Role

We are looking for a Senior Solutions Consultant - AI Security to join our Sales and Go-to-Market team. This is a remote role based in the US, reporting to the Director of Solutions Consulting - AI Security. The Zscaler Sales and Go-to-Market team is a global group of professionals passionate about delighting customers and sharing expertise to drive a secure, cloud-enabled digital future. As a key technical partner, you will demonstrate the power and agility of Zscaler cloud transformation to cement our position as the world leader in cloud security.

What you’ll do (Role Expectations)

• Drive business growth by partnering with Account Executives to deliver compelling product demonstrations and presentations

• Plan, execute, and deliver Proof of Concept (POC) and Proof of Value (POV) projects demonstrating product capabilities and business ROI

• Form lasting customer relationships to ensure success, facilitate smooth onboarding, and cultivate Zscaler product champions

• Act as the voice of the customer by channeling insights to the development team to shape the product roadmap and feature scoping

• Maintain expert-level knowledge of Zscaler offerings, developing business value propositions, and monitoring competitor products

Who You Are (Success Profile)

• You thrive in ambiguity. You're comfortable building the path as you walk it. You thrive in a dynamic environment, seeing ambiguity not as a hindrance, but as the raw material to build something meaningful.

• You act like an owner. Your passion for the mission fuels your bias for action. You operate with integrity because you genuinely care about the outcome. True ownership involves leveraging dynamic range: the ability to navigate seamlessly between high-level strategy and hands-on execution.

• You are a problem-solver. You love running towards the challenges because you are laser-focused on finding the solution, knowing that solving the hard problems delivers the biggest impact.

• You are a high-trust collaborator. You are ambitious for the team, not just yourself. You embrace our challenge culture by giving and receiving ongoing feedback—knowing that candor delivered with clarity and respect is the truest form of teamwork and the fastest way to earn trust.

• You are a learner. You have a true growth mindset and are obsessed with your own development, actively seeking feedback to become a better partner and a stronger teammate. You love what you do and you do it with purpose.

What We’re Looking for (Minimum Qualifications)

• Proven experience in a customer-facing technical role such as sales engineering or consulting

• Knowledgeable in Generative AI, cybersecurity, data science or adjacent technical domains

• Excellent communication skills for both technical deep-dives and clear executive briefings

• Proven ability in solving complex technical challenges and effectively managing multiple projects simultaneously

• BSc in Computer Engineering, Computer Science, or equivalent experience

What Will Make You Stand Out (Preferred Qualifications)

• Experience with Python or TypeScript and utilizing REST APIs with tools like cURL and Postman

• AI red teaming experience, agentic system development, or MCP server experience

• Familiarity in major cloud platforms: AWS, Azure, or GCP

#LI-AA5 #LI-Remote

Legend Biotech is seeking an Executive Director, Pipeline Clinical Lead as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Pipeline Clinical Lead is a senior clinical development leader accountable for the scientific and medical direction of early stage clinical programs. This role provides strategic and operational leadership across first in human through proof of concept studies, with accountability for clinical strategy, trial design, execution, interpretation, and regulatory interactions.

The Pipeline Clinical Lead will lead and develop a team of physicians and scientists, work closely with cross functional partners, and collaborate with external development partners and investigators. Deep expertise in clinical trial design, regulatory frameworks, and compliance in drug development—ideally within cell therapy—is essential.

This role requires strong scientific judgment, leadership presence, and a hands on approach in a fast paced, entrepreneurial environment, with a clear focus on patient safety and clinical impact.

Key Responsibilities

Clinical Development Leadership

• Serve as clinical science lead for early stage programs (pre IND through Phase 1/2), including study design, execution, data interpretation, and reporting.
• Define and integrate clinical strategies, including PK/PD, biomarkers, diagnostics, and translational approaches, particularly for cell and gene therapies.
• Provide clinical input into asset selection, review of preclinical data, and development path decisions.

Regulatory & Compliance

• Lead or support IND preparation and amendments, clinical sections of regulatory submissions, and responses to health authority questions.
• Represent the clinical function in pre IND, IND, and (as applicable) BLA/MAA interactions with regulatory agencies.
• Champion patient safety, ethical conduct, and compliance with GCP, corporate policies, and global healthcare regulations.

Cross Functional & External Collaboration

• Partner closely with Clinical Operations, Biostatistics, Regulatory Affairs, Early Discovery,
• Manufacturing, Biomarkers, and Pharmacovigilance to ensure integrated program delivery.
• Collaborate with external development partners, academic investigators, KOLs, and study sites.
• Act as a credible scientific and clinical representative for programs in internal governance and external forums.

People & Matrix Leadership

• Provide direct line management and mentorship for Medical Directors, Clinical Research Scientists, Medical Writing, Clinical Program management and other clinical staff as applicable.
• Lead effectively in a matrix environment, anticipating cross functional needs and proactively resolving conflicts or risks.
• Contribute clinical leadership to business development, due diligence, and partnership activities when required.

Requirements

• MD or MD PhD (or equivalent) with US board certification or international equivalent.
• ≥8 years of clinical development experience in industry and/or academia, with demonstrated leadership in hematology/oncology.
• Proven experience designing and executing clinical trials from first in human through registrational stages.
• Prior involvement with IND submissions; experience with BLA/MAA filings and health authority meetings strongly preferred.
• Cell therapy and/or CAR T clinical development experience highly desirable IT Skills.
• Strong scientific judgment with the ability to navigate complex clinical and regulatory challenges.
• Demonstrated ability to lead cross functional and geographically distributed teams in a matrix environment.
• Excellent written and oral communication skills, including protocol writing, regulatory documents, publications, and senior level presentations.
• Highly collaborative, influential leader with the ability to represent programs with credibility and confidence.
• Hands on, execution oriented mindset with strong organizational and analytical skills.
• Willingness to travel up to 15–20%.

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Legend Biotech is seeking a Sr. Manager, Clinical Trial Operations Planning & Analytics as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Manager, Clinical Trial Operations Planning & Analytics is responsible for the strategic planning and analytics capability to support current and future Legend pipeline studies. This role will establish scalable approaches for feasibility, site identification, study startup planning, forecasting, and trial performance analytics to improve predictability and enable earlier operational intervention. The position partners closely with Clinical Operations leadership and cross-functional stakeholders to determine and assess assumptions, refine strategy, and translate data into actionable operational decisions across the study lifecycle.

Key Responsibilities

• Lead development of standardized frameworks, tools, and processes for feasibility, site identification, enrollment forecasting, study startup planning, and predictive trial performance modeling across pipeline studies.
• Develop data-driven approaches to identify the right countries and sites globally to support activation and enrollment acceleration and to predict key operational outcomes such as startup timing, enrollment, and study completion.
• Build scenario models and planning outputs to support base and best case operational strategies and contingency planning.
• Establish contingency planning triggers, risk indicators, and escalation thresholds based on modeled performance risk.
• Partner with study teams, CROs, and cross-functional stakeholders to pressure-test trial assumptions and refine country and site strategies.
• Create and maintain dashboards and analytics to monitor startup, activation, enrollment, and delivery risk trends.
• Translate study and portfolio performance data into actionable insights and executive-ready recommendations for senior leadership.
• Support continuous refresh of assumptions as study conditions, portfolio priorities, and external dynamics evolve.
• Capture lessons learned and convert them into reusable planning tools, templates, and methodologies that improve cross-study consistency.
• Represent the function in internal planning discussions and external partner interactions related to feasibility, forecasting, and performance analytics.
• Performs other duties as required.
• Works closely with the Sr. Director and VP of Clinical Operations. Clinical Operations Capabilities & Scalability and collaborates with Clinical Operations study teams, Clinical Development, IT, ITQA Biostatistics, Regulatory, Project Management, Procurement, Finance, QA, and CRO/vendor.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, data, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience; 10+ years preferred.
• Experience working with data sources to inform trial forecast modeling
• Experience in clinical operations planning, feasibility, study startup, operational analytics, or related functions required.
• Experience supporting global site identification, country strategy, or enrollment planning strongly preferred.
• Experience building dashboards, models, or analytics to support clinical trial execution preferred.
• Oncology, cell therapy, or early-phase clinical development experience preferred.
• Ability to travel as necessary (approximately 10%).
• Knowledge/familiarity with tools to enable trial forecasting and modeling.
• Strong critical thinking, analytical, strategic planning, and problem-solving skills.
• Effective oral, written, and interpersonal communication skills with strong presentation capability.
• Forward and critical thinker with ability to translate data into decisions.
• Strong organizational and project management skills and the ability to multitask.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project, and analytics/visualization tools).
• Working knowledge of GCP, FDA, and ICH Guidelines.

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Legend Biotech is seeking a Senior Clinical Research Scientist as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Clinical Research Scientist (CS) in Clinical Development is an important role in the company supporting the development and life cycle of drug development projects. The Clinical Research Scientist will work closely with the Clinical Trial Lead/Medical Lead and Clinical Trial Manager to design and implement clinical trial protocols and manage sites, CROs and other associated work. In addition, the CS will support their manager to ensure program consistency & alignment across studies, working closely with cross-functional teams for achieving project goals, within timelines & with high quality. This clinical scientist will support early phase drug development in autoimmune indications.

Key Responsibilities

• Responsible to ensure the data review and cleaning activities meet the quality standards to support database locks in collaboration with data management and medical lead/clinical trial lead. Uses clinical and disease state knowledge to make recommendations for methods and strategy for data cleaning approach
• Collaborate with other functions to successfully support the planning and execution of clinical studies. Provides independent leadership of all areas requiring clinical input with oversight from the assigned Clinical Trial Lead/Medical Lead, and provides innovative and quality solutions for assigned problems and tasks.
• Provides clinical input and strategic recommendations for the planning and implementation of assigned clinical trial(s) including investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions.
• Contributes to the strategic planning, preparation, and review of clinical documents (Protocol, ICFs, CSR, investigator brochure). May lead certain documents or sections of documents, including incorporation of input from other cross-functional team members.
• Provides clinical input and strategic recommendations for regulatory documents needed for all stages of assigned trial lifecycle (IND documentation, HA briefing books, BLAs, and Orphan Drug Applications).
• Responsible for clinical portions of key data management/statistical documents (eg: Case Report Forms, edit checks, data review plan and reports).
• Contribute to the planning and execution of external meetings and internal stakeholder meetings (e.g., Ad Boards, IMs, Governance, DMCs, Regulatory Authority, Dose Escalation meeting); responds to or triages questions for appropriate escalations. May have a speaking role on meetings when appropriate.
• Supports their manager when asked to contribute to harmonization between clinical trials and process improvement initiatives.
• May have the authority to make decisions related to issuing data cleaning queries and can decide whether there is a need to escalate for further discussion with the medical lead. They may also be delegated tasks from the clinical trial lead/medical lead for which they have decision making authority e.g. comment resolution when leading document creation.

Requirements

• At least a Bachelor’s degree in life science discipline.
• Bachelor’s degree with 4+ years’; or MS with 3+ years’; or PharmD/PhD with 2+ years of pharma experience in clinical development or related function.
• CAR-T cell therapy and/or autoimmune disease experience is a plus.
• Good interpersonal & communication skills, including oral, written and interpersonal.
• Ability to effectively manage conflicts and negotiations while providing impact and influence.
• Collaborative with the ability to operate across multiple geographies.
• Good leadership & organizational skills, analytical skills, and presentation skills.
• Creative problem-solving skills.
• Strong organizational and project management skill and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Oncology Therapeutic Experience preferred.
• Excellent working knowledge of GCP, FDA and ICH Guidelines.

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Legend Biotech is seeking a Sr. Director, Clinical Operations Capabilities and Standards as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sr. Director, Clinical Operations Capabilities and Standards will be responsible for providing strategic leadership and oversight for foundational and centralized trial operations support towards cost-effective scalability of the Clinical Operations department. 

Among other responsibilities, this position will establish, oversee and grow Clinical Operations capability pillars that include Clinical Trial Planning and Analytics, Clinical Trial Operational Technologies, Vendor Alliance Management, Site Contracts & Payments, and Sample & Imaging Management Operations; including managing and developing staff within each pillar.

This position will also be the company subject-matter expert for clinical operations standards applied across the portfolio of Legend IND clinical trials.

Key Responsibilities

Oversee the development and strengthening of the following clinical operations capabilities and functions, with leads/teams in each of these areas:

Clinical Trial Planning & Analytics:

• Clinical Trial Planning and Analytics (CTP&A) is accountable for end‑to‑end clinical trial feasibility activities, supporting protocol optimization, country and site selection, enrollment forecasting, and risk mitigation across clinical programs.
• This function provides data‑driven feasibility insights to enable informed decision‑making during early study planning and partners closely with Clinical Operations Leads, Clinical Development, cross-functional stakeholders and external vendors to ensure trials are designed and placed for successful execution.
• This function is responsible for predictive trial performance modeling to enable proactive implementation of contingency plans

Clinical Trial Operational Technologies:

• The Clinical Trial Operations Technology function is responsible for the strategic ownership, governance, and optimization of clinical trial operations systems that enable compliant, efficient, and inspection‑ready execution of clinical trials.
• This function serves as the business owner for core clinical systems (e.g., CTMS, eTMF, and related platforms), ensuring alignment with clinical operations needs, regulatory requirements, and the company’s development portfolio. The position partners closely with Clinical Operations Leads, Quality, Regulatory, Data Management, IT, and CROs/external vendors.
• Areas of focus for capability building include leveraging technology to enable cost-efficient trial budget builds and ongoing costs optimization during study execution, enabling tools for targeted clinical operations risk management and technology-enabled eTMF oversight.

Vendor Alliance Management:

• Vendor Alliance Management is responsible for the strategic and operational oversight of external clinical operations vendors and CRO partners supporting clinical trials, including coordination of vendor due diligence for vendor qualification. Ensures vendors deliver high‑quality services in compliance with GxP and contractual expectations, while enabling efficient study execution across one or more clinical programs.
• Vendor Alliance Management is the primary interface between internal Clinical Operations Program Leads and external service providers, with accountability for vendor governance, performance management via objective metrics, issue escalation, and continuous improvement.

