The Director, Medical Information (MI) is a strategic leader responsible for building, scaling, and overseeing the MI function to ensure launch readiness and ongoing scientific excellence.
Architect the full MI infrastructure including systems, processes, governance, and content strategy to support the company’s first commercial launch and future portfolio expansion.
Lead to the end-to-end development and maintenance of MI capabilities that enable swift onboarding, integration, and operational readiness of the MI call center vendor.
Collaborate cross-functionally with Medical Affairs, Regulatory, Safety, Clinical Development, Clinical Operations, Compliance, and Commercial partners.
Serve as the internal expert on MI regulations, industry standards, and best practices.
Develop external and internal MI SOPs, work instructions, training materials, and quality monitoring processes.
Ensure readiness and adherence to the internal and external audits is always maintained.
Oversee the development, review, and approval of Standard Response Letters (SRLs), Custom Responses (CRs), and Frequently Asked Questions (FAQs).
Establish and manage MI dashboards to track inquiry trends, operational performance, and scientific insights.

Requirements

Doctoral degree in a health science discipline (PharmD, PhD, MD, or equivalent) required.
Oncology experience strongly preferred.
Minimum of 8+ years of MI experience in the pharmaceutical/biotech industry, with increasing leadership responsibility.
Demonstrated experience building or scaling MI systems, processes, or launch-readiness capabilities.
Proven success overseeing MI call-center vendors, including onboarding, training, and quality oversight.
Strong understanding of drug development, regulatory requirements, and medical affairs operations.
Experience supporting at least one US product launch preferred; first-launch biotech experience a plus.
Exceptional written and verbal communication skills with the ability to translate complex scientific data into clear, balanced information.
Strong leadership presence with the ability to influence across functions and manage external partners.
Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
Proficiency with MS Office, literature search tools, and MI databases; experience with MS Project is a plus.
Ability to travel to scientific congresses and internal meetings (~10%).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

medical informationdrug developmentregulatory requirementsmedical affairs operationslaunch-readiness capabilitiesquality oversightonboardingtrainingscaling MI systemsscientific insights

Soft skills

written communicationverbal communicationleadershipinfluenceorganizational skillsdetail-orientedmulti-priority managementcollaborationstrategic thinkingtraining development

Certifications

Doctoral degreePharmDPhDMD