Reports to:     Director, Clinical Services                         Location:        California - Texas - Arizona Region

Job Summary

Working under minimal direction, provides educational, technical and customer support for clinical issues concerned with the safe and correct implementation of Beyond Air medical devices. Engage and work closely with stakeholders (physicians, health care professionals, patients, and commercial team) involving Beyond Air products. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes.

Accountabilities

• Has a basic understanding of the competitive landscape in nitric oxide delivery devices
• Demonstrates ability to build and sustain clinical support relationships with customers and shares product expertise accordingly.
• Evaluation of new devices and review of all associated educational and support material provided to customers.
• Identifies, reports and advises of customer needs and product performance to the field-based teams / directors and/or management
• Develops, leads and/or facilitates trainings and other programs on Beyond Air products to healthcare professionals.
• Provides insight, guidance, and feedback to management on market feedback and components for future or next generation of products.
• Continuously develops clinical and technical skills and supports the commercial team strategic plans in patient care clinical trials
• Completes other tasks as necessary

Activities:

• Provide in-person or video-supported training to medical personnel in the hospital or clinic setting.
• Provides on-call support as needed on evenings and weekends post sign-off
• Operational Support
• Helps manage customer inventory needs and requests as required
• Provides education and clinical support in response to clinical field inquiries on as-needed basis. Demonstrates a thorough command of all products, related products and technical knowledge.
• Assist with Beyond Air device investigations on clinician-reported performance issues.
• Trouble Shooting
• Provides back-up support to Sales & Customer Support Representatives in the following areas:

• Internal Training
• External device training to Physicians, Nurses and Respiratory Therapists
• Clinical studies/data collection.

Requirements:

• Registered Respiratory Therapist, BSc
• Minimum 8-10 years of experience in respiratory medical device clinical support.
• Minimum 5 years clinical experience in an ICU environment.
• Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
• Demonstrated knowledge of wide range of respiratory therapy devices and treatments
• Familiarity with respiratory therapy procedures and protocol.
• Demonstrated advanced knowledge nitric oxide delivery systems is highly preferred.
• Must have comprehensive written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to meet deadlines.
• Must have the ability to concentrate on detail and work independently.
• Must be able to work effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals; must be capable of coordinating multiple assignments simultaneously and effectively.
• Must possess comprehensive computer skills (experience with Microsoft Word, Excel, Powerpoint or equivalent required).
• Self-motivated and able to work independently, whilst maintaining inclusive approaches.
• Excellent time management skills and ability to work under pressure to deadlines.
• Must exhibit high quality, ethical and work habits.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:       Vice President, Engineering                                Location:              Madison WI Area

Job Summary

The Electrical Engineer provides day-to-day support of Engineering product development activities for existing and new medical device programs. This person will be hands on, adept with hand tools for soldering, electrical measurement equipment and have strong attention to detail with the ability to work with moderate supervision.  Medical device development or service repair containing electronics, various sensors, electromechanical actuators and pneumatics experience is preferred.

Accountabilities

• Provides technical support when needed, while adhering to all applicable procedures
• Uses a variety of test equipment/instruments, assists in maintaining acceptable performance of equipment/instruments (e.g. calibration/verification) and assists in keeping applicable procedures updated
• Build a strong understanding of Nitric Oxide Gas Delivery system field of operation to provide root cause troubleshooting for field product complaint diagnosis.
• Evaluate and select components, generate component specifications
• Support Manufacturing in troubleshooting operations involving medical devices through assembly and test
• Provide technical assistance to other functional departments such as Product Engineering, Systems Engineering, Mechanical Engineering, Software Engineering, Quality, Reliability and Manufacturing
• Supports CAPAs, cost reduction, EOL and continuous improvement of products
• Comply with all standards and exercise regulatory compliance requirements such as FDA QSR and ISO 13485

Activities:

• Works in conjunction with the Engineering team to support manufacturing scale-up, incorporate new design changes, vended component qualification and make manufacturing improvements.
• Uses CAD for the creation of design output drawing to support the supply of components and mechanical assemblies.
• Perform hands-on mechanical design of a pneumatic gas delivery control systems used in medical life support equipment
• Performs engineering calculations to support design work
• Collaborates with a multi-disciplinary engineering teams in support of electro-mechanical packaging of electronics, sensors combined with pneumatics.
• May assist in preparation of materials for in-process and final verification testing, including, but not limited to medical devices. This can include component sampling, testing, measuring, recording and analyzing results.
• Work as part of a team under the direction of Development & Research Engineering and assist with New Product development feasibility testing, construction, assembly, troubleshooting the repair of electronics and electromechanical systems during the design process
• May assist, as required, with activities regarding incoming raw material inspection, in-process inspection, finished product or component inspection, and/or non-conformance reporting
• Assist with internal and external (regulatory or customer) audits, as appropriate
• Utilizes established mathematical or scientific statistical analysis techniques to compile and analyze engineering data
• Writes technical reports detailing procedures, outcomes, and observations, as directed
• Maintain orderly engineering laboratory ensuring an efficient but safe work environment
• Collaborate with manufacturing, operations and engineering functions to troubleshoot and resolve manufacturing issues, and facilitate transition of manufacturing activities to the operations group.
• Review manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Any other duties as assigned
  
