech environment where clarity, quality, and collaboration are critical.

This is a highly visible role working cross‑functionally with Clinical Development, Biostatistics, Statistical Programming, Regulatory, Quality, and external partners to ensure data integrity, inspection readiness, and timely delivery of data supporting key development and regulatory milestones.

Primary Responsibilities:

Program & Study Ownership

• Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area.
• Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials.
• Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions.
• Proactively identify data risks, trends, and operational dependencies; communicate issues early with clear, solution-oriented recommendations.

CRO & Vendor Oversight

• Serve as the primary data management contact for CROs and third-party data vendors.
• Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations.
• Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies in partnership with the Senior Director of Data Management.

Data Standards, Systems & Process Contribution

• Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models as the organization scales its clinical portfolio.
• Provide hands-on leadership for:
• CRF design and cross functional review
• Edit check specifications and user acceptance testing
• Data Management Plans and CRF Completion Guidelines
• External data transfer specifications
• Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml.

Inspection Readiness

• Support inspection readiness activities across assigned programs, ensuring documentation and data traceability meet regulatory expectations.
• Serve as a key data management participant during audits and inspections, in coordination with the Senior Director and Quality.
• Ensure data management deliverables remain inspection ready throughout the study lifecycle.

Cross-Functional Partnership

• Collaborate closely with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Regulatory, and Quality.
• Communicate complex data issues clearly and effectively to stakeholders with varying technical backgrounds.
• Build trust as a pragmatic, detail-oriented partner who balances scientific rigor with efficient execution.

Required Qualifications:

• BS or MS degree in a scientific or health-related field.
• 10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments.
• Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies.
• Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform).
• Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations.
• Proven experience overseeing CROs and external data vendors.
• Experience developing reports using J-Review and/or other CDM reporting tools.
• Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable.
• Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies.
• Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization.

Preferred Qualifications:

• Experience and knowledge of gene/cell therapy and/or rare disease.
• Prior experience supporting registrational or pre registrational programs.

Position Overview:

Beam is looking for a highly talented and motivated Associate Director / Director, Toxicology to join our growing Non-Clinical Development team.  The Associate Director / Director, Toxicology will be responsible for the nonclinical safety assessments supporting Beam's discovery and development programs. The right candidate will be responsible and accountable for the design and execution of safety studies for discovery to early/late development programs. Additionally, this role will be accountable for the authoring of documents for regulatory filings.

Responsibilities:

• Work cross-functionally to drive nonclinical safety related activities from discovery through regulatory filings and to commercialization for various programs.
• Develop and oversee the execution of phase appropriate nonclinical safety strategies along with integrated project plans including milestones, timelines, resources and budgets.
• Coordinate interactions with CRO's, in collaboration with the Nonclinical Development Operations group, to ensure delivery of study results and reports consistent with program timelines.
• Provide strategic contribution as the subject matter expert for GLP, non-GLP, and safety pharmacology studies supporting development and platform programs.
• Provide toxicology support for regulatory submissions and interactions with health authorities, including the authoring of nonclinical safety sections of US and international regulatory applications, and help resolve nonclinical safety queries.
• Drive and be accountable for delivery of high-quality safety reports to ensure clinical plans and regulatory filing submissions in multiple markets.
• Serve as the toxicology representative in cross-functional meetings both internally and externally.

Qualifications:

• Ph.D. with 8+ years of scientific experience OR MS with 12+ years of scientific experience. BS with 15+ years of scientific experience in preclinical toxicology will also be considered.
• Experience with LNPs and/or gene therapies.
• Ability to develop and deliver clear and concise presentations for both internal and external meetings.
• In-depth understanding of all aspects of nonclinical safety and experience with regulatory filings.
• Extensive knowledge of relevant FDA and EMEA regulations and processes.
• Demonstrated proven experience in working with CROs for protocol design and study execution.
• Experience working with cross-functional and collaborative project teams.
• Ability to operate effectively within an innovative and science-driven company environment; delivery-oriented, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
• Candidates are expected to come onsite 1-3 days per week.

