Job Summary

The Quality Engineer participates and assists in developing, applying and implementing methods, tools, standards and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service. Actively contributes to new product teams and functional areas in Design Assurance, Verification & Validation, Purchased Material Quality, Test Method Development, Statistical Techniques, Process and Product improvements, and Risk Management. Investigates nonconformances and complaints.  Analyzes and reports on product performance relative to quality goals.    

Responsibilities

Quality Management System (40%)

• Monitors and manages customer complaint management system.
• Investigates nonconformances / customer complaints down to the root cause; recommends, initiates and/or implements corrective / preventive actions.
• Implements Quality Systems metrics and evaluation processes. Reporting of these metrics to Beyond Air management team (e.g., Management Review)
• Oversees data collection and analysis from various sources to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
• Analyzes program quality and initiates corrective actions when necessary.
• Maintains knowledge of relevant quality and regulatory standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP, and others as required.
• Implements & maintains policies and procedures to ensure continuous compliance of our Quality Management System.
• Provides training and support to employees on all quality concerns, customer complaints and application of quality methodologies.

Design and Development (40%)

• Ensures products meet the organization’s and clinician's, patient's quality and product integrity requirements.
• Supports product development or operations team by providing analysis and expertise throughout the design and development process.
• Implements methods and systems to assure that Beyond Air development, manufacturing and clinical teams receive support in the areas of risk management, design controls including validation and verification testing, corrective and preventative action, root cause analysis, statistical analysis, quality planning and inspection processes.
• Implements quality strategies for modified and new product development.
• Oversees product and manufacturing changes (Change Control) for compliance with applicable regulations and potential impact on future and current regulatory submissions.

Supplier Management (20%)

• Coordinates and conducts audits throughout the supply chain, ensuring quality standards, safety and legal requirements, and company policies and specifications are met
• Assures component quality through supplier audit and data review.

Qualifications / Requirements/Experience

• Bachelor’s degree in Engineering, Masters preferred
• Must have 5+ years experience as Quality Engineer in Pharma or Biotech
• Medical Device Experience including FDA 21 CFR Part 820
• Familiarity with Medical Electrical Equipment standards such as IEC 60601, Software Development per IEC 62304
• Human Factors and usability engineering for Medical Devices
• Knowledge of core tools, (SPC, FMEA, Control Plans)
• Excellent verbal and written communication skills.
• Excellent interpersonal skills with ability to serve as a liaison with developers, project managers and customer support.
• Excellent organizational skills and attention to detail.
• Achievement in lean/Six Sigma environment
• Strong analytical and problem-solving skills.
• Thorough understanding of or the ability to quickly learn about the project or product being developed.
• Proficient with Microsoft Office Suite or related software.
• Experience with ISO 13485:2016 quality system maintenance
• Experience with MDSAP a plus

Specific Criteria:

• Reports to the Director, Quality Assurance
• Based in Madison, WI
• Monday – Friday, 9am – 5pm

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.

Job Summary

The US head of Sales/Commercial operations is responsible for leading the sales organization, product commercialization and sales operations for the US. This individual’s primary role is to build and develop a sales organization to maximize the opportunity for the LungFit PH system and create a strong platform for potential future additions to the LungFit brand family and beyond. This person will work closely with senior leadership in the organization, in particular the heads of marketing, business development, operations and finance to ensure that customer needs are exceeded. A proven sales leader, this individual will be able to rapidly build a loyal customer base and also identify new opportunities for growth as Beyond Air looks to expand the portfolio.

This role requires strong initiative, self-motivation and coordination with other team members. The ideal candidate for this position will be an ambitious, proven team builder with a track record of exceeding expectations.

