At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
NEUROPACE, INC. IS AN EQUAL OPPORTUNITY EMPLOYER AND DOES NOT DISCRIMINATE ON THE BASIS OF RACE, COLOR, RELIGION, GENDER, SEXUAL ORIENTATION, NATIONAL ORIGIN, MARITAL STATUS, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION OR AGE.
The Senior Clinical Trial Manager will report to the Director of Clinical Affairs and Data Management. The principal function of the position is to manage the execution of a portfolio of multicenter investigational device exemption clinical trials. In particular, the role assumes complete responsibility for clinical study planning, development, and launch as well as the execution of day to day study and data management activities. Success in this role is tied to establishing strong internal and external relationships, ensuring the highest integrity of the data collected, and for each study to achieve its intended goals on time and within budget while ensuring transparency and communication across the team and organization.
Study Development and Leadership
- Support the development of clinical study protocols and related regulatory submissions
- Develop and manage study budgets and timelines, including personnel resource estimates
- Manage operational aspects of multiple clinical trials, with competing deadlines, from study start-up through database lock in compliance with ICH/GCP, company SOP, and other regulatory requirements as relevant to the study
- Proactively manage multifunctional clinical study teams to a identify and manage critical path activities, and achieve deliverables within the larger context of corporate goals
- Ensure that team members are appropriately trained on study conduct and company procedures
- Assist in the development of internal SOPs and processes to ensure ongoing study compliance
- Maintain inspection readiness and participate in FDA or other regulatory authority inspections
- Manage study-related vendors, including review of and input on vendor contracts, SOWs, proactive management of issues, and assistance with invoice reconciliation
- Liaise between corporate finance/legal counsel and investigator institution and vendor representatives relative to the establishment of and adherence to contractual agreements
- Establish and maintain strong working relationships with internal and external teams
- Provide frequent study updates to internal teams, including senior management, and external partners
Documentation and Data
- Develop and implement clinical study processes to support study and data management operations
- Ensure development and implementation of applicable study plans (i.e., clinical trial monitoring plan), protocols, amendments, informed consent templates, CRF forms/completion guidelines and site reference guidelines/instructions
- Manage EDC database specifications, eCRF design, clinical database validation, eCRF completion guidelines, and data management and review plans to ensure high data quality and compliance with applicable industry regulations and standards
- Review protocol deviations and data listings to ensure sponsor oversight
- Manage data query, review, cleaning process to minimize data inconsistencies, errors, or omissions
- Work with data management, statisticians and research scientists to optimize the workflow for study endpoint and adhoc dataset creation and data analysis
- Work with data management to ensure timely database locks for all assigned projects
- BS in health sciences or related field with 7+ years relevant industry experience
- 2+ years’ experience managing project team members in a clinical research environment, preferably in the area of medical devices
- Working knowledge of GCP and regulatory compliance guidelines for clinical trials and quality assurance procedures
- Working knowledge of the FDA submission process, preferably for IDE and PMA submissions
- Keen understanding of clinical trial monitoring and data management requirements
- Experience in finance management (budget forecasting, change order management, etc.)
- Demonstrated skills in negotiation, multi-tasking, organization, and problem solving and the ability to work collaboratively and flexibly in a fast-paced environment
- Strong written communication and presentation skills including the use of appropriate medical and scientific terminology
- Experience and confidence in communicating across a diverse group of internal and external team members, including physicians, IRB staff, FDA staff, regulatory affairs, and senior management
- Willingness and ability to occasionally travel
- Proficiency in the use of computer applications such as MS Word, Excel, PowerPoint
- Experience working with EDC, CTMS, and eTMF systems, including system validation efforts
- Exposure or hands on experience with MedDRA and WHODrug coding
- Understating of basic statistical methods
- Experience with enterprise or customer relationship management solutions
- Experience with SQL coding
- Awareness of FDA medical device reporting requirements
This position requires strong project management skills, broad comprehension of statistical analyses and data management processes, and effective written and verbal communication skills. The position directs multifaceted activities required to produce clinical study reports for regulatory and scientific purposes, from trial conception through completion.
- Clinical Research
- Identify and assist in qualitative and quantitative analyses of clinical trial data to support clinical study reports and product development.
- Manage the generation of clinical study reports and other clinical documents.
- Collaborate with Regulatory Affairs in preparing documents/presentation materials for submission to and/or meetings with regulatory agencies.
- Provide clinical study findings to physicians as necessary in response to questions received by Medical Affairs or Product Monitoring.
- Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
- Clinical Trial Development
- Work with clinical scientists, CMO, and statisticians to establish trial endpoints and statistical methods.
