Transforming Cancer Therapy Together
At ADC Therapeutics, we are passionate about revolutionizing cancer treatment. When you join our team, you become part of a mission-driven group of talented individuals dedicated to making a difference in patients' lives.
Why ADC Therapeutics
ADC Therapeutics (NYSE): is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other agents and in earlier lines of DLBCL therapy as well as in indolent lymphomas including follicular lymphoma and marginal zone lymphoma with the potential to reach significantly more patients through expanded use.
We are a team of approximately 150 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.
Summary:
The Director, Medical Information, Content & Review is an individual contributor responsible for leading the Medical Information function and providing strategic leadership across Medical Affairs content development, medical review, and scientific training. This role ensures that accurate, current, balanced, and scientifically rigorous medical information is effectively developed and communicated to healthcare professionals, internal stakeholders, and other appropriate audiences.
The Director will have functional ownership of Medical Information strategy and operations, including medical inquiry management, development of scientific response content, literature surveillance, oversight of the outsourced Medical Information contact center, vendor and budget management, metrics and insights, and maintenance of compliant and audit-ready processes. In addition, the role will represent Medical Affairs in the review of promotional materials and oversee the medical review of non-promotional materials to ensure medical accuracy, scientific integrity, and appropriate balance. The Director will also work across medical affairs to develop and support scientific training, including onboarding and ongoing scientific training for Medical Affairs and Field Medical colleagues.
What You'll Do:
- Medical Information: Provide Medical Information strategy, inquiry management, scientific response content, literature surveillance, processes, policies, quality standards, metrics, insights, and continuous improvement.
- Scientific Response Content: Oversee the development and maintenance of high-quality Medical Information resources, including standard response letters and other scientific response materials, ensuring content remains accurate, balanced, evidence-based, current, and compliant.
- Medical Information Contact Center: Provide strategic and operational oversight of the outsourced Medical Information contact center, including vendor onboarding and ongoing disease-state, product, and escalation training, budget oversight, service-level agreements, KPIs, quality, customer experience, compliance, and audit readiness.
- Content Development: Lead or oversee development of key Medical Affairs resources, including standard response letters, Field Medical resources, scientific decks, congress materials, training materials, and medical website/digital content.
- Unsolicited Requests: Ensure all responses to unsolicited requests, including off-label inquiries, are scientifically accurate, balanced, and consistent with applicable regulations, guidance, and company policies. Train internal colleagues on how to identify unsolicited requests and route them to Medical Information.
- Medical and Promotional Review: Own the medical review of non-promotional materials and represent Medical Affairs in the review of promotional materials, providing scientific and medical expertise to support accuracy, currency, appropriate context, and fair and balanced presentation of data. Partner with Legal, Regulatory, Compliance, Commercial, and Medical colleagues to establish and continuously improve efficient, consistent, and compliant content review processes.
- Adverse Event & Product Complaint Handling: Ensure that adverse events, product quality complaints, and other safety-relevant information received through Medical Information channels, including the outsourced contact center, are identified, documented, and sent to Drug Safety/Pharmacovigilance and Quality within required timelines. Partner with these functions on intake processes, reconciliation, vendor training, and audit and inspection readiness.
- Medical Training: Work across medical affairs to develop and support Medical Affairs scientific training, including onboarding and ongoing disease-state, product, pipeline, and clinical-data training; support readiness for major data releases and congresses.
- Compendia, Guidelines & Pathways: Monitor the compendia, clinical guideline, and pathway landscape; identify appropriate opportunities for submissions or communications; and lead Medical Affairs activities related to compendia, guidelines, and clinical pathway submissions, in partnership with Market Access.
- Inquiry Insights: Establish processes to monitor and analyze Medical Information inquiries and customer interactions, identify emerging questions, knowledge gaps, and trends, and communicate actionable insights to Medical Affairs leadership and relevant cross-functional stakeholders.
- Scientific Expertise: Maintain current knowledge of relevant scientific literature, treatment guidelines, therapeutic-area developments, competitive data, and internal clinical data and apply this expertise across Medical Information, content, review, and training activities.
- Launch & Data-Release Readiness: Provide strategic Medical Information, content, review, and training support for new product launches, new indications, major clinical data releases, congresses, and other significant scientific milestones.
- Governance & Compliance: Develop, maintain, and continuously evaluate Medical Information and content-related policies, SOPs, work instructions, and processes to ensure appropriate governance, quality, consistency, compliance, and inspection readiness.
- Cross-Functional Partnership: Build strong working relationships across Medical Affairs and with Clinical Development, Drug Safety/Pharmacovigilance, Regulatory Affairs, Legal, Compliance, Commercial, Market Access, and other stakeholders to ensure coordinated scientific communication and effective execution of Medical Affairs priorities. Actively partners with contact centers (Patient Support/Access) to ensure coordinated and efficient handling of inquiries.
- Vendor & Budget Management: Manage external vendors and associated budgets within the role's areas of responsibility, ensuring appropriate scope, quality, performance, and stewardship of resources.
- Other duties, as assigned.