Senior Manager, Medical Affairs and Clinical Sciences

Senior Manager, Medical Affairs and Clinical Sciences

Job Summary

We are seeking a Senior Manager, Medical Affairs and Clinical Sciences to support product and clinical education and training internally and to external stakeholders, identify and engage patient advocacy groups through collaborative partnerships to enhance educational initiatives and to advise the department on matters of strategic importance.

Additionally, this role will lead efforts related to safety related workstreams as well as support clinical operational related activities.

This role involves strategic planning and cross functional team leadership projects ensuring that all are executed in a compliant manner.

The ideal candidate will have a strong clinical and safety background and patient facing experience, communication skills with a focus on medical devices, and a proven track record leading compliant activities.

Responsibilities (Specific tasks, duties, essential functions of the job)



* Design and implement clinical training curriculums by assessing and analyzing organizational, HCP, and patient advocacy requirements, and by obtaining educational content through participation in cross-functional teams.


* Develop approach, scope, and methodology of training to maximize impact by determining target audience, time, location requirements, and other applicable factors.


* Conduct post-program evaluations of content, remain aware of all changes that may impact training requirements, and implement changes/improvements to training protocols and materials accordingly.


* Lead the efforts of establishing strong relationships with relevant patient advocacy groups and identify gaps in patient education and areas of improvement.


* Work closely with the sales organization to support team’s ability to understand clinical information and identify insights based on field experience


* Provide technical and clinical instruction of a complex nature during various interactions with different internal and external stakeholders including physicians and respiratory therapists


* Be the primary clinical touch point of the department for the sales, patient services, and training groups within the organization


* Create insights-based summary on a regular basis to guide the MA department strategy based on various stakeholder engagement


* Learn the company's products as well as the competitor's products to better educate the product portfolio and be up to date on the literature


* Lead on key compliance related activities such as post-marketing surveillance, HHEs, CER and CEP activities


* Assist clinical operations in portfolio document storage activities, departmental SOP training, and ensure various education and training related materials are stored in easily accessible repositories


* Assist and support in departmental clinical trial activities including oversight and execution of clinical trials in compliance with required processe...