- Страна
- США
- Зарплата
- 108 000 $ – 200 000 $
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Clinical Program Manager
Исключительная возможность работать в одной из самых амбициозных компаний мира над технологиями будущего. Высокий уровень компенсации, включая RSU, и работа с ведущими экспертами отрасли компенсируют высокие требования и стресс.
Сложность вакансии
Высокая сложность обусловлена необходимостью сочетать глубокую экспертизу в медицине (Class III devices), знание регуляторики (FDA, ISO) и технические навыки (Python/R). Роль подразумевает работу с инновационными технологиями в условиях высокой неопределенности и ответственности за безопасность участников.
Анализ зарплаты
Предложенный диапазон ($108k–$200k) соответствует рыночным стандартам для Senior/Lead позиций в области клинических операций в США, однако верхняя планка и пакет акций (RSU) делают предложение конкурентоспособным для высокотехнологичного сектора Остина.
Сопроводительное письмо
I am writing to express my strong interest in the Clinical Program Manager position at Neuralink. With over 7 years of experience in clinical research and a deep focus on Class III medical devices, I have developed the strategic oversight and operational precision necessary to lead groundbreaking human clinical trials. My background in navigating complex regulatory landscapes and managing high-stakes partnerships aligns perfectly with Neuralink’s mission to revolutionize brain-computer interfaces.
Throughout my career, I have successfully translated high-level strategy into executable clinical programs, ensuring rigorous compliance with GCP and international standards. I am particularly drawn to Neuralink’s interdisciplinary approach, and I am eager to apply my skills in data intelligence and scientific diplomacy to drive the success of your first-in-human trials. My ability to thrive in high-pressure, ambiguous environments makes me a strong fit for your dynamic team.
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Описание вакансии
About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
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.
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
Base Salary Range:
$108,000—$200,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) \Temporary Employees & Interns excluded*
- 401(k) plan \Interns initially excluded until they work 1,000 hours*
- Parental leave \Temporary Employees & Interns excluded*
- Flexible time off \Temporary Employees & Interns excluded*
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Навыки
- Project Management
- Python
- Clinical Research
- Budget Management
- GCP
- R
- Class III Medical Devices
- ISO 14155
- FDA 21 CFR Part 812
- Clinical Study Design
Возможные вопросы на собеседовании
Проверка опыта работы с наиболее сложной категорией медицинских изделий и понимания регуляторных рисков.
Опишите ваш опыт управления клиническими исследованиями медицинских изделий класса III. С какими основными регуляторными препятствиями вы сталкивались?
Neuralink ищет кандидата, способного использовать данные для оптимизации процессов.
Как вы использовали Python или R для анализа клинических данных или автоматизации отчетности в ваших предыдущих проектах?
Важно понять, как кандидат справляется с этическими и операционными вызовами в пионерских исследованиях.
Какие специфические риски вы видите при проведении первых испытаний на людях (First-in-Human) для BCI-технологий и как вы планируете их минимизировать?
Роль требует взаимодействия между инженерами, хирургами и регуляторами.
Приведите пример, когда вам приходилось переводить сложные инженерные требования в клинический протокол, понятный для медицинского персонала.
Проверка навыков финансового планирования и ведения переговоров.
Расскажите о вашем опыте управления многомиллионными бюджетами и ведения переговоров с клиническими центрами.
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