Site contracts and Payments

• Site Contracts & Payments is responsible for creating and overseeing a scalable and effective operating model for site contracting visibility, investigator payment operations, serving as a central point of accountability for improving operational control, process effectiveness, financial discipline, vendor performance consistency, and sponsor-CRO-site workflow alignment.

Sample and Imaging Management Operations

• Sample and Imaging Management is responsible for end-to-end sample and imaging oversight across Legend pipeline studies. To strengthen visibility, accountability, and coordination across sites, CROs, central labs, specialty labs, imaging vendors.
• Sample and Imaging Management focuses on system‑level consistency and risk reduction, mitigating against loss of patient data, enabling acceleration of data cleaning and reducing site burden for participation in clinical trials.
• Lead business owner for clinical operations standards and practices, including functional owner for clinical operational related SOPs and guidance documents.
• Performs other duties as required.

Key Relationships

• The Head of Clinical Operations Capabilities and Standards works closely with all applicable internal cross-functional leaders and teams as well as external vendors for the clinical operations capability building and strengthening.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• 12+ years of progressive experience in pharmaceutical or biotechnology clinical operations, with demonstrated leadership responsibility across global clinical development programs.
• Significant experience in establishing, scaling, or transforming centralized Clinical Operations capabilities, including one or more of the following:
  • Clinical Trial Planning & Analytics / Feasibility
  • Clinical Trial Operational Technologies (e.g., CTMS, eTMF, analytics platforms)
  • Vendor Alliance Management
  • Site Contracts and Investigator Payments
  • Sample and Imaging Management Operations
• Proven expertise in end‑to‑end clinical trial conduct, including early‑phase through late‑phase trials, with strong understanding of protocol development, feasibility, start‑up, execution, and close‑out.
• Demonstrated strategic CRO and vendor oversight experience, including governance models, performance metrics, financial oversight, issue escalation, and continuous improvement.
• Experience acting as a functional or enterprise‑level clinical operations subject‑matter expert, defining standards, operating models, and best practices applied across multiple studies or programs.
• Strong background collaborating with Quality, Regulatory, Clinical Development, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Translational/Bioanalytical, Medical Affairs, Procurement, Legal and IT functions in a matrixed global environment.
• Experience participating in and/or supporting regulatory authority interactions (e.g., FDA inspections) related to clinical operations processes, vendors, systems, or trial conduct is strongly preferred.
• Demonstrated success leading, developing, and retaining high‑performing teams, including functional leaders.
• Willingness to travel as required (approximately 10%).
• Deep knowledge of clinical trial operations frameworks, including industry best practices and regulatory expectations (ICH‑GCP, FDA, and global health authorities).
• Strong capability in clinical operations operating model design, including centralization, standardization, governance, and scalability.
• Demonstrated leadership in clinical operations technology enablement, including business ownership of systems (e.g., CTMS, eTMF), data quality oversight, technology‑enabled risk management, and inspection readiness.
• Expertise in vendor and alliance management, including development of governance structures, KPI frameworks, financial oversight, and performance optimization.
• Understanding of clinical trial sample, imaging, and data flows, with ability to design operational controls that reduce patient data risk, site burden, and cycle times.
• Ability to translate portfolio‑level strategy into executable clinical operations capabilities, standards, and guidance.
• Proven strategic and critical thinking skills, with a data‑driven mindset and ability to anticipate operational risks and mitigation strategies.
• Strong experience developing, authoring, and governing clinical operations SOPs, standards, and guidance documents.
• Exceptional communication, presentation, and stakeholder influence skills, with the ability to engage senior leadership and cross‑functional teams.
• High proficiency with clinical operations–relevant technologies and tools, including MS Office (Excel, PowerPoint, Word) and enterprise clinical systems; ability to leverage analytics for operational decision‑making.

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Legend Biotech is seeking a Manager, Site Contracts & Payments Management as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Site Contracts & Payments Manager is responsible for site contracting and investigator payment process oversight and management, and vendor due diligence across Legend pipeline studies. The role serves as a central point of accountability for improving operational effectiveness, financial discipline, and sponsor-CRO-site workflow alignment for site contracting and payment processes.

Key Responsibilities

• Partner with CROs to develop and oversee process workflows, and create visibility into site contract and investigator payment workflow efficiency across studies.
• Partner with CROs, AP, Procurement, Finance, Legal, and study teams to align process workflows, identify gaps, and improve efficiency in contracting and payment execution.
• Monitor key milestones, bottlenecks, and escalations affecting site startup experience for contracting, payment timeliness, and financial predictability.
• Support reconciliation, issue resolution, and continuous improvement related to site contracting and investigator payment operations.
• Coordinate vendor due diligence and risk assessment activities with Procurement, Finance, QA, and other stakeholders.
• Performs other duties as required.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, business, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.
• Strong experience in vendor oversight, outsourcing, site contracts, investigator payments, or related operational functions required.
• Experience working cross-functionally with AP, Procurement, Finance, and Legal required.
• Experience working in SAP/4 Hanna preferred.
• Experience establishing KPIs and oversight models preferred.
• Oncology, cell therapy, or early-phase clinical operations experience preferred.
• Ability to travel as necessary (up to 10%).
• Effective oral, written, and interpersonal communication skills.
• Strong process management, organizational, and problem-solving skills.
• Ability to identify operational risk and drive practical mitigation strategies.
• Strong project management skills and the ability to manage multiple priorities.
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project).
• Working knowledge of GCP, FDA, and ICH Guidelines.

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Legend Biotech is seeking a Manager, Sample Management Operations as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Sample Management Operations Manager is responsible for overseeing end-to-end sample management across Legend pipeline studies. The role strengthens visibility, accountability, and coordination across sites, CROs, central labs and specialty labs.

Key Responsibilities

• Manage the operating model for sample management across current and future studies.
  
• Map and standardize workflows across sites, CROs, central labs, specialty labs, the sample management vendor, and sponsor stakeholders.
  
• Create visibility into critical handoffs, chain of custody, issue resolution, reconciliation activities, and operational dependencies.
  
• Monitor operation trends and proactively identify operational risks and mitigation plans that reduce delayed, lost, or poorly coordinated samples.
  
• Serve as lead for sample tracking and oversight capabilities enabled through the sample management vendor.
  
• Work with study teams and external vendors to reduce delays, missing data, and operational burden at sites.
  
• Support readiness for inspections, audits, and quality reviews related to sample operations.
  
• Create playbooks, templates, and role clarity to support consistent execution across studies.
  
• Capture lessons learned and apply them to future study planning and execution.
  
• Performs other duties as required.
• Works closely with Sr. Director of Clinical Operations and collaborates with Clinical Operations, Data Management, QA, ITQA, central labs, specialty labs, CROs, sites, and other cross-functional stakeholders.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific, health care, or related discipline. Advanced degree preferred.
• 7+ years of pharmaceutical, biotech, CRO, or related clinical research experience.
  
• Experience in clinical operations with exposure to sample management, lab operations, or related oversight functions required.
  
• Experience developing or improving complex operational workflows strongly preferred.
  
• Experience with central labs, specialty labs or sample tracking solutions preferred.
  
• Oncology, cell therapy, or early-phase clinical development experience preferred.
  
• Ability to travel as necessary (up to 10%).
• Effective oral, written, and interpersonal communication skills.
• Strong organizational, project management, and issue resolution skills.
  
• Ability to identify operational risk and develop practical mitigation strategies.
  
• Strong attention to detail while maintaining end-to-end process visibility.
  
• Computer literacy required (MS Word, MS Excel, MS PowerPoint, MS Project and applicable operational tools).
  
• Working knowledge of GCP, FDA, and ICH Guidelines.

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Legend Biotech is seeking an Associate Director, Operations Program Lead as part of the Clinical Operations team based in Somerset, NJ.

Role Overview

The Operations Program Lead (OPL), Clinical Operations is accountable for accelerated operational delivery of 1-2 priority cell therapy development programs across all phases. This position is responsible for leading, managing and providing operational oversight for quality delivery within budget across all Legend Pipeline studies for 1-2 assets.

This individual must be able to work and lead in a small, fast-paced environment while also wearing multiple hats at any given time as the needs of the organization change and evolve. This position requires a high-performing contributor with strong leadership and stakeholder management skills. This individual will collaborate with the cross functional team to develop operationally feasible program timelines and identify clinical trial operational risks and develop mitigation strategies to ensure accelerated and cost-efficient quality clinical trial execution.  In addition, the position will ensure program consistency across studies, drive research and operational excellence through process improvement, and represent the clinical trial operation function at internal and external meetings.

This position will oversee 1-2 contractor Clinical Trial Associates (CTA).

Key Responsibilities

Direct end-to-end clinical trial management: 

• Direct end-to-end clinical trial operations activities domestically and globally: i.e. lead and take ownership in all aspects of Study Operations for CAR-T Studies in a matrix environment.
• Responsible for the overall success of the clinical study programs
• Ensures the assigned clinical trials are executed in compliance with FDA and ICH/GCP guidelines/regulations and SOPs. Ensures audit-ready condition of clinical trial documentation including central clinical files.
• Report on all aspects of the study progress at a granular level to stakeholders and senior leaders. Effective, consistent & regular tracking of project (s). Prepare and present project reports as required. Plans, executes, and leads study-specific meetings as needed (e.g., Senior and Mid-level management Study Management Meetings).
• Supports the Development of strategic plans for clinical trial operations, ensuring alignment with the company's overall goals and objectives.
• Collaborate with the cross-functional "core" teams to integrate clinical operations strategies into broader development plans.
• Define project timelines & deliverables, by working closely with the cross-functional core program team for end-to-end execution of clinical trials.
• Collaborates in the preparation and/or review of study-related documents (e.g., study protocols, informed consents and amendments, Study Operations Plan, Monitoring Plan, Pharmacy Manual, Informed Consent, Laboratory Manual, CRF Completion Guidelines, study tools/worksheets and other study-specific documents or manuals).

Clinical Trial Operations Efficiency and optimization:

• The OPL will drive clinical Operations excellence by playing a critical role in Clinical Trial Operations Efficiency and optimization.
• Work with cross-functional teams and external vendors to identify clinical trial operational risks and develop mitigation strategies to ensure quality delivery of the clinical trial to support optimal and efficient clinical trial execution. 
• The position involves working closely with the clinical development team and collaboration with cross-functional teams, including safety, study monitoring and coordinators, data management, biostatistics, bio analytics, tech ops, manufacture, supply chain, regulatory, project management, medical affairs, finance, legal and quality.
• Create and Manage study trial execution RACI to support overall trial execution and operational excellence.
• Contribute to Clinical Operations functional initiatives and institution of best practices.

Resource Management and Direct High Performing team:

• Manage and build a high-performing clinical operations support structure. Duties include hiring, onboarding, training, and development of staff to manage studies.
• Lead, develop and manage study operation manual, new work-streams, SOPs, study template, tracking tools, dashboards to support optimal clinical operation performance.
• Provides study-specific training and leadership to clinical research staff, including CRO, sites and other study personnel to support clinical trial execution and optimization.

Direct and Support Vendor Partnership

• Oversee vendor selection process, management, of Contract Research Organizations (CROs) and vendors involved in clinical trial Operation (CRO, Central Lab, etc).
• Participates in CRO and vendor study related calls and meetings, holds team members accountable for actions, escalates issues and oversees all aspects of daily study operations. Ability to identify issues and risks. Develops and manages mitigations and/or escalate risks appropriately.
• Negotiates vendor contracts / budgets and presents to the executive study team for approval.
• Review and confirm CRO and site payment invoices.
• Lead vendor performance assessment for continuous process improvement
• Management/oversight of external vendor deliverables reports and budgets.
• Collaborate within Clinical Operations and with study leadership team to create preferred vendor list for clinical development.

Leadership Skills

• Has critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand the upstream, downstream, and lateral implications of decisions that affect study outcomes and timelines.
• Adaptable / flexible, self-starter (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Excellent team player: willingness and ability to fill functional gaps in a small organization.
• Comfortable multi-tasking in a fast-paced small company startup environment and able to adjust workload based upon changing priorities.

Key Relationships

• The Operations Program Lead in Clinical Operations works closely with the asset Core Team and cross-functional teams such as safety, study monitoring, data management, biostatistics, bioanalytics, manufacturing, supply chain, regulatory, project management, medical affairs, and quality.
• Mentoring and management of a CTA.

Requirements

• Minimum degree requirements of a bachelor’s degree (BA, BS) in scientific or health care discipline. Advance Degree Preferred.
• Oncology and/or Immunology clinical trial operations therapeutic experience required. 10+ years of pharmaceutical, biotech or CRO related/ oncology clinical research experience.
• Experience leading the operational planning and oversight of clinical trials as the point of accountability for operational delivery. (CAR-T trials experience is a plus).
• Demonstrated ability to deliver ambitious trial acceleration timelines within a competitive clinical trial landscape.
• Phase 1 clinical trial operational experience is preferred.
• Experience and knowledge of end-to-end management of clinical trial conduct, knowledge of the pharmaceutical industry and an understanding of clinical drug development, clinical trials operations and FDA/ICH regulatory requirements are essential.
• This position requires experience and leading study/project management to create study project plans, and end-to end-study timelines for execution of clinical trials.
• Demonstrated ability to multi-task and manage high performance demands.
• Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• CRO/Vendor oversight experience required.
• Project Management (biotech) experience a plus.
• Regulatory authority inspection experience a plus.
• Ability to travel as necessary (approximately 10 – 15 %); both domestically and internationally.
• Effective oral, written and interpersonal communication skills.
• Strong communication and presentation skills.
• Forward and critical thinker.
• SOP development experience preferred.
• Strong organizational and project management skills, and the ability to multitask.
• Computer literacy required (MS word, MS excel, MS PowerPoint and MS Project).
• Excellent working knowledge GCP, FDA and ICH Guidelines.

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Seeking talent near: Princeton, NJ

Position Summary:

In support of clinical development programs, the Director of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities.  Implements and ensures group compliance to procedures for the production and distribution of investigation product. Manage junior colleagues in the CTM team as required. 

