ABOUT THIS ROLE
This position has the responsibility and authority to provide leadership, allocate appropriate resources, and establish processes to facilitate successful execution of a Medical Affairs division. As the Medical Director, you, will principally be responsible for managing a team to develop the following strategic pillars: preclinical and clinical research, outcomes-based data analytics, Key Opinion Leader (KOL) development and management, and sales and marketing clinical support. As Medical Director you will have business-wide influence and responsibility and function as an internal expert resource. You will be actively called upon to provide medical and scientific guidance to leadership and project teams. Secondarily, you will be responsible for medical safety, actively review pre- and post-market products for patient safety and customer usability concerns, including participating in MDR event reviews, Health Hazard Evaluations, updating IFU wording, and creation of durable safety protocols for the business. Lastly, you will provide medical and clinical leadership on business development activities, including product creation and improvements and external acquisition opportunities.
In particular you can expect to:
Be principally responsible for managing the development, execution, and completion of clinical studies, which includes protocol writing, IRB submission, site selection, safety planning, medical monitoring, statistical analysis, manuscript composition, and publication strategy.
Establish best practices for developing, implementing, and maintaining clinical research development processes.
Support commercial organizations with scientific input, customer interactions and scientific presentations.
Engage and manage clinical research organizations (CRO).
Manage a team that builds relationships with key opinion leader (KOL), including development and conducting advisory and study review boards; development of independent research studies; and consulting services.
Provide medical input into the product development process including requirement setting, preclinical test methodology, data analysis, review, and interpretation.
Develop medical opinions, documents and Health Hazard Assessments. Serves as medical representative on Risk Evaluation teams. Assists investigation teams by providing medical input as needed.
Liaise with Quality to provide medical input to risk management files in order to maintain alignment with safety and regulatory requirements for products.
Review and approve medical affairs input into quality & regulatory customer communications, design control activities, technical bulletins and quality directives.
Collaborate with project team members and functional managers to develop project timelines, milestones and budgets.
You will have the opportunity to:
Develop and deliver clinical evidence that supports the safe and effective use of the Companys product.
Develop and execute platform specific clinical strategies, providing oversight to study design (clinical & economic endpoints, patient populations, claims/indications), sites, investigators and publishing strategy
Create a cadence of white papers, posters, and publications to effectively promote the safe and effective use of Vyaire products
Function as the clearinghouse and owner of Vyaires HCP annual need assessment aligning priorities to resources
Provide review and interpretation of medical literature for use in marketing materials and strategic planning
Build appropriate relationships with healthcare professional to advance the company towards our goals.
Develop clinical relationships with key clinicians/institutions for on-going research and data-collection efforts
Support strategic partnership discussions and initiatives
Recruit, organize and manage medical advisory board(s) in support of Product Life-cycle management (cradle to grave)
Support the Companys training and education initiatives.
Support the development and delivery of Med/Professional Education initiatives (accredited & non-accredited)
Provide insight into the development & delivery of sales training materials/curriculum
Interface directly with Sales/Marketing where applicable to ensure proper clinical messaging and advise on sales tool(s) creation
Provide directional review and subject matter expertise to members of the medical affairs team and diverse functional groups, including field sales and customer support
Provide Medical Consultation on products and process.
Collaborate with Regulatory to develop projects and programs to support clearances and filings in initiative NPD activities
Support key customer visits with medical/clinical insights regarding product performance for given procedures and indications
Provide insight to internal needs assessment for HCPs
Support HHE and Medical / Clinical feedback on product performance risk assessment
Participate /guide advanced Research & Development Programs.
Provide insight and support for sustaining engineering programs and projects for existing product lifecycle planning
Partner with Product Development leadership to guide new R+D efforts with design inputs and market needs assessment
Participate with Advance Research teams on the development of disruptive respiratory technologies Essential Functions:
Employee shall secure and maintain the credentials required by Vyaire Medical and its customers. Securing those credentials may require mandatory vaccinations and other tests. (If employee is unwilling or unable to comply with any credentialing requirement because of religious or health/medical/disability related restrictions, Employee must immediately notify Vyaire Medicals Human Resources Department to discuss possible reasonable accommodations regarding those restrictions.)
To be successful, you will need:
MD Degree, > 5 years clinical experience.
3 or more years of patient care beyond residency.
Board certifications in either Pulmonary, Critical Care, and/or Anesthesiology.
2 years experience in medical device industry working in medical affairs. Has provided medical input into product development and patient safety issues.
Track record of managing clinical trials and generating scientific study publications and presentations.
Experience working with and developing key opinion leaders.
Strong leadership skills and ability to effectively influence and work collaboratively within a diverse and global organization
We aspire to a higher calling , aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices.
Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories.
We are transforming the future of respiratory care; explore how you can be a part of it.
We are a unified breathing company, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to do the right thing every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a persons race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person's race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.