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.

Clinical Project Manager - NY or NC: Apply Now

Reports to:     Director, Clinical Services                         Location:        Remote

 

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.

Clinical Specialist - Remote: Apply Now

REPORTS TO:   Head of Global Supply Chain


SUMMARY OF POSITION:

The Supply Chain Manager will work under direct supervision of the Head of Global Supply Chain to perform activities, achieving internal and external customer service goals, optimizing inventory and minimizing cost. This includes proactive risk mitigation, supply execution oversight, monitoring and reporting of results; and may include capacity planning, logistics execution and process ownership of administrative tasks to enable the efficiencies of the larger Beyond Air team.

ACCOUNTABILITIES:

• Plan purchases for assigned products, projects, and commodities and negotiate and implement appropriate buying methods. Develop Purchase Requisition per procedural requirements and Product Specifications, issue purchase orders, confirm deliveries, and expedite deliveries as required. Request bids from suppliers as needed
• Plan and direct finished goods shipments between 3PL to final end-user and ensure timely delivery as well as inventory accuracy and serial number/lot number traceability in NetSuite.
• Maintain, monitor, and enhance the internal purchasing system to continuously meet production requirements. Use various tools like MRP to make sure appropriate inventory levels are maintained. Maintain and publish accurate tracking systems to keep all stakeholders informed of any potential disruptions in the supply chain.
• Requisitions material and establishes sequential delivery dates to departments, according to job order priorities and material availability.
• Coordinates and directs movement or transfer of materials and completed parts to meet the master production schedules.
• Establish standard cost for purchased items and maintain the standard cost files.
• Serves as backup to the Head of Supply Chain
• Prepare transportation documentation for National and International shipments.
• Process shipments by Air, Sea, Road and Parcel Modes
• Booking Shipments online (i.e. FedEx, DHL, Forwarders)
• Coordinating time sensitive deliveries and collections between Sales, Warehouse, Customer and logistics partners
• Collaborating with internal departments to optimize services and managing costs.
• Complying to transportation regulations and company policies.

ACTIVITIES:

• Support S&OP process as required engaging with Sales Operations and Finance.
• Interact with Clinical Support Team and coordinate return shipments from end users to the appropriate facility for review and checkout.
• Working closely with Engineers and Head of Global Supply develop alliances with Beyond Air’s suppliers to manage supplier performance and develop plans to alleviate any supply chain risks.
• Actively participate in MRB as required and ensure timely disposition of rejected material from supplier and assist SE/Engineering/Mfg. Engineering/Quality on corrective action and recovery plan.

EXPERIENCE / REQUIREMENTS:

• B.A. or B.S. in Business, Supply Chain or a related field
• 3-5 years or more of work experience in purchasing, materials planning and supply chain management. Medical device experience preferred.
• At least 2 years’ transportation experience - regulations & software tools
• Great communication and collaboration skills.
• Highly organized individual with strong organization and problem-solving skills.
• Excellent communication and presentation skills
• Strong analytical, decision making and problem solving skills
• Demonstrated high level of business judgment. Ability to deal with suppliers, customers and cross-functional departments positively, responsibly, and professionally.
• Must be proficient in Microsoft Office Suite. NetSuite experience is preferred
• Knowledge of LEAN, six sigma, kaizen, and continuous improvement initiatives. Green Belt a plus
• Must be able to adapt to changing priorities and tasks and demonstrate flexibility in a changing business environment. Models a positive can-do attitude and is cooperative both within their function and company-wide
• Ability to prioritize tasks in a timely manner with minimal supervision
• Demonstrate a strong commitment and dedication to the organization on a consistent basis
• NetSuite: IATA-DG is a 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.

Supply Chain Manager - Dublin , Ireland: Apply Now

SUMMARY OF POSITION:
The Administrative Assistant’s role is to administratively support the Quality/Regulatory team, which involves performing a variety of administrative and office activities associated with the operation of the business.

 

ACCOUNTABILITIES:

• Maintain/update calendars and schedules
• Arrange, help prepare (if need be) and distribute meeting materials for all department related meetings including committee, board and shareholder meetings
• Assist with tracking and reporting of initiatives
• Gain expertise in the Quality System Software used by all employees
• Work with the team in maintaining compliance in all areas (document retention and training)
• Office responsibilities including cleanliness, supplies, working equipment, deliveries, storage, shipping and distributing mail
• Organize travel arrangements and order catering for meetings
• Process monthly expense reports
• Serve as a liaison to outside vendors
• Provide administrative support for all aspects of the group
• Maintains a neat and safe work area
• Performs other duties as assigned

 

REQUIREMENTS:

Qualifications / Experience

• High School diploma minimum; associates or bachelors preferred
• Three to five years’ experience working in a professional office environment
• Ability to take the initiative to continually improve and enhance the administrative support function
• Experience in Microsoft Word, Excel, PowerPoint and Project Plan
• Experience with general office equipment
• Excellent organization skills.
• Possess the ability to prioritize and handle multiple tasks with simultaneous deadlines
• Ability to be detail-oriented and self-motivated
• Strong communication skills and customer service focus
• Ability to identify problems and recommend solutions
• Ability to establish and maintain effective/positive working relationships with management, staff and others.
• Willingness to perform all duties as assigned

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.