Responsibilities

• Builds a sales organization that will deliver the strategic objectives of Beyond Air (BA) in the US.
• Utilize market knowledge and industry contacts to grow the BA business in line with agreed commercial goals.
• Ensures the organization is highly competent in identifying and pursuing new contacts and accounts, and broadening the range of business in existing relationships.
• Develops a “customer centric” mindset within the organization and ensure alignment with the senior leadership team to sales strategy and execution.
• Ensures a talent pipeline is maintained and continually developed, champions global career development and opportunity
• Responsibility for leading specific account growth initiatives on behalf of BA and the sales organization to facilitate the success of the team as a whole.
• Ensure priority account plans are developed, executed and maintained in conjunction with annual account planning processes as well as the specific business needs
• Sales Force Effectiveness (SFE)
  • Work with product commercialization and sales operations to establish a process to manage SFE through defined strategies and tactics, supported by rigorous customer relationship management tools
• Work closely with the head of marketing to understand customers” key needs/challenges and key market trends to create a pipeline for future portfolio expansion and customer penetration.
• Gather market intelligence as input to product management and product marketing to improve offerings and communication for local market needs.
• Provide clear direction, and actively communicate with the sales team and other stakeholders within BA. Work with marketing team to identify market trends and help formulate lead-generation plans that will lead to new revenue generation opportunities.
• Participate in professional trade shows and clinical conferences, or the equivalent, (or as practically possible), setting up client meetings, exhibit coverage and lead generation.
• Build a contract management team that can work alongside legal and finance staff as well as Supply Chain groups to contribute to the design and implementation of Master Service Agreements (MSAs), negotiate preferred provider agreements and volume pricing, and provide project-level contracting and business development support.
• Build skills and processes to achieve excellence in contract management and sales operations. Document communication/discussions and all opportunity details in SalesForce.com (or similar CRM system) to ensure a tracked record of existing correspondence and/or future next steps required.
• Ensure all team members act in compliance with the company code of conduct and any relevant industry standards relating to the promotion and sale of medical devices.

Qualifications / Requirements/Experience

• 15+ years of progressive experience in pharmaceutical, biotech or medical device industry.
• Master’s degree in a Health Science, Health Economics, Epidemiology, or an advanced business degree is preferred.
• Understanding medical device sales and the business implications of different models. Specific expertise in the respiratory field is valued but not required.
• Demonstrated ability in leading high performing sales and service teams in target industries (Bio/Pharma/Medtech/Diagnostics)
• Demonstrated experience of managing client relationships, preferably in the target industries
• Able to establish clear performance and development expectations and priorities for the sales team and help them achieve revenue objectives, their personal goals and professional development.
• Excellent team building and team selling skills and collaboration with all levels of internal and client stakeholders.
• Proven track record of high level of sales performance in a competitive, dynamic marketplace.
• Consistent success in account development.
• Working knowledge of SalesForce.com and other sales/marketing software tools for managing a sales team against target metrics.
• Able to develop sales strategies into operational plans and construct sales territories and allocate key accounts in a logical fashion. Experience designing and managing commission programs.
• Work collaboratively with cross functional commercialization teams with a strong business orientation and ability to view issues from multiple functional perspectives.
• Able to operate in a team setting and be capable of building strong, trusting relationships with peers and their organizations.
• Possess well-developed interpersonal skills to maintain close working relationships at multiple levels within an organization.
• Excellent written and verbal communication skills.
• Experienced and adept in a variety of negotiating settings.
• Superior project management skills.
• Strong analytical skills with a data-driven focus.
• Flexible and able to adapt to a rapidly changing environment.
• Self-motivated professional with ability to work with minimal supervision in a team environment
• High ethical standards and personal integrity.

Specific Criteria:

• Masters preferred
• Medical Device experience strongly preferred

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.

Job Summary

The role of the Head of Marketing is to develop and execute the U.S. marketing strategy for Beyond Air, ensuring an integrated implementation strategy across all stakeholders and customers types. The position is a key leadership role within the company that will manage the strategic, tactical and financial elements of the brand and related U.S. marketing programs.

