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