Primary Responsibilities:

• Review and Interpretation of a clinical protocol or study overview:
  • Review and provide feedback during the development of the clinical protocol.
  • Calculate total demand and translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Contributes to CTM procedures in line with current regulatory requirements
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Proposes and implements improvements to ensure efficient clinical supply operations.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle ensures that all clinical trials have timely and an un-interrupted supply of CTM.
• Direct CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information.  Maintains departmental reports and files, updates SOPs and other projects assigned

Education/Experience/Skills

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years’ experience in pharmaceutical development focused on clinical trial materials
• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Demonstrated leadership skills
• Proven project management skills
• Ability to handle multiple projects simultaneously
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding of IRT system build-up and user testing
• Good negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Good organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Physical Requirements:

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #NC1

We are looking for a hardworking, innovative Principal Partner Specialist, Google Cloud with great energy, passion, and initiative to channel new business for the fastest growing and most-popular database on the planet, MongoDB.  

The Principal Cloud Partner Specialist will lead the strategic pursuit of large-scale transformation opportunities across the customer base, act as the deal-maker across Google Cloud & MongoDB, and own the end-to-end partner relationship. The role will be supported by Google Cloud & MongoDB Sales Leadership, Solution Architects, Marketing, and Sales Operations, all geared towards the success of the individual. 

This individual will own the Go-to-Market (GTM) strategy with Google Cloud in the US-East region, and  will be responsible for generating incremental pipeline via our cloud partnerships, growing deal size and accelerating sales cycle, and close business leveraging our partner programs. Must be located in the United States, preferably on the East Coast, with the ability to commute into the New York City headquarters office as needed.

Responsibilities

• Build & leverage Executive-level relationships between Google Cloud & MongoDB to create and close business
• Proactively prospect, identify, qualify, and develop a sales pipeline to and through our cloud partners
• Report to the Head of Global Co-sell for GCP  and own, on behalf of AVP Northeast & AVP Southeast, all things Google Cloud related
• Drive large and strategic deals in partnership with the MongoDB field sales, partners, and Google Cloud sales teams
• Interlock with the Global Cloud Program team for backup, support, and pipeline generation
• Own Quota for generating new business and uncovering new workloads/logos via cloud partners 
• Generate strategic joint pipeline with Google Cloud and support direct sales force on defined end-user sales pursuits
• Forecast co-sell Net ARR (Annual Recurring Revenue) and sourced new workloads by cloud partners to sales leadership on a weekly basis

Requirements

• 8 + years experience in a quota carrying direct strategic sales or partner/channel sales, ideally with experience co-selling with the hyperscalers 
• Solid experience in generating pipeline and sales forecasting
• Experience in working in a heavy sales matrix model
• Relevant experience and knowledge of open source, enterprise software apps, SaaS, Database, or Cloud Computing
• Excellent verbal, written, and presentation skills
• Proven ability to drive complex sales cycles, demonstrating multiple stakeholder management
• Experience developing successful and scalable technology partnership programs
• Ability to engage & influence C-Level executives
• Given the profile of this role, we are looking for consistent overachievers

Things we love

• Energetic, resourceful, upbeat, entrepreneurial, tenacious team player
• Previous Sales Methodology training a plus (e.g. MEDDIC, SPIN, Challenger Sales)
• College degree in business, economics, engineering, finance, science, math or similar 
• Possess aptitude to learn quickly and establish credibility. High EQ and self-aware
• The ability to work in fast paced environment, be trusted to drive initiatives autonomously and gain buy in from a wide collection of stakeholders
• Passionate about growing your career in the largest market in software and developing and maintaining an in-depth understanding of MongoDB products

About MongoDB

MongoDB is built for change, empowering our customers and our people to innovate at the speed of the market. We have redefined the database for the AI era, enabling innovators to create, transform, and disrupt industries with software. MongoDB’s unified database platform, the most widely available, globally distributed database on the market, helps organizations modernize legacy workloads, embrace innovation, and unleash AI. Our cloud-native platform, MongoDB Atlas, is the only globally distributed, multi-cloud database and is available across AWS, Google Cloud, and Microsoft Azure.

With offices worldwide and over 60,000 customers, including 75% of the Fortune 100 and AI-native startups, relying on MongoDB for their most important applications, we’re powering the next era of software.

Our compass at MongoDB is our Leadership Commitment, guiding how and why we make decisions, show up for each other, and win. It’s what makes us MongoDB. 

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From employee affinity groups, to fertility assistance and a generous parental leave policy, we value our employees’ wellbeing and want to support them along every step of their professional and personal journeys. Learn more about what it’s like to work at MongoDB, and help us make an impact on the world!

MongoDB is committed to providing any necessary accommodations for individuals with disabilities within our application and interview process. To request an accommodation due to a disability, please inform your recruiter.

MongoDB, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type and makes all hiring decisions without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Req ID: 426234

The Compliance team at MongoDB manages the strategy, execution, and maintenance of our global security certifications and regulatory requirements. We ensure that our cloud database products meet the rigorous security standards required by our customers in the most highly regulated industries worldwide.

We act as the primary interface between external auditors and our internal Product, Engineering, and Legal teams. Our goal is to translate complex regulatory requirements into scalable operational processes, maintaining a compliant and audit-ready posture across our diverse portfolio.

The Program Manager / Senior Analyst is a mid-to-senior level individual contributor role responsible for leading high-stakes audits and specialized compliance workstreams. Unlike the Analyst level, this role takes full ownership of complex international frameworks—such as IRAP and ENS High—and manages the relationship with our Financial Services customers during audit deep-dives. You will lead internal audit cadences and perform gap analyses for new market expansions.

Responsibilities:

• Lead the end-to-end execution of specialized external audits (e.g., ENS High, IRAP, ISO 22301) and coordinate all phases from initial scoping to final certification
• Serve as the lead point of contact for Financial Services customer audits, facilitating meetings, responding to security questionnaires, and defending our control environment to external stakeholders
• Lead internal audit cadences and drive the POA&M tracking process, ensuring technical teams remediate findings within required SLAs
• Map new regulatory requirements to our central control framework, performing gap analyses to identify where existing controls can be leveraged for new certifications
• Conduct NIST CSF or similar maturity assessments to monitor the effectiveness of the Compliance Program and report findings to team leads
• Author and review customer-facing security documentation, ensuring it accurately reflects our technical controls and architectural guardrails
• Partner with Engineering and Product leads to implement compliance-by-design, ensuring future product roadmaps align with global regulatory shifts

Requirements:

• 7+ years in GRC, Information Security, or IT Audit, specifically within a high-growth SaaS/Cloud environment
• Deep understanding of cloud security principles (AWS/GCP/Azure) and a proven track record leading technical audits for ISO 27001, SOC 2, or ENS High
• Solid grasp of audit processes, terminology, and risk assessment standards. Certifications such as CISA, CRISC, CISSP, or ISO Lead Implementer are highly preferred
• Exceptional ability to lead meetings with external customers and auditors, translating technical complexities into business risk and compliance assurance
• Advanced proficiency in Jira for tracking control performance data and managing high-volume remediation workflows
• Practical experience performing gap analyses and maturity assessments at an enterprise level

Responsibilities & Expectations

• You are expected to be a subject matter expert who can operate with minimal supervision
• You don't just track tasks; you own the success of the program
• You are expected to navigate complex audit negotiations with external parties and drive internal technical teams toward compliance milestones without disrupting innovation

Scope & Complexity

• The scope is international and technically diverse. You will manage overlapping audit cycles across different global jurisdictions (e.g., Spain, Australia, US) and complex industry sectors
• You are responsible for identifying how a single technical control can satisfy multiple global regulatory requirements simultaneously

Authority & Impact

• You have the authority to lead audit engagements and represent MongoDB’s security posture to sophisticated Financial Services customers
• Your impact is direct: by securing and maintaining these certifications, you enable our sales organization to close enterprise-level deals in highly regulated markets

Expertise

• You will be recognized as an expert in implementing our Common Controls Framework
• You move beyond general compliance to become a specialist in how MongoDB’s architecture satisfies specific, high-bar standards like IRAP and ENS High. You are the go-to for mapping technical evidence to regulatory intent

Leadership

• Leadership in this role is demonstrated through influence and mentorship. While you may not have direct reports, you lead cross-functional project teams through intense audit cycles and mentor junior analysts on audit methodology, documentation standards, and professional communication

About MongoDB

MongoDB is built for change, empowering our customers and our people to innovate at the speed of the market. We have redefined the database for the AI era, enabling innovators to create, transform, and disrupt industries with software. MongoDB’s unified database platform, the most widely available, globally distributed database on the market, helps organizations modernize legacy workloads, embrace innovation, and unleash AI. Our cloud-native platform, MongoDB Atlas, is the only globally distributed, multi-cloud database and is available across AWS, Google Cloud, and Microsoft Azure.

With offices worldwide and over 60,000 customers, including 75% of the Fortune 100 and AI-native startups, relying on MongoDB for their most important applications, we’re powering the next era of software.

Our compass at MongoDB is our Leadership Commitment, guiding how and why we make decisions, show up for each other, and win. It’s what makes us MongoDB. 

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From employee affinity groups, to fertility assistance and a generous parental leave policy, we value our employees’ wellbeing and want to support them along every step of their professional and personal journeys. Learn more about what it’s like to work at MongoDB, and help us make an impact on the world!

MongoDB is committed to providing any necessary accommodations for individuals with disabilities within our application and interview process. To request an accommodation due to a disability, please inform your recruiter.

MongoDB, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type and makes all hiring decisions without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

REQ ID: 1273402295

We are looking for a hardworking, innovative Cloud Partner Specialist with great energy, passion, and initiative to channel new business for the fastest growing and most popular database on the planet, MongoDB.  

The Cloud Partner Specialist will lead the strategic pursuit and will be the deal maker across Microsoft & MongoDB, with the remit of owning the end to and relationship and driving large-scale transformation opportunities across the customer base. The role will be supported by Microsoft & MongoDB Sales Leadership, Solution Architects, Marketing and Sales Operations all geared towards the success of the individual. 

This individual will own the Go-to-Market (GTM) strategy with Microsoft in the US, and  will be responsible for generating incremental pipeline via our cloud partnerships, growing deal size and accelerating sales cycle and close business leveraging our partner programs. Must be located in the US.

We are looking to speak to candidates who are based in New York City, New Jersey and Austin, TX for our hybrid working model.

Responsibilities:

• Build & leverage Executive-level relationships between Microsoft & MongoDB to create and close business
• Proactively prospect, identify, qualify, and develop a sales pipeline to and through our cloud partners
• Report to the Head of Global Cloud for Microsoft
• Drive large and strategic deals in partnership with the MongoDB field sales, partners, and Microsoft Cloud sales teams
• Interlock with the Microsoft Cloud Program team for backup, support, and pipeline generation
• Own Quota for generating new business and uncovering new workloads/logos via cloud partners 
• Generate strategic joint pipeline with Microsoft and support direct sales force on defined end-user sales pursuits
• Forecast co-sell Net ARR (Annual Recurring Revenue) and sourced new workloads by cloud partners to sales leadership on a weekly basis

Requirements

• 8+ years experience in a quota carrying direct strategic sales or partner/channel sales, ideally with experience co-selling with the hyperscalers 
• Solid experience in generating pipeline
• Experience in working in a heavy sales matrix model
• Relevant experience and knowledge of open source, enterprise software apps, SaaS, Database, or Cloud Computing
• Excellent verbal, written, and presentation skills
• Proven ability to drive complex sales cycles, demonstrating multiple stakeholder management
• Experience developing successful and scalable technology partnership programs
• Ability to engage & influence C-Level executives
• Given the profile of this role, we are looking for consistent overachievers

Things we love

• Energetic, resourceful, upbeat, entrepreneurial, tenacious team player
• Previous Sales Methodology training a plus (e.g. MEDDIC, SPIN, Challenger Sales)
• College degree in business, economics, engineering, finance, science, math or similar 
• Possess aptitude to learn quickly and establish credibility. High EQ and self-aware
• The ability to work in fast paced environment, be trusted to drive initiatives autonomously and gain buy in from a wide collection of stakeholders
• Passionate about growing your career in the largest market in software and developing and maintaining an in-depth understanding of MongoDB products

About MongoDB

MongoDB is built for change, empowering our customers and our people to innovate at the speed of the market. We have redefined the database for the AI era, enabling innovators to create, transform, and disrupt industries with software. MongoDB’s unified database platform, the most widely available, globally distributed database on the market, helps organizations modernize legacy workloads, embrace innovation, and unleash AI. Our cloud-native platform, MongoDB Atlas, is the only globally distributed, multi-cloud database and is available across AWS, Google Cloud, and Microsoft Azure.

With offices worldwide and over 60,000 customers, including 75% of the Fortune 100 and AI-native startups, relying on MongoDB for their most important applications, we’re powering the next era of software.

Our compass at MongoDB is our Leadership Commitment, guiding how and why we make decisions, show up for each other, and win. It’s what makes us MongoDB. 

To drive the personal growth and business impact of our employees, we’re committed to developing a supportive and enriching culture for everyone. From employee affinity groups, to fertility assistance and a generous parental leave policy, we value our employees’ wellbeing and want to support them along every step of their professional and personal journeys. Learn more about what it’s like to work at MongoDB, and help us make an impact on the world! 

MongoDB is committed to providing any necessary accommodations for individuals with disabilities within our application and interview process. To request an accommodation due to a disability, please inform your recruiter.

MongoDB, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type and makes all hiring decisions without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Req. ID: 1273420989

About the opportunity

Candidates must be located in the eastern time zone

Contentful strives to build a secure and safe service and commits considerable effort and resources to security. Our Security team supports organization-wide information security management programs and collaborates closely with internal teams. We believe that Security must be anchored by DevOps principles with strong repeatable processes.

We are looking for a committed and driven manager who is passionate about solving complex security problems in innovative and scalable ways. As a Manager of Security Engineering, you will own security engineering across Contentful’s corporate systems, including the tooling and platforms that support the internal security team. While this role does not own security for the customer facing product, you will partner closely with product security teams within the security organization on shared responsibilities.

