Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

As a key member of the cross-functional Development Team responsible for providing regulatory writing expertise and leadership to formulate the writing strategy for key regulatory documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for providing guidance to the medical and or regulatory writing group (contractors and internal writers) assigned to deliverables and ensuring appropriate work allocation and document preparation.; will also provide review and substantive editing of documents to ensure delivery of high-quality documents. This individual will work effectively with many other functional groups, including with Clinical Scientist(s), Medical Monitors, Regulatory and other functions as applicable, and collaborate with clinical medical writing as applicable to ensure scientific excellence in the execution of clinical trials. The Head of Regulatory Writing will build a medical writing group internally when appropriate.

Reporting to the SVP, Head of Regulatory Affairs, this role will be responsible for the regulatory writing & medical writing deliverables of assigned project(s), in accordance with the agreed timelines and quality standards.

Responsibilities:

• Ensure appropriate allocation of internal and external resources needed for all regulatory writing deliverables.
• Hire and manage medical writers internally and manage external medical writing contractors.
• Forecasting and maintaining budget for the regulatory writing team.
• Assess efficiencies, help identify areas of improvement and initiate improvement processes.
• Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
• Clinical study protocols and clinical protocol amendments (in partnership with Clinical Science/Clinical Development)
• Clinical study reports
• Investigator’s brochures and annual updates
• IND submissions and annual reports
• Lay-person summary
• Integrated summary reports
• Clinical, Nonclinical and Multidisciplinary Information Amendments
• NDA, BLA, MAA, (e)CTD submissions
• Risk Management Plans
• Health Authority responses
• Briefing Documents, ODDs, BTDs/PRIME, FTD etc
• Participate in relevant subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects.
• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
• Support and develop deliverables required for global transparency and disclosure requirements (e.g., plain language lay summary, applicable redactions to regulatory documents subject to EU posting regulations and results for EU CTR).Partner with Biometrics in developing standard TFLs and in text tables for deliverables as applicable
• Maintain and support developing and reviewing standard processes and templates.
• Review and edit documents as required.
• Work effectively and lead in cross-functional working groups.

Qualifications:

• Candidates must have a BS with 15+ years, or MS or other advanced science degree (e.g.: RN, NP, MSN, PharmD, PhD, MD) with 10+ years of experience in oncology clinical research experience as a clinical or regulatory medical writer within the pharmaceutical/biotech industry.
• Prior experience leading a regulatory writing group
• Experience writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA).
• Proficiency in the use and understanding of computer software e.g. word processing, graphics, reference manager, document management systems.
• Familiarity with all phases of drug development processes (discovery to market), clinical study protocol design, CTA/IND submissions, investigator’s brochures and clinical study data collection and results reporting.
• Advanced knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates.
• Experience writing, at a minimum, protocols (Phase 1-3, in oncology), investigator’s brochures, clinical study reports, Health Authority briefing packages, and Health Authority responses. Experience with Pediatric Investigational Plans (PIPs) is preferred.
• Advanced understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
• Ability to interpret and summarize complex tabular and graphical data presentations.
• Strong organization, documentation and communication skills with an ability to multitask.
• Adaptable / flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism.
• Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

Position Title:  

Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Job Summary:

Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team.  The successful candidate will be a core member of the Regulatory team and will be responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and future marketing of products for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.

Responsibilities:

• Provides regulatory strategic direction and support for assigned global development programs/development program activities
• Assists Sr. Regulatory Affairs staff with their development program activities and deliverables
• Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
• Acts as regulatory representative on early and/or late phase clinical studies, ensuring compliant execution of trials
• Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
• Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities
• Assist in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
• Assist in the cataloging and maintenance of regulatory application submissions
• Conduct research and stay up-to-date on regulatory requirements and changes
• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle
• Monitor and assess regulatory risks and develop mitigation strategies
• Oversee quality assurance processes to ensure compliance with regulatory standards
• Review SOPs pertaining to Regulatory
• Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix’s investigational and marketing applications
• Plays an essential part in defining requirements for, implementing, and supporting future systems and tools to be employed by Nurix in the areas of document management, submission content planning, and regulatory information management
• Tracks the status of major deliverables for regulatory submissions (e.g., study reports, summary documents, labeling) along with their dependencies
• Develops and maintains submission plan templates to ensure Nurix regulatory submissions are consistently planned and executed across programs
• Participates in cross-functional process initiatives impacting regulatory submission processes and systems
• Manages consultants and contractors as needed

Experience and Skills:

• Bachelor's degree in life-sciences or related scientific discipline; advanced degree preferred Manager:
• Must have minimum of 8 years in Regulatory affairs strategy
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Experience providing hands-on support for planning clinical trial and marketing applications to health authorities including but not limited to FDA, EMA
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory
• Ability to understand and explain detailed regulatory affairs and compliance programs and/or to effectively present information to senior regulatory management, other departments or external
• Ability to comply with changing regulatory
• Proven track record of supporting Regulatory affairs in the planning and execution of major filings and ongoing maintenance of clinical trial and marketing applications
• Strong project management and critical thinking skills
• Experience applying project management techniques and tools (e.g., MS Project, Smartsheet, Excel trackers) to the planning and execution of regulatory submissions
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).

About this Role

Our pharmaceutical team is looking for a highly motivated and creative Director of Chemistry, Manufacturing and Control (CMC) to lead expansion and growth of partner pharma activities toward clinical production. This role will be responsible for all CMC activities across the external drug development pipeline of Varda’s partners. Reporting to the VP, Pharma Program Management), this position requires collaboration across multiple departments and external partners to design, develop, and implement novel approaches to manufacture drug products in low Earth orbit. This is an opportunity in an exciting area of growth for Varda, the role will shape Varda’s product culture and will play a significant role in establishing the low Earth orbit economy. The ideal candidate must create and lead the CMC development team for drug products from early stage through clinical manufacturing.

Responsibilities

• Develop and lead all GMP CMC-related activities (biologics and small molecule) including process chemistry, drug product, analytical, and formulation from lead optimization phase through to clinical development and commercialization  
• Build and lead internal GMP CMC team with functions around process development, quality control, and quality assurance. 
• Manage external drug product manufacturing service providers and API supply chains to support clinical trial development  
• Collaborate with Varda pharma R&D teams to understand future CMC needs and handle internal tech transfers 
• Author all CMC sections of regulatory filings including FDA, EMA and other national authorities to support the conduct of clinical trials 
• Act as subject matter expert for non-clinical CMC to both preclinical and clinical development teams, interact with all internal and external stakeholders to support CMC needs 
• Ensure high-quality standards, develop SOPs, implement GMP compliance and QC/QA 
• Monitor progress and regularly report to the C-suite team 
• Manage and monitor the CMC timelines and budget 

Basic Qualifications

• 8+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• B.S. or M.S. in life sciences such as Chemistry, Biochemistry, or related fields 
• Firm understanding of cGMP and FDA regulatory guidelines as they pertain to CMC 

Preferred Skills and Experience

• 12+ years of CMC leadership experience advancing drug product development programs to successful clinical trials 
• PhD in life sciences such as Chemistry, Biochemistry, or related fields 
• Documented evidence of prior successful CMC project leadership from early phase, late phase leading to clinical trials. 
• Experience in leading and direct management of research, analytical laboratories, process development, and manufacturing 
• Advanced understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas 
• Command of global CMC-related regulatory requirements and guidelines 
• Excellent leadership, managerial and communications skills in a cross functional environment 
• Hands-on experience in managing multiple internal and external stakeholders (e.g. working with CMOs on managing drug product development) 
• Experience with writing CMC sections for regulatory filings and knowledge of current regulations in US and EU 
• Fluent communication in English, written and verbal 

Pay Range

• Salary range: $200,000 - $230,000/per year
• This role is on-site in El Segundo, CA
• Leveling and base salary is determined by job-related skills, education level, experience level, and job performance
• You will be eligible for incentives in the form of stock options and/or long-term cash awards

Seeking talent near: Princeton, NJ

Position Summary

The Associate Director, Drug Product Development is responsible for the formulation, primary package, and manufacturing process development for Acadia’s growing portfolio of drug candidates at all stages of development, and will provide technical oversight, expertise and guidance of externalized drug product development related activities. The scope includes development of formulations, package, and process for all modes of administration including oral solid, liquid, and injectable dosage forms for candidates ranging from clinical development to process validation and life cycle management. The incumbent will be responsible for management of activities relating to the above at the Contract Service Providers (CSPs) and will contribute both internally and externally in resolution of complex technological issues and implementation of new manufacturing process technology for products intended for clinical and commercial distribution. The role will be critical in ensuring that we optimize development, reduce risk and accelerate the development of new assets for commercialization.

