Orca Bio

Oversee and manage multiple projects ensuring alignment with strategic goals, timelines, and budgets, while coordinating with various stakeholders. | Requires 5+ years of project management experience, preferably in biotech or pharmaceutical industry, with knowledge of GMP, regulatory guidelines, and project management tools. | 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 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. Position Summary: The Project Manager is responsible for overseeing and managing a portfolio of projects, ensuring they align with the Orca Bio’s strategic goals. This role will involve project planning, risk mitigation, resource coordination, and communication with stakeholders, along with managing budgets and schedules for multiple projects at a time. This position will work cross-functionally with CMC, Science, Regulatory, Quality, and other key stakeholders as needed to set and track progress against timelines and deliverables. The successful candidate shall be an experienced project manager, with a proven track record of operating in a multidisciplinary, collaborative, fast-paced environment. The Project Manager may take on other projects as assigned. \n Essential Duties & Responsibilities Partners with Science, CMC, Quality, Facilities, and Manufacturing, and other client stakeholders as needed to ensure projects are scoped properly, on time, and executed meticulously: Partners and reports into the PMO function to ensure alignment Communicates progress to senior leadership on a bi-weekly to monthly basis Own end-to-end project delivery across internal technical teams and external client implementations: Ensure an appropriate level of urgency is communicated while maintaining focus on deliverables Identify potential critical issues, constraints, bottlenecks, risks, and mitigation management (and proposed solutions to support decision-making) across individual programs Drive decision making processes and escalate issues, as needed Develop detailed project plans, timelines and resource allocations Manage meetings, including agenda preparation, meeting facilitation, documentation, and communication (e.g., distribution of minutes) Maintain project documentation, timelines and KPIs Minimum Experience and Education Education/Experience: Bachelor's degree in a life science or related field or equivalent experience Advanced scientific degree preferred PMP or other Project Management certification/training preferred Meaningful prior experience in project management required (e.g. 5+ years); advanced degree may substitute for years of experience Communication: Persuasively convey ideas and suggestions for forward momentum Skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies Comfortable with negotiation and challenging the status quo and bringing forward innovative solutions Knowledge Base: Experience in GMP Quality in the biopharmaceutical or related industry Knowledge of regulatory guidelines for drug development functions (ICH and FDA) Organizational: Strong attention to detail Propensity to document at the right level Able to identify roadblocks and provide direction to teams to explore alternatives Technical: Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions Understand and edit SOPs Expert with Microsoft Project (MPP) or Smartsheet \n 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.

Lead patient advocacy outreach, build partnerships, manage grants, and integrate patient perspectives into clinical and corporate activities. | Bachelor's degree in life sciences or related field, 5+ years in patient advocacy or related roles, biotech/pharma industry knowledge, and strong interpersonal skills. | 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 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. The Manager, Patient Advocacy & Engagement, is a high-impact role that engages with patient and community stakeholders to ensure productive and enduring partnerships. This individual will lead outreach to patient advocacy groups and educate and support internal teams, ensuring they are aware of the needs and experiences of patients. This is a critical role for the team at Orca Bio, a patient-driven organization whose mission is to transform the lives of patients through high-precision cell therapy. \n Essential Duties & Key Responsibilities Build and maintain trusted relationships with patient leaders, advocacy organizations, caregivers, professional societies and other stakeholders in the blood cancer community through thoughtful and compliant engagement. Design and deliver community-focused initiatives, including advocacy roundtables, insight-gathering sessions, landscape assessments and workshops. Assist in managing patient advocacy grants, sponsorships and related requests in alignment with company policies. Coordinate with internal teams to bring patient perspectives into clinical trial activities, medical education and external engagement. Represent Orca Bio at advocacy events, reinforcing the company’s commitment to patient-focused innovation. Collaborate with Corporate Communications, Medical Affairs and Commercial teams to ensure consistent external messaging. Translate community insights into actionable recommendations that inform cross-functional strategies. Champion a patient-first culture by elevating patient stories, perspectives and unmet needs across the company. Support patient-centric initiatives such as awareness campaigns, educational events, and development of accessible lay summaries of scientific content. Desired Competencies Embodies a patient-centric mindset with a commitment to elevating patient and caregiver perspectives in all aspects of work Ability to create and sustain trusted partnerships with diverse stakeholders Skilled in developing and executing advocacy initiatives and community programs Strong written and verbal skills, including translating complex science into accessible language Understanding of oncology/hematology advocacy ecosystems and stakeholder dynamics Knowledge of regulatory compliance standards related to patient engagement and communications Experience managing budgets, grants, sponsorships and vendors in a compliant manner Required Qualifications Bachelor’s degree in life sciences, public health, social work, policy, or a related field (advanced degree preferred) Minimum 5 years of professional experience in patient advocacy, medical affairs, public health, or coalition building, with preference for oncology, hematology, or cell therapy experience Strong understanding of the biotech/pharma industry, including the drug development process and regulatory frameworks Demonstrated ability to collaborate across functions and influence at all levels of an organization Track record of building consensus and fostering buy-in among diverse stakeholders Exceptional interpersonal skills and cultural awareness to navigate a wide range of professional and community interactions \n 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.

