Fresenius Kabi USA

The Senior Director of 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.

• Salary Range: $292,500-313,100

• Position is eligible to participate in an annual bonus plan with a target of 22% of the base salary.

• Position is eligible to participate in our medium-term incentive plan.

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

• Role may be REMOTE if candidate can travel to our HQ in Lake Zurich, IL one week a 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.

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

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.