Position Overview:

Beam is seeking an experienced procurement leader to oversee end-to-end indirect sourcing and category management within its emerging Commercial and G&A organizations. Reporting to the Vice President of Procurement and Strategic Sourcing, this role serves as the primary procurement partner to Commercial, Finance, Human Resources, Information Technology, Legal, and other cross-functional stakeholders, leading all phases of the procurement lifecycle from strategy development and supplier selection through negotiation, contract execution, and implementation.

This position owns category strategy development and execution across Commercial and indirect services, driving disciplined sourcing, spend analytics, supplier performance management, and measurable cost savings. The role requires a leader who can anticipate supply markets, mitigate risk, enable scalability, and drive procurement operations that support Beam’s long-term growth objectives.

Responsibilities:

• Develop and execute multi-year category strategies aligned to Commercial and enterprise objectives, incorporating spend analytics, market intelligence, and risk assessment.
• Lead complex RFIs, RFQs, and RFPs and drive end-to-end sourcing lifecycle management, including supplier selection and negotiation strategy development.
• Negotiate and execute contracts with strategic suppliers and service providers, ensuring alignment with defined KPIs, SLAs, compliance standards, and measurable value delivery.
• Set strategic direction and own responsibility for all day-to-day purchasing and category management activities, including order accuracy, compliance, and serving as the primary escalation point for commercial and service issues.
• Serve as a strategic business partner to Commercial, Finance, Quality, IT, and Legal teams; present supplier performance, savings delivery, and risk updates to leadership.
• Collaborate with Accounts Payable to resolve purchasing discrepancies and strengthen procurement governance and controls.
• Build and manage strong supplier relationships, establish performance scorecards and dashboards, and conduct structured business reviews to ensure quality, delivery, cost, and service excellence.
• Anticipate supply market dynamics and mitigate risk through supplier rationalization, contingency planning, and proactive issue resolution to avoid operational disruption.
• Set strategic directions and responsibility for all day-to-day purchasing activities. Mange orders for completeness, accuracy, and compliance. Act as the initial escalation point for purchasing issues.
• Negotiate the execution of contracts with strategic suppliers & service providers; communicate contract details to relevant internal parties.
• Drive continuous improvement and digital enablement within procurement processes, including spend analysis, vendor consolidation, and performance reporting.

Qualifications:

• Bachelor’s degree in finance, Accounting, Economics, Business or a related field.
• 7-10 years of progressive experience in Strategic Sourcing, Category Management, or Procurement leadership within biotechnology, pharmaceutical, or regulated industries.
• Demonstrated experience supporting Commercial organizations in a life sciences environment.
• Experience managing indirect categories including IT, Professional Services, Marketing, and Corporate Services.
• Experience with SAP, Coupa, financial risk tool is a plus.
• Strong process-mapping and process-improvement skills with close attention to detail.
• High degree of customer focus and demonstrated collaboration in a team environment.
• Proven success leading complex negotiations and delivering structural cost savings Strong project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation.
• Outstanding written and verbal communication skills, with the ability to convey strategies and results to a diverse audience.
• Able to travel when needed.

Position Overview:

Beam is looking for a highly motivated and experienced Insights & Analytics leader to expand our commercial capabilities as we advance our portfolio toward potential commercialization.  The Director, Insights & Analytics will lead the development and execution of market insights, forecasting, and competitive intelligence capabilities across Beam’s portfolio. This role will serve as a strategic partner to Marketing, Market Access, Patient Operations, Medical Affairs, and Portfolio Strategy to translate key business questions into actionable insights that inform decision-making across the product lifecycle.  In addition, the Director, Insights & Analytics will directly support early pipeline assets, e.g. provide market sizing, competitive landscape analyses, drivers for therapy and brand choice.

This position requires both strategic thinking and hands-on execution in a fast-moving, cross-functional environment.

Responsibilities:

Market Insights & Research Leadership

• Build and lead market research capability across the portfolio.
• Partner with Marketing, Market Access, Medical Affairs, and Portfolio Strategy to define key business questions.
• Recommend appropriate market research methodologies and lead RFP processes and vendor selection for market research projects.
• Manage external research partners and ensure high-quality execution.
• Develop initial discussion guides, surveys, and stimuli in collaboration with cross-functional teams.
• Synthesize research findings into clear, actionable insights and facilitate cross-functional sharing.