- Contribute to clinical study protocol development, including performing literature reviews and analyses to provide clinical and scientific evidence to support clinical trial design.
- Assist trial managers in developing and maintaining investigational plan documents, including risk benefit analyses, data analysis plans, and data management plans.
- Data Management
- Lead or assist in developing datasets for research, product development, and clinical trials, including working closely with other clinical scientists, statisticians and programmers.
- Manage dataset validation to confirm accuracy, including leading or assisting in the development of methods to identify data errors and inconsistencies.
- Develop and use methods for analyzing and monitoring continuously collected product and clinical data.
- Work with Oracle databases using SQL.
- Disseminate pertinent data-related information to appropriate clinical and regulatory team members.
- Coordinate and execute other assigned project tasks to meet departmental and corporate goals.
- Advanced degree in basic or clinical neuroscience, neurology, neurophysiology, or biomedical engineering. PhD strongly preferred.
- Minimum of 2+ years of experience conducting research.
- Experience with cloud databases (e.g., GCP), relational databases (e.g. Oracle), and using APIs for data access.
- Proven written and verbal communication skills.
- Good understanding of medical terminology.
- Energetic, detail-oriented individual with strong organizational skills and excellent analytical ability.
- Work with minimal supervision in a fast-paced, dynamic environment and be able to meet critical timelines.
- Work effectively in team environment.
- Experience in clinical data management in a pharmaceutical, biotechnology, medical device or clinical research environment a plus.
- Working knowledge of FDA, GCP, and ICH regulations specific to clinical study protocols.
- Biostatistics background with experience in SAS or R.
The successful candidate will function as a key member of the preclinical research team, interacting closely with clinical, research and engineering personnel. Responsibilities include full stack development and maintenance of: (1) an Oracle database, (2) automated tools and reports for clinical product support, (3) interactive web interfaces, and (4) data acquisition, management, and analysis software for preclinical research. They will support ad hoc analyses to address research, clinical, and engineering neuroscience questions, and contribute to new technology development.
- Maintain and develop web-based automated and interactive clinical product support tools
- Maintain and develop tools for engineering and clinical groups
- Document, test, verify, and validate software
- Participate as a team member in research and software development projects
- Maintain and administer Oracle database
- Maintain and administer Linux servers
- Plan, initiate, and execute own work
- Learn new skills for effective software design and data analysis
- Receive applicable training in NeuroPace procedures and policies
- May contribute to scientific publications and intellectual property development
- Undergraduate technical degree or demonstrated technical experience
- 2-4+ years software development experience
- Speaks and writes clearly and unambiguously
- Experience working a team environment
- Strong interpersonal skills
- Excellent communication skills, especially interacting with non-technical users
- Self-starter, able to work with minimal supervision
- Strong problem-solving skills
- Back end web development using Python, SQL
- Linux systems administration, especially RedHat and Ubuntu Server
- Oracle database development and administration
- Version control using Git
- Cybersecurity best practices
- Integration of code testing with development
- Consistency with documentation of code and processes
- Proficient with Linux and Microsoft Windows operating systems
- Experience with single-page web application libraries (React.js or similar)
- Experience with HTTP server software (Nginx or similar)
- Experience building HTTP-based RESTful APIs
- Experience or interest in user interface and user experience design
- Matlab, Java, C, PL/SQL
- Experience with HIPAA regulations and building HIPAA compliant systems
The Director of Financial Planning and Analysis (FP&A) will serve as a key member of the corporate finance team, with ownership of the corporate financial model and leadership in development of the financial narrative for investors, Board of Directors and management. Responsible for driving reporting and usage of financial and operational KPIs, and providing leadership in planning, reporting, forecasting and alignment between finance and other departments. This position reports directly to the CFO.
