More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Position Summary: The Director of Medical Information will report to the Vice President of Medical Affairs. You will be responsible for directing a global medical information service at Orca Bio, be a leader in the Medical Affairs department, and be an integral team member leading a commercial launch. You will be responsible for overseeing the Medical Information service at Orca Bio, including 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
Requirements:
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
- Define Supervisory responsibilities, if applicable, including decision-making authority
- Oversee the daily workflow of the Medical Information Call Center
Travel Requirements
- Domestic and international travel will be required from time to time as needed (approximately 30%)