Forecasting & Analytical Support

• Lead forecasting processes across the portfolio, including:
• Patient flow and demand models
• Market uptake scenarios
• Sensitivity analyses and risk scenarios
• Develop and maintain analytical tools and models to support asset-level and portfolio-level decision making.

Competitive Intelligence

• Establish and lead competitive intelligence processes across the portfolio.
• Monitor competitive clinical, regulatory, and commercial developments.
• Manage external CI vendors and spearhead CI strategy and coverage for conferences.
• Synthesize competitive insights into implications for strategy, positioning, and planning.
• Support scenario planning and strategic trade-off discussions.

Early Pipeline & Portfolio Analyses

• Support early-stage assets with:
• Epidemiology and market sizing
• Competitive landscape assessments
• Unmet need and treatment paradigm analyses
• Possibly facilitate early asset TPP generation.

Qualifications:

• BS/BA in a relevant academic field; MBA, MD, PhD, or other graduate degree strongly preferred
• 15+ years business experience within the pharma/biotech/biopharma space or consulting
• Experience in cell and gene therapy is strongly preferred.
• Strong understanding of primary and secondary market research methodologies.
• Proven experience leading vendor selection and managing research partners.
• Must be capable of managing and prioritizing multiple activities.
• Hands-on forecasting experience, including scenario planning, strongly preferred.
• Ability to synthesize complex data into clear strategic insights.
• Strong cross-functional collaboration skills.
• Comfortable operating in ambiguity and building new processes from scratch.
• Excellent communication and executive presentation skills.
• Role is based in Cambridge, MA.
• Onsite requirements: Candidates are expected to come onsite 1-3 days per week.
• Ability to travel 25% as needed.

Position Overview:

Beam is looking for a highly energetic Associate Director, Commercial IT Business Partner, that will serve as a strategic liaison between the IT organization and Commercial business units, ensuring technology solutions enable successful commercialization of advanced gene therapy products. This role is pivotal in bridging business needs with IT capabilities, driving digital transformation, and supporting operational readiness for launch and post-launch activities. The position requires understanding of both IT systems and the unique complexities of cell and gene therapy commercialization.

Responsibilities:

• Lead requirements gathering, documentation, and testing for commercial platforms. Support the overall governance and lifecycle management of commercial IT applications. Ensure configuration, enhancement, and expansion of the systems aligns with broader organizational data standards, information security practices, and regulatory needs.
• Critical liaison for treatment centers, supporting onboarding, day-to-day operations, enhancements, and ongoing technology needs.
• Assist in unit testing and support configuration efforts within Salesforce and Veeva platforms. Translate stakeholder strategies and patient-focused priorities into scalable workflow designs and system features that support compliance and operational excellence.
• Gather and document analytics requirements. Support building, testing, and validation of analytics solutions to drive business insights.
• Collaborate with cross-functional teams to ensure alignment with business goals.
• Serve as a liaison for general vendor interactions. Monitor vendor performance and ensure alignment with IT and business objectives.
• Ensure seamless data flow across internal and external systems to support end-to-end business processes. Collaborate with technical teams to design and validate integration architecture that meets security and compliance standards.
• Support authoring and execution of Computer System Validation (CSV) and GxP scripts. Provide internal workflow support to ensure compliance and operational efficiency.

Qualifications:

• Bachelor’s degree in Information Systems, Life Sciences, or related field; advanced degree preferred.
• 7+ years of IT experience, with at least 5 years in Commercial IT roles within pharma/biotech.
• 3+ years of experience in cell and gene therapy or highly regulated life sciences environments. Salesforce.com and Veeva experience strongly preferred.
• Proven track record in implementing validated systems and managing complex IT projects.
• Strong understanding of CRM, ERP, and digital ecosystems tailored for CGT workflows.
• Familiarity with regulatory frameworks (GxP, HIPAA) and data integrity principles.
• Exceptional communication and stakeholder management skills.
• Ability to operate in a fast-paced, matrixed environment with strategic thinking and problem-solving capabilities.
• Onsite requirements: Candidates are expected to come onsite 2 days per week and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Position Overview:

