Orca

Director

• Establish, grow, and lead the national field-based MSL team
• Define operational frameworks, best practices, and standard operating procedures
• Recruit, train, mentor, and manage performance for the MSL team
• Translate medical strategy into actionable goals and measurable field medical initiatives
• Identify and strategically engage key thought leaders and external experts
• Oversee field-based clinical trial support, including site education, patient recruitment, and investigator engagement
• Represent the organization at scientific conferences and participate in advisory boards and scientific forums
• Build MSL infrastructure for compliant scientific insight and data collection, training, SOPs, and CRM operations
• Oversee compliant scientific engagements with KOLs, HCPs, and key stakeholders
• Guide collection and dissemination of actionable insights for internal medical and clinical development strategies
• Align and collaborate across products, disease states, and indications
• Support cross-functional business planning, special projects, strategic imperatives, and congress planning and execution
• Ensure MSL activities meet ethical standards and comply with applicable laws, regulations, industry codes, policies, SOPs, OIG, FDA, PhRMA guidelines, and the Orca Bio Code of Conduct
• Maintain scientific and clinical expertise through continuous education and key meetings and symposia
• Collaborate on publications, training, internal initiatives, and medical resources
• Direct reports include the field-based Medical Science Liaison team
• Exercise supervisory and decision-making authority
• Complete mandatory compliance and regulatory training
• Report to the Vice President of Medical Affairs

National Senior Director – Field Medical Affairs

Marketing

• Lead execution for national and regional medical conferences and trade shows, including booth build, routing, exhibit space registration, housing blocks, vendor logistics, material shipping, and field team communication
• Maintain the master commercial marketing calendar
• Track multi-channel project milestones for digital ads, print collateral, and field sales aids
• Serve as primary point of contact for external creative agencies and print vendors
• Manage purchase orders, review statements of work, and assist with budget tracking and invoice processing
• Manage commercial digital and print library assets so field representatives and marketing managers use active, current, and approved promotional materials
• Manage the print vendor relationship and portal
• Schedule, organize, and host weekly PRC and MRC review meetings
• Prepare agendas, manage live meeting flow, and record Medical, Legal, and Regulatory reviewer feedback
• Act as operational administrator for Veeva Vault PromoMats, routing materials, verifying document metadata, linking reference packages, and managing material lifecycles
• Perform preliminary intake quality-control reviews on agency submissions
• Track approval expiration dates and coordinate re-review workflows with brand managers
• Partner with the Regulatory Review Leader to create and submit FDA Form 2253 packages for applicable promotional materials
• Drive day-to-day marketing projects and support accurate, compliant promotional and non-promotional content ready for publication
• Coordinate vendor operations and provide administrative/program-management support in compliance with company policies and external regulations

Coordinator, Commercial Marketing, MLR

Medical Science Liaison

• Foster strong relationships with key opinion leaders and support Orca Bio's scientific and clinical strategy for next-generation allogeneic cell therapies
• Serve as a subject matter expert in stem cell transplantation, cell therapy, and cellular immunotherapy
• Identify, develop, and maintain scientific peer-to-peer relationships with academic experts, thought leaders, healthcare professionals, and access stakeholders
• Prepare and maintain a territory management plan
• Support onboarding activities for authorizing treatment centers, adverse event reporting, out-of-spec products, and local payer medical education
• Maintain current knowledge of hematologic malignancies, stem cell transplantation, cell therapy, cellular immunotherapy, and competitive developments
• Assess the transplant and cell therapy landscape and identify scientific trends, evidence gaps, and research opportunities
• Lead Orca Bio's Investigator-Sponsored Trial program, including research concepts, proposal and protocol development, review committee presentations, governance communications, study oversight, publication planning, and results dissemination
• Gather and communicate scientific insights and stakeholder feedback to leadership and cross-functional partners
• Provide scientific and clinical expertise in advisory boards, investigator meetings, roundtables, educational meetings, professional organizations, advocacy groups, GPOs, networked practices, and speaker bureaus
• Support clinical trial activities, patient recruitment, enrollment, and safe and effective use of investigational products while following GCP and ethical and regulatory standards
• Lead collection, analysis, synthesis, and dissemination of scientific information from congresses and scientific exchange
• Translate clinical trial data, competitive intelligence, and stakeholder feedback into recommendations
• Provide support for health outcomes, real-world evidence, and payer/provider engagement strategies
• Execute projects aligned with scientific, clinical, and business operations in partnership with research, clinical development, commercial, market access, regulatory, and quality functions
• Educate and train commercial marketing and sales teams on therapies and disease states