Primary Responsibilities

• Designs and develops pharmaceutical formulations and manufacturing processes to support clinical trials, registration and product launch.
• Evaluate and validate new drug product CSPs (Contract Service Providers) to support development, scale up, and commercialization of the new drug candidates in the Acadia pipeline.  Initiate and manage supplier contract agreements as necessary.
• Coordinate and supervise the development, scale-up to manufacturing of clinical formulations and finished dosage forms at CSPs.  Serves as person-in-the plant at the CSP sites.
• Plans project-related scientific and technical activities, e.g. interpretation of results, evaluation of data, formulates relevant and scientifically based conclusions, writes and presents technical reports.
• Review the clinical supply requirements with the clinical supply managers and plan requisite manufacturing schedule with the CSPs to ensure uninterrupted supply of clinical trial materials.
• Perform risk assessments of manufacturing process and product at key development milestones and address the findings with the relevant CSPs.
• Authors and reviews technical reports and documents suitable for regulatory submissions. Reviews MBRs, BPRs, development reports and relevant documents prepared by CSPs.
• Liaises with analytical, manufacturing, quality assurance and regulatory counterparts to develop plans and protocols for drug product development and for life cycle management of the established products.
• Adheres to cGMP work practices and works closely with the Quality Assurance to ensure strict compliance with applicable GXP procedures and compliance requirements. Assist the CSPs in preparation for health authority inspections and for pre-approval inspections.
• Other responsibilities as assigned.

Education and Experience

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field. An equivalent combination of relevant education and applicable industry experience may be considered.
• A minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development with some experience in leadership role desired.
• Demonstrated success in the field of formulations and dosage form development.  
• Experience authoring technical reports and CMC sections for regulatory filings. 

Must possess:

• Comprehensive understanding of the dosage form formulation and package development, manufacturing process development, scale-up, optimization and validation processes.
• Extensive knowledge of cGMPs.
• Skilled at managing CSPs.
• Demonstrated verbal and written communication skills.
• Adept at effectively aligning resources across multiple functional areas to achieve functional area goals.
• Flexibility to travel domestically and internationally.

#LI-HYBRID #NC1

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%.

#Li-AS1

#Li-Hybrid

Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor) as part of the Clinical Operations team based remotely. 

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.

The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross functional study teams.

Contract Duration: 12 months

Key Responsibilities

Clinical Trial Operations Support
• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance
with ICH-GCP and applicable regulatory requirements.
Documentation & TMF Management
• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.
End-to-End Trial Coordination
• Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.
Regulatory & Compliance Support
• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.
Meeting & Communication Coordination
• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.
Tracking, Reporting & Data Support
• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.
Site & Vendor Support
• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.
Problem Solving & Continuous Improvement
• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.
Training & Mentorship
• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

Education
• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.

Experience
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology and/or Autoimmune Disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
Skills & Competencies
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fastpaced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
Technical Skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

#Li-JR1

#Li-Remote

Legend Biotech is seeking a Sr. Director, R&D Finance FP&A and Portfolio as part of the Finance team based in Bridgewater, NJ.

Role Overview

A key member in the Pipeline Finance team, serving as the dedicated financial partner for the Pipeline functions, leading Finance Analyst in Data Management, Reporting and Dashboarding, and Analytics support senior management decision making. Based in the US, this role reports directly to our CFO.

This role will take charge of end-to-end financial planning, budgeting, forecasting and analysis work in the R&D field, support the establishment and optimization of a standardized FP&A system, provide professional financial support for the implementation of R&D strategies, optimal allocation of resources and investment decisions, collaborate effectively with cross-functional teams, and ensure that the R&D financial FP&A work is aligned with the overall financial strategy of Legend and Pipeline BU.

It translates Pipeline strategy into actionable plans for Pipeline projects, provides tailored financial analysis, budgeting and forecasting, and collaborates with Pipeline leadership, other FP&A colleagues and Pipeline Finance Analysts to ensure financial alignment and data-driven decisions.

The Ideal candidate should have pharmaceutical/biotech FP&A experience with RD familiarity, strong strategic thinking, data analysis and independent work abilities. Must be US-based, able to collaborate cross-functionally in a matrix environment, and support RD Finance strategy execution.

The ideal candidate will have a strong track record of driving improved financial performance, enhancing productivity, strengthening internal controls, and advancing systems and processes. Success requires high learning agility, the ability to collaborate across diverse and geographically dispersed teams, and skill navigating a complex, matrixed environment.
Strong leadership is essential to support business decision-making and ensure smart resource allocation across the R&D pipeline.

Key Responsibilities

Strategy & Portfolio Financial Leadership

• Support RD Finance Head in defining the financial strategy for Pipeline BU, as well as the overall development portfolio, including resource allocation across the pipeline.
• Align Pipeline Finance strategy with Pipeline needs, support FP&A process optimization and standardize best practices across projects and therapeutic areas.
• Provide strategic financial input into the Pipeline Strategy and business plan, enhancing transparency of cost, value, and return on investment.

FP&A Execution & Budget Management

• Develop operating plans and budgets that support timely and high-quality delivery of business objectives, including benchmarking and tracking efficiency improvements.
• Take charge of budget preparation, review, consolidation and variance analysis, ensuring alignment with R&D strategy and Pipeline priorities.
• Regularly report budget execution, forecast deviations and performance to the RD Finance Head with targeted insights.

Consolidation, Analytics, Financial Analysis & Decision Support

• Leading RD Finance consolidation, data management, reporting and analytics.
• Conduct RD-focused financial analysis (cost, ROI, resource efficiency) and apply advanced financial skills to address early development uncertainty.
• Partner with Pipeline leadership team to support project prioritization, resource allocation and investment decisions, maximizing portfolio value.
• Track Pipeline financial KPIs, establish performance measurement frameworks, analyze deviations and propose improvement measures to drive continuous improvement.
• Ensure high-quality financial evaluations for investment decisions and prepare robust financial materials for Senior Executive Team review.

Cost Control & Compliance

• Manage budget execution, warn of risks, coordinate corrective actions and control costs to ensure operational plans remain within established budgets.
• Identify cost optimization opportunities and support implementation to enhance resource utilization efficiency.
• Maintain accountability for SOX and FCF controls, ensure FP&A compliance with Finance Standards, policies and relevant global clinical trial accounting policies.

Collaboration & Process Enhancement

• Collaborate with the Pipeline team to understand business needs and resolve financial collaboration issues.
• Coordinate with other FP&A colleagues and RD Finance Analysts for data/report support, aligning ways of working.
• Identify and support partnership opportunities and external collaborations to enable portfolio growth.
• Develop and optimize FP&A processes that effectively support evolving R&D and Pipeline business needs, contributing to global policy/program implementation

Requirements

• Bachelor's degree in Finance, Accounting, Business Administration, or a related field. MBA, CPA, or CMA is a plus.
• 15+ years of progressive FP&A experience, preferably in the biotech/pharmaceutical industry, with specific experience supporting R&D functions.
• Demonstrates expertise in financial modeling, budgeting, and forecasting.
• Advanced proficiency in Excel (Pivot tables, macros, data modeling).
• Expertise in Anaplan (as the SME) and familiarity with ERP systems (e.g., SAP).
• Experience with data visualization tools (e.g., Tableau, Power BI).

#Li-LB1

#Li-Hybrid

Legend Biotech is seeking a Senior Clinical Trial Associate (Contractor)  as part of the Clinical Operations team based Remotely.

