Senior Specialist, Global QMS
The Senior Specialist, Global QMS will help implement Orca Bio’s global quality management system across all sites. This role will support and lead the internal audit program, supplier management program, and inspection readiness. This role will support the growth and expansion of the global quality program to support manufacturing of our cell therapy products. You will help establish, implement and maintain the audit program across Orca Bio sites to ensure compliance with GxP and regulatory expectations. Your role will support Orca Bios commercial readiness and ongoing clinical programs by managing and facilitating audits, resolving supplier-related quality issues and interacting with quality management teams at the site levels to ensure consistent application of quality systems across the organization.
Senior Manager / Associate Director, Gross-to-Net & Revenue Planning
Position Summary: The Senior Manager / Associate Director, Gross-to-Net (GTN) & Revenue Planning will own gross-to-net, revenue forecasting, and commercial operating expense forecasting for Orca Bio's first commercial product. Reporting to the Senior Director/Head, FP&A, this role establishes the accrual methodology, forecast architecture, documentation, and monthly cadence that a newly commercial company requires — in a product setting where individual transactions are material and where there is limited precedent to inherit. The position requires strong technical judgment, cross-functional partnership, and deep expertise in pharmaceutical revenue deductions and government pricing.
This is a hands-on individual contributor role. The successful candidate will build the models, run the monthly process, reconcile the underlying data, and present results directly to executive leadership and external auditors.
Manager, Manufacturing Systems and Master Data
Position Summary:
The Manager, Manufacturing Systems & Master Data serves as the business owner and super user for the company's Manufacturing Execution System (MES) and related manufacturing and supply chain applications. This role is responsible for governing manufacturing master data, driving system improvements, optimizing business processes, and ensuring system capabilities effectively support GMP manufacturing, inventory management, procurement, quality, planning, and commercial operations.
The Manager owns the creation and maintenance of manufacturing and supply chain master data, including material masters, inventory masters, Bills of Materials (BOMs), product specifications, packaging configurations, vendor master records, release testing requirements, and manufacturing data.
In addition, this role leads continuous improvement initiatives for ERP/MES functionality, serves as the primary business liaison to Information Technology, Finance and Software vendors, and ensures business systems evolve to meet operational and regulatory needs. No direct reports.
Medical Science Liaison - Southeast
Medical Science Liaison - Southwest
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 MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Southern California, Arizona, New Mexico, or Colorado.
\n- Serve as a subject matter expert in stem cell transplantation, cell therapy, and the evolving cellular immunotherapy landscape, providing scientific insights regarding current treatment paradigms, clinical operations, patient access and emerging competitive landscape
- Identify, develop, and maintain deep scientific, peer-to-peer relationships with academic stem cell therapy experts as well as thought leaders, appropriate HCPs, and access stakeholders, within a given geography to answer scientific and product related questions, to ensure their safe and appropriate use of Orca Bio products through peer-to-peer discussions aligned with medical strategies and needs expressed by external stakeholders
- Prepare and maintain a territory management plan that will be shared with Medical Leadership and other internal stakeholders
- Engage with Orca “Pod” field team members to provide appropriate medical support for all onboarding activities in relation to authorizing treatment centers, adverse event reporting, handling out of spec products, as well as partnering with regional Market Access colleagues to provide medical education and support to local payers in alignment with Market Access tactical plan and individual patient needs
- Develop and maintain a deep and current understanding of hematologic malignancies, stem cell transplantation, cell therapy, cellular immunotherapy and competitive developments to facilitate high level scientific exchange with health care professional and key opinion leaders
- Actively assess the transplant and cell therapy landscape through ongoing engagement with key opinion leaders, investigators, and academic research centers to identify emerging scientific trends, evidence gaps, and novel research opportunities relevant to Orca Bio's therapies. Serve as the primary liaison for Orca Bio's Investigator-Sponsored Trial (IST) program, partnering with investigators to develop and refine research concepts, evaluate scientific merit and strategic alignment, support proposal and protocol development, present qualified concepts to review committees, communicate governance decisions, and provide scientific oversight throughout study start-up, conduct, publication planning, and dissemination of results
- Gather and communicate actionable scientific insights and stakeholder feedback to Orca Bio leadership and cross-functional partners to inform medical strategy, evidence generation priorities, and lifecycle planning
- Provide scientific and clinical expertise to support internal and external stakeholders, through participation in advisory board meetings, clinical investigator meetings, roundtable discussions, educational meetings, interactions with professional organizations/societies, advocacy groups, GPOs, and large networked practices as needed, including speaker bureaus
