Celcuity

• Provide leadership and oversight of external safety vendors to ensure high‑quality, timely, and compliant execution of all outsourced safety activities. • Lead the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs. • Provide day-to-day direction to the Safety Operations team and communicate program-level updates to internal and external stakeholders. • Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership when additional insight or alignment is needed. • Oversee the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and timely expedited reporting in accordance with global regulatory requirements. • Contribute to the development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices. • Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions. • Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections. • Develop and maintain study‑specific safety management plans and related documents, ensuring clear delineation of responsibilities between Celcuity and CRO partners. • Ensure adherence to Safety Data Exchange Agreements and compliance with all agreed‑upon reporting requirements and timelines. • Review and provide expert input on safety-related sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms. • Develop, monitor, and interpret key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive continuous improvement. • Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices. • Perform other tasks as required to assist in company and departmental activities.

• Responsible for medical oversight of safety vendor(s) to ensure effectiveness, quality, and compliance of all outsourced activities, support timely triage and narratives for timely case reporting to agencies and for periodic safety reports (e.g., DSURs, PADERs, etc.) in collaboration with other cross-functional teams. • Provide day-to-day medical support for the Safety Operations team and provide updates to internal and external stakeholders, as required. • Reviews incoming adverse event reports to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices. • Support safety inspection readiness activities in collaboration with department leadership. • Support the requirements of Safety Data Exchange Agreements with Celcuity partners and ensure compliance with the agreed upon terms and timelines. • Reviews and provides input on the safety sections of clinical documents, including but not limited to the safety reporting section of protocols, Investigator Brochures, and Informed Consents. • Support the development of internal and external (with vendors) key performance indicators and metrics to track performance. • Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) • Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed • Serves as the Safety subject matter expert for internal audits and global inspections. • Other Duties as assigned.

• lead and participate in global regulatory activities • develop innovative global regulatory strategies • provide strategic regulatory guidance for global development • coordinate with internal and external stakeholders • mentor junior staff • oversee regulatory activities and submissions • ensure compliance with global regulatory requirements

• Customer facing roles responsible for the development and execution of access strategies with all target payer accounts. • Leading, managing, and developing a field team of National Account Directors. • Responsible for development of cross-functional account plans and overall customer relationship management. • Organize and oversee target customer executive exchange meetings by mobilizing teams across Market Access, Medical Affairs and the Executive Leadership Team. • Provide strategic inputs and customer insights to shape the launch strategies and the development of payer and reimbursement materials. • Partner with Sales Leadership to equip sales with clear, compliant payer and reimbursement messaging. • Ensure consistent collaboration and coordination with sales on field reimbursement initiatives to minimize access barriers and support providers in a efficient and timely manner. • Establish a closed-loop partnership with the sales team to capture/share real-time field insights and access/payer formulary wins and . • Lead payer related account activities with cross-functional teams and key internal stakeholders to ensure Access strategies are implemented and tracking to established timelines, objectives and goals. • Lead field reimbursement support for field-based teams’ post-approval. • Responsible for communicating reimbursement landscape to senior leadership; including economic understandings. • Other duties as assigned.

• Provide leadership and technical guidance for selection, transfer, and management of new CDMO manufacturing activities. • Lead current drug substance manufacturing process and optimize for continuous improvement of material. • Support ongoing CDMO manufacturing activities and troubleshoot issues and non-conformities. • Determine and resolve gaps for regulatory compliance with drug substance manufacturing and development. • Support formulation development with drug substance optimization, impurity identification, and pre-clinical study coverage involvement. • Author and review drug substance IND-enabling protocols, reports, and regulatory submissions. • Engage and support formulation development with new entity optimization and synthetic route creation/advancement. • Produce intellectual patent assessments and complete development projects intended for furthering IP generation. • Other duties as assigned.

