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Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies for blood cancer patients, aiming to improve survival rates and reduce risks associated with traditional allogeneic stem cell transplants.
The Director of Medical Information will report to the Vice President of Medical Affairs and lead the establishment and management of Orca Bio's global medical information service. This is a key leadership role within the Medical Affairs department during a critical commercial launch phase.
Key Responsibilities:
- Establish the global medical information capability, including budget management, organizational structure, business processes, and systems for disseminating reactive scientific information
- Oversee the Medical Information call center(s) covering necessary geographies, ensuring alignment with standards, processes, and technology
- Collaborate with Safety and QA on post-marketing adverse event and product quality complaint processes, ensuring audit readiness
- Develop and maintain medical information materials including standard response documents, FAQs, and scientific content
- Review and approve promotional and non-promotional materials for accuracy as a member of Medical Review and Promotional Review Committees
- Create dashboards to track and communicate medical information activities to leadership and cross-functional partners
- Collaborate with HEOR on development of AMCP and Global Value Dossiers
- Establish processes for unsolicited medical information requests and train internal colleagues
- Contribute to congress planning and on-site medical affairs representation
Travel: Approximately 30% domestic and international travel required.
Requirements:
- Advanced clinical/scientific degree required (Pharm.D. or Ph.D. preferred)
- 8+ years of experience in medical information and/or relevant pharmaceutical industry experience
- Hematology/Oncology therapeutic area experience and knowledge required; cell therapy experience preferred
- Experience on promotional and medical review committees
- Experience managing an external call center
- Working knowledge of legal and regulatory guidelines in the pharmaceutical industry
- Strong computer and technical skills with proficiency in Medical Information database systems, SharePoint, Veeva, PowerPoint, and similar platforms
