Director, Medical Affairs (Nutrition)

Job Summary The Director, Medical Affairs (Nutrition) will lead and manage medical affairs for approved nutrition products and those in development. The role supports product pre-launch and launch activities, product development, lifecycle management, business development, and post‑marketing medical affairs strategies. The Director will collaborate cross‑functionally and globally to meet corporate goals, direct the region’s medical needs for drugs and devices, cultivate relationships with health‑care providers and decision makers, maintain scientific expertise in treatment guidelines and clinical data, communicate complex medical concepts, and support execution of medical affairs strategy. Priority is for candidates in the Chicagoland area who can regularly work at the Lake Zurich, IL site. The position does not offer visa sponsorship. Responsibilities Lead the strategic planning, launch, and lifecycle support of nutrition products, including high‑risk medications. Develop and execute medical affairs strategy to support product launches, ensuring alignment with commercial, clinical development, regulatory teams, and internal stakeholders. Maintain professional integrity and high‑quality medical deliverables on time, ensuring scientific accuracy. Keep current with the medical landscape for key clinical conditions supported by the products. Identify, engage, and build relationships with key opinion leaders, influencers, scientific experts, and medical societies to support scientific exchange and advocacy. Lead the nutrition team to achieve compliant and effective interactions with healthcare professionals per engagement plans and targets. Establish and maintain relationships with HCPs and decision makers for scientific exchange. Represent the company at major medical and scientific conferences, manage congress activities including symposia, booth presence, and thought‑leader engagements. Oversee publication planning and execution—abstracts, posters, manuscripts, and scientific communications—ensuring timely, compliant dissemination of clinical data. Drive medical education initiatives for internal and external stakeholders, including training programs, advisory boards, and peer‑to‑peer education aligned with the product’s scientific platform. Provide scientific leadership and oversight for investigator‑initiated trials, including review, approval, and collaboration with investigators. Collaborate cross‑functionally to design and implement company‑sponsored clinical studies supporting product differentiation, real‑world evidence generation, cost‑effectiveness analysis, HEOR studies, and post‑marketing commitments. Lead and manage a team of medical affairs professionals; coach, develop, and manage performance to ensure high effectiveness. Collaborate with Global Medical Affairs in supporting USA‑based clinical trials, both internal and external. Review, develop, and approve clinical summaries for NDA 505(b)(2), ANDA, and NDA submissions. Serve as a medical expert for on‑market parenteral nutrition products, products in development, and potential acquisition targets, providing due diligence and strategy. Write and review relevant SOPs as needed. Travel 20‑50%, including overnight stays, and maintain a valid U.S. driver’s license with a clean driving record. Job Requirements Medical or clinical professional degree; Licensed Registered Dietitian preferred. Clinical nutrition knowledge. 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role. 3+ years of hands‑on patient‑care experience in hospital, clinic, or home infusion settings, including management of formula selection for oral supplements and tube feeding regimens. 5+ years of clinical experience preferred. 5+ years of direct people‑management experience with demonstrated ability to develop high‑performing teams. Ability to understand and interpret regulatory requirements under which drugs and devices are developed, reviewed, and supported post‑approval. Experience with the clinical drug development process and product launch experience preferred. Scientific research and writing skills; ability to evaluate literature and write medically accurate, scientifically fair‑balanced documents. Knowledge of FDA 505(b)(2), 505(b)(1), 505(j) submission requirements. Knowledge of PC systems and Microsoft Office Suite (Word, Excel). Valid U.S. driver’s license and clean driving record. Benefits Annual bonus plan with a target of 16% of base salary. Medium‑term incentive plan. Comprehensive benefits including 401(k) with company contributions, paid vacation, holiday and personal days, employee assistance program, medical, prescription drug, dental, and vision coverage. Other health and wellness programs. Equal Opportunity Employer 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. #J-18808-Ljbffr 301044 Fresenius Kabi USA, LLC