Beam is seeking a dynamic, visionary, and strategic Senior Director, Global HEOR to spearhead the global HEOR strategy for our sickle cell disease program (risto-cel) and other pipeline programs as they emerge . In this high-impact role, the Senior Director, Global HEOR will develop and execute evidence-generation plans, manage stakeholder relationships, and shape external communication strategies. You will partner closely with Clinical Development, Medical Communications and Scientific Publications, Value and Evidence Strategy, Commercial, R&D, and additional cross-functional teams. If you thrive in a collaborative, mission-driven environment and are eager to shape the future of sickle cell disease care, we want you to bring your expertise and passion to Beam.

Responsibilities:

• Provide strategic input to disease prioritization, target product profiles, clinical trial protocols, clinical development plans, and regulatory submissions; lead development of clinical sections for Investigator’s Brochures, briefing books, safety updates, IND/NDA materials, and responses to Health Authority questions. 
• Develop, validate, and integrate patient‑centered outcomes (PROs) into protocols and analyses.
• Interpret clinical trial results (including PROs and healthcare resource use) and partner with Clinical Development/Biostatistics on Statistical Analysis Plans (SAPs) and post‑hoc analyses.
• Lead a fit‑for‑purpose RWE strategy (EHR, claims, registries, hybrid/open datasets) including natural history/registry design and governance to inform endpoints, recruitment, and post‑authorization effectiveness/safety assessments.
• Develop and operationalize external/synthetic control arm approaches (e.g., matched registry cohorts, Bayesian borrowing) for single‑arm or small‑population studies typical in cell & gene therapy.
• Provide operational oversight of Medical Affairs evidence generation, including vendor/CRO governance, milestone/deliverable tracking, data‑quality plans, risk management, and on‑time execution across Medical Affairs–led studies; contribute to long‑term capability building (digital health, real‑world studies).
• Elicit and integrate perspectives from patients, KOLs, policy leaders, and internal stakeholders (market access, marketing, patient advocacy) to ensure plans meet the needs of patients, HCPs, and payers.
• Support Market Access on internal and external payer/policy initiatives (pricing and reimbursement, unmet medical need, regional market dynamics, evidence gaps) across the portfolio.
• Support business decisions around ex-US strategy including, but not limited to, scoping ex-US opportunities, prioritizing country engagement, early scientific advice / parallel consultations with EMA and HTA bodies (e.g., HTACG/JSC), providing advice to development programs on endpoint selection to support product and reimbursement approvals ex-US, etc. 
• Anticipate payer evidence needs and budget‑impact critiques (including preparation for ICER Reviews). 
• Build and maintain economic models (cost‑effectiveness, budget impact) tailored to one‑time CGTs, addressing uncertainty/durability and caregiver burden. 
• Collaborate with Market Access to design innovative payment models and outcomes‑based agreements with pragmatic outcomes and tracking. 
• Lead the AMCP dossier and pre‑approval information exchange (PIE) strategy (6–12 months pre‑launch). 
• Work collaboratively with internal teams, consultants, and CROs to advance development of the portfolio. 

Qualifications:

• Master’s Degree or higher in Health Economics and Outcomes Research or a relevant discipline.
• Formal training in Epidemiology/Health Services Research required.
• At least 10+ years’ experience in observational research study management AND data analytics, either within industry or with an observational research consulting firm.
• Proven track record in drug development, with rare disease experience and an existing network of hematologists preferred.
• Demonstrated ability to lead in a matrixed, cross-functional environment, combining strategic agility with strong business acumen.
• Independent, proactive operator with strong ownership.
• Cross functional collaboration with Clinical, Regulatory, Commercial, Medical Operations, and Publications while maintaining medical/scientific integrity.
• Excellent communication, collaboration, and problem-solving skills.
• #LI-Hybrid 

Position Overview:

The Senior Director, Global Logistics, Warehousing and Trade Compliance is responsible for defining and executing the global strategy, operational leadership, and compliant storage and movement of materials supporting R&D, Clinical, and Commercial programs across Beam. This role provides end‑to‑end leadership across global logistics operations, warehousing networks, and trade compliance, ensuring reliable supply, regulatory adherence, and scalable infrastructure to support pipeline growth and commercialization.