You will balance people leadership with hands-on technical execution, including designing, building, and operating security controls and tooling at scale, with a particular focus on areas such as identity and access management, data security, and SaaS platforms. You will provide strategic guidance and lead initiatives while remaining directly involved in implementation. You may work independently at times, but will more often collaborate closely with security, IT, and cross-functional partners to align strategies, execute shared initiatives, and ensure comprehensive risk mitigation while minimizing impact on end users across the organization.

What to expect?

• Develop a team, providing coaching, mentorship, goal setting, and performance feedback.
• Define roles and make hiring decisions to grow the team in line with department needs.
• Remain hands on, balancing technical leadership with direct implementation work.
• Own execution and prioritization across projects and operations, using agile delivery practices.
• Scale and mature effectiveness and efficiency by improving processes and tooling.
• Champion continuous improvement across all aspects of the security program.
• Continuously improve effectiveness and efficiency by evolving processes and tooling.
• Communicate risks and technical concepts with clarity to leadership and stakeholders.
• Collaborate with security leadership to execute business aligned, risk reduction roadmaps.
• Shape work scope, sequencing, and success criteria inline with department and company needs.
• Drive security processes, standards, and best practices across information technology assets.
• Partner with stakeholders to evolve security awareness and specialized training across all functions.
• Mature capabilities across endpoint, SaaS, and cloud configuration.
• Own strategy evolution of corporate capabilities, including configuration, IAM, and data security.
• Enhance tooling, automation, and integrations to improve visibility and reduce manual effort.
• Support and guide security incident response efforts as a technical leader.
• Support cross functional vulnerability management while advancing the program capabilities.
• Define and maintain metrics to measure impact, optimize execution, and guide investment.
• Partner with cross-functional teams for security enhancement and drive risk reduction.
• Accelerate adoption of AI, balancing practicality enablement, and risk management.
• Stay current on threats, vulnerabilities, and tactics, translating insights into actionable strategies.

What you need to be successful?

• 8+ years of progressive engineering and security experience.
• 3+ years managing people and security engineering teams.
• Comfort operating in ambiguity, balancing strategic thinking, security, and practicality.
• Expertise with AWS, GCP, and Azure.
• Strong hands-on experience designing, implementing, and operating security controls at scale.
• Demonstrated experience securing endpoint, SaaS, and cloud environments.
• Experience working within identity and access management and data security programs.
• Software development experience in modern programming language (Python, Go, etc)
• Hands-on experience using Terraform and infrastructure-as-code.
• Experience applying modern practices to improve efficiency and scalability or security programs.
• Passion for solving complex security problems in innovative and scalable ways.
• Experience using metrics to measure impact, optimize execution, and guide investment decisions.
• Strong communication skills with the ability to explain technical topics to non technical audiences.
• Ability to support occasional off-hours incident response efforts.
• Familiarity with attacker techniques in cloud-native and traditional environments.
• Hands-on experience owning security technologies (e.g., EDR, AntiVirus, etc.)
• Proven ability to lead cross-functional initiatives and influence outcomes without direct authority.
• Experience owning end to end security programs, proactively driving incremental improvement.
• Strong systems thinking, with the ability to design security solutions that scale through efficiency.

What's in it for you?

• Join an ambitious tech company reshaping the way people build digital experiences
• Full-time employees receive Stock Options for the opportunity to share in the success of our company
• Comprehensive healthcare package covering 100% of monthly health premiums for employees  and 85% of costs for your dependents. 
• Fertility and family building benefits, including a lifetime reimbursable wallet to support your growing family.
• We value Work-Life balance and You Time! A generous amount of paid time off, including vacation days, sick days, compassion days for loss,  education days, and volunteer days
• Company paid parental leave to care for and focus on your growing family 
• Use your personal annual education budget to improve your skills and grow in your career
• Enjoy a full range of virtual and in-person events, including workshops, guest speakers, and fun team activities, supporting learning and networking exchange beyond the usual work duties 
• An annual wellbeing stipend to care for your physical, financial, or emotional health
• A monthly communication stipend and phone hardware upgrade reimbursement.
• New hire office equipment stipend for hybrid or distributed employees. Get the gear you need to work at your best.

This role will need to be conducted in a state in which we are currently registered to do business. In addition, this position is not eligible for visa sponsorship. Applicants must be authorized to work without the need for visa sponsorship by the start date of employment.

This position is eligible for equity awards in accordance with the terms of Contentful’s equity plans.

New Jersey Salary Statement: The salary range displayed is specifically for those potential hires who will work or reside in the state of New Jersey if selected for the role. Any offered salary is determined based on internal equity, internal salary ranges, market data/ranges, applicant's skills and prior relevant experience, certain degrees and certifications (e.g. JD/technology), for example.

New Jersey Salary Range: $187,000 - $253,00

#LI-Remote

FEQ227R170

Solutions Architects at Databricks lead the growth of the Databricks Data Intelligence Platform. As a team, we have expertise in cloud platforms, data engineering, data analytics, and data science, machine learning, and AI. As a member of our team, you will exercise and grow your expertise in those areas, using open source projects such as Apache Spark™, Delta Lake, and MLflow. This is a customer-facing role, where you will work with customers, your teammates, the product team, our post-sales team,s and partners, to identify use cases for Databricks, develop architectures and solutions using our platform, and guide customers through the implementation, to accomplish meaningful outcomes for their businesses. In this process, you will build relationships with our customers, identify and cultivate champions, and establish yourself as a trusted advisor. You will report to a Field Engineering Manager within the Financial Services team at Databricks.

The impact you will have:

• Partner with the sales team to help customers understand how Databricks can help solve their business problems
• Provide technical leadership for customers to evaluate and adopt Databricks
• Consult on big data architecture, execute proof of concepts for strategic customer projects, and validate integrations with cloud services and other 3rd party applications
• Build and present reference architectures, how-tos, and demonstrate applications for customers
• Become an expert in, and promote open source projects (Apache Spark™, Delta Lake, MLflow, and Unity Catalog) across developer communities through meetups, conferences, and webinars
• Travel to meet with customers in your territory

What we look for:

• 6+ years in a customer-facing pre-sales role, or consulting role - preferably working with big-data technologies to solve data engineering and big-data analytical challenges
• Experience designing and architecting distributed data systems
• Comfortable programming in, and debugging, at least one of: Python, SQL, Scala, Java, or R
• Experience working with global system integrators, consulting organizations, or financial services technology, or financial services data providers is a positive differentiator 
• Experience building solutions with public cloud providers such as AWS, Azure, or GCP
• Experience with Data Engineering technologies (Ex: Spark, Hadoop, Kafka)
• Experience with Data Warehousing technologies (Ex: SQL, OLTP/OLAP/DSS)
• Undergraduate degree or higher in an engineering or mathematics discipline such as Computer Science, Applied Mathematics, Electrical Engineering, etc.)

SUMMARY

As a Senior Solutions Engineer, you will be responsible for supporting our Strategic accounts in the NY/NJ Region reporting to the regional Manager, Solutions Engineering. You will partner directly with regional account executives to help change our customers view and how they approach cloud security. You will be their trusted advisor for all matters related to cloud security across AWS, Azure, and GCP. We are passionate about technical sales and helping our customers achieve the maximum value from our solution. 

LOCATION

Seeking candidates in the New York/New Jersey metro area. 

WHAT YOU’LL DO

• Partner with the sales team to provide technical leadership to our customers and prospective customers in conjunction with helping our team meet their quarterly sales targets.
• Provide presentations to our customers and prospective customers such as whiteboards, product demonstrations, slides, and proof of value outcomes.
• Help our customers and prospective customers plan in-depth test plans for showing the value of the Wiz platform in their environment (proof of value).
• Invest time in learning new product features, industry related developments, and broadening your overall technical skillset.
• Represent Wiz in technical forums such as trade shows, technical meetups, and industry events.

WHAT YOU’LL BRING

• Ability to deliver world class demonstrations and training experience to our channel customers
• Mastered the technical sales process
• Thrive in a creative technical role assisting partners to build a technical business delivery model
• Experience in a sales engineering role delivering solutions to C-level executives at strategic customers
• Ability to travel
• Cloud security experience
• AWS/Azure/GCP hands on experience
• Network engineering experience
• Strong operating system, virtual machine, and container knowledge
• Knowledge of risk-based security assessments and frameworks
• Understanding of cloud identity, access, certificates, and keys

BONUS POINTS: 

• Experience with traditional CSPM tools
• SaaS experience
• Awareness of the CI/CD process
• Familiarity with Infrastructure as Code

Position Overview 

The Vice President (VP), Clinical Development - Infectious Disease is a leadership role responsible for guiding Tonix Pharmaceuticals' clinical development programs. Reporting directly into the Chief Medical Officer, this position provides strategic oversight to ensure excellence in clinical research, regulatory interactions, and product approvals within Tonix's core therapeutic area of Infectious Diseases, initially with focus on prophylactic monoclonal antibodies, live virus vaccines and Lyme disease. 

Essential Duties

• Define and lead the company’s clinical development strategy for assigned vaccines and prophylactic antibodies, ensuring alignment with corporate vision and regulatory expectations with Tonix’s pipeline and therapeutic focus.
• Oversee the planning, design, execution, and completion of clinical trials (Phases I-IV), ensuring efficiency, scientific rigor, and compliance with regulatory standards, timelines, and budgets. Oversee the development of clinical protocols, investigator brochures, statistical analysis plans, and other critical regulatory documents. Collaborate with clinical operations to ensure the quality and integrity of clinical data; and support scientific communications and publications regarding pipeline programs. Maintain a strong focus on innovation in clinical trial design, patient-centric approaches, and biomarker-driven strategies.
• Oversee the selection and management of CROs, academic partnerships, and external collaborations to optimize clinical trial execution.
• Drive a culture of operational excellence, regulatory compliance, quality assurance, adherence to GCP guidelines, ethical considerations, and scientific integrity across Clinical Development.
• Represent the company at key scientific conferences, industry consortia, and investor presentations to enhance corporate reputation.
• Provide leadership to the Clinical Development, Clinical Operations, and Safety/Pharmacovigilance teams.
• Provide medical and scientific leadership to cross-functional teams, integrating insights from medical affairs, regulatory affairs, and commercial teams to drive program success.
• Partner with R&D, Medical Affairs, Commercial, and Business Development teams to align clinical development with broader corporate objectives.
• Serve as the clinical development leader for assigned pipeline programs in interactions with global regulatory agencies (FDA, EMA, etc.), ensuring effective engagement, submission strategies, and post-approval commitments; lead the preparation and review of regulatory submissions, including INDs, NDAs, BLAs, and CTAs.
• Cultivate and maintain strong relationships with Key Opinion Leaders (KOLs) and patient advocacy organizations specific to the products and indications for the programs led.
• Build, mentor, and lead high-performing teams, fostering a culture of excellence, innovation, and accountability.  
• Strong ability to build and sustain meaningful relationships with KOLs, regulatory bodies, and external strategic partners.
• Exceptional leadership, mentorship, strategic planning, and operational management skills.
• Excellent communication, interpersonal, and negotiation abilities

Necessary Skills and Abilities:

• Demonstrated success in leading clinical development programs.
• Regulatory Compliance: Extensive experience with regulatory interactions, submissions, and product approvals.
• Experience in comprehensive budget management.

Educational Requirements:

• MD or DO

Experience Requirements:

• Experience: 10-15 years of relevant experience, demonstrating progressive leadership in clinical development within pharmaceutical or biotechnology companies, including prior experience serving at the Senior Director level or above in Clinical Development organizations.
• Board certification in Infectious Disease a plus
• Expertise and experience in infectious diseases.
• Prior work with Lyme disease, live viral vaccines and or prophylactic monoclonal antibodies a major plus.

Please note that this position can be based in Princeton, NJ, San Diego, CA, or San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Sr. Director, Commercial Advanced Analytics & Data Strategy is a strategic leadership role responsible for defining, building, and scaling the analytics capabilities, data strategy, and governance frameworks that enable commercial decision-making across the organization. This role ensures that high quality data, advanced analytics, and AI enabled insights are seamlessly integrated into commercial strategy, planning, launch execution, and in market optimization.  The Sr. Director serves as a strategic partner cross-functionally, translating business priorities into scalable analytics products and platforms while ensuring governance, compliance, and measurable business impact.

Over time, this role will build and mature commercial advanced analytics and data capabilities, establish fit‑for‑purpose operating models, and define future talent and capability needs to support the evolving business. The role will work closely with Acadia’s AI team, which provides shared AI expertise across Commercial and R&D, as well as with IT teams responsible for enterprise data, infrastructure, and platform enablement.

Primary Responsibilities

Commercial Analytics Strategy & Leadership

• Partner with Commercial leadership to define the advance analytics vision, strategy and initiatives that enables the development of scalable analytics and decision-support capabilities that drive business outcomes

• Lead and govern advanced analytics projects, predictive analytics, and AI/machine learning solutions  supporting brand strategy, launch planning, patient support, segmentation, targeting, omnichannel optimization, and sales effectiveness.

• Enable AI-driven commercial use cases such as next-best-action, customer engagement optimization, automated forecasting, and scenario planning.

• Balance innovation with rigor by ensuring analytics solutions are interpretable, validated, and compliant with internal and external requirements including privacy laws

• Translate commercial business questions into analytics use cases, models, and decision frameworks.

• Ensure analytics outputs and insights are actionable, adopted, and embedded into commercial planning, existing workflows, processes, systems and demonstrate measurable outcomes.

• Act as a trusted advisor to Commercial leadership, influencing decisions through data-driven insights

• Partner with the Enterprise AI team to identify, prioritize, and scale high-value AI and advanced analytic capabilities, solutions and governance.

Data Strategy, Governance and Cross-Functional Enablement Leadership

• Establish commercial data strategy to support the organization in achieving its business objectives. This includes leading the acquisition, implementation, and evolution of the commercial data assets, including syndicated claims, EMR, prescription, HUB/SP/Partner, promotional, and digital data.