- Support clinical trial activities to enhance patient recruitment, enrollment and/or discussions around the safe and effective use of Orca Bio investigational products, leveraging clinical trial experience and knowledge of Good Clinical Practice (GCP) to ensure adherence to ethical and regulatory standards
- Lead the collection, analysis, synthesis and dissemination of scientific information presented at congresses and during scientific exchange. Translate emerging clinical trial data, competitive intelligence and external stakeholder feedback into actional recommendations for Orca Bio leadership and cross functional teams. When assigned, coordinate the efforts of other MSLs to provide coverage for a specific congress to maximize organizational impact
- Provide medical and scientific support of the strategy of health outcomes, real-world evidence, and payer/provider engagements
- Initiate and autonomously execute projects that align with Orca Bio’s scientific, clinical and business operations partnering with research, clinical development, commercial, market access, regulatory, and quality functions to drive company strategy
- Provide education and training to commercial marketing and sales teams on therapies and disease states
- Advanced clinical degree in a life-science or basic-science discipline (MD, DO, PharmD, NP, PA, DNP, M.Sc, or Ph.D.) and industry experience as an MSL
- Significant clinical and/or industry experience in malignant hematology, hematopoietic stem cell transplant (HSCT), cellular therapy, CAR-T, immune effector cell therapies, and/or other advanced therapy modalities
- Strong understanding of cell therapy ecosystem, including transplant center operations, apheresis and cell processing workflows, treatment center authorization, patient referral pathways and competitive cell therapy products
- Strong understanding of clinical development, regulatory requirements, and commercial strategies; experience with HEOR data is a plus
- Excellent interpersonal and communication skills, with the ability to engage and influence a wide range of stakeholders
- Demonstrated ability to interpret and present complex scientific data to diverse audiences
- Strong strategic thinking, problem-solving skills, and solution-oriented mindset
- Demonstrated ability to collaborate with cross-functional colleagues to best serve the needs of internal and external stakeholders
- Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment
- 5+ years of industry experience as an MSL
- Demonstrated experience with field medical launch planning, execution, and post-launch support
- Direct experience supporting cell therapy, stem cell transplantation, CAR-T or other advanced therapeutic platforms
- Experience working in a small biotech company or start-up environment
The anticipated annual salary range 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.
Medical Science Liaison - Southwest
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Southern California, Arizona, New Mexico, or Colorado.
Medical Science Liaison - Southeast
The MSL reports to the Sr. Director, National Field Medical Affairs and will be responsible for fostering strong relationships with key opinion leaders (KOLs) and supporting the scientific and clinical strategy of Orca Bio's next generation allogeneic cell therapies. The ideal candidate will possess deep expertise in hematopoietic stem cell transplantation (HSCT), cellular therapy, and the evolving cell therapy landscape, including clinical, operational, regulatory and market access considerations. The MSL will serve as trusted scientific partner between Orca Bio and external healthcare providers (HCPs) establishing strong professional collaborations with investigators and other HCPs within the designated territory. Additionally, you will serve as an active leader and contributor on projects in support of the Medical Affairs Strategic Objectives.
Candidate must reside in Florida, South Carolina, Georgia, Alabama, Mississippi, Louisiana, or Arkansas.
Senior Director, Regulatory Affairs
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 Senior Director, Head of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the Chief Medical Officer to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Significant strategy decisions and major agency positions remain subject to executive leadership approval. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves. The incumbent leads and develops the Regulatory Affairs team and is a clear, proactive communicator who keeps executive leadership informed, surfaces risks early, and brings forward well-reasoned recommendations.
\n- Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions.
- Develop and recommend regulatory strategy in partnership with executive leadership, and own execution of agreed strategic priorities across the organization.
- Lead near-term post-approval regulatory execution, including commercial-stage supplements and variations, annual reports and lifecycle maintenance submissions, labeling updates, and post-marketing commitments.
- Provide ongoing compliance support for the commercialized product, including leading Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials through the company's cross-functional review process.
- Lead ongoing interactions and correspondence with the FDA, EMA, and other health authorities on routine and operational matters, while helping prepare for and participate in major strategic health-authority engagements; partner with Quality on inspections, regulatory commitments, and follow-up actions.
- Lead the assessment of significant regulatory, policy, and health-authority issues, providing executive leadership with clear recommendations, risks, and proposed paths forward.
- Partner closely with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams to execute regulatory deliverables supporting the commercialized product and broader pipeline, and maintain regulatory readiness for future development programs, new indications, global expansion, and other significant milestones.
- Maintain and continuously improve regulatory affairs systems, trackers, and records to ensure accurate, audit-ready documentation of submissions and commitments.
