Fresenius Medical Care North America VP of Medical Support in Waltham, Massachusetts
Job ID 20000A8E
Available Openings 1
Position Specific Information This position can be located anywhere in the country and can be fully remote
PURPOSE AND SCOPE:
The Vice President of Medical Support will be responsible for providing scientific and medical support for product development, quality systems including risk analysis, manufacturing and regulatory affairs. This will include defining development plans, aiding in the creation of clinical protocols and study conducts, Medical monitoring for clinical trials, supporting regulatory affairs submissions, providing medical input in risk analyses, and supporting R&D and Quality teams as needed.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provide strategic leadership of overall objectives through the application of thoughtful techniques in the communication of the company’s mission and core values as a means to effect positive change and/or create organizational structure within the assigned business unit(s)
Ensure that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and the recommendation and implementation of current practices.
Provide support for Clinical Research and assist in the writing, reviewing and medical oversight of clinical trials:
Contribute to the creation of clinical protocols.
Contribute to creation of investigator brochures (IBs), clinical study reports, and documents dealing with INDs, NDAs, supplements and amendments.
Supervise clinical trials as designated.
Respond to medical questions relating to the clinical trials, from other departments, study sites, authorities and/or other external entities relevant to the trial in question.
Ensure the medical and scientific quality of clinical trial protocols and clinical trial reports
Provide safety review during clinical trial execution, in consultation with the study team and safety oversight committees, including review of safety information and provision of applicable recommendations.
Evaluate adverse events, serious adverse events (SAEs) and safety reports.
Review Serious Adverse Events submitted from the sites to determine the causality of the event in conjunction with the trial safety officer (if applicable) and the relationship of the event to the study product in conjunction with the trial safety officer (if applicable).
Confer with Independent Safety Monitors and actively provide support to Data Monitoring Committee (DMC)/ Clinical Events Committee (CEC) if applicable.
Review the scientific and medical sections of all publications of clinical trial results.
Provide Medical Support for Regulatory Affairs and R&D Device Activities.
Provide medical support for regulatory filings.
Provide medical input for risk analyses, usability studies and R&D development activities.
Interact with the FDA (with Regulatory Affairs) on medical device issues/projects.
Interact with R&D and participate in R&D teams
Medical department subject matter expert in designated therapeutic areas and product development
Ad Hoc Projects
Strategize and brainstorm on scenarios, options, consequences, what if situations, expectations for possible outcomes, etc.
Provide Literature evaluation on specialized issues.
Write summary reports or other special reports
Design and perform special projects as directed.
Create presentations and present at expert meetings.
Other ad hoc projects as directed by the RTG Chief Medical Officer.
Contribute to Advanced Renal Education Program – (ARE P )
Contribute to the development of new modules for AREP as directed by the RTG Chief Medical Officer. Presenting to physicians, Medical Information staff, nurses and patients to support current initiatives.
Present at special symposia, universities and other medical meetings as requested.
Contribute to Specific Medical Device Projects.
Liaison with Products R& and business development.
Provide additional Clinical/Medical support for development and deployment.
Provide additional Clinical/Medical support for development and deployment teams as directed by the RTG Chief Medical Officer.
Communication and other activities
Work with consumer groups.
Lobbying as directed by the RTG Chief Medical Officer.
Work with key opinion leaders.
Work with special contractors (e.g. Medical Device Advice) on business development issues of devices or drugs.
Technical issues: HD, PD, HHD, access, etc.
Performs other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS :
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel may be required 25% SUPERVISION:
May be responsible for the direct supervision of various levels of staff.
- Physician (MD or DO) with specialty in Internal Medicine and Nephrology
EXPERIENCE AND REQUIRED SKILLS:
15+ years experience care of ESRD patients both acute and chronic care
10+ years experience in research
5+ years experience internal senior management level role (e.g., Vice President); or 5+ years external experience in a senior management or leadership level role.
Demonstrated experience managing one or more departments.
Strong management skills with the ability to lead cohesive and productive teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills.
Proven leadership and executive management skills.
Excellent written and verbal communication skills including presentations to medical groups and meetings.
Demonstrated ability to successfully develop and deploy medical management initiatives.
Vision and entrepreneurial approach.
Proven ability to develop/lead teams in the development and delivery of products and services.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.