Role Overview

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of complex Phase I/II CAR-T oncology clinical trials by providing high-quality operational, administrative, and coordination support.
The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP. This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross-functional study teams.

Key Responsibilities

Clinical Trial Operations Support

• Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-related forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials, ensuring all activities are conducted in compliance with ICH-GCP and applicable regulatory requirements.

Documentation & TMF Management

• Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is current, complete, and compliant with ICH-GCP and company SOPs.

End-to-End Trial Coordination

•  Assist with the planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.

Regulatory & Compliance Support

• Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• Maintain working knowledge of applicable regulations and standards to support ongoing study compliance.

Meeting & Communication Coordination

• Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings.
• Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion.

Tracking, Reporting & Data Support

• Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for internal and external stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.

Site & Vendor Support

• Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication.
• Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues.

Problem Solving & Continuous Improvement

• Proactively identify operational issues and risks, propose solutions, and escalate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate.
• Contribute to the development and continuous improvement of clinical operations processes and best practices.

Training & Mentorship

• Provide guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred.
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.

#Li-JR1

#Li-Remote

#Li-Contract

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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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 Sr. Medical Director/Executive Director, Early Clinical Development as part of the Clinical Development team based in Somerset, NJ.

Role Overview

The Sr. Medical Director/Executive Director of Early Clinical Development is a critical role in the company with significant impact on the development and life cycle of drug development projects. The candidate for this role will be responsible to lead the Early Clinical Development Team, for IND submission and the design, execution and oversight of first-in-human, dose finding clinical trials. Full understanding of tenets of FIH studies (e.g. dose selection rationale, biomarker plans, etc.) and the relevant compliance framework for clinical development activities are essential. Candidate must possess passion for science and patients, as well as entrepreneurial drive to help the organization succeed.

Key Responsibilities

• Lead clinical science aspects of design, execution, interpretation and reporting of early (first in human) stage clinical trials.
• Collaborate with scientists and technical experts to integrate cellular therapy specific aspects of PK/PD, diagnostic, and biomarker plans into the overall clinical development strategy.
• Contribute clinical leadership and expertise in the development of study protocols and clinical study reports, study medical monitoring, safety reporting, regulatory documentation and interactions, and other clinical deliverables.
• Collaborate with academic scientists, clinical experts, and study investigators.
• Represent and advocate for the project in internal and external venues.
• Clinical leadership for business development and partnership activities as needed.
• Act as a champion for high standards of compliance, ethics and safety, and putting patients first.

Requirements

• MD or MD-PhD or equivalent medical degree with US board certification in hematology and/or oncology.
• 3+ (Senior) / 6+ (Executive) years’ industry/ academic clinical development experience in hematology/oncology, leading cross-functional development teams is required.
• Sub-specialization and/or clinical development experience in cell therapies or CAR-T is highly desirable.
• Experience in biotech - preferred but not required.
• Demonstrated capacity to think creatively when addressing complex situations
• Demonstrated excellence and experience in first-in-human clinical development including the design, execution of first in human trial, and submission of INDs.
• Experience leading pre-IND and IND meetings with health authorities is highly desirable.
• Excellent communication and leadership skills; willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment; stellar writing skills, a track record of publications; superb presentation skills
• Able to anticipate biometrics, regulatory, clinical operations, development sciences, pharmacovigilance, and other development needs to ensure successful program delivery
• Ability to communicate effectively with cross functional teams such as pre-clinical scientists, clinical operations, safety-PV, biomarker, biostatistics, regulatory, and project management including peer to peer interactions with academic scientific experts, KOLs and stake holders.
• Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the team work
• Ensures compliance with corporate policies and procedures, as well as, all related healthcare laws and regulations
• Highly collaborative & effective influencing skills and the ability to operate across multiple geographies
• Strong track record of delivering results through effective team and peer leadership in matrix
• Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams. Ability to effectively manage conflicts and negotiations while providing impact and influence. Communicate regularly and effectively with senior leaders.
• Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating medical/clinical information into clinical development strategies.
• Travel requirement up to 15-20 % of the time.

The advertised pay range covers both levels of this position.

Here's the base pay range by level:

Sr. Medical Director, Early Clinical Development- $294,483 - $386,511

Executive Medical Director, Early Clinical Development- $338,656- $444,486

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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 Legal Operations Manager, Contracts & Privacy as part of the Legal team based in Bridgewater, NJ.

Role Overview

The Legal Operations Manager, Contracts & Privacy supports the Legal Department by managing day-to-day contract lifecycle administration, coordinating operational aspects of the company’s Global Privacy program and assisting with legal operations processes and tools. This role is highly execution-oriented and works closely with attorneys and cross-functional partners to ensure efficient, compliant, and well-organized legal workflows in a fast-paced biotech environment. The position will coordinate closely with Legend Biotech’s Chief Privacy Officer and reports to Legend Biotech’s Deputy General Counsel.

Key Responsibilities

Contract Lifecycle Administration

• Coordinate the end-to-end contract process, including intake, routing, approvals, execution, and filing
• Maintain and update contract records in the company’s CLM system, ensuring accuracy and completeness of data
• Ensure contracts comply with company standards, regulatory requirements, and approval processes
• Populate basic contract template agreements (e.g. NDAs, consulting agreements, etc.)
• Track contract status, key dates (e.g., expirations, renewals), and obligations
• Assist in maintaining contract templates, standard forms and clause libraries
• Respond to internal inquiries regarding contract status and process
• Perform other contracts-related activities and tasks as assigned

Privacy Program Support

• Support day-to-day operations of the company’s Global Privacy program
• Assist with privacy impact assessments, security risk assessments and other privacy reviews and documentation
• Maintain records related to data processing activities and ensure compliance with data subject right requests
• Help coordinate privacy training, awareness initiatives and policy updates
• Track and escalate privacy-related issues and requests to appropriate stakeholders
• Organize and coordinate privacy champions meetings to ensure privacy requirements are understood and implemented
• Coordinate implementation of data mapping plan to maintain up to data inventory, liaising with system/business owners, and assist with other EU GDPR operational matters
• Track key privacy metrics (e.g., breaches report, PIAs conducted, DSARs received)
• Assist with clinical trial privacy matters, including informed consent (ICF) updates, investigator/HCP notice, and related matters

Legal Operations Support

• Maintain organized legal files, databases, and corporate records
• Support subsidiary management across US & EU jurisdictions
• Support reporting efforts by compiling basic KPIs, metrics and data for the Legal Team
• Assist with invoice processing and vendor onboarding as needed
• Support implementation and ongoing management of legal systems and tools

Requirements

• Bachelor’s degree or equivalent experience required
• 4+ years of experience in legal coordination, contract administration, paralegal support or legal operations
• Experience with contract management systems or similar tools strongly preferred
• Basic familiarity with data privacy concepts and regulations (e.g., GDPR, CCPA, HIPAA) is a plus
• Strong organizational and administrative skills with high attention to detail and accuracy
• Ability to manage multiple tasks and deadlines effectively
• Effective communication and responsiveness
• Ability to follow established processes and identify opportunities for improvement
• Comfort working with systems, data and cross-functional teams

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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 Sr. Medical Science Liaison as part of the Medical Affairs team based Remotely in the Mid Atlantic Territory.

Role Overview

The Senior Medical Science Liaison (MSL) is a field‑based scientific expert within U.S. Medical Affairs, responsible for fostering credible, compliant, and non‑promotional scientific exchange with healthcare professionals (HCPs), investigators, and other external stakeholders in hematology/oncology.

This role serves as a key scientific partner across academic and community settings, supporting Legend Biotech’s marketed and pipeline assets through evidence‑based dialogue, clinical trial support, medical education, and generation of actionable medical insights. The Senior MSL operates with a high degree of autonomy, contributes to territory and national medical strategy execution, and may mentor or support the development of junior MSL colleagues.

