Responsibilities

• Lead the strategic planning, launch, and lifecycle support of nutrition products including high-risk medications.
• Lead the development and execution of medical affairs strategy to support successful product launch ensuring alignment with commercial, clinical development, regulatory teams and internal stakeholders.
• Maintain the highest levels of professional integrity & performance standards by consistently providing high quality medical deliverables on time. Maintains a high standard for medical and scientific accuracy, representative of a comprehensive understanding of the medical concept at hand. Maintains a high level of professional expertise by staying abreast of current medical landscape with regard to key clinical conditions our products support.
• Identify, engage, and build strong relationships with Key Opinion Leaders (KOLs), influencers in HCP community, scientific experts, and medical societies to support scientific exchange and advocacy.
• Lead the nutrition team ensuring achievement of compliant and effective healthcare professional interaction for scientific exchange related to disease states and/or associated Company products per predefined engagement plans and targets.
• Establish and maintain relationships with HCPs and HCDMs to provide scientific exchange related to disease states and/or associated Company products.
• Represent the company at major medical and scientific conferences; manage planning and coordination of congress activities, including symposia, medical affairs booth presence, and thought leader engagements.
• Oversee publication planning and execution, including abstracts, posters, manuscripts, and scientific communications, ensuring timely and 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 (IITs), including review, approval, and ongoing collaboration with investigators.
• Collaborate cross-functionally to design and implement company-sponsored clinical studies to support product differentiation, real-world evidence generation, cost-effectiveness analysis, HEOR studies and post-marketing commitments.
• Lead and manage a team of medical affairs professionals; provide coaching, development, and performance management to ensure high team effectiveness.
• Collaborate with Global Medical Affairs in the support of USA-based clinical trials, both internal and external.
• Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications.
• Serve as a medical expert for on market parenteral nutrition products, products in development, and potential acquisition targets providing medical affairs strategies and due diligence for on market products and business development opportunities.
• Responsible for writing and/or review of relevant Standard Operating Procedures (SOPs) pertaining to the role as needed.

Job Requirements:

• Medical/clinical professional degree required, such as Licensed Registered Dietitian.
• Clinical Nutrition knowledge is required.
• 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required.
• 3+ years of hands-on experience in patient care and in hospital and/or clinic and/or home infusion settings is required, with demonstrated expertise in clinical nutrition including experience in managing formula selection for oral nutritional supplement use and tube feeding regimens.
• 5+ years of clinical experience preferred.
• 5+ years of direct people management experience with demonstrated ability to develop and lead high-performing teams.
• Ability to understand and interpret the regulatory requirements under which drugs and devices are developed, reviewed, and supported after approval.
• Experience with the clinical drug development process and product launch experience is highly preferred.
• Scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents.
• Position will require travel (20-50%), including overnight stays. A valid US driver’s license and clean driving record are required.
• Ability to understand and interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required.

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 contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.