Leads the pharmacovigilance function, including safety data review, risk management, regulatory documentation, inspection readiness, signal detection, labeling, and safety governance. Provides cross-functional product safety leadership, oversees regulatory filings and compliance with US and EU requirements, manages resources and budgets, and mentors the pharmacovigilance team in a small biotechnology environment.
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.
The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.
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.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
Orca Biotech Menlo Park, California, USA Office
3475 Edison Way, Suite B, Menlo Park, CA, United States, 94025
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