Key Responsibilities

Scientific Engagement & External Partnerships

• Develop and maintain long‑term, peer‑to‑peer scientific relationships with key opinion leaders (KOLs), investigators, and other relevant healthcare stakeholders within the assigned territory.
• Deliver fair‑balanced, scientifically rigorous medical information in response to unsolicited requests, consistent with PhRMA Code, FDA regulations, and company SOPs.
• Serve as a trusted scientific resource on disease state, mechanism of action, clinical data, and emerging evidence related to Legend Biotech and relevant competitive landscapes.

Clinical Research & Development Support

• Act as the primary field‑based medical contact for investigators and research staff involved in company‑sponsored and investigator‑initiated studies.
• Support clinical trial feasibility, site identification, site initiation, and enrollment discussions in collaboration with Clinical Development and Clinical Operations.
• Provide education and support related to protocol concepts, safety reporting, and adverse event (AE) management, as appropriate and compliant.

Medical Strategy Execution & Insights

• Execute Medical Affairs strategies and tactics at the territory level in alignment with national medical plans.
• Collect, synthesize, and communicate high‑quality medical insights related to clinical practice, unmet needs, treatment paradigms, and competitive intelligence.
• Translate field insights into actionable recommendations for internal stakeholders to inform medical, clinical, and research strategies.

Scientific Exchange & Medical Education

• Support and participate in scientific congresses, symposia, advisory boards, and investigator meetings.
• Interpret scientific data presented at meetings and communicate key findings, trends, and implications to cross‑functional partners.
• Contribute to the development and continuous improvement of medical resources, training materials, and scientific content.

Cross‑Functional Collaboration & Leadership

• Collaborate effectively with internal partners including Medical Affairs, Clinical Development, Commercial (as appropriate), Regulatory, and strategic alliance teams while maintaining appropriate medical independence.
• Collaborate with alliance partners on field-based strategies and tactics
• Mentor and provide informal leadership support to newly hired or less experienced MSLs, as needed.
• Demonstrate strong judgment, adaptability, and professionalism in complex and evolving environments.

Compliance & Operational Excellence

• Adhere to all company policies, SOPs, and external regulations, including PhRMA Code, FDA guidance, and internal compliance standards.
• Maintain accurate and timely documentation of field activities, insights, and metrics using approved systems and tools.
• Manage territory operations effectively, including planning, prioritization, and travel logistics.

Requirements

• Advanced terminal degree (PharmD, PhD, MD, DO) or other advanced clinical degree (e.g., NP, PA) with relevant clinical experience.
• Minimum of 3-5 years of Medical Science Liaison experience in a therapeutic area aligned with hematology/oncology, immunology or CAR-T therapy; or 3-5 years of hematology/oncology clinical experience.
• Strong foundational knowledge of clinical research, trial design, and drug development processes.
• Demonstrated ability to engage in high‑level scientific exchange with expert clinicians and researchers.
• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific concepts clearly.
• Proven ability to work independently while collaborating effectively in a matrix organization.
• Valid U.S. driver’s license and ability to travel extensively, including overnight and occasional weekend travel.
• Residence within the assigned territory or within reasonable commuting distance.
• Core Competencies:
  • Scientific and Clinical Acumen
  • Strategic Thinking and Problem Solving
  • Insight Generation and Communication
  • Stakeholder Relationship Management
  • Emotional Intelligence and Professional Presence
  • Adaptability and Change Management
  • Compliance Mindset and Ethical Judgment
  • Digital and Technical Proficiency

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Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Members of the Caribou herd open their minds to new ideas and welcome diverse perspectives. We proudly assert that teams do their best work when their members are personally engaged, their ideas are taken seriously, and contributions are recognized. Members of the herd work from our headquarters in Berkeley, California, or remotely.

About the Role

The Director of Clinical Operations will serve as the cross-functional study team lead for a high-priority hematology program, with overall accountability for the strategic planning and execution of all operational activities. This role will provide leadership and oversight of CROs and vendors, including governance, to ensure delivery against timelines, quality, and budget expectations.

The individual will work collaboratively with internal functional leads (Clinical Development, Regulatory, Translational, Data Management, and Biostatistics) to drive integrated study execution, while providing strategic direction and ensuring alignment across stakeholders. They will demonstrate strong matrix leadership, proactive risk identification and mitigation, and effective problem-solving to achieve key program milestones.

This role requires the ability to balance budget, timelines, and evolving trial needs, maintaining transparency and a solution-oriented approach to decision-making. A strong focus on data quality, inspection readiness, and overall trial execution excellence is essential.

This candidate can be remotely based, and ideally attends relevant congresses, conducts on-site visits and joins the greater team at Caribou headquarters (Berkeley, CA) as able.

Responsibilities:

• Provide strategic operational leadership and oversight for a key clinical program, ensuring alignment with clinical development objectives and corporate goals
• Oversee CROs and vendors, leading governance and partnering closely to ensure accountability for delivery of operational activities, timelines, quality, and budget, and driving proactive risk management and mitigation across the study
• Lead study-specific and cross-functional meetings, driving clear decisions, accountability, and timely issue resolution
• Collaborate cross-functionally (Clinical, Regulatory, Translational, Data Management, Biostatistics) to ensure integrated and efficient study execution
• Oversee study progress and performance using key metrics (e.g., enrollment, eligibility, data quality, primary endpoints), ensuring transparent communication and a solution-oriented approach
• Proactively identify, assess, and manage study and program-level risks, including mitigation planning and escalation of critical issues
• Ensure data quality, integrity, and completeness to support analyses, regulatory submissions, and program decision-making
• Establish and oversee vendor governance, including performance management, SOW/budget review, and financial tracking (forecasts, accruals)
• Ensure inspection readiness, including TMF quality, audit preparedness, and compliance with GCP and internal SOPs
• Build and maintain strong relationships with investigators, study staff, and external partners, and represent Clinical Operations in internal governance and external interactions

Requirements:

• Bachelor’s Degree is required, in a science or a health-related field
• A minimum of 10 years of global clinical trial management experience within the pharmaceutical or biotechnology industry
• Early phase oncology focus is key, preferably within the hematology space
• In-depth understanding and experience across clinical operations with a track record of success in CRO and vendor delivery oversight
• Being a key contributor to study planning, execution, data cleaning, database locking, study report generation and regulatory inspection
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred
• Ability to lead cross functional study teams in a dynamic, evolving organization
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions (internally and externally)
• Ability to travel up to 20% based on business needs

Nice-to-Haves:

• Prior experience in the CAR-T space, with a specific focus in hematology
• An emphasis on inspection readiness for Clinical Operations
• Ease and confidence in being Investigator and site-facing

Caribou compensation and benefits include:

• Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
• Salary Range: $240,000-$255,000; this represents the present low and high end of the Company’s pay range for this position; actual pay will vary based on various factors, including but not limited to location, skill, experience, and performance
• Generous paid vacation time, in addition to company-observed holidays
• Excellent medical, dental, and vision insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program

The benefits and stock purchase described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.

Caribou is an equal opportunity employer and does not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law. In addition, Caribou prohibits the harassment of any individual on any of the bases listed above or any other characteristics protected under federal, state, or local laws.

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

We do not accept unsolicited resumes or candidate submissions from staffing agencies. All agencies must have a valid written agreement with Caribou Biosciences, Inc. for service in place. Any resume or candidate submitted by a staffing agency without such an agreement in place will be considered unsolicited, and Caribou Biosciences, Inc. will not be obligated to pay any referral or placement fee.

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

The Opportunity:

Revolution Medicines is seeking a motivated Summer Intern to support a strategic Clinical Operations initiative focused on optimizing study-level execution and alignment with internal Clinical Operation tools such as the Clinical Operations Handbook. This individual contributor role will partner with the Clinical Operations Execution (CORE) Team to assess consistency, tool utilization, and workflow execution from protocol finalization through site activation. The intern will gain hands-on exposure to cross-functional clinical trial operations while delivering actionable process improvement insights.

Responsibilities:

• Review one to two active clinical studies for detailed operational assessment.

• Evaluate utilization of key study management tools including logs used for study tracking, e.g., risks, actions, issues, decisions.