  

Requirements:

• BSEE equivalent degree in an Engineering Discipline (Masters preferred)
• Minimum 5+ years of relevant experience in a medical device Company or related field
• Good Communication skills and an eye for detail are required
• Knowledgeable in Design Engineering, New Product Development, trouble-shooting and repairs related to medical device design and manufacturing.
• Ability to read electrical schematics and electropneumatic system diagrams
• Understanding of electrical engineering test equipment
• Understanding of electrical engineering principles for sensors, electromechanical actuators.
• Understanding of electronics for both analog, digital embedded processor power, power regulation and current control.
• Knowledge of ISO 13485/FDA requirements
• Experience with electro-mechanical devices: Previous work with pressure sensors, flow sensors, solenoids, power supplies, motor control, and transducers.
• C and Verilog experience
• Experience with Design Controls, electronic components, Failure Analysis
• Computer literate with an excellent working knowledge of Microsoft Office, including Word, Excel, and Databases.
• Strong mathematical skills are required  

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Head of Clinical Research and Development

The Head of Clinical Research and Development will report to the CMO and will be responsible for leading clinical strategy and development across the Beyond air program portfolio. This role will provide medical oversight for studies with a focus on safety. This role oversees data generation in house and with CROs and collaborators meeting the highest standards scientifically and ethically to enable highly effective regulatory interactions. This individual will lead the clinical development programs for branded products, as well as provide key subject matter expertise to portfolio expansion and business development opportunities.

Key Responsibilities:

• Responsible for the preparation of the Global-initiated clinical development plans, medical input to Investigator’s Brochures, study protocols, study reports, clinical components of IND/IDE and NDA/PMA applications.
• Establish and assess the strategy for clinical trial planning, design, execution, and analysis with assurance of alignment with regulatory activities.
• Contribute to assessment of medical safety in clinical trials
• Coordinate with Regulatory Affairs to ensure adequate input into clinical dossiers and labelling matters. Participate in FDA and Scientific Advisory Committee meetings. Provide annual IND clinical updates.
• Lead a team focused on the clinical development programs associated with the branded products and business development opportunities.
• Advise clinical team on protocol development and execution
• Interact with internal and external stakeholders for the clinical strategy and study operations, inclusive of external engagement with consulting healthcare professionals, trial site investigators, Contract Research Organizations, and other vendors.
• Identification and maintenance of key resource support to the clinical project managers for study execution, project management, program management, data integrity, and medical writing.
• Accountability for Clinical R&D compliance with policies, procedures, and standard operating procedures.
• Evaluate and contribute to potential business development opportunities.
• Attend, and if relevant, lead in training curricula, symposia, and conferences in order to maintain medical and leadership expertise associated with Clinical R&D's goals and objectives.
• Communicate effectively with partners, affiliates, and stakeholders to ensure alignment and time-bound clinical and business commitments.
• Adhere to Good Clinical Practice (GCP) and assure the adherence of all clinical team members (internal and external) to GCP.
• Work closely with functional partners to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s)
• Regularly interact with cross-functional teams to provide input on strategic clinical development issues and clinical trial operations relating to R&D projects.
• Serve as the clinical representative to lead key regulatory discussions
• Ensures adherence to Good Clinical Practices, standards, standard operating procedures and to all other quality standards in conducting research
• Develop high quality and relevant real world evidence data that demonstrate clinical, economic, and humanistic value to healthcare decision-makers.
• Ensure Medical, R&D, and cross organizational alignment on publication strategy.
• Demonstrate a high level of credibility with external KOLs, and internal stakeholders to identify tactical gaps in strategy and utilize understanding of clinical trial design, statistical methods, and clinical data to develop studies and communicate their results to address those deficiencies.
• Driving the medical writing strategy for all clinical programs, and for the provision of managerial oversight
• Leads cross-functional teams to develop a medical communication strategy

Qualifications:

