Director, Medical Information, Content & Review (Remote)

ADC Therapeutics•New Providence, NJ

18h•Remote

About The Position

The Director, Medical Information, Content & Review is an individual contributor who leads the Medical Information function and provides strategic leadership across Medical Affairs content development, medical review, and scientific training. The role ensures accurate, current, balanced, and scientifically rigorous medical information is developed and communicated to healthcare professionals, internal stakeholders, and other appropriate audiences. The Director owns Medical Information strategy and operations, including inquiry management, scientific response content, literature surveillance, oversight of the outsourced Medical Information contact center, vendor and budget management, metrics and insights, and compliant, audit-ready processes. The role also owns medical review of non-promotional materials and represents Medical Affairs in promotional review, ensuring medical accuracy, scientific integrity, and appropriate balance. In addition, the Director works across Medical Affairs to develop and support scientific training for Medical Affairs and Field Medical colleagues. The position supports launches, new indications, major clinical data releases, congresses, and other significant scientific milestones. It partners with internal functions and external vendors to ensure coordinated scientific communication and effective execution of Medical Affairs priorities. Travel is less than 10%.

Requirements

PharmD, PhD, MD, or other relevant advanced scientific or clinical degree required.
Minimum of 8 years of relevant pharmaceutical or biotechnology industry experience, including significant experience in Medical Information.
Demonstrated experience developing and maintaining Medical Information content, including scientific response materials.
Demonstrated experience in Medical Affairs content development and translating complex scientific and clinical information into clear, accurate, audience-appropriate communications.
Experience performing medical/scientific review of non-promotional materials and representing Medical Affairs in promotional review processes.
Strong understanding of Medical Information requirements, scientific communication principles, pharmaceutical industry standards, and applicable regulatory and compliance considerations.
Ability to independently lead complex initiatives and functional responsibilities in a cross-functional, matrixed organization.
Working knowledge of U.S. requirements for unsolicited requests, adverse event and product complaint reporting, and promotional review.
Strong scientific acumen and ability to critically evaluate clinical data, scientific literature, treatment guidelines, and other sources of medical evidence.
Excellent written and verbal communication skills, including the ability to communicate complex scientific concepts clearly and accurately to scientific and non-scientific audiences.
Strong project management, prioritization, problem-solving, and decision-making skills, including the ability to manage multiple priorities in a fast-paced biotechnology environment.
Ability to build effective relationships and influence cross-functional stakeholders without direct authority.
Travel requirement of less than 10%.

Nice To Haves

Hematology/oncology experience.
Experience developing or delivering Medical Affairs scientific training and onboarding programs.
Experience managing outsourced Medical Information contact centers and/or other external Medical Affairs vendors.
Product launch and major clinical data-release experience.
Experience with compendia, clinical guideline, and/or clinical pathway submissions.
Experience managing vendors and budgets.

Responsibilities

Lead Medical Information strategy and operations, including inquiry management, scientific response content, literature surveillance, processes, policies, quality standards, metrics, insights, and continuous improvement.
Oversee development and maintenance of Medical Information resources, including standard response letters and other scientific response materials, ensuring they remain accurate, balanced, evidence-based, current, and compliant.
Provide strategic and operational oversight of the outsourced Medical Information contact center, including vendor onboarding and training, budget oversight, service-level agreements, KPIs, quality, customer experience, compliance, and audit readiness.
Lead or oversee Medical Affairs content development, including standard response letters, Field Medical resources, scientific decks, congress materials, training materials, and medical website or digital content.
Ensure responses to unsolicited requests, including off-label inquiries, are scientifically accurate, balanced, and consistent with applicable regulations, guidance, and company policies; train colleagues to identify and route unsolicited requests.
Own medical review of non-promotional materials and represent Medical Affairs in promotional review, ensuring scientific accuracy, currency, context, and fair and balanced presentation of data.
Partner with Legal, Regulatory, Compliance, Commercial, and Medical colleagues to establish and improve efficient, consistent, compliant content review processes.
Ensure adverse events, product quality complaints, and other safety-relevant information received through Medical Information channels are identified, documented, and sent to Drug Safety/Pharmacovigilance and Quality within required timelines.
Partner with Drug Safety/Pharmacovigilance and Quality on intake processes, reconciliation, vendor training, and audit and inspection readiness.
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.
Monitor compendia, clinical guidelines, and pathways; identify opportunities for submissions or communications; and lead Medical Affairs activities related to submissions in partnership with Market Access.
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 stakeholders.
Maintain current knowledge of scientific literature, treatment guidelines, therapeutic-area developments, competitive data, and internal clinical data, applying it across Medical Information, content, review, and training.
Provide strategic Medical Information, content, review, and training support for launches, new indications, major clinical data releases, congresses, and other significant scientific milestones.
Develop, maintain, and evaluate Medical Information and content-related policies, SOPs, work instructions, and processes to support governance, quality, consistency, compliance, and inspection readiness.
Build working relationships across Medical Affairs and with Clinical Development, Drug Safety/Pharmacovigilance, Regulatory Affairs, Legal, Compliance, Commercial, Market Access, and other stakeholders.
Partner with Patient Support/Access contact centers to coordinate and efficiently handle inquiries.
Manage external vendors and associated budgets, ensuring appropriate scope, quality, performance, and stewardship of resources.
Perform other duties as assigned.

Benefits

Competitive biotech base salary.
Annual target bonus, with eligibility based on company performance.
New hire stock options.
Medical, dental, and vision benefits starting on the first day of employment.
401(k) with company match.
Paid time off and company holidays, including a company-wide end-of-year shutdown.
Paid parental leave.
Life and disability insurance.
Tax-advantaged health savings and spending accounts.
Hands-on, collaborative culture with passionate biotech professionals.
Mission-driven work focused on patients.