Senior Director, Medical Information

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and oversee the Medical Information function to support both product launches and future pipeline expansion.

• Create a comprehensive Medical Information strategy encompassing infrastructure, content, governance, workflows, intake and triage processes, response standards, escalation pathways, and content lifecycle management.

• Formulate and uphold Medical Information SOPs, work instructions, training standards, and quality assurance processes.

• Outline the technology roadmap for Medical Information, which includes inquiry management, content repositories, literature surveillance, analytics, and suitable AI-enabled tools.

• Direct the onboarding, integration, training, and ongoing administration of the Medical Information call center vendor.

• Ensure call center launch readiness by managing systems, content, workflows, escalation pathways, safety and product complaint reporting, service levels, and business continuity.

• Create vendor training and certification protocols.

• Manage complex and escalated inquiries while connecting the vendor with internal scientific experts.

• Set vendor KPIs, oversee quality monitoring, governance, audit readiness, and corrective-action processes.

• Spearhead the content strategy for Medical Information, including the development of Standard Response Letters, tailored medical responses, FAQs, and other scientific response documents.

• Conduct literature reviews, data synthesis, and formulate responses to complex or novel unsolicited inquiries.

• Assist with scientific congresses by providing inquiry coverage, reference materials, escalation planning, and updates post-congress.

• Oversee the development and lifecycle management of AMCP dossiers and other payer evidence materials.

• Lead the creation and submission of evidence packages to the NCCN Drugs & Biologics Compendium.

• Facilitate evidence submissions for various oncology guidelines and clinical pathways.

• Act as a scientific reviewer in PRC/MLR/MRC processes.

• Support post-approval long-term follow-up obligations for cellular therapies, including potential participation in the CIBMTR registry and postmarketing evidence initiatives.

• Collaborate with various departments such as Medical Affairs, Clinical, Safety, Regulatory, Legal/Compliance, Market Access, HEOR/RWE, Quality, and Commercial.

• Contribute Medical Information expertise to launch planning, focusing on labeling readiness, content priorities, inquiry forecasting, training, and day-one readiness.

• Establish metrics and reporting for Medical Information, monitor inquiry trends and service performance, and translate findings into Medical Affairs strategy.

• Provide insights and performance updates to Medical Affairs leadership and cross-functional partners.

• Build and enhance the Medical Information organization, including internal talent, contractors, vendor support, medical writing, and technological capabilities.

• Develop annual and long-term plans, setting priorities, identifying resource needs, and budgeting.

• Promote a culture of scientific quality, accountability, collaboration, and practical problem-solving.

⛳️ Requirements

• A Bachelor's degree in life sciences is required.

• 15+ years of experience in pharmaceuticals or biotechnology, with significant exposure to Medical Information and/or Medical Affairs and increasing leadership responsibilities.

• An advanced scientific or clinical degree is mandatory (PharmD, PhD, MD, or equivalent).

• Experience in oncology is strongly preferred.

• Background in cell therapy is highly desirable.

• Proven experience in supporting a U.S. product launch, particularly in an emerging or first-launch biotech environment.

• Experience in building or scaling Medical Information systems, processes, content capabilities, or launch-readiness infrastructure.

• Proficient in developing Medical Information scientific content, including SRLs, custom medical responses, and FAQs.

• Experience managing Medical Information call center vendors, focusing on onboarding, training, escalations, quality, and performance oversight.

• Strong understanding of U.S. Medical Information requirements, unsolicited inquiry responses, pharmacovigilance and product complaint reporting, and relevant compliance standards.

• Exceptional scientific writing and judgment skills, with the ability to articulate complex data into clear, balanced responses.

• Excellent leadership, communication, project management, and cross-functional collaboration abilities.

• Comfortable working in a fast-paced biotech environment with multiple launch-critical priorities.

• Familiarity with payer evidence dossiers, NCCN Compendia or other oncology guideline/pathway submissions, and medical review committees.

• Experience with Medical Information technology platforms, analytics, and emerging AI-enabled capabilities.

• Must possess authorization to work in the United States without current or future sponsorship.

• Successful completion of background checks, reference checks, and pre-employment drug screenings where permitted by law.

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• 4 weeks of vacation, provided upfront each year and prorated for the first and last year of employment.

• 12 company-paid holidays.

• 7 days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-covered short- and long-term disability insurance.

• 401(k) plan with immediate eligibility and company matching.

• Partially paid parental leave for eligible staff members.

• Additional voluntary employee-paid benefits and services, which include accident, hospital indemnity, critical illness insurance, identity theft protection, and pet insurance.

• Fully remote work arrangement.

• Approximately 10–20% travel, including participation in scientific congresses, vendor meetings, and internal meetings; occasional international travel may be necessary.