• A minimum of 10 years of experience in clinical research.
• MD/PhD/PharmD required
• Requires proven experience with developing efficient discovery processes and directing complex cross-functional team collaborations.
• Must have a proven track record of advancing programs through discovery, IND-enabling studies and IND filing.
• Demonstrated expertise in therapeutic development process including technical, business, and regulatory issues.
• Evidence of successful ongoing career development and leadership skills; additional Medical, Safety, or other pharmaceutical development experience is preferable. Experience as a project team leader with major responsibility for at least one New Drug Application (NDA) or equivalent device submission desired
• Experience in leading discussions with FDA and other health authorities at all phases of development
• Requires the ability to build strong relationships with key stakeholders.
• Excellent scientific writing and editing as well as written/oral communication skills with several years of professional experience in medical or scientific writing (clinical protocols)
• Experience managing CROs and working within cross functional teams
• Self-starter with ability to learn new disciplines
• Strong analytic skills, problem-solving skills, and medical writing skills. Experience in writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis, and presenting data to internal and external audiences.
• Ability to think strategically and communicate/problem-solve within a team structure.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Senior Software Engineer

Reports to:     Head of Software Engineering                      Location:        Madison, WI Area

Job Summary

The Senior Software Engineer designs and develops embedded software solutions for medical products. They are familiar with the software development life cycle (SDLC) from preliminary system analysis to tests and deployment. Ultimately, the role of the Software Engineer is to build high-quality, innovative, and fully performing software that complies with IEC Medical Standards and FDA Guidance.

Accountabilities

• Collaborate with development team to establish requirements
• Develop software to satisfy system and software requirements
• Produce documentation to satisfy IEC Medical Standards and FDA Guidance

Activities:

• Execute full lifecycle software development
• Program well-designed, testable, efficient code
• Produce specifications for architecture and design of device software
• Integrate software components into a fully functional software system
• Collaborate with verification engineers on verification plans and protocols
• Collaborate with electrical and mechanical engineers during system development
• Troubleshoot, debug and upgrade systems
• Deploy programs, develop installation methods and scripts for manufacturing
• Comply with project plans and industry standards
• Any other duties as assigned
  
  

Requirements:

• BS or MS degree in Computer Engineering / Computer Science / Electrical Engineering
• Minimum 10 - 15 years of experience in Software Engineering for a medical device Company
• Languages: C, Python 
• Experience with embedded projects using ARM Cortex Microprocessors
• Experience with multi-processor systems
• Experience with embedded GUIs, testing, and internationalization
• Experience developing unit tests
• Experience with various embedded peripherals such as CAN, SPI, I2C, Serial, DMA, ADC, DAC, Flash
• Experience with NFC and RFID technologies
• Experience with LCD / display interfaces
• Experience developing embedded installation utilities and bootloaders
• Experience as a software technical team lead
• Ability to work independently and drive results
• Ability to travel as needed.
• Work outside the normal office hours as required

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Reports to:     SVP, Clinical Operations & Biometrics          Location:        Remote

Job Summary

The VP, Clinical Pharmacology will be responsible for developing, driving, and implementing (with internal collaborations and working with consultants/external partners) global Clinical Pharmacology strategies across multiple indications. You will be a core member of the program team providing Clinical Pharmacology perspectives and delivering modeling and analyses necessary to evaluate clinical options, enable plans, and optimize development programs. This includes gap analysis, study design, PKPD analysis and modeling, program assessment, and internal collaborations to help execute programs. The successful candidate will bring extensive experience in clinical pharmacology and work cross-functionally with research and clinical teams to drive programs to success.

Accountabilities

• Provide expertise for the design of pre-clinical and clinical studies
• Ensuring/performing appropriate PKPD analysis including population PK, PKPD modeling and simulation, meta-analysis, and disease modeling as required by the program to aid in dose selection, trial design, and/or program decision-making.
• Design, implement, drive, and monitor Clinical Pharmacology strategies.
• Work with internal teams and external partners to execute program team objectives
• Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures.
• Leads the resolution of clinical pharmacology queries from regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.
• Analysis of PK data Directs the planning of all relevant PK-PD analyses.
• Use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical trials in collaboration with translational science and statistics (as relevant).
• Full knowledge about the clinical pharmacology profile of NO on which studies are being conducted or which are called for in the protocol.
• Ensuring that there are valid methods for measuring concentration (and any biochemical biomarkers) in the R&D lab.

Activities:

• Participate in implementing model-based device development using quantitative approaches to address complex question arising during development spanning from target validation to analysis and interpretation of results.
• Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and development teams and in regulatory documentation.
• Develop and execute modeling and simulation plans when appropriate; use model-based approaches to improve the efficiency of drug development and support dose selection and optimization when appropriate.
• Serve as in-house expert on scientific matters
• Discuss pharmacology, pharmacokinetics and toxicology issues with regulatory authorities in order to convey key concepts and facilitate understanding of both risks and results.
• Contribute to program strategy, protocol preparation, study execution, data review/analysis, study reports, and regulatory document preparation; write and review clinical pharmacology summary documents.
• Oversee vendors and consultants as appropriate.
• May act as clinician for Phase I studies or clinical lead / research project lead for specific NO development projects.
  
