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

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 critical  in translating Neuralink’s BCI technology for clinical use!

Job Description and Responsibilities:

As a Clinical Program Manager, you will be the primary architect of Neuralink’s human clinical trial operations, transforming high-level strategy into rigorous, executable clinical programs. We are seeking a high-autonomy leader who thrives on ambiguity and drives projects to completion with surgical precision. In our hyper-dynamic environment, you aren't just managing timelines—you are building the infrastructure for the future of neurotechnology. You will be expected to:

Strategic Oversight & Relationship Management

• Act as the Principal Lead for complex clinical programs, owning end-to-end delivery and ensuring all milestones align with broader organizational objectives.
• Cultivate High-Stakes Partnerships across internal engineering and regulatory teams, as well as external vendors, strategic partners, and world-class clinical research sites.
• Champion Stakeholder Readiness by overseeing the training and credentialing of cross-functional teams, ensuring every contributor is equipped to operate within the trial’s rigorous requirements.

Operational Excellence & Scalability

• Engineer Scalable Frameworks to expand clinical operations across diverse global geographies, prioritizing safety, quality, and regulatory compliance at every inflection point.
• Lead Commercial & Financial Negotiations with trial sites, driving contract execution, budget optimization, and long-term financial planning to maximize trial efficiency without compromising site engagement.
• Drive Data Intelligence by leading the synthesis and analysis of clinical data to provide actionable insights for program refinement.

Compliance & Regulatory Stewardship

• Navigate Global Regulatory Landscapes to secure study approvals and maintain impeccable standing with Institutional Review Boards (IRB), Research Ethics Committees (REC), and relevant governing bodies.
• Enforce Rigorous Quality Standards, maintaining an expert-level command of Good Clinical Practices (GCP), international regulatory requirements, and site-specific Standard Operating Procedures (SOPs).
• Foster a Culture of Accountability, proactively identifying operational risks and implementing mitigation strategies to ensure the integrity of the clinical program.

Required Qualifications: 

Strategic Leadership & Clinical Expertise

• Extensive Industry Tenure: 7+ years of progressive leadership experience in clinical research, specifically within Class III medical devices, neurology, or high-complexity life sciences.
• Clinical Architecture: Advanced proficiency in clinical study design, endpoint selection, and the development of robust data analysis plans for first-in-human or pivotal trials.
• Regulatory Mastery: Deep technical knowledge of Global Good Clinical Practice (GCP) and international regulatory standards (e.g., ISO 14155, MDR, FDA 21 CFR Part 812).

Data Intelligence & Analytical Rigor

• Quantitative Fluency: Professional experience leveraging statistical methods or programming languages (Python, R) to drive data-led decision-making and trial optimization.
• Complex Problem Solving: Proven track record of interpreting multi-dimensional datasets and translating complex scientific findings into executive-level strategy.
• Meticulous Precision: A high-level of organizational rigor with the ability to manage competing high-priority workstreams in a fast-paced, high-stakes environment.

Communication & Interdisciplinary Integration

• Cross-Functional Catalyst: Demonstrated success leading integration between neural engineering, clinical neurosurgery, and regulatory affairs to achieve unified program goals.
• Scientific Diplomacy: Exceptional written and verbal communication skills, with the ability to distill complex technical and clinical concepts for diverse audiences, from internal engineers to external ethics committees.
• Operational Autonomy: A self-starting leader who initiates critical workstreams independently and maintains a relentless focus on deadline accuracy and operational efficiency.

Mission-Critical Mindset

• High-Stakes Resilience: A documented history of thriving in high-pressure, rapidly evolving environments where pivots are frequent and the margin for error is razor-thin.
• Advocacy & Influence: Strong presence and "scientific diplomacy" skills, with the ability to represent Neuralink’s clinical vision to world-class neurosurgeons, key opinion leaders (KOLs), and global health authorities

Preferred Qualifications: 

Advanced Academic & Technical Background

• Advanced Degree: PhD, MD, or Master’s degree in a relevant field (e.g., Neuroscience, Biomedical Engineering, Clinical Research, or Biological Sciences).
• Neurotech Specialization: Direct experience managing clinical trials for Class III active implantable medical devices (AIMDs), specifically Brain-Computer Interfaces (BCI) or Neuromodulation systems.
• Computational Fluency: Advanced proficiency in Python or R for automated data visualization, clinical dashboarding, or sophisticated statistical modeling.

