Celcuity

Executive Assistant

• Provide general administrative support to Chief Commercial Officer and some members of the Commercial leadership team
• Manage and prioritize calendars for the key members of our senior leadership team, focusing on productivity, urgency, and stakeholder needs
• Arrange travel plans, coordinate 'offsite' team meetings and events
• Keep internal filing system/folders organized and updated
• Organize team meetings including reserving meeting space, hotel, and other logistics
• Prepare and submit expense reports for executives according to company policies and procedures
• Ensure seamless coordination and follow-up throughout the vendor/consultant contract process, including overseeing the timely routing of documents for signatures, tracking each document to ensure prompt return, verifying the accuracy of all returned documents, and saving them in their designated storage locations
• Maintain confidentiality and discretion in handling sensitive information and communications
• Assist in the development and organization of support materials for meetings and conferences (e.g. slide decks, presentations, meeting materials, etc.)
• Assist with the coordination and execution of special projects and initiatives as directed by our senior leaders
• Assist with the purchase order process including submission and ensuring appropriate approvals are secured
• Lead onboarding processes for new hires
• Understanding and educating team members on company policies (i.e. meal limits, hotel price caps etc.)
• Other duties as assigned

Executive Assistant, Market Access

• Provide general administrative support to Chief Commercial Officer and some members of the Commercial leadership team
• Manage and prioritize calendars for the key members of our senior leadership team
• Arrange travel plans, coordinate “offsite” team meetings and events
• Keep internal filing system/folders organized and updated
• Organize team meetings including reserving meeting space, hotel, and other logistics
• Prepare and submit expense reports for executives
• Ensure seamless coordination and follow-up throughout the vendor/consultant contract process
• Maintain confidentiality and discretion in handling sensitive information
• Assist in the development and organization of support materials for meetings and conferences
• Assist with the coordination and execution of special projects and initiatives
• Assist with the purchase order process including submission and securing appropriate approvals
• Lead onboarding process for new hires
• Understanding and educating team members on company policies
• Other duties as assigned

Executive Assistant – Commercial

Director

• 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.

Associate Director, Drug Safety and Pharmacovigilance

Medical Director

• 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.

Senior Medical Director, DSPV

Compliance

• 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

Executive Director, Regulatory Affairs – Global

• 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.

Senior Director – National Accounts, Field Reimbursement

Accounting Manager

• Lead the monthly, quarterly, and annual financial close processes to ensure timely and accurate reporting in accordance with US GAAP.
• Lead complex accounting areas, including revenue recognition and gross-to-net estimates, equity compensation, collaboration agreements, and equity and debt financing.
• Assist with the design, implementation, and maintenance of robust internal control procedures to mitigate financial reporting risks.
• Assist with the preparation of SEC filings, including 10-K, 10-Q, and other periodic filings, ensuring accuracy, completeness and compliance with regulatory requirements.
• Coordinate with external auditors, legal teams, and management to facilitate efficient quarterly reviews and annual audits.
• Assist with the optimization of financial systems and accounting processes to improve operational efficiency and support accurate reporting.
• Assist with developing and maintaining accounting policies and procedures, ensuring alignment with evolving industry standards and regulatory requirements.
• Mentor and lead the accounting and accounts payable functions, fostering a collaborative environment focused on professional growth.
• Collaborate closely with the Assistant Controller, Controller and Vice President, Accounting and Financial Reporting on strategic initiatives and cross-functional projects.

Senior Manager, Accounting

• 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.

Director, API Development

Research Scientist

• 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.