  

Requirements:

• PhD in Pharmaconkinetics or Pharmaceutical Sciences or related field
• Minimum 10 years of experience in biopharma industry in a Clinical Pharmacology role
• Proven ability to represent Clinical Pharmacology on project teams
• Experience with FDA regulatory interactions
• Experience partnering with DMPK and translational science colleagues to ensure relevant clinical pharmacology strategy is developed.
• Experience working cross-functionally and working with external partners.
• Strong knowledge of the role of clinical pharmacology in medical device company, including the application of translational pharmacology as well as model-based approaches.
• Ability to perform in fast-paced, dynamic, constantly evolving environment.
• Excellent communication and organizational skills and attention to detail.
• Strong time management skills; ability to prioritize multiple tasks efficiently.
• Work outside the normal office hours as required

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Head of Investor Relations

Reports to:     CEO                                         Location:        Garden City, NY

Job Summary

The Head of Investor Relations, you will be an interface between Beyond Air’s CEO and the investment community, working regularly with senior management. In this role, you will contribute to Beyond Air’s mission by communicating our investor relations message in a consistent and strategic manner while monitoring the view of the investment community.

This role is responsible for assisting the CEO in developing & executing the global investor relations program with a focus on the science and technology of medical devices. This will include helping develop corporate messages, presentations and analyses in support of quarterly earnings, website & corporate media, investor conferences, roadshows, and other investor events. This individual is expected to serve as liaison for day-to-day inquiries from investors and in the future, sell-side analysts. To perform these activities, this individual will need to be competent across multiple functional areas in the company across different time zones.

Responsibilities

• Further develop, implement, and manage a comprehensive strategic plan for investor relations that helps ensure the maximum sustainable fair valuation of the company and understanding of the company story.
• Ensures the company is appropriately and strategically positioned with analysts, investors, media, advocacy and other relevant stakeholders.
• Manage investor relationships and work closely with analysts to assist them with understanding those objectives while maintaining close relationships with key investors and analysts.
• Communicate Beyond Air’s story on a transparent and consistent basis and in compliance with corporate policies, and securities regulations.
• Plan and ensure execution of key investor events and communications, including road shows, investor days, as well as developing investor-facing communications.
• Collaborate on the press release process.
• Help develop overall IR strategy and workplan.
• Helps manage Beyond Air’s corporate website and internal intranet governance, collaborating with stakeholders throughout the organization to develop critical and creative content
• Research and monitor competitors and competitive environment
• Provide accurate, consistent and timely responses to all external inquiries from investors and analysts

Qualifications / Requirements/Experience

• Bachelor’s degree required; scientific or medical background preferred
• Must have a minimum of 7 years of experience in pharmaceutical industry or financial industry or closely related industry experience.
• Pharmaceutical / med tech / life sciences experience is required.; however, banking, research or investing experience supporting life sciences/pharma as clients will be considered
• Must be an excellent communicator, including messaging strategy and execution, business presentations, Q&A and business writing and presentations. Strong organizational skills; attention to detail
• Experience in managing relationship with external agency
• Must have strong interpersonal and collaboration skills. Must be able to build relationships and trust both internally and externally.
• Experience in publicly traded, commercial-stage company desired, with understanding of FDA regulations that impact communications
• Familiarity with regulatory and compliance standards in the healthcare industry
• Ability to set and drive strategies while also tactically implementing them
• Detail-oriented, self-initiating, organized, and capable of managing multiple projects simultaneously and independently
• Ability to understand various therapies and the disease states, as well as emergent sciences developed internally and by competitors
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Specific Criteria:

• Reports to the CEO
• Based in Garden City, NY.
• Monday – Friday, 9am – 5pm
• Minimum 25% travel is required

Quality Systems Specialist

Reports to:     Director, Quality                                            Location:        Garden City, NY

Job Summary

Quality Systems Specialist will contribute to a passionate and collaborative Quality Assurance team to enable the overall success of our QMS. In this role, you will support the maintenance of Quality Systems including CAPAs, Nonconformances, Audits, Quality Metrics and Analytics, and continuous improvement activities.

Accountabilities

• Responsible for support management and tracking of quality records (i.e., CAPA’s, Audits, Nonconformances, Effectiveness Checks and Change Controls)
• Develop and deliver training in quality systems topics (i.e., configuration changes to the electronic QMS system).
• Support management review process through development and generation of quality system metrics and trending; escalate issues as required.
• Author/revise/approve standard operating procedures (SOPs) and other GMP documents as needed.

