Role Summary
The Director, Medical Information will establish and lead the Medical Information function in support of two rare disease programs (encaleret for Autosomal Dominant Hypocalcemia Type 1 and chronic hypoparathyroidism; infigratinib for skeletal dysplasia). This role combines strategic direction with operational leadership to develop, approve, and deliver high-quality, accurate, and compliant medical information to internal and external stakeholders, working across Medical Affairs, Clinical Development, Regulatory, Pharmacovigilance, Commercial, and external vendors.
Responsibilities
- Develop and implement the global Medical Information strategy for encaleret and infigratinib, aligned with overall Medical Affairs and program objectives
- Serve as the subject matter expert and functional lead for Medical Information across both assets
- Oversee development, review, and maintenance of Medical Information materials, including core response documents, FAQs, and standard response letters
- Ensure scientific accuracy, medical rigor, and content consistency; ensure Medical Information activities comply with applicable regulations, company policies, and industry standards
- Partner with Clinical and Translational teams to incorporate latest data and insights
- Establish and oversee SOPs, workflows, and quality controls for intake, response, documentation, and reporting of Medical Information inquiries
- Partner with Pharmacovigilance to ensure appropriate adverse event and product complaint reporting
- Manage external Medical Information vendors, including scope definition, training, quality oversight, and performance metrics
- Oversee intake and response to unsolicited medical inquiries from healthcare professionals, patients, and other stakeholders
- Collaborate with Field Medical, Publications, Commercial, and Patient Advocacy teams for aligned scientific messaging and seamless stakeholder experience
- Provide Medical Information insights and monitor inquiry trends to inform medical strategy, evidence generation, and educational initiatives
Qualifications
- Required: Advanced degree (MD, PharmD, PhD, or equivalent)
- Required: 8+ years of experience in Medical Information and/or Medical Affairs within biotechnology or pharmaceutical settings
- Required: Demonstrated experience leading Medical Information strategy and operations, including vendor management
- Preferred: Experience in rare disease and/or endocrinology, metabolic disease, or skeletal disorders
- Required: Deep understanding of Medical Information compliance, regulations, and industry best practices
- Required: Strong leadership, communication, and cross-functional collaboration skills
- Required: Ability to operate effectively in a fast-paced, matrixed, and evolving organization
- Required: High level of scientific curiosity, attention to detail, and commitment to patient-focused medical excellence
Additional Requirements
- This is a U.S.-based remote role that will require quarterly, or as-needed visits to the San Francisco office