Administrative Assistant - Office Coordinator - Garden City, NY: Apply Now

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

 

Job Summary

We are seeking an experienced Mechanical Engineer to join our R&D Team. The qualified candidate will be responsible for developing the mechanical design, performance, manufacturability, and reliability of our portfolio of devices.

 

 

Accountabilities

• Take Responsibility for design and development projects aiming at improving medical device reliability and performance while meeting customer / user needs.
• Identify opportunities for design improvements in a complex mechanical system containing electronics, sensors and pneumatics.
• Develop testing processes, and perform testing and validation of new designs
• Manage design projects involving sub-contractors designer, component suppliers and contract manufacturers.

 

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.
  
  

Requirements:

• BSc in Mechanical Engineering or equivalent (Masters preferred)
• Minimum 5+ years of relevant experience in a medical device Company
• FDA Class III experience preferred
• Mechanical Engineering Experience
• Firm grasp of engineering concepts
• Must be knowledgeable in designing products to meet both FDA and ISO 13485 quality management requirements
• Background in design and development, including design with Solid Works
• Deep technological understanding and creativity in hands-on problem solving
• Ability to work in a team environment
• Excellent verbal and written communication skills
• Self-starter, self-learner, and self-organizer
• Possess a keen attention to detail
• Ability to travel 10%

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.

Mechanical Engineer: Apply Now

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.

Electical Engineer: Apply Now

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

 

Job Summary

The Systems Engineer will play a key role in supporting the design, technology development, product definition, testing, and documentation of Beyond Air products. They will collaborate with a diverse team of engineers and work in a dynamic and fast-paced environment. This individual will support systems engineering related activities on product development programs, guiding integration with software electro-mechanical systems.

 

 

 

Accountabilities

• To support systems engineering efforts for a complex, software-driven medical device; responsibilities may include managing parts flow, system builds (including hardware assembly and integration), software loads and updates, configuration control, and test execution and reporting.
• Supporting a cross-functional design transfer process to ensure the product designs are manufacturable and serviceable
• Supporting product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
• Owns and drives resolution of design issues/defects both electrical and mechanical, under guidance from senior R&D engineers

 

Activities:

• Translate customer needs into requirements and engineering specification as documenting design input and output.
• Collaborate and support the development and maintenance of design history files (i.e. product specifications), hazards analysis documents, usability and other technical documentation.
• Perform complaint, failure and Risk Management activities, develop risk mitigation strategies to ensure that design or process shortcomings are identified and appropriately addressed.
• Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
• Provide technical guidance for product design, manufacturing, service, development, integration, testing, and reliability improvements.
• Provide system level solutions required to meet Electromagnetic regulatory compliance.
• Performs product tests to confirming compliance to regulatory standards.
• Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors for determination of root cause.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Work closely to respond rapidly to emerging issues for released product in the field, production, quality, engineering, and supply chain of key components.
• Create and review manufacturing assembly or test process, design, and fixture documentation including assembly work guidelines, specifications, and CAD models / drawings.
• Perform engineering, integration, verification and validation testing, including protocol development, report generation and change regression analysis.
  
  

Requirements:

• BSc in Engineering, Biomedical Engineering, Electrical, or Mechanical (Masters preferred)
• MS preferred
• Minimum 10 years of relevant experience in a medical device Company is a plus
• 2+ years as a Systems Engineer on Product Design, development and/or testing medical devices
• Experience in the Respiratory field specifically supporting Nitric Oxide products / devices highly desirable.
• Understanding of medical device product design and regulatory processes.
• Able to communicate effectively, both verbally and in writing.
• Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
• Strong understanding of system design, electronics, mechanical and software integration.
• Strong understanding of working principle of sensor technologies and electro-mechanical assemblies
• Broad experience with laboratory test instrumentation, electrical test equipment, test methods for reliability HALT and HASS or related verification data analysis activities.
• Knowledge of design of experiments
• Technical understanding of and experience with best-practice product development methodologies.
• Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
• Medical Device Manufacturing experience
• Medical device product development experience from concept phase to device production
• Experience with design & testing for manufacturing assembly and test
• Experience with electronic design and systems level electro-mechanical packaging
• Experience with pneumatic gas delivery control systems used in medical life support equipment
• Work outside the normal office hours as required.
• Mission-Driven & Committed
• Team Oriented

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.