Activities

• Responsible for support management and tracking of quality records (i.e., CAPA’s, Audits, Nonconformances, Effectiveness Checks and Change Controls)
• Provide oversight of open quality records, collaborating closely with internal customers to ensure compliance and timeliness. Provide support and guidance as needed.
• Identify and drive opportunities for enhancement to existing quality systems/tools to achieve improved quality performance.
• Participate in and support FDA Inspection Readiness activities, including participation in regulatory inspections, as needed.
• Actively assuring compliance to ISO13485, EU-MDR 2017/745 & 21 CFR part 820.
• Actively participate and provide guidance in additional quality topics, as needed, including risk management, training, and quality culture excellence.
• Collaborate with a broad range of internal customers (Supply Chain, Quality Assurance, Quality Engineering, Regulatory Affairs, Clinical Affairs, Engineering, Operations).
• Work hands-on with all aspects of Quality and Regulatory documentation within 21 CFR 820 (Quality System Regulation, Medical Device)
• Assist with categorizing (including assigning designated approvers) and updating file names within the eQMS to ensure ease-of-use for retrieving documentation.
• Retire or obsolete eQMS documents as applicable
• Identify compliance/non-compliance with procedures and resolves necessary amendments to the Quality System and GMP documentation
• Ensure job descriptions, resumes and certifications for new employees are up-to-date
• Coordinate the training of new employees and current employees to applicable Quality Procedures and GMP documentation
• Develop training curriculum that adheres to Quality Procedures for authors with “edit permissions” within the eQMS
• Provide administrative support for customer feedback process including documentation of information

Qualifications / Requirements/Experience

• BS in a scientific or equivalent work experience. CQA or CQM/OE is a plus
• 3+ years of experience working as a Quality Systems Specialist in FDA regulated medical device environment
• Understanding of ISO 13485:2016 requirements and how to apply them to a QMS, including a broad knowledge of documentation control requirements.
• Good communicator with excellent attitude and willingness to learn, grow and contribute in a fast-paced environment
• Demonstrated experience with Microsoft office suite and Adobe Acrobat, including Excel, Word PowerPoint

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Headquartered in Garden City, New York, the company has locations in Madison, WI, Rehovot, ISR and Dublin, IRE. The Beyond Air leadership team has deep industry experience developing nitric oxide delivery systems. The team has decades of experience in bringing lifesaving medicines and devices to markets and patients around the globe. 

Assistant General Counsel

Reports to:     General Counsel                                             Location:        Garden City, NY

Job Summary

Under the direction of the General Counsel, the Assistant General Counsel will be responsible for managing, completing, directing, coordinating and supervising corporate activities at the company. Primary responsibilities include advising on SEC compliance, licensing & collaborations, commercial contracts and corporate compliance and governance. The individual is expected to implement and maintain a corporate legal function that supports the company’s key business objectives and ensures compliance with applicable laws, regulations, and company policies. The individual is expected to develop a thorough understanding of and familiarity with the Company’s business, its people, products, technology, markets, facilities, commercial opportunities and competitors in order to identify trends and formulate structures and strategies accordingly.

Accountabilities

• Develop and train Company personnel on corporate governance, compliance, regulatory and healthcare compliance and other legal issues as needed.
• Manage and conduct internal investigations if required.
• Develop and implement training on key policies, procedures, practices and requirements for healthcare and related legal compliance issues.

Activities

• Proactively identify legal and compliance risks affecting the company and collaborate with key business leaders to develop and incorporate risk mitigation strategies as needed;
• Draft annual and quarterly reports, current reports, proxy statement and other regulatory filings;
• Assist with all operational aspects of preparation for board and committee meetings including review processes, corporate governance compliances, SEC reporting compliance and oversight of the preservation of board, committee and subsidiary materials and minutes, and support of the document retention policy for the corporate secretary’s office;
• Assist in strategic collaboration activity;
• Review and revise external communications (i.e., press releases, corporate presentations, scientific posters, etc.) for consistency and regulatory compliance including Reg FD and U.S. FDA;
• Supervise the drafting, review and negotiation of confidentiality agreements, master services agreement, consulting agreements, clinical services agreement and various other commercial contracts and assist in the development of forms;

Qualifications / Requirements/Experience

We are looking for applicants with an established track record of high achievement, self-motivation, professionalism, reliability and excellent organizational skills.