• Partner cross-functionally with Enterprise Data, IT, and infrastructure teams to enable scalable data platforms, data pipelines, and tools that support analytics, AI, and self-service insights.

• Oversee vendor selection and management for data sources, analytics tools, and platforms.

• Establish governance frameworks for data access, analytics validation, and model lifecycle management.

• Collaborate with legal/compliance teams to mitigate risk and ensure compliance with HIPAA, GDPR, CCPA, and internal data privacy and security policies.

• Partner with IT data and infrastructure teams to align commercial analytics needs with enterprise architecture, platform standards, security requirements, and long-term data strategy.

Leadership & Communication

• Serve as a bridge between business stakeholders and technical teams, ensuring clarity of requirements and outcomes.

• Influence senior executives through concise storytelling, visualization, and business impact measurement.

• Build, lead, retain and mentor a high-performing team and capability in support of advanced analytics, data acquisition, and data governance, while fostering a culture of accountability, continuous improvement, and innovation.

• Assess and evolve organizational capabilities, talent, and ways of working needed to scale commercial advanced analytics over time.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in data science, statistics, engineering, computer science, or a related field; Advanced degree (MS, PhD, or MBA) preferred.  Targeting 12 years of progressively responsible experience in commercial analytics, data science, or data infrastructure data strategy, or related functions, with significant experience in biotech or pharmaceutical organizations.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Advanced analytics, modeling, and visualization tool experience (AI/ML, predictive analytics (Python), SQL, R and PowerBI).

• Experience working with modern data platforms and cloud technologies (e.g., Snowflake, Databricks, DataRobot, Dataiku, AWS, Azure, GCP).

• Deep experience and understanding of commercial datasets, data environments, and data vendors (including Hub, Specialty Pharmacy, patient services, Veeva CRM, syndicated claims, prescriptions, payer, social media/website, Google, Facebook etc.).

• Proven ability to lead cross-functional AI/ML and Analytical initiatives and influence senior stakeholders and to drive adoption of analytic solutions.

• Solid understanding of pharmaceutical commercialization concepts including launches, brand planning, and lifecycle management.

• Demonstrated experience in leading data governance initiatives and processes.

• Demonstrated ability to design and communicate complex systems and analytical solutions to both technical and non-technical audiences, aligning resources and execution to achieve functional and enterprise goals.

• Proven abilities with executive-level communication, data storytelling, and change leadership.

• Demonstrated impact of analytics on commercial strategy, decision making, performance, and ROI.

• Proven ability to lead, coach, and develop talent while building organizational capability in a fast-evolving environment.

• Experience partnering effectively with cross-functional partners and business stakeholders to deliver scalable analytics solutions.

• Ability to balance strategic vision with hands-on prioritization and execution in fast past environment.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-CA1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Associate Director, Trial Master File (TMF) Oversight & Inspection Readiness (IR) is responsible for leading the operational oversight of the TMF and supporting the framework that ensures Trial Master File integrity, sustained inspection readiness, and regulatory compliance within Clinical Operations.  This role leads TMF health governance, inspection preparedness, and risk identification processes to safeguard the organization during regulatory inspections and audits.  The Associate Director serves as the Clinical Operations lead for inspection defense, by advancing consistent standards, proactive risk visibility, and clear organizational insight into TMF integrity and inspection readiness.

Primary Responsibilities

TMF Oversight & Governance

• Establish TMF health oversight framework across studies, ensuring compliance with GCP and industry standards.

• Monitor TMF quality metrics across programs, ensuring completeness, timeliness, and accuracy of essential documents; Escalate any TMF metrics falling outside of KPIs to appropriate stakeholders for resolution and corrective action.

• Lead and share TMF best practices with internal and external stakeholders, as appropriate. Oversee TMF risk trending and remediation plans.

• Maintain inspection-readiness standards for documentation.

Inspection Readiness Leadership

• Develop and maintain a sustainable inspection readiness model, including development and maintenance of comprehensive inspection readiness tools, reference materials and coordinating training guidance to staff on preparation efforts for health authority inspections.

• Lead inspection storyboarding and narrative development. Coordinate inspection preparation activities. Lead designated Clinical Operations activities during regulatory inspections.

• Support post-inspection CAPA alignment, in partnership with Quality.

• Support Clinical Operations team on all inspection commitments, responses, post-inspection activities and implementation of corrective and preventative actions; provide lessons learned from mock and actual inspections. Ensure portfolio-level visibility of inspection risk.

Other Responsibilities

• Partner cross-functionally to align on audit and inspection strategy, as well as TMF platform integrity. Align with functional study teams on TMF accountability expectations. Maintain awareness of industry trends and developments to help define the future strategic direction for TMF and Inspection Readiness.

• Other responsibilities as required.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field; Advanced degree preferred.  Targeting at least 8 years pharmaceutical industry and/or clinical research organization experience, with at least 5 years TMF experience in a leadership role.  Health Authority inspection and eTMF experience is required. An equivalent combination of relevant education and experience may be considered.

Key Skills

• Thorough understanding of GCP and ICH guidelines; thorough understanding of the drug development process.

• Knowledge and understanding of the current regulatory requirements (e.g., FDA, EMA, MHRA) in a global environment.

• Thorough understanding of the CDISC TMF Reference model; direct experience with the TMF Reference Model working group is preferred.

• Veeva Vault eTMF/CTMS experience preferred.

• Ability to lead, motivate, and influence others, including prior leadership experience, is strongly preferred.

• Adept at creating and communicating a clear vision among, effectively aligning resources and motivating stakeholders to achieve goals.

• Demonstrated analytical abilities and proficient planning and negotiation skills. Demonstrated technical, administrative and project management capabilities. 

• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.

• Demonstrated success with cross-functional collaboration and managing multiple assignments with timely and accurate output. Demonstrated problem-solving abilities, with strong attention to detail. 

• Able and willing to travel both domestically and internationally.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.  Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

#LI-Hybrid #LI-SL1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director will lead Translational Sciences operations to support nonclinical, toxicology, and pharmacology/pharmacometrics clinical functions.  The role will own and manage systems to facilitate clinical and nonclinical activities within the Translational Science department including internal and external vendor and contract management, oversight and due diligence of agreements, management and oversight of budgets and timelines. Interfacing with internal and external stakeholders is central to the role to ensure smooth and timely operational execution across Acadia programs.

Primary Responsibilities

• Oversees the operational management of Translational Science project activities, partnering with functional representatives to ensure delivery to plan and budget and in accordance to Program Team plans/commitments

• Provides Translational Science team cross-functional project support to ensure seamless progress of activities across programs and with adjacent functions (CMC, Clinical Development)

• Identifies and manages vendors and consultants needed to complete Translational Science studies, including associated contracts and budgets. Key partner for Finance, Legal, Vendor Management and Project Management Functions

• Provides guidance to team members to objectively assess and resolve operational project issues to improve project effectiveness

• Owner of operational Translational Science group meetings to ensure budgetary compliance across programs and co-ordination with CMC to ensure compound supply is met for seamless program progression

• Partners with Head of Translational Sciences to maximize group efficiency and coordination, anticipating potential hurdles and developing mitigation strategies

• Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in life sciences or a related field.  Targeting 10 years of progressively responsible experience in project operations and/or project management, preferably supporting early‑stage drug development. Experience managing team resources, budgets, and external vendors or consultants., preferably in a pharmaceutical or biotech environment.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Experience managing cross-functional project activities and deliverables across complex programs

• Strong understanding of the drug development process, including pharmaceutical project management principles and GxP regulations (GLP, GCP, and related guidelines)

• Deep experience managing operational aspects of early-stage drug development, including academic and CRO-based contracts, timelines, and execution

• Demonstrated operational management of Toxicology and Clinical Pharmacology activities

• Proven experience overseeing vendors and consultants, including performance and deliverables management

• Ability to manage multiple priorities in a fast-paced, cross-functional environment

• Demonstrated experience in budget and resource planning, tracking, and management

• Strong interpersonal, negotiation, and problem-solving skills, with the ability to work effectively with business partners and leadership

• Advanced proficiency in Microsoft Project, Word, Excel, and reporting/tracking tools; ability to lead management of Translational Sciences systems and represent the function across tools

• Self-motivated team player who thrives in dynamic environments, with willingness to travel domestically and internationally

   

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI #SL-1

Seeking talent near: Princeton, NJ ; San Diego, CA

Position Summary

The Associate Director, Vendor & Relationship Management will support and optimize strategic partnerships with clinical vendors, CROs, and functional service providers to ensure operational excellence, compliance, and value delivery across global clinical development programs. This role will drive vendor governance, performance management, and continuous improvement initiatives while collaborating cross functionally to support R&D business objectives and foster a culture of partnership and innovation.  The Associate Director will partner closely with R&D stakeholders, Procurement, Quality, Finance, and Legal to enable effective vendor oversight and consistent outsourcing practices across the Acadia R&D organization.

Primary Responsibilities

Vendor & Relationship Management

• Support the development and execution of vendor and supplier relationship management strategies, including identification and management of critical partners (CROs, central and specialty labs, functional service providers, clinical technologies, patient recruitment and retention vendors).

• Serve as a primary point of contact for vendor related operational issues, coordinating resolution and escalating unresolved matters through established governance pathways.

• Coordinate and facilitate, when appropriate, vendor governance, including operational and steering committee meetings.

• Develop and maintain supplier scorecards, dashboards, and KPIs to monitor vendor performance and identify trends and risks.

• Conduct routine business reviews with vendors to ensure alignment on priorities and performance expectations, partnering with Sourcing and Legal as needed.

Operational Oversight & Excellence

• Oversee vendor performance supporting outsourced clinical trials, through partnership with the Clinica Operations team. Ensure alignment with program timelines, budgets, and quality expectations.

• Partner with Clinical Operations, Clinical Supply Chain, Quality, Finance, and other cross functional teams to support timely and compliant delivery of services.

• Support inspection readiness activities, including audits, vendor oversight documentation, and CAPA development in collaboration with Quality.

• Contribute to process mapping, documentation, and implementation of standardized vendor oversight practices.

Innovation & Continuous Improvement

• Identify opportunities to improve vendor performance, efficiency, and collaboration through data driven insights and process improvements.

• Support innovation initiatives within vendor relationships, including new operating models, technologies, or ways of working.

• Contribute to the development and rollout of best practices, standards, and tools for R&D vendor management.

• Identify opportunities for cost optimization, demand management, and improved vendor utilization.

Data, Reporting & Technology Enablement

• Support the development and maintenance of vendor performance reporting and dashboards.

• Analyze performance metrics to proactively identify risks, issues, and opportunities for improvement.

• Partner with internal teams to support implementation and optimization of vendor management tools and systems.

• Act as a mentor and subject matter resource for team members and matrixed stakeholders involved in vendor oversight.

• Foster strong, collaborative relationships with internal stakeholders and external partners to enable transparent communication and proactive issue resolution.

• Effectively influence stakeholders across a matrixed organization without direct authority.

• Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life science or a related field; Advanced degree preferred.  Targeting 8 years of experience in clinical trial operations, vendor/CRO oversight, supplier relationship management, or related roles within the biopharmaceutical industry.  Experience managing complex vendor relationships and supporting performance improvement initiatives required.  An equivalent combination of relevant education and experience may be considered.

Key Skills:

• Strong understanding of clinical trial operations and outsourced service models.

• Working knowledge of ICH GCP, regulatory requirements, and quality expectations for outsourced clinical activities.

• Strong analytical skills, including experience with supplier scorecards, KPIs, and performance dashboards.

• Experience in R&D outsourcing, vendor governance, or business operations functions.

• Exposure to financial management of outsourced services, including budgeting and accruals.

• Experience supporting audits, inspections, or inspection readiness activities.

• Familiarity with alliance or partnership management methodologies.

• Excellent communication, interpersonal, and organizational skills.

• Ability to work effectively in a fast paced, matrixed environment while managing multiple priorities and working cross-functionally.

• Willing and able to travel both domestically and internationally.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HBRID #NC1

Please note that this position can be based in Princeton, NJ, OR San Diego, CA, OR San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

This role is responsible for supporting Clinical Operations’ management objectives to perform clinical trials that are of high quality, and that are delivered to agreed timelines and budget. This role manages clinical operations processes including project planning, budget, resource management, and contract research organization management. This role serves as a key contact and resource for Clinical Study Managers, CRA’s and Clinical Trial Assistants. Responsible for ensuring that clinical studies are carried out and delivered according to GCP and company SOPs. Assists with the creation and implementation of policies. Works cross-functionally to ensure that the teams provide required inputs and receive updates to carry out clinical trials in an effective manner.

Primary Responsibilities

· Manages clinical operations teams and represents clinical operations on multi-function projects teams, internally/externally. Works with clinical investigators, other roles, and Clinical Service Providers (CSP) to develop, execute, and deliver clinical studies/programs that are of high quality.

· Ensures quality delivery of study enrollment within agreed budgets and timelines.

· Participates in the design/review of clinical protocols, case report forms, tools and tracking systems, and IXRS systems.

· Develops and manages relationships with critical and non-critical 3rd party vendors and clinical site staff; maintains ongoing documentation, performs risk analyses, and may participate in due diligence and audit reviews.

· Effectively communicates project status and issues to management and the team.

· Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF)) etc.

· Manages and reviews the work of Contract Research Organization (CRO) to ensure that tasks are performed to scope and budget.

· Liaises with other functional groups to ensure that timelines, budgets, and study objectives are met.

· Liaises closely with Clinical GCP group to ensure that quality metrics are met throughout a trial.

· Oversees clinical study budgets.

· Provides day-to-day direction to Study Managers and Clinical Trial Assistants to carry out their work.

· Ensures compliance with good clinical practices (GCP), good documentation practices (GDP), and regulatory guidelines.

· Recommends and implements innovative process ideas to positively impact clinical trials management.

· Other responsibilities as assigned.

Education/Experience/Skills

Bachelor’s degree in life sciences or related field. Targeting 8 years’ progressively responsible pharmaceutical experience with a focus on clinical trials and late phase development. Leadership experience and CNS therapeutic experience preferred. An equivalent combination of relevant education and applicable job experience may be considered.