• Study Dashboards, Vendor Oversight Plans, and Study Startup Timelines.

• Document end-to-end workflows from protocol finalization through site activation.

• Identify gaps, redundancies, and inconsistencies in process execution across studies.

• Conduct structured interviews with Clinical Operations Leads (COLs) and Clinical Trial Assistants (CTAs).

• Shadow Clinical Study Execution Team (CSET) meetings to observe dashboard and RAID log utilization.

• Review Smartsheet tools and Egnyte folder structures to assess organization and consistency.

• Compare real-world study execution against documented Clinical Operations Handbook processes.

Required Skills, Experience and Education:

• Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Public Health, Clinical Research, Business, or related field.

• Strong analytical and organizational skills.

• Effective written and verbal communication skills.

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

• Interest in clinical trial operations and process optimization.

Preferred Skills:

• Familiarity with Smartsheet or similar project management tools.

• Prior exposure to clinical research or regulated environments. 

  #LI-Hybrid  #LI-AP1

Position Overview

The Senior Clinical Data Manager (Sr. CDM) is responsible for leading end-to-end data management activities across one or more complex clinical trials. This role ensures high-quality, reliable clinical data that meets regulatory standards and supports timely clinical development decisions. The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration. 

Responsibilities

Study Planning & Start-Up 

• Serve as the data management lead for assigned clinical studies, providing strategic input into protocol design and data collection strategy. 

• Develop and manage Data Management Plans (DMPs), CRF/ eCRF specifications, edit check specifications, and data validation plans. 

• Lead EDC system set-up, UAT, and deployment; coordinate with external vendors and internal biometrics teams. 

Execution & Oversight 

• Oversee all data review activities, including query management, data cleaning, discrepancy resolution, and ongoing data quality monitoring. 

• Ensure adherence to CDISC/CDASH/SDTM standards where appropriate, as well as applicable regulatory requirements (ICH-GCP, FDA, EMA). 

• Track study metrics, identifying risks and implementing mitigation strategies to maintain high-quality and timely deliverables. 

• Manage interactions with CROs, central labs, imaging vendors, and other data contributors. 

Close-Out & Reporting 

• Lead database lock activities, ensuring audit readiness and complete documentation. 

• Support statistical programming and medical writing teams in delivering data for interim analyses, CSR outputs, and regulatory filings. 

• Contribute to process improvements and knowledge sharing within the data management function. 

Qualifications

• Bachelor’s degree in relevant field 

• A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry. Oncology experience is strongly preferred.  

Knowledge and Skills

• Demonstrated expertise with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva CDMS). 

• Understanding of clinical trial methodology, regulations, and data standards. 

• Experience leading data management activities for Phase I–III global clinical trials. 

• Vendor oversight experience and ability to drive cross-functional alignment. 

• Knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance. 

• Excellent communication, documentation, and project management skills. 

Position Overview

The Senior EDC (Electronic Data Capture) Programmer (Sr. EDCP) is responsible for leading the design, development, and maintenance of clinical trial databases in an EDC system. This role will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure high-quality, compliant data collection systems that support efficient trial execution. 

Responsibilities

• Lead the design, build, validation, and deployment of a study build within an EDC system. 

• Develop and maintain edit checks, custom functions, derivations, and integrations. 

• Review study protocols and provide input on CRF design and database structure. 

• Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). 

• Perform User Acceptance Testing (UAT) and support database releases and migrations. 

• Ensure EDC systems comply with regulatory requirements (FDA, ICH-GCP, 21 CFR Part 11). 

• Troubleshoot and resolve database issues in a timely manner. 

• Oversee and/or mentor junior programmers or external vendors. 

• Contribute to SOP development and process improvements. 

• Support data integrations with external systems (IRT, ePRO, labs, etc.). 

• Maintain documentation including specifications, validation records, and audit trails. 

Qualifications

• Bachelor’s degree in relevant field. 

• A minimum of 5 years of EDC programming experience in the biotech/pharma industry. Oncology experience is preferred.  

Knowledge and Skills

• Strong hands-on experience with at least one major EDC platform (Medidata Rave preferred). 

• Solid understanding of clinical trial processes and data flow. 

• Experience with CDISC standards (SDTM, CDASH) is preferred. 

• Familiarity with regulatory requirements (ICH-GCP, 21 CFR Part 11). 

• Strong problem-solving skills and attention to detail. 

• Ability to manage multiple studies and priorities. 

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is searching for a Clinical R Programmer Consultant to join one of our clients. 

We are seeking a Clinical R Programmer with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADaM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams.

Key Responsibilities

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support TLF (Tables, Listings, Figures) generation in R or SAS as needed.
• Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting.
• Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
• Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA).
• Contribute to programming workflows, documentation, and version control best practices.
• Support automation initiatives and R-based pipeline development.
• Utilize SAS for legacy studies or where SAS support is required.

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 4–6+ years of experience in clinical programming, with a strong focus on R.
• Proven experience in creating SDTM and ADaM datasets using R.
• Working knowledge of SAS programming.
• Solid understanding of CDISC standards (SDTM, ADaM).
• Experience with clinical trial data, regulatory submissions, and QC processes.
• Strong analytical, problem-solving, and documentation skills.

Preferred Qualifications

• Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits.
• Understanding of R Markdown, Shiny apps, or reproducible reporting tools.
• Exposure to GxP validation, version control (Git), and automated workflows.
• Experience working in a CRO or pharmaceutical environment.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training are the core instruments to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our low industry-average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-#TT1 #LI-Remote #Senior#Contract

The Opportunity:

We are seeking an experienced drug developer and effective leader to serve as Executive Director of Clinical Development in support of Revolution Medicines’ clinical-stage molecule(s) and/or pre-clinical molecule(s). In this critical role, you will be responsible for developing the strategic plans and ensuring efficient operational execution of the molecule(s)’ clinical development program in one or more disease indications, from early-stage studies to regulatory submissions and potential commercialization. You will play a pivotal role in shaping the future of our pipeline and driving the development of transformative therapies for patients.

• Provide critical insights/contributions and implement comprehensive/execute upon the clinical development plans for Revolution Medicines’ molecules, ensuring alignment with scientific, regulatory, and commercial objectives.

• Lead, mentor, and manage a high-performing cross-functional team of clinical development professionals, fostering a culture of collaboration, innovation, and excellence.

• Oversee all aspects of clinical trial design and execution, including site selection, patient recruitment, data management, and regulatory compliance.

• Establish and maintain strong relationships with clinical investigators, regulatory agencies, and key stakeholders.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions and guide program development.

• Manage clinical development timelines effectively, ensuring efficient resource allocation and achievement of milestones.

• Stay abreast of the latest scientific advancements and regulatory trends in the field of clinical development.

• Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals.

• Manage multiple direct reports; potentially be a manager of managers.

Required Skills, Experience and Education:

• MD, PhD or similar advanced biomedical graduate degree with 13+ or more years experience in pharmaceutical/biotech industry or academic background at the level of Associate Professor or higher.

• Extensive experience working with the principles and techniques of data analysis, interpretation, and clinical relevance as related to the pharmaceutical/biotech industry.

• Proven track record of successfully designing and conducting multiple clinical trials as part of a wider clinical development programs from early-stage to late-stage, direct experience with Phase 1 drug development.

• Experience authoring and clinical development strategy(ies) and bringing forward for governance.

• Extensive understanding of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations.

• Proven experience to steer an IMP during its clinical development plan through major and varied Health Authority interactions (e.g. FDA, EMA, others). Has led Health Authority interaction(s).

• Strong orientation to teamwork. Excellent leadership, communication, and interpersonal skills, with the ability to inspire, motivate and mentor a diverse team.

• Expertise in building and maintaining strong relationships with internal and external stakeholders.

• Superb strategic thinking and analytical skills, with the ability to make data-driven decisions in a fast-paced environment. Able to recognize trade-off decisions and can determine priorities and goals.

• Outstanding written and business presentation skills. Experience publishing results of a clinical trial in a peer-reviewed journal is required.

• Proven ability to manage budgets and timelines effectively.