Lead strategic planning and execution of scientific communications, oversee publications and training, manage budgets and vendors, and support medical affairs for cell therapy products. | Advanced clinical/scientific degree (Pharm.D. or Ph.D.), 8+ years in Medical Affairs/pharmaceutical industry, 5+ years in medical/scientific communications, hematology/oncology and cell therapy experience, and regulatory knowledge. | 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 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. The Director of Scientific Communications will report to the Vice President of Medical Affairs. You will be responsible for strategic planning and execution of deliverables including MSL materials, training, congress coverage and scientific symposia at Orca Bio. Additionally, you will oversee the publications function, be a leader in the Medical Affairs department, and be an integral team member in preparation for a commercial launch. Travel: as needed to Orca Bio HQ in Menlo Park, CA. Local candidates preferred. Essential Duties & Key Responsibilities • Establish the Scientific Communications capability within Medical Affairs • Lead the development of an Annual strategic plan for scientific communications and training • Create scientific tools and materials in support of the Orca Bio pipeline products and therapeutic areas of interest including but not limited to education/training materials, disease state and product slide kits, etc. • Oversee the Publications function and build a team of individuals over time that will execute on the planned deliverables • Oversee continuing medical education grant program, set up and lead the process for a Grant Review Committee • Support training of Medical Affairs employees with a focus on the MSL team(s), product, disease state and soft skills • Contribute to clinical content for advisory boards and investigator meetings; and coordinate company sponsored satellite symposia • Lead the development of a compendia and treatment guideline plan • Create congress materials (briefing books, content analysis, etc); congress session coverage and reporting plan and post congress executive summary report • Provide support for various pathway initiatives and interactions • Manage platform for MSL resources • Manage the Medical/Scientific Communication and Publications budget • Directly manage vendors where required Minimum Experience, Education, Certifications, Licenses • Advanced Clinical/Scientific degree required (Pharm.D. or Ph.D preferred) • 8+ years of experience in Medical Affairs and/or relevant experience in the pharmaceutical industry • 5+ years of experience in medical/scientific communications and/or publications • Hematology/Oncology therapeutic area experience and knowledge required, cell therapy experience preferred • Experience on promotional and medical review committee • 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. 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.

Establish and lead global medical information services including call center oversight, content development, regulatory compliance, and cross-functional collaboration for commercial launch preparation. | Requires advanced clinical/scientific degree, 8+ years pharmaceutical medical information experience, hematology/oncology expertise, call center management, and promotional review committee participation. | 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 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. 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. \n 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. \n 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.

Manage end-to-end case activity for patients receiving cell therapy, coordinate scheduling and documentation, communicate with treatment centers, and collaborate cross-functionally to ensure seamless patient experience. | 3-5 years in patient case coordination or healthcare operations, experience with transplant or specialty pharmacy, knowledge of regulated healthcare workflows, strong organizational and communication skills, and familiarity with CRM or case tracking systems. | 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 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. Summary of Role: The Cell Therapy Case Manager is the central point of contact for treatment centers managing the case journey for patients receiving Orca-T. This includes receiving orders, verifying documentation, managing scheduling, coordinating cross-functional activities, and ensuring a seamless experience for both the treatment center and internal stakeholders. This is a foundational hire, where you will help to build the case management organization from the ground up, including the processes, SOPs, and tools that will define Orca Bio’s standard of excellence in institutional engagement. You will be a critical partner to transplant coordinators and serve as the primary case quarterback within Orca Bio’s ecosystem, aligning activities across Account Managers, Medical Science Liaisons, supply chain, and commercial operations. This role requires empathy, precision, and a proactive mindset to deliver an exceptional customer experience. \n Responsibilities Case Lifecyle Management Serve as the main point of contact for assigned transplant centers, managing end-to-end case activity from order intake through product infusion and follow up. Receive, review, and track all case orders and associated documentation in accordance with internal SOPs and regulatory requirements. Facilitate product scheduling considering patient treatment timelines, treatment center constraints, donor availability, apheresis center availability, and manufacturing capacity. Monitor and update case management software systems to ensure accurate real-time data capture and audit readiness. Customer Communication & Relationship Management Proactively communicate case updates, schedule confirmations, and documentation needs to treatment centers. Build trusted relationships with transplant center staff, ensuring a responsive, clear, and reliable support experience. Escalate issues and delays as needed while maintaining a solutions-oriented approach. Partner with commercial account management as the first-in-line customer service function of Orca Bio, ensuring exemplary customer experience. Cross-Functional Collaboration Coordinate with internal stakeholders (Logistics, Manufacturing, Commercial Operations, Medical Affairs, Account Management) to align on product logistics, compliance, and customer needs. Support field teams in center onboarding and activation efforts, including new site training on case flow and software tools. Process Development & Continuous Improvement Contribute to the development and refinement of case management SOPs, communication templates, and escalation protocols. Identify opportunities to streamline workflows, reduce treatment center burden, and improve service efficiency. Assist in documenting best practices and onboarding materials for internal team growth. Team & Operational Support Participate in team huddles, case review meetings, and ongoing training sessions. Support peer coverage for holidays, vacations, or spikes in case volume. Ensure service availability during Pacific Time business hours; may require shift flexibility during process exceptions impacting delivery of patient products. Required Qualifications 3-5 years of experience in patient case coordination, transplant scheduling, specialty pharmacy, or healthcare operations, preferably in oncology, cell therapy, or rare disease. Experience working with academic medical centers, transplant programs, or hospital-based specialty practices. Familiarity with regulated healthcare workflows, including HIPAA, chain-of-identity/custody, and documentation compliance. Strong organizational, communication, and relationship management skills. Experience using CRM or case tracking systems (e.g., Salesforce Health Cloud, Vineti, TrakCel). Ability to thrive in a dynamic, evolving environment and contribute to building new capabilities. \n 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.