Responsibilities

• Responsible for the annual marketing plan, including comprehensive strategy and tactics.
• Leads integration of the US Brand strategy across all customer types aligned to the Global Brand Plan. Facilitates Brand Planning process including application of Brand Planning guidance, design and facilitation of key workshops, cross-functional collaboration.
• Build impactful marketing campaigns and supporting materials, working closely with the Beyond Air teams.
• Establish measurements of success, analyze marketing performance, and identify test-and-learn opportunities.
• Ensure alignment of creative strategy with campaign objectives, provide audience insights to aid in development of creative, and act as stewards of overall brand positioning across Beyond Air.
• Responsible for the marketing development, implementation and coordination of an annual, strategic, special events calendar, to include conferences, trade shows and events.
• Build, manage and coach a high-performing marketing team (as BA grows)
• Direct and support market research collection, analysis, and interpretation of market data for short- and long-term market forecasts and reports
• Responsible for web design, content management and online brand awareness
• Responsible for SEO (search engine optimization) and generation of inbound/outbound traffic
• Oversees all online communication; and maintain/update coverage contained and posted through these outlets as well as review and edit any content or coverage posted by staff members or by the general public
• Manages marketing budget and expenditures
• Maintains brand standards and ensure compliance across all marketing and communications channels
• Identify competitors and evaluate their strategies and positioning and devise counter-strategies
• Leads the marketing team to facilitate the commercial planning process for Beyond Air.
• Understand and gain deep customer insights for all critical stakeholders (Respiratory Therapists, Neonatologists, Finance Directors and Registered Nurses). Identifies growth opportunities, understanding brand and market dynamics, and working with the team to ensure all activities drive the business.
• Develops strong cross-functional collaboration with key internal and external stakeholders to deliver against financial objectives for the portfolio.
• Leads the US marketing team in the development of strategy, execution and measurement of promotional campaigns, congresses, sales force national meetings, marketing execution and promotional speakers’ bureau activities and direction.
• Maintains deep understanding of customer and market trends. Monitors and assesses changes in the industry and competitive landscape and their impact on marketing strategies and programs.
• Evaluates strategic choices advising on investment optimization & commercial decisions.
• Manages the Marketing budget and supports preparation for key financial and budget timepoints throughout the year.

Qualifications / Requirements/Experience

• 10+ years of progressive experience in marketing, including 5+ years experience of new product launches.
• 5+ years in healthcare, Medical device industry preferred.
• Deep understanding of commercial functions and campaigns (Marketing, Sales, Medical Affairs, Market Access, etc.).
• Demonstrated ability to think and act strategically.
• Strong leadership, communication and presentations skills with a demonstrated capacity for developing teams.
• Ability to communicate and influence Key Opinion Leaders to incorporate the use of BA products into their practices.
• Demonstrated ability to lead and set direction for a cross-functional team, positively influence coworkers toward common goals, foster collaboration, and enable teamwork.
• Ability to understand and leverage analytics to drive decision making.
• Capable of acting as a thought-partner for senior leadership and key stakeholders.
• Ability to effectively mobilize internal and external resources and make trade-offs.
• Capacity to managing multiple priorities.

Specific Criteria:

• Masters preferred
• Knowledge of marketing compliance rules and regulations
• Medical Device experience strongly preferred

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.

Job Summary

The Manager, Sales Operations is responsible for the overall management of the sales operations process including sales administration, product support, sales training, and sales analysis. Designs and implements policies and programs that direct the sales growth of the company’s products and initiatives and provides direction on Customer Relationship Management (CRM) and Sales Force Automation and Administration (SFAA) aspects of the sales support infrastructure.