This position reports to the Vice President, Supply Chain and serves as a key member of the Supply Chain Leadership team, partnering closely with Technical Operations, Quality, R&D, Finance, Legal, Procurement, Clinical Patient Supply and Commercial Patient Operations.

Responsibilities:

• Global Logistics: Provides operational and strategic leadership for all R&D, Clinical, and Commercial shipments. Serves as subject matter expert for ambient, low‑temperature, and ultra‑low‑temperature cold chain systems, including shipping systems qualification and lane validation, in support of CMC development and commercialization. Supports Commercial Patient Operations for Risto-cel Patient shipments.
• Warehousing: Leads internal warehouse operations and the global 3PL network supporting storage, inventory management, kitting, and production support for critical raw materials, drug substance, and drug product. Ensures inventory accuracy, material availability, and scalable warehouse capabilities aligned with clinical and commercial demand.
• Trade Compliance: Acts as the enterprise risk leader for global trade compliance, ensuring compliance with international, federal, and state import/export laws and regulations. Leads the development and governance of compliant, efficient trade processes across North America, Europe, and Asia‑Pacific regions, and serves as the primary interface with customs brokers, government agencies, and external auditors. Champions a culture of compliance while enabling business agility and uninterrupted supply. Supports Market Access team for any commercial trade or channel distribution aspects.
• Strategy & Leadership:
  • Develop and execute global logistics, warehousing, and trade compliance strategy to support R&D, clinical trials, and commercial operations.
  • Establish long‑term vision for a flexible, scalable global distribution and storage network, aligned with Beam’s growth and commercialization plans.
  • Serve as a senior leader influencing enterprise and site‑level supply chain strategies, including readiness for new product launches and expansion of cell and gene therapy programs.
  • Build, lead, and develop high‑performing teams, fostering a strong talent pipeline, culture of accountability, and continuous improvement mindset.
• Logistics Operations
  • Provide operational leadership for global distribution, including domestic and international shipments from internal sites and external partners.
  • Lead shipping operations supporting R&D, clinical, and commercial programs, ensuring on‑time, in‑full delivery and patient‑centric execution.
  • Own cold chain strategy and execution, including qualification, validation, monitoring, and continuous improvement of shipping lanes and systems.
  • Ensure logistics operations comply with GMP, GDP, EHS, product security, and data integrity requirements.

• Warehousing & Inventory Management:
  • Lead internal and external warehousing operations, including inventory control, materials management, kitting, and production support.
  • Ensure no disruption to production schedules while proactively identifying and mitigating supply risks.
  • Drive inventory optimization, accuracy, and visibility across the network using ERP and digital tools.

• Trade Compliance & Governance
  • Create, lead, and chair the Trade Compliance Committee, ensuring adherence to all applicable global import/export laws, regulations, and guidance.
  • Develop and maintain a robust global import/export compliance framework, including permits, licenses, valuation, duties, VAT, sanctions, HTS classification, country of origin, and applicable Tariffs/Free trade agreements.
  • Serve as primary respondent to regulatory agency inquiries; investigate issues, develop corrective strategies, and ensure timely, compliant responses.
  • Lead duty savings and optimization strategies in collaboration with Finance and Supply Chain, while maintaining full regulatory compliance.

• Performance, Financial & Operational Excellence
  • Establish and monitor KPIs across logistics, warehousing, and trade compliance with clear, data‑driven reporting.
  • Manage operating budgets, capital expenditures, and cost optimization initiatives.
  • Drive automation, digitalization, and process improvements to enhance efficiency, scalability, and compliance.
  • Champion lean principles, continuous improvement, and right‑first‑time execution across the organization.

