Fort Lee Director, Global Medical Affairs, Immunoglobulin NJ 07024

Job description

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization. Job Summary Shape the medical strategy that advances immunoglobulin therapies and helps address meaningful unmet needs for patients. Lead the development and execution of Medical Affairs strategy for the Immunoglobulin therapeutic area within Kedrion’s global organization. In this highly collaborative role, you’ll provide medical and scientific leadership across the product lifecycle, working with Clinical Research, Marketing, Regulatory Affairs, Drug Safety, Business Development, and other cross-functional partners. You’ll build relationships with clinical experts and investigators, translate emerging evidence and real-world insights into Medical Affairs priorities, and help strengthen Kedrion’s scientific presence within the medical community. What you'll do Lead the development and execution of global Medical Affairs strategy and tactical plans for the Immunoglobulin therapeutic area. Partner with Marketing and other functions to shape portfolio strategy and contribute to lifecycle management initiatives. Maintain deep medical-scientific expertise by monitoring relevant literature, emerging evidence, treatment trends, and developments within the therapeutic area. Collaborate with Clinical Research on relationships with KOLs and investigators and on the development of global clinical and observational studies. Serve as a core contributor to Drug Safety teams supporting approved products and assets in development. Partner with Regulatory Affairs to develop medical content addressing unmet needs and the treatment landscape and provide medical review of regulatory documents. Build and engage a strong network of clinical experts to generate insights into clinical practice, evolving treatments, and unmet medical needs. Develop and execute scientific communication plans, including publications and scientific symposia. Evaluate and recommend evidence-generation opportunities that deepen understanding of clinical practice and inform future Medical Affairs activities. Contribute to educational materials for licensed Kedrion products and participate in appropriate internal training activities. Review clinical study materials, including protocols and clinical study reports, in collaboration with Clinical Research. Support Business Development by analyzing clinical data and providing scientific perspectives on diseases, treatment options, and unmet needs. Represent Kedrion with credibility and integrity across medical and scientific communities and patient organizations. Lead therapeutic-area cross-functional meetings and provide medical expertise and leadership on relevant cross-functional committees. Attend scientific congresses, gather relevant insights, and stay current on scientific developments important to Kedrion. Foster strong collaboration between Medical Affairs and cross-functional teams to advance therapeutic-area priorities. Qualifications and need-to-know MD, PharmD, PhD, or master’s degree in a life sciences discipline. 10+ years of progressive experience in pharmaceutical/biotech Medical Affairs, clinical development, or academic/clinical practice, including at least 5 years of Immunoglobulin experience. Deep expertise in the relevant therapeutic area, US and global healthcare and regulatory environments, including FDA compliance and Good Clinical Practice, and evidence-based medicine. Experience with product launches, lifecycle management, and evidence generation. Demonstrated experience managing, mentoring, and developing cross-functional team members. Proven proficiency delivering live engagements to healthcare professionals and staff. Strong written and verbal communication skills, with strong organizational and time-management capabilities. Proficiency in Microsoft Office applications. Ability to travel up to 70% domestically and/or internationally for activities including KOL engagements and scientific congresses. Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future. Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications. Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including: Medical, vision and dental insurance Life and AD&D insurance Paid holidays PTO accrual and much more! Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have! If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com . Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security. Apply now © Kedrion 2025 / Kedrion S.p.A Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. 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