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: Reporting to our Chief Development Officer, the Director/Head of Pharmacovigilance will lead and develop the safety function, providing direct guidance to a small, dedicated team while driving end-to-end operational oversight.
Key Responsibilities
Lead risk management and mitigation activities for assigned products, leading safety data review and analysis for all products.
Responsible for providing safety-related content for all clinical and regulatory documents.
Lead inspection preparedness efforts for pharmacovigilance and represent Orca’s pharmacovigilance organization at regulatory inspections.
Stay abreast of changes in regulations, leading updates to SOPs and other documentation to address any process gaps.
Identify and address resource and infrastructure needs, contribute to departmental budgets and planning to align with Orca products’ stage of development.
Represent product safety in the cross-functional team environment.
Lead safety governance activities in collaboration with medical monitors and leadership.
Lead safety related activities for regulatory filings including development of meeting request and briefing book content, SAP and TFL review, signal detection and risk identification, responses to regulatory queries, RMPs, REMs, ISS strategy, and regional safety related labeling activities.
Provide guidance and mentorship to all direct reports within the pharmacovigilance function, including support and oversight of operations.
Qualifications
Advanced degree in a biologic/medical/clinical/nursing field: Pharmacist/PharmD, Nurse Practitioner, MD, or PhD.
10+ years of experience in drug safety, safety science and risk management at a pharmaceutical, biotech, or CRO, including people leadership experience.
Knowledge of US and EU safety regulations pre and post marketing pharmacovigilance requirements.
Experience with pharmacovigilance risk management, preferably at a commercial-stage company.
Proficiency in preparing pre-marketing and post marketing safety regulatory documents, including PSURs, PBRERs, PADER, and Risk Management Plans.
Experience with clinical development, risk/benefit analysis, and safety assessment.
Strong clinical, analytical, problem-solving, scientific writing, and communication skills.
Prior experience working on a BLA/NDA. Prior experience leading risk management activities for a BLA/NDA preferred.
Hands-on mentality, ability to operate in a small biotech environment.
Knowledge of cell therapy, bone marrow transplant or hematology oncology is a plus.
Expertise in analyzing safety data from clinical and safety databases.
Experience in MedDRA coding and search strategies.
Excellent independent judgment based on knowledge and expertise.
Strong personal time management and project management skills.