• Stakeholder & External Engagement
  • Build and maintain strong partnerships with Legal, Finance, Clinical, Commercial, Quality, Manufacturing, Procurement, IT, and HR.
  • Represent the company with customs authorities, regulatory agencies, industry groups, and external counsel as required.
  • Participate in global forums to influence policy, standardization, and best practices across the supply chain network.

Qualifications:

• Bachelor’s degree in Business, Supply Chain, Engineering, Life Sciences, or related field; MBA or Master’s degree preferred.
• 18+ years of progressive experience in global logistics, warehousing, supply chain, and/or trade compliance within biotech, pharmaceutical, or other highly regulated environments.
• Proven senior leadership experience managing complex global networks of internal operations and external partners (CMOs, CDMOs, 3PLs).
• Working knowledge of global trade compliance regulations, including U.S. Customs and relevant international authorities; experience with permits, licenses, duties, VAT, sanctions, and duty savings strategies.
• Demonstrated expertise in pharmaceutical cold chain logistics (ambient, refrigerated, frozen, ultra-low temperature) across R&D, clinical, and commercial programs.
• Strong strategic and operational leadership skills, with the ability to influence cross-functional and matrixed stakeholders globally.
• Excellent analytical, communication, and decision-making skills in high-complexity environments.
• Financial acumen including budgeting, cost control, and KPI management.
• Experience with ERP systems (SAP preferred) and electronic Quality Management Systems.
• Relevant certifications or formal trade compliance training are preferred (e.g., Customs, Export Compliance, APICS, HAZMAT).

Travel / On-site Requirements:

Up to 20% travel required to support internal sites, external partners, and global supply chain initiatives.

Onsite requirements: Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.

Position Overview:

Beam Therapeutics is seeking a highly skilled attorney to serve as the Corporate Counsel/Senior Corporate Counsel, Commercial Contracts. This role will partner with Beam’s medical affairs, commercial and manufacturing teams to provide contracting support for Beam’s transition to a commercial stage company. Ideal candidates will excel in negotiating complex agreements, managing risk, and achieving business objectives in a fast-paced, cutting-edge biotechnology company.

Responsibilities:

• Draft and negotiate high-stakes agreements in support of Beam’s anticipated product launches, including complex commercial contracts with gene therapy treatment centers, channel partners and manufacturers.
• Assist with legal review of other pre-commercial activities, including advisory boards, patient engagement events, patient support programs, market access activities, speaker programs, and market research.
• Provide legal support to Beam’s various promotional material review committees.
• Provide ongoing contracting support and lifecycle management, including agreement interpretation and risk analysis, for Beam’s commercial, medical affairs, manufacturing and other teams.
• Collaborate with business teams and subject matter experts on continuous review and updates of Beam contracting playbooks and standards.
• Draft and negotiate a range of other key agreements in support of Beam’s broader business, including clinical trial agreements, material transfer agreements, sponsored research agreements, service provider agreements, and non-disclosure agreements.

Qualifications:

• Juris Doctor (JD) from an accredited law school; admission to practice in at least one U.S. jurisdiction.
• 5+ years of experience with complex biotechnology contracting, ideally with commercial-stage cell and gene therapy companies.
• Ability to manage multiple, overlapping, high-stakes agreements to completion on tight timelines.
• Flexible, must be able to work collaboratively with team members for a diverse range of projects.
• High degree of professional ethics and integrity.
• Sound judgement and ability to quickly analyze different sources of information.
• Practical and business-minded, capable of recognizing, assessing, and responding to urgent matters with timely, pragmatic, and clear solutions.
• Exceptional and demonstrated written and verbal communication skills.
• Candidates are expected to come onsite 2 days per week.

Additive Qualifications:

• Experience advising medical affairs and commercial teams on legal and regulatory legal requirements related to product launches.
• Ability to provide legal counsel on health care laws, such as anti-kickback, false claims and transparency statutes.
• Service on promotional material review committees for pre-commercial or commercial biotechnology companies.

Position Overview

We are seeking a Scientist II/ Senior Scientist I with hands‑on experience in phase‑appropriate analytical method development, optimization, qualification, and transfer to support the release, stability, and characterization of cell and gene therapy products. This role will mainly support Beam’s in vivo lipid nanoparticle (LNP) based programs and will be based in a laboratory environment.