Responsibilities

• Contributes to the design and development of CRM and SFAA resources.
• Develops strategies to grow the company’s client base in new and existing locations, in and outside of the U.S.
• Identify / document key business acumen skills across team members for overall understanding of KPIs and metrics.
• Partner with leaders across the organization (Marketing, IT, and Operations) to streamline and harmonize data stewardship principles and practices.
• Collaborate with Marketing, Operations and Finance teams to establish the optimal customer service process and experience.
• Direct and Maximize commercial effectiveness via automation and data management.
• Understand and mine database for opportunities and insights that provide actionable direction.
• Establish standard operating procedures (SOPs) to streamline system preparedness.
• Lead the development of data reporting systems.
• Collaborate with stakeholders across the organization (Marketing, Quality, Commercialization, Sales, Laboratory, Investor Relations, IT) to achieve operational efficiencies on key project initiatives and quarterly change processes.
• Enable collaborative culture and drive organization to improve customer/client satisfaction levels and responsiveness.
• Adaptable, open to change and able to work in ambiguous situations and respond to new information or unexpected circumstances.
• Communicate goals clearly to stakeholders to ensure understanding and success in achieving them.
• Regularly monitors and shifts, if necessary, sales campaigns to ensure most efficient and effective outreach to new business opportunities. Provides detailed analytics to the CCO and Head of Sales that include current and projected business opportunities.
• Analyzes sales data to forecast and identify new opportunities or areas of improvement. Analyzes trends and practices of competing companies. Provides input into tactical shifts or new initiatives to grow business and create/retain an advantage over competitors.
• Engages and influences a network of both internal and external relationships that support the overall effectiveness of the team’s operations.
• Regularly monitors and ensures all activities are recorded into SalesForce.com or equivalent CRM. Analyzes and provides reports on activities to CCO and head of Sales.
• Helps identify key opinion and thought leaders in the industry. Works with management to translate to strategies to identify and retain key account relationships.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.
• Contribute to the establishment of the optimal customer service process and experience through collaboration with Marketing, Operations and Finance departments.

Qualifications / Requirements/Experience

• Bachelor’s degree in Business, Sales, Marketing, or related field.
• 5+ years of progressively responsible sales operations experience
• Demonstrated ability in establishing processes and procedures leveraging CRM systems; including alignments, targeting, data stewardship and integrity.
• Demonstrated ability to improve sales productivity and results
• Strong analytical skills with the ability to translate complex data into actionable deliverables and presentations.
• Proficiency in Microsoft Office with expert Excel skills.
• Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes. Ability to build/foster relationships.
• Excellent organizational, planning, and time management skills with the ability to manage multiple and often changing priorities and issues of varying complexity, while meeting time-sensitive deadlines and deliverables.

Specific Criteria:

• Masters preferred
• 5 years+ sales operations experience, ideally in the healthcare industry.
• Strong understanding of Salesforce.com or equivalent CRM.
• Medical Device experience strongly preferred

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.

Job Summary

The Director, Business Development is responsible for the global business development activities of Beyond Air. They are responsible for identifying, negotiating, assessing and finalizing new business opportunities that are in line with the strategic growth and business objectives for Beyond Air. For all new business opportunities, the person will assess technical relevance, financial and market potential and any proprietary and legal implications. They will work collaboratively with internal functions to complete financial modeling of all opportunities which will be presented to senior leadership.

Responsibilities

• Implementation of Business Development Strategy for Beyond Air.
• Ensuring that Beyond Air’s activities lead to the development of world class and commercially successful products.
• Alliance management with Beyond Air global partners. Oversees and manages all relationship aspects with our global partners.
• Lead the business development function in alignment with the CCO and CEO’s vision and objectives
• Provide specific recommendations and projections for immediate and longer-term growth
• Develop and secure new business opportunities through identification, outreach and follow-ups with high potential contacts
• Plan and lead presentations and meetings with prospective clients, from initial contact through to deal close
• Conduct and lead financial analysis and market research activities to assess financial viability of target, evaluate market potential, differentiating technology and product leadership that will generate targeted revenue
• Attend conferences and trade shows as needed
• Manage the business development annual budget
• Works with the leadership team to align priorities and achieve overall business results and objectives.
• Any other duties as assigned

Qualifications / Requirements / Experience

• MBA Preferred
• 8+ years of progressive business development experience in Medical Device or a Life Sciences Technology-driven company
• Good Communication skills and an eye for detail are required
• Experience in establishing relationship with large pharmaceutical and medical device companies, especially in respiratory field
• Exceptional negotiating skills along with financial acumen
• Thorough understanding of FDA regulations within the US, in addition to global laws and regulations related to IP and legal implications with acquisition of technology, products or companies.
• Direct experience with Nitric Oxide is preferred.