Strategic Clinical Leadership

• First-in-Human (FIH) Mastery: Proven success in leading Early Feasibility Studies (EFS) and navigating the unique safety and ethical rigors of pioneering human trials.
• Global Expansion Experience: Experience scaling clinical operations across international jurisdictions, including familiarity with O-US regulatory bodies and localized clinical trial infrastructure.
• Financial Stewardship: Demonstrated expertise in multi-million dollar budget management, including sophisticated resource allocation and vendor contract optimization.

Innovation & Process Design

• Clinical Systems Architecture: Experience implementing and optimizing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF platforms for high-growth environments.
• Agile Clinical Operations: Ability to apply "lean" or "agile" methodologies to clinical trial workflows, reducing cycle times while maintaining absolute compliance.
• Interdisciplinary Synthesis: A rare ability to translate high-level engineering specifications into clinical protocols that are both scientifically rigorous and operationally feasible for surgical teams.

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, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. 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 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.

• 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
• Mentor others in achieving engineering excellence and be a catalyst on the team through code review, design review, and technical presentations
• Write algorithms to decode brain activity
• Design user experiences centered around brain control

Note: The team is hiring software engineers at all levels, both junior and senior. What matters most is evidence of exceptional abilities and a drive to succeed.

Required Qualifications: 

• Strong experience with full-stack development; experience with native (desktop/ Android/ iOS) preferred 
• Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking
• 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
• Bachelor’s degree in Computer Science or a related field or equivalent experience

Fast forward to 37:43 to learn more about software and UI:

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match 

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the Heartflow Clinical Research staff and collaborate effectively with Heartflow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Job Responsibilities:

• Participates in clinical research activities including management of clinical study sites, management of study documentation, vendor management, and completion of project management tasks
• Develops clinical trial timelines, enrollment projections, and instructional materials in support of trial execution, including project, communication, monitoring, recruitment, risk mitigation, and contingency plans
• Participates in and leads process improvement activities within the department and cross functionally, including SOP development
• Conducts study start-up activities including the development of protocols, informed consent forms, source document worksheets, training presentations, etc.
• Reviews site regulatory documents (informed consents, IRB approvals, research agreements) to ensure compliance with study requirements and GCPs
• Maintains effective working relationships with investigators/investigational site research coordinators, and vendors including core labs and data management
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint

Educational Requirements & Work Experience:

• Bachelor’s degree in science or health related field
• Demonstrated 5 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus

Travel required: up to 25%

A reasonable estimate of the base salary compensation range is $95,000 to $125,000 and cash bonus. #LI-IB1

POSITION OVERVIEW

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research

The Medical Director is a leader of the Science37 clinical team. Working within the department of Medical Affairs, this individual is responsible for a broad range of activities across several core functions. We are seeking an energetic physician to help drive innovation in the clinical research ecosystem​​.  This is a full-time, remote position and the individual chosen to fulfill this role can work from home. 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

Science 37 studies

• Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Direct to Patient Site or fully decentralized trial
• Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies.
• Coordination with Site Operations Manager to identify, onboard and train investigators for Science 37 studies
• Educate and train Science 37 study team about target patient population and treatment paradigms for given indication for Science 37 studies

Support for Science 37 Commercial Team

• Collaboration with Business Development counterpart to review study opportunity synopses/protocols to assess fit/feasibility for decentralized trial model 
• Support Business Development counterpart during sponsor/client meetings and teleconferences
• Support Science 37 study opportunities as a subject matter expert in the development of study opportunity proposals

Regulatory Engagement

• Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies
• Work with sponsors/collaborators to identify clinical endpoints that are fit for decentralized clinical trial conduct
• Collaborate with sponsors and regulatory bodies to migrate endpoints from clinic-based conduct and validate their use for in-home conduct 

Thought Leadership

• Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise at industry/clinical conferences and webinars
• Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise and the decentralized clinical trial model

QUALIFICATIONS & SKILLS

Qualifications 

1. Advanced degree in Medicine (MD or equivalent)
2. Board-certification in Med/Peds or Pediatrics
3. 7+ years of demonstrating clinical & research excellence within academia and/or pharma
4. Experience as a Principal Investigator with a focus on pharmaceutical-sponsored studies

Skills/Competencies

1. Expertise in project management - Demonstrates ability to successfully lead/manage research personnel. Proactive problem-solving abilities and follow through.
2. Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
3. Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the feasibility/pathway to success of a project.
4. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive sponsor, project team members and internal Science37 relationships. Ability to conduct effective presentations.
5. Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. 
6. Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, responsibility, and flexibility to get the work done.
7. Other – Ability to communicate in English (both verbal and written).
8. Preferred knowledge of Spanish

REPORTING

• Position Reports to the Chief Medical Officer

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!