Medical Science Liaison – Great Lakes

Account Executive

• Serve as the single point of contact for Authorized Treatment Centers regarding field-related payer-access engagements, including onboarding
• Develop and execute payer strategies for assigned regional and national payer accounts, state Medicaid agencies, and Medicare Administrative Contractors
• Secure access to Orca products and execute ongoing payer segmentation and business strategy tactics
• Present scientific data, clinical practice goals, guidelines, and anticipated economic program outcomes to support the product value proposition
• Utilize Medical Science Liaison or medical-provider clinical expertise for product and disease-state presentations to key decision-makers
• Deliver and maintain favorable access, advantageous payer medical policy, and appropriate reimbursement for Orca products throughout portfolio life-cycle management
• Partner with targeted Academic Hospitals and Health Systems to ensure patient access on a case-by-case basis
• Interact frequently with the Case Management team to resolve patient access issues
• Track KPIs and ensure dashboard accuracy to measure account market-access results
• Adhere to Orca Bioscience’s core values, policies, procedures, and business ethics
• Perform miscellaneous duties as assigned

Payer Account Director

Compliance

• Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader.
• Advise the C-Suite and executive leadership on regulatory strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements.
• Develop and recommend regulatory strategy with executive leadership and execute agreed strategic priorities.
• Lead post-approval regulatory execution, including commercial-stage supplements and variations, annual reports, lifecycle maintenance submissions, labeling updates, and post-marketing commitments.
• Provide compliance support for the commercialized product, including Regulatory Affairs review of labeling, promotional, advertising, and other commercial materials.
• Lead interactions and correspondence with the FDA, EMA, and other health authorities.
• Partner with Quality on inspections, regulatory commitments, and follow-up actions.
• Assess significant regulatory, policy, and health-authority issues and provide recommendations to executive leadership.
• Partner with Clinical, CMC, Quality, Pharmacovigilance, and Commercial teams on regulatory deliverables and pipeline readiness.
• Maintain and improve regulatory affairs systems, trackers, and audit-ready records.
• Lead and develop the Regulatory Affairs team and keep executive leadership informed on status, risks, and timelines.

Senior Director, Regulatory Affairs

• Develop and execute a comprehensive trade, channel and patient assistance strategy for Orca Bio products, including the design and oversight of TREGZI’s distribution network.
• Serve as the primary point of contact for the 3PL relationship, owning the operational relationship and issue resolution.
• Finalize and maintain the 3PL Business Requirements Document and ensure distribution processes reflect approved requirements.
• Own end-to-end distribution model design, including title flow, order intake, delivery, returns/replacement handling, and reconciliation.
• Establish and maintain state licensing.
• Develop, maintain, and oversee SOPs and governance processes, including returns, credits, chargebacks, and trade-related policies.
• Collaborate with Finance on data reporting, customer payments, orders, credits, reinvoicing, and chargebacks.
• Manage credit and cancellation policies and processes.
• Monitor 3PL performance and compliance.
• Own specialty pharmacy channel strategy and lead activation of operational specialty pharmacy pathways.
• Manage specialty pharmacy relationships through contracting and implementation.
• Finalize end-to-end specialty pharmacy process flows and ordering with Product Supply, Finance, and Market Access.
• Lead contract negotiations and oversee compliance with specialty pharmacy agreements.
• Monitor specialty pharmacy performance against service-level agreements and KPIs.
• Identify continuous-improvement opportunities and evaluate data to identify trends.
• Develop and maintain compliant patient assistance program policies.
• Partner with the patient assistance program hub on travel, lodging, and other patient assistance program operations.
• Partner with Finance on government price reporting, gross-to-net, and revenue recognition.
• Partner with Legal and Compliance on trade agreements, channel practices, policies, laws, and regulations.
• Coordinate with Technical Operations and Supply Chain on ordering, manufacturing slot allocation, cold-chain logistics, and delivery.
• Support Authorized Treatment Center agreement execution involving distribution, ordering, credit, and cancellation terms.
• Provide trade and distribution input into pricing changes and downstream channel coordination.

Director of Trade, Distribution, Patient Assistance

• Lead the U.S. Payer Account Director team, establishing clear priorities, performance expectations, and account engagement strategies
• Integrate market access insights into brand strategy, commercialization plans, and lifecycle management objectives
• Evaluate healthcare market trends affecting product access, reimbursement, pricing, and contracting strategy
• Direct and execute pricing and access strategies for TREGZI and potential future indications, including reimbursement analysis and appropriate contracting and discount strategies
• Develop pre- and post-launch market engagement strategies communicating the brand’s value proposition and supporting patient access
• Lead market access analytics and evaluate team and business performance against defined KPIs
• Partner with Medical Affairs and stakeholders to anticipate payer evidence requirements and develop long-range evidence strategies
• Recruit, develop, and retain a high-performing team while fostering a results-driven, customer-focused, and collaborative culture
• Develop and manage operating budgets consistent with corporate financial objectives
• Ensure compliance with corporate policies, procedures, and applicable U.S. healthcare laws and regulations