Director, Medical Information

Position Summary

The Director of Medical Information will report to the Vice President of Medical Affairs. You will be responsible for establishing a global medical information service at Orca Bio, be a leader in the Medical Affairs department, and be an integral team member in preparation for a commercial launch. You will be responsible for establishing the Medical Information service at Orca Bio, including set up and oversight of a Medical Information Call center.

Essential Duties & Key Responsibilities

• Establish the Global Medical information capability within Medical Affairs, creating and managing the Medical Information budget, setting up the structure, business processes and systems governing the dissemination of reactive scientific information and other activities performed by Medical Information
• Collaborate with Safety and QA on the process for the receipt of post marketing adverse events and product quality complaints, ensure audit ready
• Identify, implement, and lead the oversight of the Medical Information call center(s) that will cover the necessary geographies, aligning with and integrating standards, processes, and technology
• Contribute to congress planning and on-site representation associated with the medical affairs and medical information presence
• 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 the Medical Review Committee and Promotional Review Committee
• Create informative dashboards to track and communicate Medical Information activities to leadership and cross-functional business partners, identifying and trends or data gaps
• Collaborate with HEOR on the development of the AMCP and Global Value Dossiers with scientific data input and reviews
• Create a process of the submission of unsolicited requests for medical information and train internal colleagues on this process

Minimum Experience, Education, Certifications, Licenses

• Advanced Clinical/Scientific degree required (Pharm.D. or Ph.D preferred)
• 8+ years of experience in medical information and/or relevant experience in the pharmaceutical industry
• Hematology/Oncology therapeutic area experience and knowledge required, cell therapy experience preferred
• Experience on promotional and medical review committee
• 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 various technology platforms, such as Medical Information database systems, SharePoint, Veeva, PowerPoint, etc.

Reporting Structure & Authority

• Direct reports include: None
• Oversee the daily workflow of the Medical Information Call Center

Training & Continuous Improvement

• Mandatory training: compliant scientific exchange, protected health information, preapproval information exchange, adverse event and quality complaint reporting, regulations regarding prescription drug advertising and promotion

Travel Requirements

• Domestic and international travel will be required from time to time as needed (approximately 30%).