Key Skills:

· Knowledge and understanding of Good Clinical Practices (GCP) and other Clinical Trials Regulations and guidelines.

· Experience developing clinical protocols, Standard Operation Procedures (SOP), Clinical Study Reports, and other documents to support New Drug Application (NDA).

· Demonstrated ability to successfully develop, implement, and manage clinical trials.

· Practical experience in clinical trial strategies, methods, and processes; knowledge of clinical trial design.

· Demonstrated technical, administrative, and project management capabilities.

· Strong interpersonal, organizational, and workload planning skills, along with excellent verbal and written communication skills.

· Proficient computer skills, including Microsoft Word and Excel.

· Skilled at negotiating with business partners or management and influencing leaders regarding matters of significance to the department or segments of the organization.

· Adept at creating and communicating a clear vision among team members effectively aligning resources to achieve functional area goals.

· Ability to manage multiple priorities and work cross-functionally in a fast-paced environment.

· Must be willing and able to travel both domestically and internationally.

#LI-HYBRID #LI-CA1

Please note that this position can be based in San Diego, CA OR San Francisco, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

The Director of Clinical Pharmacology will bring deep expertise across both preclinical and clinical development, with a strong track record of success in advancing drug candidates through early development. This individual will serve as a key representative of the Clinical Pharmacology function on cross-functional Asset Teams and will be responsible for leading early-stage programs. Core responsibilities include the strategic planning and execution of Phase 1 clinical trials, including First-in-Human (FIH) and proof-of-concept (PoC) studies in healthy volunteers.  This role supports drug development across multiple therapeutic areas, with a focus on neuroscience.

Primary Responsibilities

• Interpret nonclinical data and translate findings into clinical pharmacology development plans that position Acadia programs for successful clinical transitions

• Design and oversee early-phase clinical trials (e.g., FIH, food effect, DDI studies)

• Collaborate with colleagues on the selection and implementation of appropriate biomarker, imaging, and pharmacodynamic endpoints for proof-of-concept (PoC) studies in healthy volunteers

• Develop and review study protocols, statistical analysis plans, and tables, listings, and figures (TLFs) for Phase I studies

• Represent Translational Sciences / Clinical Pharmacology within asset teams

• Support regulatory submissions including IND enabling packages, NDAs, MAAs, and NDSs

• Acquire and maintain knowledge of national and international regulatory guidelines

• Collaborate effectively with multidisciplinary teams including clinical, regulatory, nonclinical, and CMC functions to ensure alignment and integration of clinical pharmacology strategies

• Ensure compliance with GCP, ICH guidelines, and internal Standard Operating Procedures (SOPs) for all clinical pharmacokinetic-related studies

• Work with the quality assurance team on SOP development, revision, and implementation

• Evaluate licensing and partnership opportunities, with a focus on clinical pharmacology aspects

• Other duties as assigned

Education/Experience/Skills

• Ph.D. in Pharmacology or related field.  Targeting 10 years of relevant industry experience, including all aspects of drug development.  An equivalent combination of relevant education and experience may be considered

• Track record of successful design and execution of Phase I studies

• Proven success in the design and selection of endpoints for PoC studies in healthy volunteers

• Deep knowledge of requirements for clinical pharmacology-related regulatory submissions (IND, NDA/MAA/NDS), with hands-on filing experience

• Experience in rare disease is a strong plus

• Strong analytical and problem-solving skills, with the ability to integrate multifactorial inputs into clear and actionable strategies

• Strong organizational skills and able to effectively multitask and prioritize

• Excellent interpersonal skills, with the desire to work as part of a multi-functional team

• Excellent written and verbal communication skills

• Excellent trouble-shooting and decision-making skills; able to listen to and consider different functional perspectives and escalate response to situations when appropriate

• Ability to identify inconsistencies and ensure accuracy in all aspects of work

• Must be able to travel on occasion

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds.  This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#transmed

#LI-Hybrid #LI-SL1

Position

We are seeking a physician with a strong clinical background and a passion for drug development to join our Clinical Development team to serve as a Study Responsible Physician, Senior Director, Clinical Research. In this role, you will play a pivotal part in advancing our oncology and/or non-oncology pipeline by providing medical expertise, leadership, and operational oversight for a clinical development study(ies).

About You

You are a highly accomplished professional who excels in the development and execution of clinical projects. As a key member of the cross-functional Development Teams and the Clinical Study Teams, you will employ your expertise in clinical development to advance new therapies to patients in need. Your dedication to scientific rigor and meticulous attention to detail is evident in all your work. With a deep passion for creating important new medicines, you are committed to advancing the field of medical research and improving patient outcomes.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our New Jersey or California offices to ensure effective collaboration and high-quality execution of your clinical work.

What You’ll Do in partnership with your Manager

• Design and conduct early-stage or late-stage clinical development trials as needed, including, but not limited to assessing clinical safety and efficacy data, performing medical monitoring, and be responsible for other study-related clinical activities.
• Interpret reports, and prepare oral and written results of product research.
• Be proactive in fulfilling your responsibilities and pay particular attention to quality and accuracy of work as well as timeliness of deliverables.
• Collaborate closely with relevant functions within Eikon including discovery, translational and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, and regulatory personnel.
• Work closely with functional partners (Clinical Science, Data Management, Clinical Operations, Biostatistics) to ensure an integrated approach to flawless execution and systematic oversight of study protocol(s) in clinical development.
• Work closely with functional partners to address protocol questions from Health Authorities and Ethics Committees in a consistent fashion.

Qualifications

• MD or DO degree with significant experience in Oncology.
• Minimum of 5-7 years of clinical experience, including 3+ years in drug development.
• Experience in clinical practice with direct patient care.
• Proven track record in leading clinical trials, including medical monitoring of early and late stage clinical trials.
• In-depth knowledge of clinical research methodologies, GCP, and regulatory requirements.
• Ability to work effectively in a matrixed environment.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Passion for clinical trials and improving patient outcomes.
• Experience with IND and/or NDA/BLA filings is preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $270,000 to $294,500 depending on skills, competency, and the market demand for your expertise.

COMPANY OVERVIEW

Lynx Analytics was founded in 2010 by a group of INSEAD students and professors with a strong research background in graph analytics. Several of our founders since then became professors and faculty directors of analytics centers at leading US universities. Our founding purpose? To apply graph theory to simplify and solve complex, real-world business problems.

Our mission has evolved over the years, and we currently offer a range of cutting edge data analytics and AI solutions to help companies transform their operations and optimise their commercial performance. Back then, graph theory was mostly the purview of social networking sites. We wanted to expand this technology and help companies leverage their communities to unlock greater growth.

Lynx has offices in Singapore, US, Hong Kong, Hungary, and operations in several other countries such as Canada, Germany, Indonesia. We work with some of the world’s largest companies and are constantly looking to expand our knowledge base and geographical footprint. Lynx Analytics’ technology is deployed with various Clients internationally and has significant growth potential.

We have a diverse and inclusive global team comprising Professors, PhDs, MSc’s, and MBAs from Ivy Leagues, INSEAD and NUS with a broad spectrum of experience in start-ups and blue-chip companies (Google, Databricks, ZS, Abbvie, Amgen, Vodafone, Morgan Stanley, Palantir, Katana Graph to name but a few). It is the combination of our industry insight and experience, scalable proprietary technology, and highly qualified people that drives our compelling value proposition.

We are looking for ambitious, innovative, empathetic and relentless team players to explore the career opportunities that we offer as we continue to scale our operations.

About the Role:

We are looking for a Senior Software Engineer to join our growing engineering team. In this role, you will design, build, and operate scalable software platforms that support analytics and AI solutions. You will lead system architecture, cloud deployments, and modern containerized environments, while collaborating with multidisciplinary teams across regions.

What This Involves: 

• Design, develop, and maintain high-quality software solutions using Python.
• Contribute to the design and evolution of scalable and maintainable software architectures.
• Deploy, operate, and monitor applications in cloud environments (AWS, Azure, or GCP).
• Build and manage containerized applications using Docker and Kubernetes.
• Support the development and deployment of AI and analytics solutions, working closely with data scientists and data engineers.
• Collaborate with cross-functional and client-facing teams to deliver end-to-end solutions.
• Participate in technical discussions, architectural reviews, and continuous improvement initiatives.

Skills, Qualifications and Experience: 

• Strong Python knowledge with experience building production-grade software.
• Experience designing software architectures for scalable applications.
• Hands-on experience operating and deploying solutions in cloud environments (any major cloud provider).
• Practical knowledge of container technologies and architectures, including Docker and Kubernetes.
• Basic understanding of AI solution components and technologies, such as LLMs, vector databases, APIs/protocols, and supporting infrastructure.
• Experience in systems design, particularly in cloud-native or distributed environments.
• Experience creating project implementation plans, timelines, and effort estimations.
• Experience leading or mentoring engineering teams and driving projects to completion.

Why You Will Love It Here: 

• Work on real-world AI and advanced analytics solutions with measurable business impact.
• Collaborate with a global team of engineers and data scientists.
• Exposure to diverse industries, modern cloud platforms, and cutting-edge AI technologies.
• A collaborative culture that values real outcomes
• High ownership, zero micromanagement
• Rapid learning opportunities and diverse challenges
• Flexible work hours, remote-friendly setup
• Flat organisational hierarchy with high visibility and accessibility to our leaders

Position

The Clinical Program Manager, Oncology, Clinical Study Management, will plan and oversee the execution of clinical trials in oncology and other therapeutic areas, as needed. This role  works in close partnership with cross-functional teams to ensure studies are delivered on time and within budget, with a strong focus on quality,  operational excellence, and best-in-class clinical study management. The successful candidate will play a key role in driving study execution, managing risks, and enabling high-performance collaboration across functions and regions.

This role will require a minimum of 3 day a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. 

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology or neuroscience.

What You’ll Do

• Develop and own the operational strategy, timelines, and operational plans for clinical trials, ensuring alignment with program objectives and overall business goals.
• Oversee and lead cross-functional clinical trial execution, leading proactive risk identification, assessment, management, and driving alignment on mitigation strategies.
• Ensure high standards of quality by overseeing that clinical studies are conducted in accordance with approved protocols, company SOPs, applicable regulations, and maintain ongoing inspection readiness across the program lifecycle.
• Serve as central point of contact to facilitate cross functional team effectiveness, drive operational efficiency, and provide clear direction and guidance to ensure successful study execution.
• Work with minimal oversight from the Clinical Study Management Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development, Finance, and Legal functions.
• Oversee and manage vendor relationships and performance to ensure that clinical studies are completed in accordance with contractual specifications for quality, timelines, and cost.
• Provide regular, clear updates on study progress, risks, and mitigation plans to stakeholders and executive management (e.g., Clinical Study Management, Project & Portfolio Management, Clinical Research).
• Ensure that all study-related documents are accurate, complete, and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems in a timely manner.
• Lead, manage, hire, develop, and mentor global and regional Clinical Study Management personnel.
• Contribute to improvement initiatives, operational excellence efforts, and cross-functional projects that add value to Eikon Therapeutics.

Qualifications

• Bachelor’s degree with 8 years, a Master’s degree with 6 years, or a PhD with 3 years of relevant experience in life sciences, healthcare, or related field preferred. 
• Fluency in English (strong reading, writing, and speaking skills with the ability to effectively communicate with colleagues and stakeholders at all levels) is required.
• In-depth knowledge of ICH-GCP, regulations, directives, and guidelines.
• Proficiency in clinical trial management systems (CTMS, RTSM (IRT), Veeva Vault suite) and electronic data capture (EDC) systems.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience managing budgets, resources, processes and controls, productivity, quality, and project delivery.
• High sense of accountability and urgency to prioritize deliverables effectively.
• Growth mindset and ability to independently.
• PMP certification preferred.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.

Position

The Associate Director, Clinical Study Management, will be responsible for overseeing the execution of clinical trials in oncology and other therapeutic areas, as required. The successful candidate will work closely with cross-functional Clinical Research & Development teams to ensure successful completion of studies within timelines and budget, with a focus on exquisite quality to support operational excellence and world class inhouse clinical study management.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are collaborative, solutions oriented, flexible and have global clinical operational experience, with a passion for excellence in advancing patient care in oncology.

What You’ll Do

• Team leader and builder, who manages clinical trial deliverables, timelines, and budgets per the Clinical Development and Operational Plans
• Works with minimal oversight from the Clinical Operations Senior Director or Director, in collaboration with Clinical Study Management teams and Clinical Research and Development functional teams
• Demonstrate broad understanding of therapeutic and clinical drug development expertise to influence study design and program-level decisions 
• Provide direction to cross-functional study teams to ensure successful study execution Ensure that clinical studies are conducted  following approved protocols, FDA Regulations, ICH-GCP, EMA, PMDA, other relevant regulations, directives, and guidelines, and company procedures and quality documents
• Oversee risk identification, assessment, and mitigation strategies to ensure patient safety and data integrity
• Responsible for the implementation of processes and systems that will facilitate inspection readiness throughout the lifecycle of the trial.
• Oversee the preparation and maintenance of detailed clinical trial project timelines
• Manage ancillary (non CRO) vendor relationships and performance to ensure that clinical studies are completed following contract specifications of time, cost and quality.
• Work with finance, legal, and external vendors to ensure the assigned studies are meeting the target milestones
• Provide regular updates on study progress to stakeholders (e.g., Clinical Operations, Project & Portfolio Management, Clinical Research)
• Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems.
• Responsible for hiring, performance management, career development, and providing mentorship to Clinical Study Management personnel.
• Contribute to initiatives and projects adding value to Eikon Therapeutics

Qualifications

• Minimum of 10 years of related experience with a Bachelor’s degree or 8 years and a post-graduate degree.
• Experience leading large, global clinical trials, preferably in oncology
• In-depth knowledge of ICH-GCP, EMA guidelines and other relevant regulations and guidelines.
• Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety.
• Strong leadership and communication skills, with a demonstrated ability to work collaboratively with cross-functional teams.
• Experience with management of the budget, resources, headcount, processes and controls, productivity, quality and project delivery.
• High sense of accountability and urgency to prioritize deliverables.
• Growth mindset and capable of working independently.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $183,000 to $199,500 depending on skills, competency, and the market demand for your expertise.

