Director, Medical Affairs – Parenteral Nutrition
Fresenius Kabi USA
full-time
Posted on:
Location Type: Hybrid
Location: Lake Zurich • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $200,000 - $220,000 per year
Job Level
Lead
About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PharmDMDPharmacologysterile compoundingTotal Parenteral Nutrition (TPN)clinical drug developmentscientific researchmedical writingFDA 505(b)2clinical summaries
Soft skills
leadershipteam managementcoachingcommunicationrelationship buildingstrategic planningperformance managementcritical evaluationscientific accuracyprofessional integrity