• JD from accredited US law school with strong academic credentials.
• Related experience, preferably in the biotech industry and/or public company experience.
• Licensed to practice in at least one state
• Min 5 years of experience as a corporate attorney in a large to mid-size law firm or corporate in-house legal department.
• Experience providing legal advice on a broad set of general corporate matters in the biotech/pharmaceutical industry and/or public company setting.
• Excellent people, analytical, and written/verbal communication skills.
• Strong motivation, independence, and ability to work in a high-paced multidisciplinary environment.
• Well-organized and hardworking, with the ability to manage numerous projects simultaneously under deadline pressure.
• Detailed-oriented with a high level of intellectual, professional and interpersonal agility and flexibility, combined with strong analytical and problem-solving skills.
• The position involves extensive direct contact with senior business personnel at Beyond Air and with our business partners.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Headquartered in Garden City, New York, the company has locations in Madison, WI, Rehovot, ISR and Dublin, IRE. The Beyond Air leadership team has deep industry experience developing nitric oxide delivery systems. The team has decades of experience in bringing lifesaving medicines and devices to markets and patients around the globe. 

Manager, Accounting

Reports to:     US Controller                                     Location:        Garden City, NY

Job Summary

The Manager, Accounting is responsible for performing general ledger account and bank statement reconciliation, preparing journal entries and financial statements for both internal and SEC reporting, recommending improvements to our NetSuite platform and fixed asset system, preparing statistical and financial reports for external partners, technical accounting research, SOX, organizing month end close and assisting the Chief Financial Officer and Controller in preparation of adhoc reporting.

Accountabilities

• Lead monthly close and responsible for closing calendar, prepares closing journal entries, prepare accrual entries, and prepares financial statements and variance analyses, while ensuring the records and financial statements follow US GAAP
• Demonstrates effective communication and problem-solving skills
• Utilizes NetSuite accounting system, Excel, and presentation software.
• Perform various complex account analyses and reconciliation.
• Reconciles the general operating account bank statements to the General Ledger.
• Researches and recommends policies from technical accounting literature
• Uses statistical, economic and financial principles and techniques to prepare reports
• Responsible for reporting and managing all equity-based transactions (options, grants and ESPP)
• Responsible for reporting equity compensation, including reviewing and analyzing stock-based compensation (SBC) spending to ensure accuracy
• Review purchase requisitions and contracts/work orders for terms of payment, GL coding, and proper invoice approvals

Activities

• Provides input into, and analysis supporting budget analyses and variance reporting;
• Prepares various financial documents for compliance with regulations.
• Coordinates and maintains miscellaneous reports; verifies all billings are complete and reconciled to the general ledger; and supervises expense report postings.
• Monitors and submits for mailing all periodic financial documents.
• Maintains records retention log to facilitate the orderly file system of permanent records for adherence to record retention policy.
• Assists Chief Financial Officer/Controller in compilation of miscellaneous confidential reports
• Assists in preparation of SEC filings, including Form 10-Q’s, Form 10-K’s, Form 8-K’s, and press releases.
• Maintains fixed asset system, which includes preparation of journal entries, reconciliation of general ledger to fixed assets system, and preparation of depreciation schedules for budgeting purposes.
• Review semi-monthly payrolls
• Assist and support quarterly review and annual audit with external audit team
• Assist Senior Director of Finance, Controller in establishment and oversight of financial policies, procedures, controls, and reporting systems including SOX 404 compliance
• Perform other duties and ad hoc projects, as assigned, to support the Finance department
  
  

Qualifications / Requirements/Experience

• Must have a Bachelors Degree, or above, in Accounting or Finance or equivalent
• Minimum of 5 years of accounting experience – preferably in a biotech, life science, pharma or medical device firm is a plus
• Active CPA or pursuing CPA desired
• Proven experience with financial statements
• Proficiency in NetSuite is highly preferred
• Excellent planning, prioritization and time management skills and willingness to take ownership of tasks
• Must be highly proficient in MS Excel.
• Strong data entry skills and attention to detail are required.
• Previous experience in audit processes and procedures is desirable.
• Prior experience designing, implementing, and documenting policies and procedures—in a SOX environment

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

FP&A Analyst

Reports to:     CFO                                                     Location:        Garden City, NY

Job Summary

This role will help develop financials metrics to support operations and improve the quality of financial planning at Beyond Air, including, but not limited to, a 3 or 5-year plan, budget, forecast and Actuals reporting. The position will also support key closing processes and for the reporting of internal and external financial metrics. This role will evolve to support Investor relations and competitive analysis.

Accountabilities

• Drive sales estimate discussions with regional teams leveraging backlog conversion and Supply Chain metrics. 
• Drive and measure improvements on data quality across areas of accountability  
• Responsible for assessing the amount, timing, and predictability of cash- outflows as the basis for budgeting and business-planning.