- Lead and develop the Regulatory Affairs team, and proactively keep executive leadership informed on regulatory status, risks, and timelines, bringing forward clear recommendations that foster accountability and continuous improvement.
- Bachelor’s degree in life sciences or a related discipline required.
- 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA.
- Track record of participating in approval of a commercial-stage product strongly preferred; experience in hematology, oncology, cell therapy, or bone marrow transplant preferred.
- Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments.
- Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review.
- Proven people leader with a track record of building, coaching, and developing high-performing teams.
- Excellent written and verbal communication skills, with the ability to proactively engage and inform executive leadership and translate complex regulatory matters into clear, actionable recommendations; strong project management and organizational skills suited to a hands-on, detail-oriented, small commercial-stage biotech environment.
The anticipated annual salary range 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.
Senior Director, Head of Regulatory Affairs
Position Summary:
The Senior Director, Head of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the Chief Medical Officer to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Significant strategy decisions and major agency positions remain subject to executive leadership approval. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves. The incumbent leads and develops the Regulatory Affairs team and is a clear, proactive communicator who keeps executive leadership informed, surfaces risks early, and brings forward well-reasoned recommendations.
Vice President, Medical Affairs
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.
The Vice President of Medical Affairs will build, develop, and lead our Medical Affairs function including Medical Science Liaisons, Medical Affairs Operations, Medical Information, Medical Communications, and Investigator Sponsored Trials for Orca-T (our lead, late-stage product), and other products in development as needed (responsibility shared with the Clinical R&D team for products in development).
You will lead the medical affairs team while working closely with the R&D team to support the publication and promulgation of clinical/pre-clinical data as well as other important information. You will present a strong outward-facing presence with key KOLs and will support the company in many different capacities, including business development. You will provide medical support for our trials in Advanced Hematologic Malignancies undergoing Allogeneic Hematopoietic Cell Transplantation.
- Reporting directly to the Chief Medical Officer (CMO), the VP of Medical Affairs is accountable for the management, development, and execution of the Medical Affairs department—including the design and structure of the supporting functions of a Medical Affairs team such as Med Information, Medical Communications, Publications planning, Medical Science Liaisons, etc., allocating and directing internal resources while effectively utilizing outsourcing to achieve project and business goals in a timely manner.
- Provide scientific and functional leadership to the Medical Affairs team.
- Working closely with the CMO, develop and lead outreach by establishing and maintaining strong relationships with key opinion leaders, academic institutions, and medical societies in the field of hematology/oncology, particularly cell therapy.
- Manage the leader of the field-facing Medical Science Liaison function, with overall accountability for the team.
- Working with the CMO, in developing the strategy for Medical Affairs including external communications, publications, investigator sponsored Trials (ISTs), congress and Advisory Boards planning and scientific communications.
- Lead publication planning and objectives and planning, CME education, symposia, and congress planning and assess full Medical Communication requirements to support launch.
- Assess and implement Medical Information requirements to support launch.
- Manage the investigator-initiated studies program review process post-launch
- Establish policies and procedures for key Medical Affairs activities, ensuring compliance with the principles of Scientific Engagement, including leading discussions around compassionate use programs
- Lead the medical objectives for Advisory Board meetings.
- Work closely with the Regulatory Affairs and Commercial organizations to ensure timely, accurate and compliant preparation and review of promotional and educational material.
- Partner with Legal and Compliance to ensure Medical Affairs activities are conducted according to Orca’s policies and procedures, and in a manner compliant with all external laws and regulations.
- Collaborate closely with cross-functional teams, including Clinical Development, Clinical Operations, Project Management, Regulatory Affairs, and Commercial, to drive the successful development and commercialization of Orca-T.
- Provide medical and scientific information to the relevant teams of the organization, as well as guidance to Commercial/Marketing Organizations on promotional material and campaigns.
- Educational requirements: M.D., Ph.D., PharmD with MD degree preferred.
- Minimum of 15 years of Medical Affairs or clinical research experience, from which minimum 5 years in Medical Affairs within Allogeneic Hematopoietic Cell Transplantation.
- Minimum of 8 years’ experience in leading a Medical Affairs function; prior experience with new product launch.
- Previous Medical Affairs expertise within hematology and/or transplant experience (specific diseases include AML, ALL, MDS) a must.
- Previous cell therapy experience is highly desirable.
- Track record of success in building and leading teams.
- Collaborative Medical leader who can establish and drive strong cross-functional partnerships and scientific exchange with diverse stakeholders.
- Experience in the US health care marketplace is required.
- Extensive travel is required as part of this position (up to 50%).
- Ability to maintain confidentiality and to operate with the highest ethical standards and professionalism.
The anticipated annual salary range 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.
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