Areas of responsibility:
- Provide leadership and take primary responsibility for developing the company’s annual financial plan
- Work with leadership to develop, maintain and improve long term financial forecasts
- Develop, implement and maintain quarterly rolling forecasts, continuously improving accuracy
- Collaborate with Commercial Operations on revenue analysis and forecasting
- Report performance against plan to internal stakeholders
- Collaborate effectively with extended leadership team in all financial planning activities; provide meaningful insights and facilitate alignment
- Develop best-in-class reporting packages and presentations to Board of Directors and investors, including analysis of key business drivers and creation of financial narrative
- Develop and maintain externally communicated KPIs, including related research, comparable company analyses, data visualization and reporting
- Identify and drive process improvements relating to financial planning and reporting including creation of relevant tools and dashboards
- Perform analysis of gross margin and cost of goods sold including quarterly flux
- Develop metrics to track department and company performance; identify opportunities, provide recommendations, and collaborate across all levels
- Develop an understanding of cost accounting in the company’s ERP system; provide high level cost accounting support to operations
- Support ad hoc projects and system improvements to support company’s growth
- Ensure compliance with all relevant regulatory requirements and internal accounting and financial reporting policies
- Bachelor’s or master’s degree in Finance or Accounting; minimum 8 years of relevant work experience including financial planning and analysis; CPA a plus
- Experience with a medical device manufacturing company highly desired
- Strong experience building financial models and reports for executives, board of directors and investors
- Excellent problem-solving skills; ability to think independently
- Excellent written and verbal communications and presentation skills
- Highly organized, flexible, and easily adapts to change
- A strong team player who can work effectively with multiple functions within the company
- Entrepreneurial, self-sufficient
- Energetic go-getter who thrives on new challenges
- Demonstrated willingness to roll up your sleeves as necessary to help get things done
- Excellent Excel, data management and PowerPoint skills
- Strong proficiency in accounting and corporate finance concepts
The Sr. Mechanical Development Engineer will support the mechanical design, development, documentation, verification, and transfer to manufacturing of products and processes required to produce an implantable Neurostimulator System. The individual will also provide support to manufacturing.
- Supports the design and documentation of component and assembly specifications for a neurostimulator system.
- Designs, procures and qualifies product assembly and component inspection tooling.
- Completes risk analysis activities including design and process FMECAs and FTA of designs and processes.
- Performs assembly tolerance analyses to ensure reliable fit of components.
- Researches, justifies and applies manufacturing technologies to projects.
- Applies DFM/DFX principles to component and assembly designs.
Works closely with suppliers, operations and other development stakeholders to address DFX issues and drive resolutions.
- Identifies and develops suppliers to produce parts and assemblies that meet requirements.
- Develops and validates manufacturing processes to defined requirements. Process development includes analysis of process data for capability in meeting defined requirements. Documents validation protocols and reports. Designs, procures, installs and qualifies all necessary tools and equipment.
- Verifies designs against product and/or design requirements including execution of functional testing and design analyses.
- Support manufacturing including the investigation into root cause of manufacturing defects and/or failures and recommendation and implementation of appropriate corrective actions.
- Perform responsibilities in compliance with NeuroPace Quality system procedures.
- BS degree in mechanical, manufacturing or industrial engineering or similar field, and a minimum of 7 years relevant work experience; preferably in the medical device field.
- Knowledgeable in many of the following:
- Familiar with design of electro-mechanical systems.
- Familiar with typical metal and plastic manufacturing processes.
- Familiar with fabricating, joining and molding typical engineering thermoplastics.
- Familiar with small component assembly while working under a microscope.
- Familiar with metallurgy and metal joining processes, including laser and resistance welding.
- Experience in the medical device industry (3years minimum) and training in GMP and ISO 13485 design control procedures.
- Proficient with CAD design tools (Creo solid modeling preferred).
- Capable of performing hands on work in a laboratory including the assembly and evaluation of prototypes. Familiar with typical laboratory equipment and tools.
- Experienced in selecting and working with suppliers to develop custom assemblies.
- Individual must be a self-starter with good problem solving and analytical skills, capable of independent work.
- Demonstrate effective cooperation and collaboration with multidisciplinary project teams.
- Knowledgeable in DOE/SPC/DFM tools and methods.
- Proficient in office PC applications, including MS Word, Excel, PowerPoint and Project.
Culture & Values
NeuroPace is dedicated to developing, manufacturing and marketing safe and effective medical devices that improve the quality of life for patients with neurological disorders. Company priorities include the development of high quality products focused on customer needs and the maintenance of a work environment where employees are respected and encouraged to excel.
By fostering individual performance, teamwork and the spirit of partnership, we provide both the tools and the environment to help employees excel as individuals as well as team members.
NeuroPace offers a comprehensive package including:
- Pre-IPO stock option plan
- 401(k) plan
- Medical insurance with PPO and HMO options
- Dental insurance
- Vision insurance
- Domestic partner health coverage
- Life insurance
- Long-term disability insurance
- Section 125 flexible benefits program, including Health Care Spending Accounts and Child Care Spending Accounts
- Section 529 college savings plan
- Three weeks paid vacation to start
- Eleven paid holidays
- PTO for sick time and family emergencies
- Other benefits
– Health club membership
– Patent awards program
– Anniversary rewards
– Casual dress – everyday
– Company picnics, parties and barbecues
– Fully stocked kitchen
– and more!