Activities

• Coordinate the process for each short-range-outlook
• Support the closing process, including external reporting for product cost, service cost and SG&A.
• Partner with all budget holders to ensure alignment with P&L estimates and risk/opportunities
• Responsible for financial planning, analysis, budget, forecast and Actuals reporting
• Interpret and analyze results to provide clear and concise insights on trends.
• Help prepare materials and supporting schedules for internal leadership reviews as well as Investor Relations, Board presentations and external SEC reporting
• Identify and recommend process improvement opportunities across the company
• Regular interaction with controller and cross- functional interaction with senior levels of the organization including Commercial, Supply Chain, HR, and Corporate

Qualifications / Requirements/Experience

• Bachelor’s degree in Accounting or Fianace and minimum of 5 years of progressive work experience in a business environment
• Strong analytic skills: able to clearly link financial results to operational performance drivers, generate alternatives and drive positive change
• Able to multi-task & handle tasks with competing priorities effectively
• Strong communication skills: experience working across multiple levels (including executive level), functions and regions; able to clearly communicate complex financial information in an easy to understand manner
• Proven ability to lead cross-functional projects and process improvement within the operations/finance functions; able to quickly grasp new ideas.
• Self-starter, energizing, and results oriented with the ability to see the big picture
• Experience with NetSuite is a big plus

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Analyst, Market Research & Insights

Reports to:     CEO                                                     Location:        Garden City, NY

Job Summary

Reporting to the CEO and working with the Global Head of Business Development, this position is responsible for supporting organizational understanding of the company’s business environment and drive actionable insights through innovative analytics and modeling approaches, as well as provide market dynamics and their implications in support of the company strategy.

Accountabilities / Activities

• Aid in the creation of final presentations with insights, analyses, and recommendations
• Select and produce data visualizations that clearly and effectively depict results.
• Research potential competitors in preparation for sales and marketing & business development meetings
• Support Commercial teams with secondary market research, identify key trends across industry, report relevant impacts and implications through routine tracking and monitoring.
• Work with large datasets to examine changes in the relevant markets, therapeutic categories, growth trends, drivers, and impacts.
• Conduct in-depth market opportunity assessments, understand customers and markets, their pipeline dynamics, identify opportunities and develop forecasts.
• Develop thorough understanding of competitive market landscape, key activities, product offerings, planned product development and go-to-market strategies.
• Maintain a market model to track revenue, share and pricing trends
• Able to plan, design and implement projects independently, know how to tackle a business case, capable of answering business questions and solving complex problems.
• Advanced data manipulation skills, capable of working with large data sets, identify gaps, interpret findings, and draw conclusions, cap! able of summarizing/presenting key findings via Power Point charts.
• Track FDA New Drug Approvals, investigate and confirm participation
• If necessary, conduct primary market research (qualitative and quantitative) to support strategic, tactical, and operational initiatives as well as planning and implementation of new and potential products and programs
• Establishes and manages schedules for projects and monitors progress to ensure timely delivery of results.
• Ensures results provided are accurate and offer meaningful and actionable insights.
  
  

Qualifications / Requirements/Experience

• Bachelor’s degree required. Master’s degree preferred. Preferred specialization in market research, business, or other social science, marketing, or related discipline.
• 5+ years of Market research experience in the pharmaceutical or biotech industry preferred
• Excellent conversational and written English
• Advanced Data Manipulation skills with Excel and Strong PowerPoint skills
• Ability to translate data and analytics into charts and business cases
• Experience working in statistical models, multiple regression, cross validation and variable selection
• Ability to synthesize research findings into a succinct, insights-driven reports.
• Ability to present complex information in a clear and insightful manner.
• Demonstrated capability in building and managing multiple projects concurrently.
• Experience using Excel, SPSS, or other software for data analysis.
• Excellent communication skills: verbal, written, and interpersonal.
• Excellent time and project management skills.
• Must be self-motivated
• Can handle change and ambiguity.
• Thoroughness, attention to detail, and accuracy in work products required.

Essential Duties And Position Responsibilities

• Thoroughness, attention to detail, and accuracy in work products required.
• Build a market model to track revenue, share and price trends and present monthly market dynamics reports to the senior management team
• Establish and maintain media monitoring in existing and potential markets as defined by the strategic plan
• Create and maintain company dashboards tracking progress against strategic goals
• Support business development initiatives with modeling and research
  
  

Qualifications, Knowledge, And Skills Required

• Thoroughness, attention to detail, and accuracy in work products required.
• Bachelor’s degree or equivalent demonstrated work experience
• Expertise in Excel and proficiency in Word and PowerPoint.
• Ability to quickly learn software and tools as needed to meet the needs of the role.
• Creative problem solver
• Excellent communication (verbal, visual and text), analytical and presentation abilities
• Strong, collaborative interpersonal work style
  
  

Preferred Skills Or Experience

• Experience in biotech, pharmaceutical and medical technology industry (medical device, surgical instruments, equipment and disposables)

Internal Relationships

• Marketing Research, Marketing, Business Development, Finance and Sales

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Project Manager

Reports to:     Director of Engineering & Program Management  
Location:        Madison, WI

Job Summary

This Project Manager will help organize, manage, and plan complex projects for the organization’s research, development, and product implementation efforts. 