The ideal candidate will have experience in design and development of analytical methods for mRNA, gRNA, protein, protein conjugate, lipid, and LNP, experience working collaboratively with cross-functional research and CMC teams, and have a working knowledge of analytical ICH/USP guidelines.

Primary Responsibilities:

• Lead early through late phase method development, optimization, and transfer for lot release, stability, and characterization of drug substances, critical materials, and drug products.
• Establish technical leadership as subject matter expert in multiple analytical techniques during method development and transfer and provide technical troubleshooting support when needed.
• Work with cross-functional groups including Research & Development, Quality Control, and Process Development teams to participate in various aspects of method development, transfer, characterization, comparability, and investigation.
• Coordinate routine sample testing including requests from Research and Development groups and Process Development teams.
• Author and review SOPs, technical reports, and assist in the preparation of CMC regulatory submissions.
• Analyze, track, and trend data to monitor analytical assays and ensure consistency in assay performance.
• Maintaining detailed documentation of experiments in ELN system.
• Adapting to a fast-paced, dynamic research environment.
• Mentor and train junior scientists
• Living Beam Therapeutics core values of being part of a community of fearless innovators, being rigorous and honest in our research, listening with open minds, and committed to each other.

Qualifications:

• Degree in a relevant discipline (biochemistry, biotechnology, biological sciences, bioengineering, or related fields). Minimum PhD with 2+ years or BS/MS with 10-15 years (title based on experience) industry experience including biotech, biopharma, CRO, and CDMO.
• Must have hand on experience on analytical method development, optimization, qualification, and testing at GMP or non-GMP environments, supporting clinical phase programs.
• Experience with analysis of RNAs, proteins, protein conjugates, lipids, and lipid nanoparticles (LNPs) is highly desirable and will be key to success in this role.
• Extensive experience with at least one or several of the analytical techniques is required: HPLC (RP, IPRP, SEC, IEX), capillary gel electrophoresis, ELISA. Experience with qPCR, DNA and RNA extraction, western blotting, UV spectrophotometry, DLS, MALS, mass spectrometry, and compendial testing will be a plus.
• Experience with analytical CMC development, method transfer, and QC technical support is highly desirable.
• A good understanding of ICH Q2 and Q14, with working knowledge on analytical Quality by Design concept.
• CMC project management and people management experience will be a plus.
• Familiarity with data analysis software such as Openlab, Chromeleon, and statistical software such as JMP.
• Team player with excellent oral and written communication skills.
• Independently motivated, detail-oriented scientist with excellent critical thinking and problem-solving abilities.
• Excellent organizational skills towards multi-tasking in an extremely fast-paced environment with changing priorities.
• Must be able to work onsite daily

Position Overview:

Beam is seeking an experienced and motivated Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this role, you will serve as the operational lead - driving timelines, fostering collaboration, and ensuring the successful execution of clinical trials. The CTM will oversee day-to-day activities throughout the clinical trial lifecycle. Key responsibilities include managing start-up, conduct, and close-out activities in alignment with industry and corporate standards within ICH/GCP Guidelines.

Responsibilities:

• Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities.
• Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals.
• Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO to manage the daily operational management activities of CROs and study vendors.
• Oversee preparation and submission of essential documents to IRBs/ECs and regulatory authorities.
• Contribute to (or oversee the management of) the creation of the trial plans and site facing documents.
• Develop (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members.
• Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
• Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
• Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate.
• Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study.
• Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial.

Qualifications:

• Bachelor's Degree in life sciences or related field with 8+ years' experience in biotech and/or pharmaceutical industries managing clinical trials.
• Phase I experience is strongly preferred; a background in rare disease and/or metabolic disorders is highly desirable, and experience with cell & gene therapy is a plus.
• Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes.
• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
• Ability and willingness to travel up to 20% (domestic and international).
• #LI-Hybrid

Position Overview:

Beam is seeking a scientist with expertise in formulation and ligand conjugation. The candidate will work on formulation, ligand conjugation, and scale-up of lipid nanoparticles (LNPs) targeting different organs and cell types. They will work as part of a team to develop drug products with the goal of bringing in vivo base editing to patients.