• Lead projects to support development of novel and existing formulations, spanning the product lifecycle including pre-formulation, dosage form selection, formulation development, process development, and manufacturing scale-up. • Design, execute, and interpret formulation and process development experiments in an outsourced environment at contract laboratories and CDMOs. • Identify and vet new contract organizations to support formulation and process development. • Help define & execute the project plans for formulation lifecycle management. • Support writing technical sections for intellectual property and regulatory filings. • Develop and maintain an in-depth knowledge of formulation development trends, techniques, and technologies. • Serve as a subject matter expert for formulation development within the Pharmaceutical Development group and the broader Celcuity team. • Summarize, document, and present information to subgroup, group, and cross-functional audiences. • Other duties as assigned.

• Develop and execute strategies to reduce/remove barriers to access for Celcuity product(s) • Partner with leadership of assigned strategic account • Develop, present and implement approved business case proposals • Prepare and present strategic account performance and market insights to stakeholders • Regularly engage with cross-functional teams • Drive projects to ensure Market Access event sponsorship

• Responsible for different aspects of the day-to-day operations of Celcuity’s field teams including Sales, Market Access, Marketing and Medical Affairs. • Responsible for working with field team and external vendors to implement, maintain and provide support for CRM. • Responsible for CRM analytics for internal stakeholders. • Manages field enablement programs including credentialing, vehicle reimbursement and field sponsorships. • Work with external vendor, field team leadership, legal/compliance and IT to implement CRM. • Work with vendor to develop training materials and assist in ongoing training to new field employees post launch. • Responsible for developing ongoing CRM roadmap and working in partnership with stakeholders and vendor to implement periodic enhancements and changes to CRM as needed. • Collaborate with Celcuity IT to implement help-desk support for CRM and other field technology and respond to CRM specific help desk requests as needed. • Responsibility for developing and implementing call reporting to track sales force call activity. • Work with external vendors to integrate CRM with other business systems (i.e. promotional material ordering, speaker bureau, sunshine reporting etc.). • Work with Associate Director Sales Analytics to pull through updates in customer targeting to CRM. • Support marketing in pull-through of digital assets into CRM as required. • Initiate relationship with field credentialing vendor, stand up credentialing office, and provide field support for the credentialing program. • Responsible for standing up Celcuity’s vehicle reimbursement program. Work with external vendor, field leadership, and Finance colleagues to develop program, document policies and roll out program to field employees. • Develop training materials for vehicle program and perform training on a periodic basis as needed in addition to at launch. • Responsible for working with RxVantage to stand up program as needed for Field Sales team. • Partner with HR and Celcuity IT to develop a field onboarding process. Represent Sales Operations during onboarding and execute training on systems, policies and processes in coordination with Sales and Marketing Operations colleagues. • Manage operational processes related to ongoing field territory alignments and ensure pull through to reporting and incentive compensation. • Manage projects related to sales force sizing/balancing for all field teams. Ensure all systems and individuals have access to territory alignment and map deliverables. • Manage process of ongoing alignment exceptions, primary address requests and apportionments. Ensure pull-through to reporting and incentive compensation. • Develop system and process for field sponsorships and grants. Implement system, train team and own process in coordination with field leadership, Celcuity IT and finance.

• Provide technical expertise and oversight of programming by CRO partners • Work as part of a multidisciplinary team, providing programming support for clinical trials • Coordinate and execute on preparation, execution, reporting and documentation of statistical programming activities • Design and develop SAS programs to execute statistical analysis and clinical trial reporting deliverables • Develop and perform appropriate quality control and validate clinical trials outputs • Establish collaborative partnerships with internal and external programmers, data managers, and clinical staff

• Manages curricula and learner roles, including periodic review of curricula, learner roles, and training requirements with department heads and QMS Admin. • Coordinates with study team leads to update study-specific training documents, routes for approvals, and manages study team learner role membership in the LMS. • Coordinates with document owners and Doc Control to create or revise Training Requirements with new or revised controlled documents and training materials. • Coordinates with hiring managers to launch Training Plans for new or changing learner roles. • Works with hiring managers and HR to review and approve onboarding forms. • Coordinates information about training and QMS orientation for new hires; adds new hires to appropriate training curricula and learner roles per their onboarding training plan. • Collects signed new or updated CVs and job descriptions and uploads them to the associated Job Title in the eQMS.