Senior Director, Medical Affairs
Denver, CO, United States
Job Summary The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and execution of clinical developments supporting new product development and product changes and contribute to post-market evaluations according to applicable regulations. Positively impact the business relative to product development strategies, with consideration for medical benefit and value differentiation, as well as resource planning and cost. As a member of the MedTech R&D leadership, participate in decision making within the business, including alignment with internal and external peers in support of MedTech R&D goals.
*This position may be worked remotely, with an expectation of traveling to our Lake Zurich, IL U.S. headquarters one week per month. Responsibilities
Liaison with Global Medical Director, MedTech to develop and implement medical strategy that supports and meets company strategies, performance objectives and relevant healthcare provider expectations.
Provide functional expertise in medical and clinical strategies in support of R&D product development and sustaining initiatives.
Provide medical safety inputs, including product harms/hazard, risk management plans and reports, risk assessment of product changes, and health/hazard assessments.
Participate in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Includes design, execution, analysis, interpretation, and reporting of scientific content of protocols and clinical study reports, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, customers, markets, business operations, and emerging issues.
Develop highly effective relationships with other functions including R&D team, commercial team and global and/or divisional medical functions with other segments of Fresenius Kabi.
Develop and maintain external network of healthcare providers, KOL's and experts in fields of transfusion, therapeutics, cell therapy, and infusion, to gain insights and help shape direction of product development in line with Fresenius Kabi's business objectives.
Manage strategy, develop targets, and process for US Key Opinion Leader and HCP scientific exchange in PN.
Engage with 3rd parties to identify, evaluate, and provide medical input for Investigator Initiated Trials (IIT).
Liaison with internal and external post-market medical function to given inputs as needed for regulated post-market processes such as such as Clinical Evaluation Plans and Reports (CEP and CER), Period Safety Update Reports (PSURs).
Manage Lake Zurich Donor Room and Medical Affairs support staff, and associated budget for department.
If licensed in Illinois, provide medical oversight for the Donor Room, including CLIA-waived testing. If not licensed in Illinois, then liaison with external medical director contracted for this purpose.
This job position within the Business Unit - Transfusion and Cell Technologies (BU-TCT) of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).
Job Requirements:
Medical Degree required. Active physician license in the U.S preferred.
Board certified clinical pathologist and/or Transfusion Medicine preferred
12+ years of medical experience in the regulated pharmaceutical or medical device industry
7 years of management experience preferred
Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of clinical strategy and the design of study protocols
Experience in development of FDA class II and III medical devices and associated solutions (pharmaceuticals), PMA products; experience in development of CE Mark class IIa, IIb, and III devices also preferred
Experience in blood collection, therapeutic and cellular therapies, and infusion
Must have advanced skills in Microsoft Office applications including Word, Excel and PowerPoint
Position can be REMOTE, but expectation to be present in office at least one week per month
Travel domestically and internationally as required
Anticipated base salary range: $188,716-300,000 annually
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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