• Passion for innovation and a commitment to developing therapies that make a meaningful difference in patients' lives.

Preferred skills:

• Experience in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources in the pharmaceutical/biotech industry.

• Experience creating clinical development strategy(ies) that led to label-enabling outcomes and commercialization.

• Experience submitting an NDA/BLA/MAA to global health authorities is a significant plus.

• Has led regulatory and other internal partners/stakeholders in the completion and submission of regulatory documentation. Successfully provided clinical science information and input for regulatory development of label(s) and packaging language, etc.

• Has led or overseen data generation to address unmet medical needs and identify new or extended Clinical Development studies for the assigned program or other programs.

• Direct experience with Phase IV drug development.

• Has proven abilities to present [a] compelling business case and facilitates effective and expeditious decision-making. Has demonstrated the ability to serve as a company spokesperson both internally and externally.

• Has demonstrated collaborate behaviors on enterprise-level strategic initiatives with a variety of internal and external partners and stakeholders - including clinical investigators/clinicians, scientists and key opinion leaders (KOLs), as well as internal groups, including other groups in development, research, business development, commercial, legal, etc. - resulting in demonstrable outcomes (e.g. new study proposals or new disease indications).

• Has demonstrated courage and conviction in past positions and responsibilities. Skilled in conflict resolution.  

  #LI-Hybrid  #LI-GL1

Position Summary:

• The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction

Essential functions of the job include but are not limited to:

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency, and efficiency in execution.
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Represent Precision for Medicine in a professional manner
• Manage CRA staff in accordance with Precision for Medicine’s values and policies.
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
• Perform other duties as assigned by Leadership

Qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

• At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
• Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
• 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:
  • Experience creating effective development programs for clinical staff.
  • Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards

• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

Preferred:

• Experience in the Therapeutic area/country of the staff assigned to manage

Skills:

Competencies: 

• Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
• High capacity for Emotional Intelligence and a passion for people management and development.
• As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
• Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
• Demonstrates understanding and ability to work with EMRs and EDCs
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Highly organized, ability to set priorities and possesses excellent problem-solving skills.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Ability to develop, coach and mentor CRA staff.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Communicates both verbally and in written form in an acceptable manner.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Possesses practical knowledge of IT tools and systems in use on project teams.
• Values system and work ethic consistent with Precision Values and Company Principles

Position Summary:

• The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
• This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction

Essential functions of the job include but are not limited to:

• Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
• Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
• Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
• Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
• Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
• Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
• Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
• Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
• Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency, and efficiency in execution.
• Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
• Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
• Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
• Represent Precision for Medicine in a professional manner
• Manage CRA staff in accordance with Precision for Medicine’s values and policies.
• Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
• Perform other duties as assigned by Leadership

Qualifications:

Minimum Required:

• Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline

Other Required:

• At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
• Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
• 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:
  • Experience creating effective development programs for clinical staff.
  • Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards

• Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.

Preferred:

• Experience in the Therapeutic area/country of the staff assigned to manage

Skills:

Competencies: 

• Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
• High capacity for Emotional Intelligence and a passion for people management and development.
• As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
• Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
• Demonstrates understanding and ability to work with EMRs and EDCs
• Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
• Motivates other members of the project team to meet timelines and project goals.
• Highly organized, ability to set priorities and possesses excellent problem-solving skills.
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
• Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
• Ability to develop, coach and mentor CRA staff.
• Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
• Communicates both verbally and in written form in an acceptable manner.
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
• Possesses practical knowledge of IT tools and systems in use on project teams.
• Values system and work ethic consistent with Precision Values and Company Principles

The Opportunity

This Real World Evidence (RWE)/Health Economics (HEOR) Contractor role supports the RWE/HEOR Senior Director in leading RWE execution for pipeline assets. The role is fun and flexible with a mix of both study execution and data analytics. This person will be accountable for developing and delivering components of the evidence generation plan (including RWE and economic value evidence), and driving high-quality deliverables that inform internal decision-making during product development, pre-launch readiness, and lifecycle planning. The role is anchored to 1–2 priority pipeline assets/indications.

This is a remote role based with flexible hours. We are currently seeking an individual with 20-30 hours of weekly availability with potential to increase hours in late 2026/2027.

Responsibilities

• Evidence strategy and planning: Maintain US RWE & HEOR plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs; translate strategy into actionable workplans, timelines, and resourcing proposals.
• Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors.
• Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts; ensure adherence to SOPs and high scientific/operational quality.
• Analytic execution and statistics: Execute ad hoc analyses in clinical trial, claims and PCOR data as needed for ad hoc and protocol/SAP driven analyses. This may include feasibility or full protocol execution.
• Governance, compliance, and capability building: Complete required training, adhere to company/department SOPs, and contribute to continuous improvement of processes that enable efficient planning, execution, and dissemination of RWE & HEOR deliverables.

Required Qualifications

• Master’s degree or PhD in epidemiology, health economics and outcomes research, public health, biostatistics, or related discipline.
• At least 1+ years of experience in the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application
• Proficiency with SAS and/or R for statistical programming. Preference for experience in clinical trials OR claims data.
• Expertise in RWE and study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols, reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with ICJME criteria
• Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences

Preferred Qualifications

• Demonstrated success developing and executing health outcomes research plans and delivering high-quality data generation outputs.
• Experience managing real-world data sources and vendors (e.g., claims, EHR, registries) and translating findings into actionable insights and value messages.
• Demonstrated ability to influence without authority in a matrix environment, evidenced by aligning cross-functional stakeholders on objectives/trade-offs, documenting decisions, and driving actions to closure.
• Experience in PCOR implementation and validation

Work Location and Condition

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
• You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location

Position Overview

We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.

Key Responsibilities

Regulatory Compliance & Risk Management

• Experienced with the compliance aspects of clinical trial & clinical research
• Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
• Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
• Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
• Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
• Monitor evolving AI regulations and their impact on clinical trial optimization platforms

Quality Management & Documentation

• Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance 
• Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
• Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
• Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection

Contract & Vendor Compliance

• Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
• Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
• Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
• Support commercial team with compliance aspects of customer onboarding and due diligence processes

Training & Cross-Functional Support

• Develop and deliver compliance training programs for employees across all functions
• Serve as primary compliance liaison with external auditors, regulators, and certification bodies
• Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
• Maintain compliance calendar and ensure timely completion of regulatory filings and renewals

Required Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
• OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
• Direct experience with clinical trial regulations and GCP requirements
• Proven track record managing compliance programs in regulated industries

Technical Expertise

• Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
• Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
• Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
• Financial compliance awareness including regulatory reporting requirements
• Deep knowledge of GDPR and HIPAA requirements and implementation
• Hands-on experience with SOC 2 audits and information security compliance frameworks
• Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
• Understanding of AI/ML regulatory landscape in healthcare and clinical trials

Core Competencies

• Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
• Excellent written and verbal communication skills for regulatory correspondence and training delivery
• Project management experience with ability to manage multiple compliance initiatives simultaneously
• Detail-oriented approach with strong documentation and process improvement capabilities

Preferred Qualifications

• Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
• Experience with international regulations (EU Clinical Trials Regulation, other global markets)
• Background in clinical research or pharmaceutical compliance
• Familiarity with AI ethics and algorithmic bias considerations in healthcare
• Experience with healthcare technology or SaaS compliance programs

About the Role

The Regional Director is responsible for owning and optimizing site-level performance across a portfolio of GI-focused clinical research sites. This role ensures operational excellence by aligning teams around key performance goals, elevating site capabilities, and maintaining consistency in trial execution. As a strategic operations leader, the Regional Director plays a central role in connecting site level performance with broader business objectives.