Position

As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I–III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients.

This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices.

This position requires fluency in one of the following languages due to the nature of site interactions in various regions in EMEA or LATAM: Portuguese, German, Italian, French, Polish. 

About You

You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence.

What You’ll Do

• Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution.
• Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers.
• Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams.
• Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times.
• Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM.
• Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues.
• Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.
• Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up.
• Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence.
• Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.).
• Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.

Qualifications

• Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.
• Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.
• Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).
• Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus.
• Excellent organizational and time management skills with high attention to detail.
• Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
• Previous oncology trial experience preferred but not required.
• Working experience in LATAM/EMEA

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.

Position 

We are seeking a talented, experienced, and highly motivated Clinical Trial Manager (CTM) to join our oncology Clinical Operations team. This role will require onsite presence a minimum of 3 days a week in our Millbrae, CA or Jersey City, NJ office to ensure effective global clinical trial management. The candidate must have the ability to work independently, be an effective leader, and an engaged clinical study team member in a dynamic, fast-paced environment.  You will play a key role in contributing to high quality in-house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and the successful completion of global clinical studies. 

This position requires proficiency in Mandarin, Cantonese, Japanese, or Korean and English (strong reading, writing, and speaking skills and an ability to effectively communicate with colleagues and stakeholders at all levels). 

About You 

You have strong communication skills and are a collaborative, agile, detail oriented trial leader with global trial experience, and you have a passion for operational excellence and advancing patient care for grievous diseases. 

What You’ll Do 

• In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international in-sourced clinical trials, delivering high quality study data, on time and on budget 
• Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials 
• Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective. 
• Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagement & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines 
• Collaborate with other Clinical Operations functions (Site Engagement & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention 
• Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines 
• Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle 
• As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial 
• Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs) 
• Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements 
• Lead the creation and maintenance of all study files, including the study master file, and oversight of site files  
• Lead periodic review of the Sponsor Trial Master File

Qualifications 

• PhD and 3 years of relevant experience, or Masters Degree and 6 years of relevant experience, or Bachelors Degree and 8 years of relevant experience  
• Proven experience in Clinical Operations; Oncology trial management experience preferred 
• In-depth knowledge of clinical trial regulations, guidelines, and best practices, including ICH-GCP and FDA requirements, specific to oncology research 
• Demonstrated experience in managing and executing clinical trials from start-up to closeout 
• Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets 
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary 
• Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations 
• Proficiency in using Veeva clinical trial management systems (CTMS)  
• Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology
• Ability to work onsite at least 3 days a week

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $130,000 to $142,500 depending on skills, competency, and the market demand for your expertise.

Position

We are currently seeking an experienced leader for the clinical operations role of Director Clinical Study Management & Operational Excellence within Clinical Study Management.  The Director will manage all aspects of clinical operations study management, for assigned Eikon clinical programs, and be responsible for exquisite inhouse execution of all interventional clinical trials and oversight of requisite clinical vendors. The role will also support the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical study management via a focus on operational excellence. Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Director is responsible for trial quality and audit responses and completion of CAPAs. They will be a single point of contact for managing clinical trial operationally excellent execution in all its aspects across clinical study phases. The position has multiple stakeholder touch points within Clinical Research & Development (CR&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth and collaboration.

About You

You are agile of mind, systematic, and a collaborative leader with global oncology clinical development experience and a passion for operational excellence and advancing patient care. You possess a deep understanding of clinical trial regulations, guideline, and the principles of GCP, ensuring compliance throughout the clinical trial process.

What You’ll Do

• In collaboration with senior clinical operations management, build and lead inhouse clinical operations study management teams responsible for operationally excellent delivery of assigned clinical protocols and programs.
• Manage clinical study management personnel across assigned clinical protocols and programs.
• Ensure that compliance, quality and timeline objectives are met for all assigned trials.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver company clinical trial objectives on time, on budget and with high quality.
• Work with the CR&D Functional Area (FA) leads, as appropriate, in site management to accelerate enrollment and drive high quality.
• Take responsibility for any assigned clinical trial audits, working closely with the Clinical Quality Assurance group.
• Represent Clinical Study Management in operational excellence initiatives, in the systematic pursuit of optimal performance, efficiency, and quality across all aspects of clinical trial management and execution. Key components of operational excellence, in clinical study management, are: (1) quality and compliance, (2) process optimization, (3) technology integration, (4) risk management, (5) performance metrics, (6) cross-functional collaboration.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve CR&D objectives.
• Responsible for ensuring appropriate scientific and operational training for staff members.
• Serve as a talent magnet and develop, coach, and retain top talent in the clinical program team.
• Sets clear performance standards and holds self and organization accountable for achieving results with flawless execution.
• Embrace metrics and performance standards (KPIs) to drive continuous improvement in execution.

Qualifications

• A post-graduate degree with 12+ years of relevant experience with a Bachelor’s degree or 10+ years of relevant experience with a Master's Degree with a demonstrated working experience in clinical study management within the biotechnology, pharmaceutical, or healthcare industry. 
• Significant experience managing international clinical studies and programs in oncology.
• Proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different CR&D stakeholders in a matrix organization.
• Demonstrated situational leadership, independence, problem solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
• Significant management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English.
• The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong operational excellence mindset and experience.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff.
• In addition, leadership skills that enable and drive alignment with the goals, purpose and mission of our company.

The expected hourly range for this role is $108.65 to $118.75 depending on skills, competency, and the market demand for your expertise.

Enterprise Account Executive — New Jersey/Philly Enterprise
Primary location: New Jersey / Greater Philadelphia Area
OTE: $300–$320K (50/50 split)

About Salt Security

Salt Security pioneered API security to protect the interfaces behind every modern app. Today, our AI-driven platform secures APIs and AI Agents end to end—including the action layer that powers AI Agents and MCP servers—so enterprises can innovate faster without sacrificing safety. We’re a collaborative, high-ownership team that values curiosity, execution, and customer impact.

About the role

You’ll own net-new and expansion business across enterprise accounts in the New Jersey / Greater Philadelphia region. You’ll drive multi-threaded cycles with CIO/CISO, AppSec, Platform, and Cloud leaders; align partners; and land multi-solution wins across discovery, posture, and runtime protection.

What you’ll do

• Build and manage a territory plan for enterprise accounts across New Jersey and the Greater Philadelphia Area, with clear coverage of major hubs (Newark, Jersey City, Princeton, Trenton, Philadelphia, King of Prussia, Wilmington).
• Create pipeline through targeted prospecting, partner co-sell (AWS, CrowdStrike, etc.), and executive networking.
• Run full-cycle sales: discovery, value mapping, business case, security validation, legal/procurement, and close.
• Position Salt’s portfolio (Cloud Connect, Surface, Posture Governance, Runtime Protection, and AI Agent/MCP Security) and integrations to displace incumbents and consolidate tools.
• Lead account strategies with SEs, product, and customer success to ensure fast time-to-value and expansion.
• Maintain accurate forecasts in Salesforce and report on risks, next steps, and executive asks.
• Host on-site sessions and workshops; travel regularly throughout New Jersey and the Greater Philadelphia Area as required.

What you’ll need

• Proven success selling enterprise cybersecurity/SaaS into large accounts (Fortune/Global 2000 preferred).
• Track record closing complex deals with multiple stakeholders and security validation, including 6- and 7-figure TCV.
• Strong familiarity with cloud-native environments (AWS/Azure/GCP), API security, and adjacent platforms (WAF, CNAPP, EDR/XDR, SIEM).
• Comfortable executing MEDDIC, SPICED, or similar methodology; crisp discovery and business case building.
• Executive presence with the ability to engage C-level and board-level influencers; excellent written and verbal communication.
• High ownership mindset: territory planning, partner alignment, and disciplined deal execution.
• Salesforce proficiency.

Why Salt Security

• Category leadership and a product roadmap that wins technical and business evaluations.
• Competitive compensation, equity, and comprehensive benefits.
• Remote-friendly culture with real autonomy and growth.
• Inclusive environment where great ideas win and careers accelerate.

Join us to help the Northeast’s most innovative enterprises secure the APIs that power their business.

FEQ427R309

Mission

Solutions Architects at Databricks lead the growth of the Databricks Data Intelligence Platform. As a team, we have expertise in cloud platforms, data engineering, data analytics, and data science, machine learning, and AI. As a member of our team, you will exercise and grow your expertise in those areas, using open source projects such as Apache Spark™, Delta Lake, and MLflow. This is a customer-facing role, where you will work with customers, your teammates, the product team, our post-sales team,s and partners, to identify use cases for Databricks, develop architectures and solutions using our platform, and guide customers through the implementation, to accomplish meaningful outcomes for their businesses. In this process, you will build relationships with our customers, identify and cultivate champions, and establish yourself as a trusted advisor. You will report to a Field Engineering Manager within the Financial Services team at Databricks.

The impact you will have:

• Partner with the sales team to help customers understand how Databricks can help solve their business problems
• Provide technical leadership for customers to evaluate and adopt Databricks
• Consult on big data architecture, execute proof of concepts for strategic customer projects, and validate integrations with cloud services and other 3rd party applications
• Build and present reference architectures, how-tos, and demonstrate applications for customers
• Become an expert in, and promote open source projects (Apache Spark™, Delta Lake, MLflow, and Unity Catalog) across developer communities through meetups, conferences, and webinars
• Travel to meet with customers in your territory

What we look for:

• 6+ years in a customer-facing pre-sales role, or consulting role - preferably working with big-data technologies to solve data engineering and big-data analytical challenges
• Experience designing and architecting distributed data systems
• Comfortable programming in, and debugging, at least one of: Python, SQL, Scala, Java, or R
• Experience working with global system integrators, consulting organizations, or financial services technology, or financial services data providers is a positive differentiator 
• Experience building solutions with public cloud providers such as AWS, Azure, or GCP
• Experience with Data Engineering technologies (Ex: Spark, Hadoop, Kafka)
• Experience with Data Warehousing technologies (Ex: SQL, OLTP/OLAP/DSS)
• Undergraduate degree or higher in an engineering or mathematics discipline such as Computer Science, Applied Mathematics, Electrical Engineering, etc.)

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.

Essential Functions:

Risk-Based Quality Management (RBQM) Leadership
•    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
•    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
•    Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
•    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.

Central Risk Identification, Monitoring & Mitigation

•    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
•    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
•    Oversee centralized risk monitoring and trending to enable early detection of critical risks.
•    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons 

Learned & Risk Library Management (Core Ownership)

•    Establish and maintain a centralized Clinical Risk Library, capturing:
o    Known and emerging risks
o    Root causes
o    Mitigation strategies
o    Effectiveness of controls
•    Lead lessons learned activities across trials, audits, inspections, and CAPAs.
•    Ensure lessons learned are:
o    Systematically captured
o    Analyzed for trends
o    Fed back into RBQM planning, SOPs, training, and future studies
•    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.

Quality Oversight & Regulatory Compliance

•    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
•    Provide centralized quality oversight across trials, CROs, and vendors.
•    Support audit and inspection readiness activities, including:
o    Risk-based inspection preparation
o    Impact assessments
o    CAPA development and effectiveness checks

Vendor & CRO Risk Oversight

•    Design and implement risk-based oversight strategies for CROs and external vendors.
•    Monitor vendor performance using quality metrics and risk indicators.
•    Lead or support quality governance discussions with external partners.
•    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.

Data-Driven Quality & Continuous Improvement

•    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
•    Generate enterprise-level risk trend reports and insights for senior leadership.
•    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
•    Champion a culture of proactive quality and continuous improvement across Clinical Operations.

Cross-Functional Collaboration & RBQM Expertise

•    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
•    Provide RBQM training and coaching to study teams and cross-functional stakeholders.
•    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
•    Participate as an observing member on assigned study teams to provide real-time quality and risk support.

SOP Management & Governance Support

•    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
•    Support governance activities, senior management reporting, and quality metrics standardization.
•    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.

Requirements:

Education
•    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)
•    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)

Experience
•    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
•    Demonstrated experience leading enterprise or cross-study risk management frameworks
•    Strong background in audit/inspection readiness, CAPA management, and vendor oversight
•    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements

Technical Skills
•    Expertise with RBQM tools, centralized monitoring systems, and risk analytics
•    Experience defining and using KRIs, QTLs, and quality metrics
•    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
•    Exposure to AI or predictive analytics for quality monitoring (preferred)

Working Conditions:

Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.

The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

FEQ227R259

Mission

Solutions Architects at Databricks lead the growth of the Databricks Data Intelligence Platform. As a team, we have expertise in cloud platforms, data engineering, data analytics, and data science, machine learning, and AI. As a member of our team, you will exercise and grow your expertise in those areas, using open source projects such as Apache Spark™, Delta Lake, and MLflow. This is a customer-facing role, where you will work with customers, your teammates, the product team, our post-sales team,s and partners, to identify use cases for Databricks, develop architectures and solutions using our platform, and guide customers through the implementation, to accomplish meaningful outcomes for their businesses. In this process, you will build relationships with our customers, identify and cultivate champions, and establish yourself as a trusted advisor. You will report to a Field Engineering Manager within the Financial Services team at Databricks.

The impact you will have:

• Partner with the sales team to help customers understand how Databricks can help solve their business problems
• Provide technical leadership for customers to evaluate and adopt Databricks
• Consult on big data architecture, execute proof of concepts for strategic customer projects, and validate integrations with cloud services and other 3rd party applications
• Build and present reference architectures, how-tos, and demonstrate applications for customers
• Become an expert in, and promote open source projects (Apache Spark™, Delta Lake, MLflow, and Unity Catalog) across developer communities through meetups, conferences, and webinars
• Travel to meet with customers in your territory

What we look for:

• 8+ years in a customer-facing pre-sales role, or consulting role - preferably working with big-data technologies to solve data engineering and big-data analytical challenges
• Experience designing and architecting distributed data systems
• Comfortable programming in, and debugging, at least one of: Python, SQL, Scala, Java, or R
• Experience working with global system integrators, consulting organizations, or financial services technology, or financial services data providers is a positive differentiator 
• Experience building solutions with public cloud providers such as AWS, Azure, or GCP
• Experience with Data Engineering technologies (Ex: Spark, Hadoop, Kafka)
• Experience with Data Warehousing technologies (Ex: SQL, OLTP/OLAP/DSS)
• Undergraduate degree or higher in an engineering or mathematics discipline such as Computer Science, Applied Mathematics, Electrical Engineering, etc.)