We are looking for an ambitious candidate who wants to grow within the LNP Sciences group. This candidate will help shape the LNP platform and grow with the aspirations of the organization as we advance into later stages of development.  

Primary Responsibilities:

• Responsible for formulation design, development, characterization, and technology transfer to enable development of Beam sterile drug products.
• Accountable as an individual contributor to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development.
• Independently design, execute, analyze, and document experiments to optimize LNP potency, tolerability, biodistribution, and ligand conjugation.
• Design and execute experiments to enable a robust and reproducible process for manufacture of ligand conjugated LNPs at-scale. Interface closely with Analytical Development and Biotherapeutics teams to characterize different unit operations for the manufacturing of DP to understand process robustness.
• Provide support with tech transfer activities for manufacturing of drug products.
• Generate high quality documentation as per Beam SOPs and in support of regulatory filings.
• Communicate scientifically rigorous findings via verbal and written communications, and presentations both internally and externally.

Qualifications:

• PhD or MS in Pharmaceutical Sciences, Chemical Engineering, Bioengineering or related field with drug product and CMC development experience (PhD 4+ years or MS 12+ years).
• Deep understanding of sterile product development. Prior industry research experience, especially in nucleic acids and drug delivery, is required. Experience with development of antibody-drug conjugates and/or biologics is preferred.
• Knowledge of statistical techniques and concepts (regression, properties of distributions, statistical tests, and proper usage, etc.).
• Ability to adapt to increasing scope and complexity of work brought on by growth/change and help others manage through change.
• A successful candidate will have excellent computational, written, and verbal communication skills, strong organizational abilities, and an ability to work with a diverse group of scientists and engineers.
• Ability to work in a hybrid environment with sufficient on-site presence.

Position Overview:

Beam is looking for a highly talented and motivated Senior Manager, Statistical Programming, to join our growing Statistical Programming team in the Biometrics department. The senior manager will be responsible for developing and maintaining statistical programming functions within a therapeutic area to support various clinical studies and submissions to ensure successful execution for Beam’s clinical programs. In this role, you will work with the lead of statistical programming to develop statistical programming strategies and timelines. You will manage CROs, oversee programming activities and provide timely support to the cross-functional teams on statistical programming matters according to the project strategies and requests.

Responsibilities:

• Participates in statistical programming activities on clinical studies and oversees CROs to generate analysis data sets and tables, listings and figures needed for clinical study reports and regulatory submissions.
• Reviews and validates SDTM, ADaM analysis datasets and TFLs created by CROs.
• Works collaboratively and communicates effectively with Biostatistics, Data Management, clinical operations, clinical development, Regulatory and other functions.
• Manages creating CDSIC SDTM and ADaM datasets, analysis metadata results and Define.xml for Electronic Submission from the clinical database or external data sources.
• Manages the activities of data summary, statistical analysis, patient profile, safety and efficacy tables, listings and figures using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS and R.
• Participates and manages the workflow of generating study specific and ad-hoc clinical data listings, summary tables and figures.
• Partners with Statisticians and other members of the clinical study team, performs ad hoc analysis.
• Reviews SAP, DMP, CRF, annotated CRF, table shells and other relevant documents by CROs and provides expert feedback from functional perspective.
• Develops SAS programming infrastructure and programming processes improve data deliverables and ad hoc analyses quality and efficiency.
• Builds and mentors a team of programmers as needed to support Beam clinical trials and development pipelines.

Qualifications:

• MS or higher degree in Statistics, Mathematics, or related scientific Discipline.
• At least 10 years Pharmaceutical/Biotech programming experience.
• Advanced SAS programming skills and strong Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Experience and in-depth knowledge in CDISC including STDM, ADaM and controlled terminologies.
• NDA or BLA submission experience is required.
• Excellent organizational skills and ability to prioritize tasks.
• Excellent communication and interpersonal skills.
• Experience managing CROs and other data vendors.
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance.
• Experience with R-Shiny is a plus.
• #LI-Hybrid