Responsibilities

• Manages staff across multiple sites, ensuring execution is aligned with protocol, regulatory requirements, and IH standards.
• Owns overall performance of assigned sites, including enrollment, data quality, compliance, and team culture.
• Ensures sites are set up for success (i.e. staffed appropriately and equipped with the appropriate equipment and training) and makes recommendations to allocate resources based on business needs. 
• Builds strong relationships and collaborates with PIs to align their engagement with study goals and operational strategy.
• Influences study portfolio, optimizing for profitability and value to patients. 
• Identifies and manages issues, concerns and problems related to site performance.
• Leads and develops CRCs, and other site-based research staff through clear expectations, performance coaching, and team development.
• Serves as a visible, hands-on people manager who builds high-performing, accountable teams.
• Identifies levers to drive site level KPIs through monitoring KPIs and performance trends, escalating to appropriate parties. 
• Implements corrective actions or process improvements as needed.
• Serves as the primary operational liaison between site staff and central functions.
• Drives a culture of ownership, collaboration, and continuous improvement across all assigned sites.

What We’re Looking For

Required Qualifications

• Knowledgeable about the critical elements for success in clinical trials: Ability to review protocols, programs, and assess the success of a project.
• Ability to influence change management and model flexibility
• Problem-Solving Skills: Ability to identify problems, develop and implement solutions.
• Strategic Planning: Ability to plan for short, medium and long term success and make recommendations for growth
• Ability to use data as a tool, identify trends, and draw conclusions. 
• Project Management: Demonstrated ability to successfully manage people/projects.
• Proactive problem-solving abilities and follow-through.
• Practices professionalism and integrity in all actions. 
• Communication Skills: Excellent written and verbal communication skills. 
• Working knowledge of CTMS, eDC and other core research systems. 
• Ability to travel: Up to 30% travel to provide operational oversight, hold team meetings, and attend other professional meetings/conferences as needed.

Preferred Qualifications

• Experience in managing a large site network and demonstrated success in achieving targets and optimizing operations.
• Experience with gastroenterology and/or hepatology studies. 

What We Offer

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off

How This Role Makes a Difference

• Management of Studies and Site Workload:
  • Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols 
  • Coordinate Investigator and Sub-Investigator coverage  
  • Work with Region Manager to identify outside vendors needed for studies
  • Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
  • Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
  • Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
  • Update Region Manager on all pending and active study details
  • Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
  • Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
  • Attend all study audits and play an active role in their management and execution of follow up items
  • Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
  • Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
  • Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
• Personnel:
  • Review and approve PTO requests, ensuring there is adequate coverage at the site
  • Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
  • Participate in the interview process for site staff
  • Ensure site staff complete all required training
  • Encourage a positive team-oriented environment
  • Work with Region Manager to ensure high staff morale and low turnover rates
  • Report all personnel issues to Region Manager
  • Conduct weekly one on ones with staff and maintain appropriate documentation
  • Lead by example and display a high level of integrity and professionalism.
• Financial:
  • Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
  • Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
  • Work with Region Manager to identify and communicate staff needs
  • Ensure there are adequate supplies and equipment on site
• Site Maintenance: 
  • Keep Region Manager apprised of any site maintenance issues 
    • Coordinate building and equipment maintenance 
  • Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives 
  • Ensure staff are following guidelines and SOP’s as pertain to the sites 
    • Ensure that site have the equipment necessary to safely perform job responsibilities 
    • Work with the Region Manager to review and address injury reports if necessary 
  • Ensure the lab follows IATA guidelines and applicable staff are properly certified 
  • Collaborate and communicate with other departments regarding inter-site issues 
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

How This Role Makes a Difference

• Management of Studies and Site Workload:
  • Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols 
  • Coordinate Investigator and Sub-Investigator coverage  
  • Work with Region Manager to identify outside vendors needed for studies
  • Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
  • Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
  • Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
  • Update Region Manager on all pending and active study details
  • Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
  • Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
  • Attend all study audits and play an active role in their management and execution of follow up items
  • Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
  • Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
  • Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
• Personnel:
  • Review and approve PTO requests, ensuring there is adequate coverage at the site
  • Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
  • Participate in the interview process for site staff
  • Ensure site staff complete all required training
  • Encourage a positive team-oriented environment
  • Work with Region Manager to ensure high staff morale and low turnover rates
  • Report all personnel issues to Region Manager
  • Conduct weekly one on ones with staff and maintain appropriate documentation
  • Lead by example and display a high level of integrity and professionalism.
• Financial:
  • Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
  • Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
  • Work with Region Manager to identify and communicate staff needs
  • Ensure there are adequate supplies and equipment on site
• Site Maintenance: 
  • Keep Region Manager apprised of any site maintenance issues 
    • Coordinate building and equipment maintenance 
  • Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives 
  • Ensure staff are following guidelines and SOP’s as pertain to the sites 
    • Ensure that site have the equipment necessary to safely perform job responsibilities 
    • Work with the Region Manager to review and address injury reports if necessary 
  • Ensure the lab follows IATA guidelines and applicable staff are properly certified 
  • Collaborate and communicate with other departments regarding inter-site issues 
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

How This Role Makes a Difference

• Management of Studies and Site Workload:
  • Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols 
  • Coordinate Investigator and Sub-Investigator coverage  
  • Work with Region Manager to identify outside vendors needed for studies
  • Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
  • Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
  • Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
  • Update Region Manager on all pending and active study details
  • Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
  • Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
  • Attend all study audits and play an active role in their management and execution of follow up items
  • Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
  • Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
  • Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
• Personnel:
  • Review and approve PTO requests, ensuring there is adequate coverage at the site
  • Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
  • Participate in the interview process for site staff
  • Ensure site staff complete all required training
  • Encourage a positive team-oriented environment
  • Work with Region Manager to ensure high staff morale and low turnover rates
  • Report all personnel issues to Region Manager
  • Conduct weekly one on ones with staff and maintain appropriate documentation
  • Lead by example and display a high level of integrity and professionalism.
• Financial:
  • Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
  • Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
  • Work with Region Manager to identify and communicate staff needs
  • Ensure there are adequate supplies and equipment on site
• Site Maintenance: 
  • Keep Region Manager apprised of any site maintenance issues 
    • Coordinate building and equipment maintenance 
  • Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives 
  • Ensure staff are following guidelines and SOP’s as pertain to the sites 
    • Ensure that site have the equipment necessary to safely perform job responsibilities 
    • Work with the Region Manager to review and address injury reports if necessary 
  • Ensure the lab follows IATA guidelines and applicable staff are properly certified 
  • Collaborate and communicate with other departments regarding inter-site issues 
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

Team Description:

The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, gaming consoles, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. In addition,the team is also working on restoring speech to mute individuals, this will also open the option for direct and natural silent communication with AI agents.  The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.

Job Description and Responsibilities:

As a Software Engineer Intern  in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software. Additionally, you will be expected to:

• Develop, test, and validate software systems
• Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
• Work with study participants to iterate on and further refine the software
• Design and implement algorithms to decode brain activity
• Design user experiences centered around brain control

Required Qualifications:

• Strong experience with full-stack development 
• Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
• Experience in architecting elegant, maintainable, performant and reliable user facing software applications 
• Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
• Evidence of exceptional ability in engineering
• Strong understanding of engineering first principles
• You are resourceful, flexible, and adaptable; no task is too big or too small
• Excellent communication and collaboration skills
• Currently pursuing a Bachelor’s degree in Computer Science or a related field 

Preferred Qualifications:

• Experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking

Team Description:

The Convoy team, a specialized group within the Robot Mechanical Engineering team, is working on developing a first-of-its-kind brain-controlled assistive robotic arm (ARA). Our focus is on developing high-dimensional neural control of hardware, specifically robotic arms and hands. We design and integrate robotics systems, work directly with our clinical trial participants, and collaborate cross-functionally with hardware, software, electrical, and BCI engineers. We believe this work may be one of the best and most advanced paths to giving physical independence back to users with unmet medical needs.

