Associate Director, Medical Information

About Orca Bio

Orca Bio is a late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

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.

About the Role

The Associate Director, 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 to 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 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.

Who We Are

• We are driven by a passion for science and compassion for patients.
• We act with urgency to ensure our treatments are one day accessible to all who need them.
• We live by our core values of passion, courage, and integrity.
• Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
• We innovate on a path that hasn’t been paved.
• We embrace an entrepreneurial spirit and take calculated risks to achieve our mission.
• We aren’t afraid to ask “why not” and challenge the status quo.
• We maintain a start-up culture of camaraderie and leadership by example, regardless of title.