Associate Director Medical Information Oncology

Job description

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Position Summary: The Associate Director, Medical Information (Oncology) is responsible for the medical review of promotional materials across the life cycle of a product, including launch execution. This role partners closely with Medical Affairs, Commercial, Market Access, Regulatory, Legal, Corporate Communications, and Compliance to ensure materials are medically accurate, balanced, supported by appropriate evidence, and consistent with applicable FDA requirements and guidance. The role requires strong oncology experience, deep scientific expertise and sound judgment, and the ability to provide clear and practical guidance during the review process. Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager. Domestic and international travel may be required: 2-3 times per year. Responsibilities will include, but are not limited to, the following: Serve as the medical reviewer for promotional materials, including but not limited to disease-state education, product materials, core visual aids, congress booth materials, training materials, and payer communications as well as patient education materials and patient support services materials. Evaluate materials for medical accuracy, fair balance, clinical relevance, appropriate presentation of data, and consistency with available evidence. Participate in concept reviews to provide recommendations for development of materials. Provide medical guidance during cross-functional review meetings and work with stakeholders to resolve scientific and medical review questions. Conduct and document consistent-with-FDA-required-labeling (CFL) and scientific information for unapproved use (SIUU) analyses which include scientifically appropriate and statistically sound (SASS) assessments. Support launch readiness and execution as a medical reviewer of promotional materials. Maintain current knowledge across relevant oncology therapeutic indications, the broader solid tumor landscape, relevant treatment guidelines, emerging clinical data, and competitor activity. Work with Medical Affairs, Commercial, Market Access, Regulatory, Legal, Corporate Communications, Compliance, and Training to support accurate and consistent product communications. Contribute to medical review operating procedures, training, and process-improvement initiatives. Work with agencies and other external partners involved in content development and review to provide guidance and training on appropriate use of references. Communicate with the Medical Information team to inform on key marketing initiatives. Serve as a preceptor to fellows/students and provide guidance to other members of the Medical Information team. Experience & Skills: Advanced scientific or healthcare degree, such as a PharmD, PhD, MD, or equivalent required. Minimum 5 years of pharmaceutical or biotechnology industry experience, including direct experience in medical, promotional, or medical-legal-regulatory review of oncology products. Experience supporting product or indication launches in oncology, including familiarity with Veeva PromoMats. Experience reviewing payer, health-economic, or real-world evidence communications. Working knowledge of FDA requirements and guidance related to prescription-drug promotion and scientific communications. Ability to communicate medical review decisions and recommendations clearly and align with cross-functional stakeholders to ensure medical integrity. Strong written and verbal communication skills. Ability to manage multiple projects and work effectively in a cross-functional environment. Firm understanding of the drug development process including key phases and processes. Demonstrated ability to build alignment, negotiate and collaborate. Strong leadership and organization skills with a solutions orientated approach driving optimal business results in a complex matrix environment. Must be a strong team player and be willing to work in a high-paced environment where individual initiative and accountability to the team are required. For US based candidates, the proposed salary band for this position is as follows: $157,600.00---$236,400.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X . Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com) . Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.