Job Description and Responsibilities:

As a Mechanical & Robotics Engineer at Neuralink, you will design and produce hardware solutions for our assistive robotic arm. Your responsibilities may also include working on our brain-computer interface devices, surgical robotics, automation, microfabrication, and more. You will have the opportunity to own projects from concept to production, leveraging your mechanical engineering background in the challenging field of brain interfaces and human-robot interaction. Your responsibilities will include:

• Designing and integrating robot mechanical and electrical components and assemblies with a heavy emphasis on usability and safety
• Collaborating with clinical trial participants, neuroscientists, biologists, and engineers to establish design criteria
• Rapidly and effectively building systems to meet project goals
• Applying analytical methods, including calculations and simulations, for the design and optimization of structures and mechanical components
• Actively driving every phase of device launch, from hands-on early feasibility prototyping through manufacturing release

Required Qualifications:

• Bachelor’s degree in one of the following disciplines or equivalent experience: Mechanical Engineering, Robotics, Mechatronics
• Strong understanding of engineering first principles
• Minimum of 3 years of mechanical engineering industry experience, including internships and project teams where you owned products from concept to production
• Proficient in 3D CAD

Preferred Qualifications: 

• Experience with robotic systems such as robot arms, grippers, actuators, human-robot interaction
• Multidisciplinary experience in robotics software and control (e.g., Python, ROS, MATLAB, control theory)
• Electrical engineering proficiency (e.g., PCB design, wire harnessing, circuit design)
• Proficiency with conventional machining and rapid prototyping technologies

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Field Clinical  Engineer, you will be on the front lines of Neuralink’s clinical programs, working directly with participants, clinicians, and internal teams to translate cutting-edge neurotechnology into meaningful functional outcomes. This role is ideal for individuals with a background in PM&R, occupational therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.

You will play a critical role in bridging clinical care, engineering, and research by supporting device use, optimizing participant performance, and ensuring high-quality data collection in both clinical and home settings.

This role requires someone who is hands-on, clinically grounded, technically curious, and able to adapt quickly. You should be comfortable working with participants with significant neurological impairments and motivated by improving independence and quality of life.

In this role, you will:

• Work directly with study participants to support device use, training, and optimization during clinical sessions and at home
• Apply principles of rehabilitation (PM&R, OT, PT) to maximize participant outcomes and functional performance with the system
• Collaborate closely with surgeons, investigators, and site staff to ensure seamless clinical execution across all phases of the study
• Serve as the primary interface between participants and the technology, troubleshooting issues in real time and escalating when needed
• Support surgical and post-operative workflows, including intraoperative and early post-implant sessions where applicable
• Ensure high-quality, protocol-compliant data collection by aligning participant activities with study endpoints and data capture requirements
• Partner with clinical, engineering, and data teams to translate real-world use into actionable insights for product and algorithm development
• Identify trends in participant performance, usability challenges, and safety signals, and communicate clearly to cross-functional teams
• Contribute to development and refinement of training protocols, user workflows, and clinical best practices
• Support site onboarding, training, and ongoing engagement to ensure consistency and scalability across clinical sites
• Assist in preparation for regulatory inspections and ensure activities are conducted in compliance with GCP, protocol requirements, and internal procedures
• Travel to clinical sites as needed to support study execution and participant care

The ideal candidate:

• Has a clinical background in PM&R, occupational therapy, or physical therapy, with hands-on experience working with neurological populations (e.g., SCI, ALS, stroke)
• Has experience working with medical devices in a clinical or field-based role
• Is highly adaptable, proactive, and comfortable operating in a fast-paced, evolving environment
• Is technically curious and able to engage with engineers to troubleshoot and improve system performance
• Communicates clearly and builds trust with participants, clinicians, and cross-functional teams
• Is detail-oriented and understands the importance of protocol adherence and data integrity in clinical research

Required Qualifications: 

• Clinical training and hands-on experience in PM&R, occupational therapy, or physical therapy, with a focus on neurological populations (e.g., SCI, ALS, stroke)
• 3+ years of experience in a clinical, field-based, or medical device–adjacent role (rehab, neuromodulation, assistive technology, or similar)
• Demonstrated experience working directly with patients and clinicians in dynamic care environments
• Strong problem-solving skills with the ability to troubleshoot clinical and technical issues in real time
• Ability to interpret participant performance, functional outcomes, and device behavior to inform next steps
• Comfort working with technology, including basic data review and interaction with software-driven systems (no need to be a coder, but not afraid of one either)
• Working knowledge of clinical research principles, including protocol adherence, endpoint-driven activities, and data quality expectations
• Familiarity with Good Clinical Practice (GCP) and general clinical study conduct
• Ability to collaborate effectively across clinical, engineering, and operations teams
• Strong communication skills, with the ability to engage both participants and highly technical teams
• High attention to detail, with the ability to manage multiple participants, sites, and priorities simultaneously
• Willingness to travel frequently to support clinical sites and participants

Preferred Qualifications:

• Degree or formal training in bioengineering, biomedical engineering, or a related field, with exposure to neurotechnology or implantable systems
• Experience working with neuromodulation, brain-computer interfaces, or other neurorehabilitation technologies
• Prior experience in a clinical field engineer, clinical specialist, or applications role within a medical device company
• Experience supporting surgical procedures, intraoperative environments, or early post-implant programming and troubleshooting
• Familiarity with signal-based systems (e.g., neural data, EMG, EEG) and comfort interpreting system performance in real time
• Exposure to rehabilitation technology integration, including assistive devices, digital interfaces, or adaptive control systems
• Experience supporting multi-site clinical studies or working directly with investigators and study coordinators
• Comfort working with data systems (e.g., EDC platforms, basic data visualization tools) to review participant performance and study metrics
• Understanding of usability, human factors, and patient-centered design principles
• Prior involvement in training clinicians or participants on device use and workflows
• Experience working in early-stage or rapidly evolving clinical programs where processes are still being defined

Team Description:

The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!

Job Description and Responsibilities:

As a Clinical Scientist I, you will support the development, design, and execution of Neuralink’s clinical evidence strategy. This role focuses on translating product and research objectives into clinical study designs, supporting data analysis, and ensuring scientific rigor across clinical programs.

This individual is  a self-driven and analytically strong individual who can contribute to clinical strategy while executing with precision. The ideal contributor is detail-oriented, collaborative, and comfortable working in a fast-paced, multidisciplinary environment.

In this role, you will:

• Support the design and development of clinical study protocols, including endpoints, inclusion/exclusion criteria, and statistical considerations
• Contribute to clinical strategy by translating research and product goals into evidence-generating study plans
• Partner with other team members to support execution of clinical studies and ensure alignment between scientific intent and operational delivery
• Build and maintain strong working relationships with internal teams, investigators, and external partners
• Support preparation of study-related documents, including protocols, investigator brochures, clinical study reports, and regulatory submissions
• Contribute to EDC and CRF design by ensuring alignment between protocol objectives, endpoints, and data collection strategy
• Translate clinical and scientific requirements into structured, high-quality data capture and validation approaches
• Assist in data review, analysis, and interpretation to evaluate safety and performance outcomes
• Contribute to development of abstracts, presentations, and publications
• Support interactions with ethics committees (e.g., IRB, RECs) and regulatory bodies as needed
• Ensure scientific and clinical activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and internal SOPs
• Identify data trends, inconsistencies, or risks and proactively communicate findings to the broader team

Required Qualifications:

• Familiarity with statistical methods or programming (e.g., Python, R)
• 5+ years of experience in clinical research or scientific roles within medical devices or related fields
• Strong analytical and problem-solving skills with the ability to interpret complex data
• Familiarity with clinical study design, endpoints, and data analysis concepts
• Working knowledge of Good Clinical Practice (GCP) and basic regulatory requirements (e.g., ISO 14155)
• Ability to work cross-functionally with clinicians, engineers, and operational teams
• Strong written and verbal communication skills, particularly in scientific and technical contexts
• High attention to detail and ability to manage multiple priorities

Preferred Qualifications:

• Experience with neurological, neurosurgical, or implantable medical device studies
• Experience supporting protocol development, data analysis, or clinical reporting
• Publications or scientific presentations in biomedical engineering or neuroscience
• PhD  in neuroscience, biomedical engineering, or a related field
  

Additional Requirements and Competencies: 

• Willingness to travel (up to ~20–30%) to support site visits, investigator meetings, and study activities
• Strong organizational and documentation skills
• Ability to work independently while collaborating closely with cross-functional teams
• Adaptability and comfort in a fast-paced, high-growth environment
• Commitment to scientific rigor, patient safety, and high-quality evidence generation