 

Systems Engineer: Apply Now

Chief Financial Officer for Beyond Cancer

 

Reports to:     Chief Executive Officer - Beyond Cancer                                 Location:        Atlanta, GA Area

 

Job Summary

Chief Financial Officer is accountable for the administrative, financial, and risk management operations of the company, to include the development of a financial and operational strategy, metrics tied to that strategy, and the ongoing development and monitoring of control systems designed to preserve company assets and report accurate financial results.

 

Accountabilities

• Delivering leadership for financial planning and growth of the company.
• Developing collaborative working relationships within the organization in pursuit of the of the company’s overall business goals.
• Ensuring the company stays in financial compliance at all times with various regulatory bodies.
• Setting strategic goals and making sure they are measurable and describable.
  
  

Activities:

 

            Planning

• Assist in formulating the company's future direction and supporting tactical initiatives.
• Monitor and direct the implementation of strategic business plans.
• Develop financial and tax strategies.
• Manage the capital request and budgeting processes.
• Develop performance measures and monitoring systems that support the company's strategic direction.

 

            Operations

• Participate in key decisions as a member of the executive management team.
• Maintain in-depth relations with all members of the management team.
• Manage the accounting, tax, and treasury departments.
• Oversee the financial operations of subsidiary companies and foreign operations.
• Manage any third parties to which accounting, or finance functions have been outsourced.
• Manage the company's transaction processing systems.
• Implement operational best practices.

 

            Financial Information

• Oversee the issuance of financial information.
• Coordinate with the parent Company to ensure consolidation for external financial reporting
• Liaison with Company’s auditors and the parent Company for its quarterly and annual financial statement
• Report financial results to the parent Company and the board of directors

 

            Risk Management

• Understand and mitigate key elements of the company's risk profile.
• Monitor all open legal issues involving the company, and legal issues affecting the industry
• Construct and monitor reliable internal control systems.
• Manage the Company’s information technology systems.
• Monitor and review appropriate corporate insurance.
• Ensure that the company complies with all regulatory requirements.
• Ensure compliance of the Company’s record retention policy.
• Review contract with suppliers, vendors and others to minimize third-party risk.

 

            Third Parties

• Manage relationships with certain third parties.
• Participate in conference calls with the investment community.
• Maintain banking relationships.

 

Requirements:

• CPA & BSc required (Masters preferred)
• 5 yrs. biotechnology Senior Executive Position
• Strong skills in Financial Planning and Strategy
• Ability to manage Profitability, Strategic Planning, Vision, Quality Management
• Ability to Promoting Process Improvement, Forecasting, Corporate Finance, Developing Budgets, Financial Skills, Dealing with Complexity
• Excellent communications skills, both written and verbal.
• Ability to travel as needed.
• Work outside the normal office hours as required.

EEO Statement:

Beyond Cancer 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.

CFO - Beyond Cancer: Apply Now

Head of Clinical Research and Development

The Head of Research and Clinical 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.

Head of Clinical Research and Development - Garden City, NY: Apply Now

Special Projects Manager to the CEO

The role will be to act as a resource to the CEO across all strategic and operational initiatives, activities, deliverables and special projects. The role will assist the CEO in supporting operational, clinical research, commercial & engineering leaders to identify and implement priorities, track project status, timelines, strategic initiatives, and revisit them regularly to assess progress. You will act as a key thought partner for identifying solutions to challenges across the organization.

Responsibilities

• Work alongside the CEO to assist on all aspects of company growth and operations
• Respond to the day-to-day needs of the CEO including preparing presentations and correspondence, taking notes at meetings the CEO attends, attending internal meetings on behalf of the CEO and organize project tracking.
• Maximize CEO's reach across the organization. .
• Support on areas related to corporate matters and cross-team project management of large-scale company initiatives.
• Manage high priority initiatives with timely delivery
• Researches, compiles and prepares various data for reports and analysis
• Think strategically to identify opportunities for improved communication flow, innovation, and efficiency across departments
• Engage in, support and implement high priority projects and special assignments
• Work with executive staff to prepare CEO for internal and external meetings, presentations and events; provide staff support to/at external meetings, activities and events and ensure timely follow up of all action items
• Provide ad hoc support on projects small to large; this could include research, supporting the roll-out of internal initiatives, project management, and more

 

Qualifications

• Experience working in the life sciences industry
• Bachelor’s degree in a Science-related field
• Excellent verbal and written communication skills
• 5 years of experience in business administration, operations or leadership
• 5 years of experience working/managing projects
• Organized and detail oriented, with the ability to prioritize competing priorities
• Creative problem solver willing to think outside the box
• Maintain strict confidentiality.
• Medical or scientific background
• Product and/or engineering-minded a strong plus
• Ability to establish effective working relationships, professional rapport, and effectively accomplish work within a setting that includes a wide array of policies, processes, individuals, and groups.
• Demonstrated experience working in a fast-paced environment, preferably with growing startups
• Intellectual curiosity and personal integrity
• Proficiency with MS Office Suite

 

EEO Statement:

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

Special Projects Manager To The CEO: Apply Now