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 device and 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.

Regional Business Manager

Reports to:     Head of Sales                                                  

Job Summary

This hospital-based sales position is responsible for launching and promoting assigned Beyond Air Inc. products and devices within the hospital setting. The Regional Business Manager (RBM) is the primary contact for the customer and is responsible for coordinating with all cross-functional teams. In addition, the RBM is responsible for passing all training requirements and assisting customers in all training needs with the Beyond Air Inc. family of products as well as managing the contract process. The RBM’s primary external customers are NICU Health Care Providers and Hospital Administrators.

Responsibilities

• Establishing and executing a go to market plan that maximizes strategic market growth
• Establishing and executing best customer experience
• Communicating effectively the needs of patients and customers to key stakeholders to ensure that Beyond Air’s activities lead to commercial success
• Effectively communicates about the product & overcomes objections
• Understands disease state and therapeutic area
• Uses clinical data in selling product
• Understands the market landscape and competitive landscape
• Develops and executes a regional plan to optimize success
• Develops KOLs and implements programs consistent with product strategy to drive future sales
• Manages Regional expense budget
• Ensures compliance with all applicable laws and policies in conducting business
• Monitors competitive activity and maintain competitive intelligence databases for the Nitric Oxide market within the region and nationally
• Leads and supports the launch and sales efforts in the Central Region and assists Nationally
• Attends local, regional and national conferences

Qualifications / Requirements/Experience

• A. or B.S. degree in relevant field
• 5 plus years recent hospital sales experience
• Strong technical and clinical presentation and selling skills
• Excellent verbal and written communication and interpersonal skills
• Proven track record of sales success and strong business acumen
• Excellent planning and organizational skills
• 5 plus years of hospital contracting experience
• Strong collaboration and teamwork skills
• Respiratory Medical Device experience preferred
• Overnight travel
• Excellent computer and analytical skills

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:     Head of Sales                                                  Location:        Garden City, NY

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.

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:     Chief Commercial Officer                              Location:        Remote

Job Summary

Working under minimal direction, provides advanced engineering, commercial, educational, technical and customer support. 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.

Responsibilities

• Has a basic understanding of the competitive landscape
• Demonstrates ability to build and sustain credible business 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, product performance and potential commercial partnership opportunities to the field based teams / directors and/or management to support business needs.
• Assures completion of patient registration and any other required hospital documentation
• 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 engineering, clinical and technical skills and supports the commercial team strategic plans.in patient care clinical trials
• Acts as the liaison between the medical community and the business needs
• Provides on-call support as needed on evenings and weekends post sign-off
• Provide troubleshooting support as requested
• Operational Support
• Helps manage customer inventory needs and requests
• Provides engineering, education and clinical support in response to the most complex field inquiries on as-needed basis. Demonstrates a thorough command of all products, related product and technical knowledge, trends and players.
• 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;
  • Trouble Shooting

Qualifications / Requirements/Experience

• Master's degree in a Clinical Lab Science/Medical Technology, Biomedical/Medical Engineering and/or closely related discipline is preferred (PhD would be beneficial). At a minimum – a Bachelor’s degree in Bio-Medical Engineering, related field or equivalent healthcare experience.
• Minimum 8-10 years of experience in medical devices or pharmaceutical organization in a Clinical, Research & Development, Scientific and Medical Affairs or Regulatory role.
• Experience in developing strategies to generate clinical evidence and working with clinicians to establish and manage clinical evidence generation activities is required.
• Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
• Demonstrated knowledge of all respiratory technology
• Familiarity with respiratory procedures and protocol.
• Demonstrated advanced knowledge nitric oxide delivery systems of is highly preferred.
• Must apply engineering skills and abilities to interpret and solve complex clinical problems
• 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 Office or equivalent required) to develop presentation materials.

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.