Hybrid Director, Medical Affairs – Parenteral Nutrition

at Fresenius Kabi USA

• Job title: Director, Medical Affairs – Parenteral Nutrition
• Job type: Full Time
• Experience level: Lead
• Salary: $200,000 - $220,000 per year
• Degree requirement: Professional Certificate
• Location requirements: Hybrid, Lake Zurich, United States

About the role

• Director of Medical Affairs at Fresenius Kabi managing medical affairs for parenteral nutrition products. Leading strategies for drug development and lifecycle management in pharmaceuticals.

Responsibilities

• 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 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.
• 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 identifies 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.

Requirements

• Medical/clinical professional degree required (PharmD or MD).
• Pharmacology knowledge required.
• 10+ years of experience in the pharmaceutical industry in a medical affairs or clinical development role required.
• 3+ years’ hands-on experience in hospital and/or home infusion pharmacy settings required, with demonstrated expertise in sterile compounding of injectable medications, including Total Parenteral Nutrition (TPN).
• 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.
• Experience in managing and developing high-performing teams is required.
• 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.
• 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.
• 20-30% travel (about 5-6 conferences per year).

Benefits

• Position is eligible to participate in an annual bonus plan with a target of 16% of the base salary.
• Position is eligible to participate in our medium-term incentive plan.
• 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.