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 Florida, South Carolina, Georgia, Alabama, Mississippi, Louisiana, or Arkansas.
Responsibilities
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
Required Qualifications
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
Preferred Experience
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