Role Overview

The Senior CTMS Delivery Product Manager is responsible for technical delivery, system design coherence, and architectural integrity of the Salesforce-based Clinical Trial Management System (CTMS), including Cloudbyz components.

This role sits within the technology organization and serves as the technical design authority for CTMS delivery, ensuring that ClinOps-owned business decisions and outcomes are implemented using a holistic, end-to-end system architecture that supports scalability, compliance, and long-term maintainability.

The role focuses on how CTMS changes are designed and delivered technically, while system roadmap and final business decisions remain with Clinical Operations, consistent with the CTMS governance model .

Key Responsibilities

CTMS Technical Architecture & System Design

(IT Delivery Accountability | ClinOps Consulted)

• Act as the CTMS Technical System Architect for Salesforce and Cloudbyz implementations

• Maintain a holistic architectural view of the CTMS platform across:

  • Study, site, subject, and financial modules

  • Integrations with EDC, eTMF, IRT, ERP, and analytics systems

• Evaluate proposed changes for cross-module, cross-study, and cross-system impacts

• Define and enforce technical design standards, data models, and integration patterns

• Prevent fragmented, study-specific configurations that introduce technical debt

Architectural accountability is technical delivery-focused and does not include ownership of business processes, system outcomes, or regulatory risk, which reside with ClinOps .

CTMS Delivery & Execution

(IT Accountable | Cloudbyz Responsible under IT)

• Serve as the IT delivery owner for CTMS enhancements and platform changes

• Execute delivery against a ClinOps-defined and approved CTMS roadmap

• Manage Cloudbyz as an IT vendor, ensuring execution aligns with internal architectural standards

• Lead Agile delivery activities including backlog refinement, sprint planning, and release execution

• Balance configuration vs. customization decisions to support scalability and maintainability

Business Intake & Translation (Design-Governed)

(ClinOps Accountable | IT Responsible for Translation)

• Partner with Clinical Systems and business stakeholders to:

  • Review approved change requests from a system-design and delivery feasibility perspective

  • Translate requirements into technically sound user stories and acceptance criteria

• Surface architectural risks and recommend alternative technical approaches when business requests may compromise system integrity or scalability

Salesforce Technical Leadership

(IT Responsible)

• Provide technical product leadership across:

  • Salesforce configuration, customization, automation, and reporting

  • Cloudbyz CTMS modules and extensions

• Coordinate and oversee integrations to ensure data consistency and architectural alignment

• Collaborate with developers, architects, and vendors to ensure adherence to CTMS delivery standards

Compliance Support & Validation-Ready Delivery

(Quality Accountable | IT Supports)

• Design and deliver CTMS changes that support:

  • GxP principles

  • 21 CFR Part 11 requirements

  • Validation and audit readiness

• Partner with Quality and Clinical Systems to support CSV activities, recognizing that validation accountability resides with Quality

Stakeholder Communication & Delivery Governance

(Shared Governance Model)

• Communicate delivery status, architectural decisions, and technical risks to:

  • Clinical Systems leadership

  • IT leadership

• Serve as the escalation point for technical design and delivery conflicts

• Proactively identify systemic design issues and delivery risks before they impact production or compliance

Required Qualifications

• 10+ years of experience in technical product management, system architecture, or enterprise application delivery

• Hands-on experience designing and delivering Salesforce-based platforms

• Strong experience with CTMS platforms 

• Proven ability to act as technical design authority while operating within a business-owned governance model

• Experience in GxP-regulated environments with validated systems

Preferred Qualifications

• Experience combining delivery ownership and system architecture responsibilities

• Familiarity with EDC, eTMF, IRT, safety, and financial systems

• Salesforce certifications (Admin, Platform App Builder, Integration Architecture Designer)

• PMI Certification