
Orca
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• 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. • Lead and manage field facing Medical Science Liaison 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.
• Serve as the primary liaison between Orca Bio and Authorized Treatment Centers (ATCs). • Build and manage key relationships, supporting treatment site readiness and execution. • Drive appropriate use of Orca Bio’s approved therapies. • Create a smooth and effective experience for treatment sites, physicians, and healthcare stakeholders. • Analyze account performance and identify opportunities to optimize site engagement and therapy utilization. • Represent Orca Bio at key conferences and professional meetings as needed.
• Lead the commercial legal function with primary responsibility to support the expected first U.S. product launch • Serve as a trusted strategic partner and providing practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access), Medical Affairs, and Patient Support functions • Subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities • Partner with Compliance to ensure that the Company’s U.S. compliance program remains risk-based, fit-for-purpose and aligned with corporate values • Support cross-functional teams through advisory responsibilities, training and policy development
• Serve as the primary liaison between Orca Bio and identified hospitals becoming Authorized Treatment Centers (ATCs). • Responsible for building and managing key relationships, supporting site readiness and execution, and driving appropriate use of Orca Bio’s investigational therapies. • Report into the VP of Account Management and Site Enablement. • Create a smooth and effective onboarding experience for treatment sites, physicians, and other healthcare stakeholders. • Lead site onboarding activities including qualification, training, and workflow setup. • Oversee training activities related to product handling, including Chain of Identity (COI) and Chain of Custody (COC) compliance. • Work closely with cross-functional teams to support ATC needs and resolve barriers to treatment. • Analyze onboarding activities and timelines to proactively identify opportunities to optimize site onboarding and activation.
• Serve as the primary liaison between Orca Bio and our Authorized Treatment Centers (ATCs). • Build and manage key relationships, supporting treatment site readiness and execution. • Drive appropriate use of Orca Bio’s approved therapies. • Create a smooth and effective experience for treatment sites, physicians, and other healthcare stakeholders. • Must live in assigned territory and willingness to travel up to 50%, based on business needs.
• Successfully execute the commercial strategy for ORCA T® • Work collaboratively with cross-functional field-based partners to ensure efficient customer engagement • Identify, evaluate and assist in authorizing potential ORCA T® treatment sites • Collaborate with cross-functional internal commercial partners such as marketing, sales training and sales operations to improve efficiency, effectiveness, and maximize teamwork • Develop, implement and monitor strategy in conjunction with VP of Account Management, Brand Team, Sales Training and Sales Operations to meet and exceed goals • Develop mechanisms and processes to regularly monitor account activity against goals and provide ongoing feedback within organization • Motivate, train and coach on complex clinical and operational acumen (cell therapy/transplant/oncology/process) • Performance management; leading/managing individual contributors • Cascade and compliantly train to brand plan and organizational goals • Retain top talent and develop individualized career development plans for team • Work regularly with Orca Therapeutic Account Managers (OTAMs) in the field to provide support and active coaching that deliver on Orca Bio forecast and objectives • Lead all facets of US Account Management Team in a compliant manner to ensure optimal results
• Responsible for all aspects of clinical trial data management from study start up through database lock and study close. • Ensures optimized data collection, flow and access across EDC and non-EDC data sources. • Ensures accuracy, consistency, completeness and CDISC compliance of all clinical databases. • Operate as a key member of the Clinical Operations team.
• Serve as the primary operational liaison to NMDP and other registry partners across clinical and commercial programs. • Manage the full domestic and international registry partnership lifecycle: onboarding, alignment, issue escalation, and business reviews. • Track and monitor registry, donor center, and apheresis center performance against service levels; identify and drive resolution of operational gaps. • Serve as the single point of contact internally and externally for issue reporting and resolution. • Design, implement, and continuously improve scalable donor cell acquisition processes supporting the commercial launch of Orca-T and Orca Bio's clinical programs, incorporating transplant center feedback and industry best practices. • Author SOPs, work instructions, and process maps. • Inform OrcaLink (clinical and commercial scheduling and coordination system) product requirements for donor request workflows, with emphasis on transplant center experience and legal/regulatory compliance. • Assess capacity constraints in apheresis and patient operations infrastructure across the transplant center and registry network and proactively engage partners on solutions.
• Responsible for monitoring the progress of clinical studies, either at investigative sites or remotely • Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements • Conduct interim monitoring visits (IMVs) and ISF review • Review electronic medical records (EMR)/patient data • Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting • Provide support to site staff including research coordinators and physicians • Assist in the development of trial materials as needed • Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates • Author and submit high-quality monitoring visit reports within required timelines • Ensure completeness and accuracy of monitoring documentation in the eTMF
• Leads the promotional launch of Orca-T, driving robust pre-launch, launch, and post-launch strategies and omnichannel tactics that maximize market penetration and product adoption • Drives development of unique and effective HCP engagement strategies aligned to Orca-T Brand strategy • Collaborate with the Market Development team and other Commercial personnel to shape a comprehensive HCP Marketing tactical plan, budget, and performance plan aligned to Brand KPIs to enable a robust promotional launch • Lead Orca-T message development across HCP and patient audiences, including insights generation and analysis • Lead the execution of a full HCP-facing tactical suite for personal and non-personal channels, including PRC review and approval, for Day 0, Now Approved, and Campaign assets • Contribute to omnichannel strategy, deployment, and management • Manage agency partners effectively to deliver consistent results • Contribute to advisory board content, execution, and analysis • KOL Engagement at major congresses, advisory boards, and site visits as necessary to support Commercial onboarding workstreams • Lead consistent engagement with Sales team to ensure optimization of messaging and assets • Effectively manage the promotions tactical budget to Launch Readiness and Orca-T launch • Manage one Product Marketing FTE
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