FEQ227R228

While candidates in the listed location(s) are encouraged to apply for this role, exceptionally well-qualified candidates in other East Coast locations will also be considered.

Mission

Solutions Architects at Databricks lead the growth of the Databricks Data Intelligence Platform. As a team, we have expertise in cloud platforms, data engineering, data analytics, and data science, machine learning, and AI. As a member of our team, you will exercise and grow your expertise in those areas, using open source projects such as Apache Spark™, Delta Lake, and MLflow. This is a customer-facing role, where you will work with customers, your teammates, the product team, our post-sales team,s and partners, to identify use cases for Databricks, develop architectures and solutions using our platform, and guide customers through the implementation, to accomplish meaningful outcomes for their businesses. In this process, you will build relationships with our customers, identify and cultivate champions, and establish yourself as a trusted advisor. You will report to a Field Engineering Manager within the Financial Services team at Databricks.

The impact you will have:

• Partner with the sales team to help customers understand how Databricks can help solve their business problems
• Provide technical leadership for customers to evaluate and adopt Databricks
• Consult on big data architecture, execute proof of concepts for strategic customer projects, and validate integrations with cloud services and other 3rd party applications
• Build and present reference architectures, how-tos, and demonstrate applications for customers
• Become an expert in, and promote open source projects (Apache Spark™, Delta Lake, MLflow, and Unity Catalog) across developer communities through meetups, conferences, and webinars
• Travel to meet with customers in your territory

What we look for:

• 3+ years in a customer-facing pre-sales role, or consulting role - preferably working with big-data technologies to solve data engineering and big-data analytical challenges
• Experience designing and architecting distributed data systems
• Comfortable programming in, and debugging, at least one of: Python, SQL, Scala, Java, or R
• Experience working with global system integrators, consulting organizations, or financial services technology, or financial services data providers is a positive differentiator 
• Experience building solutions with public cloud providers such as AWS, Azure, or GCP
• Experience with Data Engineering technologies (Ex: Spark, Hadoop, Kafka)
• Experience with Data Warehousing technologies (Ex: SQL, OLTP/OLAP/DSS)
• Undergraduate degree or higher in an engineering or mathematics discipline such as Computer Science, Applied Mathematics, Electrical Engineering, etc.)

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Specialist, Bioanalytical, Translational Research supports multiple pharmaceutical development programs by managing clinical sample use and disposition for biomarker testing, coordinating with external vendors, and providing data analysis support to biomarker teams. This role also facilitates collaboration with project teams and contributes to related clinical trial activities as needed.

Essential Functions:

•    Implement and coordinate with other functional areas to institute processes for clinical sample management, from informed consent to data generation, including biobanking processes.
•    Support biomarker teams in managing biomarker activities, such as organizing and analysis of biomarker data, conducting biomarker data verification and quality control, etc.  
•    Assist in coordinating and overseeing vendors for biomarker and bioanalytical assays, including selection, contracting, performance monitoring, and collaboration with colleagues across regions (e.g., Japan) and functions (Clinical Operations, Biometrics, Medical Sciences). Represent Translational Research on study teams.
•    Maintain and keep bioanalytical assay and clinical study-related files and documents organized and archived in the trial master file (TMF).
•    Ensure regulatory and procedural compliance by following applicable standards, guidelines, and regulations for patient sample handling and biomarker data management.
•    Contribute to process improvement and innovation by developing optimized methods for sample handling, data management, and integration of results into the design of new clinical studies. 
•    Develop and maintain SOPs and related documents (manuals, work instructions) for sample acquisition, handling, and use.
•    Collaborate across functions to support departmental and company goals, including contributions to study action plans and broader program objectives.

Requirements:

Education: 
Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Pharmacology or closely related discipline. Masters degree a plus.

Experience: 
•    Minimum 2 years of experience in bioanalytical, translational research, or clinical research settings, preferably in the pharmaceutical or biotechnology industry.
•    Exposure to handling and processing clinical samples, including sample tracking and storage.
•    Hands-on experience with biomarker assays, data analysis, or quality control activities.
•    Participation in cross-functional project teams or collaborative research initiatives.
•    Experience interacting with external vendors or laboratory partners is a plus.

Technical Skills
•    Knowledge of bioanalytical and biomarker assay principles, sample handling, and biobanking processes.
•    Familiarity with clinical sample documentation and regulatory requirements (e.g., GCP, SOPs, TMF).
•    Proficiency in basic data analysis and reporting using standard software tools (e.g., Excel, GraphPad, or equivalent).
•    Strong organizational skills with the ability to track multiple samples, datasets, and projects.
•    Effective written and verbal communication skills for scientific documentation and cross-functional collaboration.
•    Ability to follow protocols, standard operating procedures, and quality guidelines with attention to detail.
•    Familiarity with scientific analytical software (JMP, R, Etc)
•    Proficient in MS Office Suite 

Working Conditions:

Requires up to 5% domestic and international travel

The anticipated salary for this position will be $90,000 to $105,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Manager, R&D QA, Global Audits, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The R&D QA Manager will collaborate and provide key quality input to KK’s R&D function. 

Essential Functions:

•    Serve as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
•    Perform and report assigned GCP/GLP audits of KK studies, including clinical investigator sites, vendors/CROs, internal systems/processes, and clinical data/documents, as applicable. 
•    Prepare timely, high-quality audit reports; evaluate audit responses; and oversee CAPA development, adequacy, implementation, and tracking in accordance with KK standards.
•    Maintain expert-level knowledge of global GCP/GLP regulations and industry expectations. Serve as a subject matter expert to KK staff, provide interpretation of regulatory requirements, and actively contribute to the company’s Regulatory Intelligence program.
•    Design and deliver GCP training to KK staff to enhance compliance awareness, inspection readiness, and quality culture.
•    Support continuous improvement initiatives; develop, revise, and administer SOPs and controlled documents; and ensure effective maintenance within quality document management systems.
•    Participates in Health Authority inspection activities for domestic and international projects (as applicable).
•    Provides input to the annual risk-based audit plan, schedule and execution of audits based on changing business environment and interaction with cross-functional teams.
•    Undertake other QA-related duties as directed by the supervisor to support departmental and organizational objectives.

Requirements:

Education
Bachelor’s degree in Life Science or closely related scientific discipline (e.g., Pharmacy, Chemistry, Microbiology, Biology, or Pharmaceutical Sciences) required

Experience
•    Minimum three (3) experience in drug development in GCP/GLP Quality Assurance, including hands-on experience in auditing, CAPA management, and deviation review.
•    Demonstrated knowledge of global regulatory requirements, including EMA, FDA, MHRA, ICH, and other applicable standards, with proven ability to interpret and apply them in operational settings.
•    Experience supporting Health Authority inspections, including preparation, participation, and follow-up actions.
•    Proven track record in developing and implementing risk-based audit plans, SOPs, and quality systems, with experience in quality document management.
•    Experience in training and mentoring staff on GCP/GLP compliance and fostering a culture of quality.
•    Exposure to global, cross-functional collaboration with clinical, regulatory, and operational teams on QA-related matters.
•    Prior involvement in vendor/CRO management, clinical site audits, and quality agreement development is highly desirable.

Technical Skills
•    Experience with Veeva or other electronic Quality Management Systems (eQMS) for document control, audit tracking, and CAPA management.
•    Ability to generate comprehensive audit reports and perform trend analysis.
•    Familiarity with regulatory intelligence tools and systems to track evolving GCP/GLP requirements.
•    Strong skills in risk assessment and quality metrics reporting.
•    Excellent written and verbal communication skills for interacting with internal teams and external regulatory authorities.
•    Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) for reporting, data analysis, and presentations.

Working Conditions:

Requires up to 20% domestic and international travel

The anticipated salary for this position will be $135,000  to $150,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

#LI-TT1 #Hybrid #Princeton

Staff Full Stack Engineer

Location: Richmond, VA, McLean, VA, or Jersey City Area, NJ

Work Environment: Hybrid

Role Summary:

We are seeking a highly experienced Staff Full Stack Engineer to lead the architecture, development, and scaling of our next-generation, cloud-based platforms. This role is ideal for a senior technical leader who thrives in both hands-on engineering and strategic influence. You’ll own key architectural decisions, guide engineering best practices, mentor teams, and drive major multi-team initiatives that shape the future of our technology organization.

What You’ll Do:

• 60% coding, 20% design, 20% leadership and influence
• Lead architectural strategy across teams and set long-term technical direction
• Unblock engineering teams and design scalable, high-performance solutions
• Drive major cross-team initiatives aligned with product and business priorities
• Make high-impact architectural and technical decisions
• Promote a culture of learning, ownership, and technical excellence
• Contribute to planning, budgeting, and understanding financial drivers

What You Need:

• 8+ years developing with JavaScript/TypeScript and one OO language (Java, Go, C/C++, C#, Python, etc.)
• 6+ years architecting and delivering Micro Frontends or similarly complex cloud-based systems (AWS, GCP, Azure)
• Experience with WebGL, D3.js, or SVG visualizations
• Experience with modern UI libraries (e.g., Angular Material)
• Hands-on experience with Terraform and AWS or other IaC/cloud environments
• Deep understanding of Data Structures, Algorithms, frontend best practices, UI/UX, design systems, accessibility, and responsive design
• Strong background in Agile/Scrum and optimizing global, enterprise-scale software
• Excellent communication and collaboration skills
• Familiarity with SOAP, REST, XML, JSON, HTML, GraphQL, RPC

What's Nice to Have:

• Graduate degree in Computer Science or equivalent
• Strong system design experience (scaling, reliability, design patterns)
• Professional speaking or client-facing experience
• Background in supply chain, cyber supply chain, risk, or analytics
• Experience building modern web platforms from the ground up

Additional Knowledge & Skills

• Expertise in Micro Frontends and large-scale frontend architecture
• Strong skills in cross-browser compatibility, mobile responsiveness, accessibility, performance optimization, and advanced debugging
• Ability to define and champion a “Golden Path” for frontend development
• Strong balance of code quality and delivery speed
• Highly collaborative with strong problem-solving and communication abilities
• Skilled in guiding architectural decisions and influencing technical direction

Why You’ll Love Working at Exiger:

• High-performance culture rooted in accountability, collaboration, and a shared commitment to excellence.
• Discretionary Time Off for all employees, with no maximum limits on time off
• Industry leading health, vision, and dental benefits
• Competitive compensation package
• 16 weeks of fully paid parental leave
• Flexible, hybrid approach to working from home and in the office where applicable
• Focus on wellness and employee health through stipends and dedicated wellness programming
• Purposeful career development programs with reimbursement provided for educational certifications

#LI-Hybrid

This is a full-time hybrid opportunity.

Senior Database Administrator 

Role Summary:

Exiger is seeking a motivated, self-driven Senior Database Administrator who designs, builds and optimizes database, works within a continuous integration and delivery pipeline, and embraces test automation as a discipline. You will manage core transactional databases and cloud data platforms, ensuring they are secure, performant, resilient, and aligned with our data strategy. You’ll work closely with engineering, data, and security teams to support new product features, data initiatives, and ongoing operational excellence.

What You’ll Do: 

• Architect and evolve cloud-native data platforms for production and analytics (RDS, Snowflake, S3, Iceberg, Trino/Athena).
• Drive architectural changes to improve scalability and reduce cost, including migration to open, storage-centric designs.
• Own performance optimization across data workloads, partnering on query, schema, and data model improvements.
• Lead modern data architecture beyond traditional databases (data lakes, open table formats, decoupled compute).
• Design and own high availability, disaster recovery, and multi-region strategies, balancing resilience, performance, and cost.
• Apply FinOps best practices to analyze and optimize cloud data spend.
• Collaborate cross-functionally with engineering, infrastructure, and security teams.
• Promote DevOps and platform best practices (IaC, automation, self-service, lifecycle management).
• Define standards for scalable, reliable, and cost-transparent data storage and access.
• Ensure security, compliance, and governance across databases and lakehouse platforms.
• Mentor engineers and DBAs on modern, cost-aware cloud data architecture.

Technical Environment

• Cloud platforms: AWS, GCP, and/or Azure
• Managed and self-managed databases: Snowflake, MySQL, SQL Server
• Lakehouse environments: S3, Iceberg Tables, Trino
• Infrastructure-as-Code: Terraform, AWS CloudFormation
• Monitoring, alerting, and observability tooling: DataDog, Kibana
• High-volume, highly regulated datasets

What You Need: 

• 8+ years of experience in database administration with increasing ownership of cloud architecture decisions
• Deep expertise in cloud-based database design, cost and efficiency planning, performance tuning, and scaling strategies
• Hands-on experience with high availability, replication, backup, and disaster recovery in the cloud
• Strong understanding of cloud networking, security, and identity as it relates to data platforms
• Experience supporting enterprise SaaS platforms with strict uptime and compliance requirements
• Prior experience in compliance, risk, financial services, or data-intensive SaaS environments preferred

Why You’ll Love Working at Exiger:

• High-performance culture rooted in accountability, collaboration, and a shared commitment to excellence.
• Discretionary Time Off for all employees, with no maximum limits on time off
• Industry leading health, vision, and dental benefits
• Competitive compensation package
• 16 weeks of fully paid parental leave
• Flexible, hybrid approach to working from home and in the office where applicable
• Focus on wellness and employee health through stipends and dedicated wellness programming
• Purposeful career development programs with reimbursement provided for educational certifications

#LI-Hybrid

This is a full-time hybrid opportunity.