Director, Medical Affairs; Parenteral Nutrition

Join to apply for the Director, Medical Affairs (Parenteral Nutrition) role at Fresenius Kabi USA
.

Base pay range
: $/yr - $/yr

Additional compensation types
:
Annual Bonus

• Salary range: $,000.
• Position eligible to participate in an annual bonus plan with a target of 16% of the base salary.
• Position eligible to participate in our medium-term incentive plan.
• Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.
• Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits (medical, prescription drug, dental, vision coverage).

Location and Work Hours
:
This position requires working onsite 3 days per week at our U.S. headquarters in Lake Zurich, IL.

Visa Sponsorship
:
This position does not offer visa sponsorship either now or in the future.

• Lead the strategic planning, launch, and lifecycle support of nutrition drugs and devices for sterile IV drug preparation 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 ntains 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.
• 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.
• Work closely with commercial, regulatory, legal, compliance and R&D teams as needed.
• Proactively identify opportunities for efficiency for the medical work stream and cross-functionally to support deliverables of the highest quality.
• Review, develop, and approve clinical summaries in support of NDA 505(b)(2), ANDA, NDA applications.
• Provide scientifically balanced, clear & concise yet comprehensive medical information on pharmaceuticals to external and internal customers.
• 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.
• Select, develop, and evaluate personnel to ensure high level functioning of the department.
• Train staff regarding current knowledge of disease/treatment, applicable local and global regulations, standard operating procedures, and guidelines.
• Responsible for writing and/or reviewing relevant Standard Operating Procedures (SOP’s) pertaining to the role as needed.

• Medical/clinical…