Supervisory Responsibilities

• Oversee a team of analysts and technicians to ensure projects are completed on time and to specifications.
• Delegates work and assignments to team members based on expertise, work experience, and time constraints.

Activities

• Assists in leading an interdepartmental team to complete an assigned project on time, to specifications, and with accuracy and efficiency.
• Outlines the tasks involved in the project and delegates accordingly.
• Conducts cost analysis, estimating expected costs for the project.
• Prepares and implements a budget based on estimates.
• Conducts risk assessments; reports identified risks to management; provides recommendations for mitigation of risk (including termination of the project if appropriate).
• Ensures products manufactured meet company established specifications by enforcing SOP’s, DMR’s, and cGMP standards as required by the Quality Systems Regulations – CFR 820 and ISO 13485 regulations.
• Addresses questions, concerns, and/or complaints throughout the project.
• Acts as a liaison between company, customers, and vendors.
• Communicates and collaborates with sales and marketing teams to provide training and information required to promote and sell new projects, programs, and systems.
• Ensures compliance with federal, state, local, industry, contractual, and company regulations, standards, specifications, and best practices.
• Ensures DMRs and BOMs are kept up to date, including processing of change orders as needed.
• Performs other related duties as assigned.

Qualifications / Requirements/Experience

• Bachelor’s degree in Engineering
• Minimum of 4 years’ experience required with 2 years’ experience directly in a manufacturing environment - medical device industry
• Medical Device Experience including FDA 21 CFR Part 820
• PMP, PgMP, CAPM or comparable PM certification is highly desirable
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Thorough understanding of or the ability to quickly learn about the project or product being developed.
• Proficient with Microsoft Office Suite or related software with fluency in MS Project program
• Background in mechanical or electrical engineering.

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Marketing Manager

Reports to:     Head of Marketing                                        Location:        Garden City, NY

Job Summary

Beyond Air seeks a Marketing Manager ready to employ their expertise and ingenuity to help our team transform iNO care. In this role, you will make the brand strategy a reality, developing and executing marketing plans and events. Collaboration is key to the position’s success, reporting to the head of marketing, but working collaboratively with sales, clinical, and operations to support a robust portfolio of products from pre-clinical to commercialization.

Responsibilities

• Oversee implementation of marketing strategy, including marketing campaigns, content marketing, and events
• Own the development and execution of the marketing planning calendar, making real-time adjustments as required and leverage key learnings going forward
• Track, prioritize, and manage each project, ensuring key stakeholders are informed of its progress
• Execute and manage social media to promote corporate and product brand awareness
• Work collaboratively with all marketing-related resources, in-house personnel, marketing agencies, consultants, etc
• Participate in ideation and strategy sessions to develop compelling campaigns that tell the brand story
• Manage tradeshows and events from conception through end of show, including administration, scheduling, design, and logistics
• Support business analysis and reporting, results tracking, lessons learned, and continuous improvement assessments
• Lead market research and voice-of-customer activities to maintain understanding of our customers’ needs and translate that to our product story

Qualifications / Requirements / Experience

• Bachelor’s Degree from an accredited institution in Marketing, Communications, or related field of study required
• Minimum of 5-7 years of experience in healthcare marketing
• Strong verbal and written communication skills
• Knowledge of social media, online display advertising, email marketing, print advertising, and website/landing page best practices
• Experience in developing successful new products campaigns from end-to-end, from ideation through go-to-market strategies, working closely throughout with product development, operations, and sales teams
• Advanced proficiency in Word, Excel, and PowerPoint, Wordpress, and Canva. Proficiency in Adobe Creative Suite and Salesforce Marketing Cloud a plus
• Conference and event management experience, including AV management associated with conferences and events
• Detail-oriented, self-initiating, organized, and capable of managing multiple projects simultaneously and independently
• Financial analysis and budget management at the project level required
• Familiarity with regulatory and compliance standards in the healthcare industry or other highly regulated industries
• Ability to understand various therapies and the disease states, as well as emergent sciences developed internally and by competitors

Specific Criteria

• Reports to the Head of Marketing
• Based in Garden City, NY
• Minimum 20% travel is required

EEO Statement:

Beyond Air is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Headquartered in Garden City, New York, the company has locations in Madison, WI, Rehovot, ISR and Dublin, IRE. The Beyond Air leadership team has deep industry experience developing nitric oxide delivery systems. The team has decades of experience in bringing lifesaving medicines and devices to markets and patients around the globe.