Specific Criteria:

• Ability to travel as needed.
• Strong presentation skills
• Ability to quickly establish credibility, trust and support with both internal and external constituents
• 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:        NY or NC

Job Summary

The Clinical Project Manager is responsible for the routine cross-functional operations of assigned studies.  The Clinical Project Manager acts as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget, according to the expectations and with the highest level of quality possible.

Responsibilities

• Responsible for the overall coordination and management of clinical trials from start-up through close-out activities.
• Serve as the primary liaison with the project team for assigned studies.
• Oversee activities with respect to regulatory document collection and Trial Master File maintenance for applicable studies and directly assist with such activities as needed.
• Negotiate site contracts and/or budgets and oversee accurate and timely distribution of investigator grants.
• Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects.
• Develop, implement and communicate project plans, monitoring plans, regulatory plans and all other applicable study materials.
• Facilitate team training in accordance with the protocol and/or project requirements, including therapeutic, protocol specific and process training.
• Direct all project staff across functional areas to facilitate study progress.
• Assist with initial investigator recruitment and evaluation by reviewing site feasibility questionnaires and investigator CVs.
• Develop study specific Standard Operating Procedures (SOPs) and other study-specific management tools as needed.
• Coordinate, plan and execute Investigator Meetings as needed.
• Oversee the supply of Investigational Product and other study materials to sites.
• Evaluate site activation and site enrollment against projections throughout the course of the study, escalating issues as required.
• Determine and implement patient retention strategies as needed.
• Assist with resolution of site and facility issues such as outstanding queries, overdue documentation, lab and study drug issues.
• Manage overall study budget, provide accurate budget forecasts, review pass-through costs and ensure project invoices and site/vendor payments are accurate, timely and in alignment with applicable agreements and Statement of Work (SOW).
• Lead internal project team meetings
• Communicate the progress of the study, potential risks and appropriate recommendations for identified risks to appropriate client and internal team members on a regular basis.
• Attend project team meetings.
• Oversee the creation and distribution of study-specific newsletters as required.
• Ensure monitoring reports are received, reviewed and signed off per specified timelines as defined in the Monitoring Plan and/or applicable SOPs.
• Ensure project documentation is complete, current, stored appropriately and audit-ready.
• Develop and maintain a close working relationship with study management team.
• Establish a strong working relationship with and act as a resource for investigative sites; troubleshoot site and patient concerns and critical project matters.
• Escalate issues and critical project matters in a timely manner to appropriate team members and senior management.
• Support study audits and respond to audit reports.
• Provide performance feedback on project team members to management.
• Collate and communicate end-of-study site performance metrics, issues and lessons learned to appropriate parties.

Qualifications / Requirements / Experience

• Bachelors degree or RN in related field
• PMP Certification a plus
• 5+ years of experience in clinical trials in medical device or life sciences technology-driven company.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• At least 3 years of Clinical Project Management experience in CRO setting
• Ability to travel as needed (investigator meetings & sites meetings)
• Experience in managing a group of CRA’s
• Work outside the normal office hours as required.  

Specific Criteria:

• Experience in establishing relationship with key opinion leaders, investigators and study personnel, especially in the respiratory field
• Exceptional negotiating skills along with financial acumen
• Strong knowledge of the drug development process and FDA regulations, ICH GCP guidelines, and their application to clinical trials.
• Excellent written, oral communication and presentation skills
• Excellent interpersonal and organizational skills with demonstrated attention to detail.
• Ability to read, write and speak fluent English.
• Ability to build positive, productive client and team member relationships.
• Demonstrated management and problem-solving capabilities, strong critical thinking, and analytical skills
• Good computer skills with good working knowledge of a range of computer applications included but not limited to MS Work and Excel
• Ability to meet deadlines, multitasks, and prioritize based on project needs
• Ability to make sound decisions based on available information
• Ability to work both as part of a team and independently
• Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes

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.