Celcuity Inc.

Position Summary: We are seeking a Senior Manager/Associate Director, Statistical Programming, who will report to the Director, Statistical Programming. You will provide technical expertise, and oversight of programming by CRO partners developing all aspects of statistical programming deliverables for the analysis and reporting of clinical study data in accordance with departmental SOPs and regulatory guidelines. The Senior Manager/Associate Director, Statistical Programming will work as part of a multidisciplinary team, providing programming support for clinical trials. The Statistical Programmer will coordinate and execute on the preparation, execution, reporting and documentation of statistical programming activities internally and externally (CRO). They will demonstrate state-of-the-art programming knowledge/skills, develop datasets and analysis result displays for study monitoring and clinical study reports and develop analysis datasets to support exploratory analyses and data analytics for biomarker, publications, and/or modeling work. The successful candidate will effectively design and develop SAS programs to execute statistical analysis and execute clinical trial reporting deliverables, including tables, listings, graphs for clinical study reports, displays for publications, interim and/or ad hoc analysis, and submission-ready data in alignment with assigned clinical plans and strategies. This role will develop and perform appropriate quality control and validate clinical trials outputs in support of assigned clinical studies, while creating and maintaining statistical programming documentation including programming specifications as appropriate and in alignment with industry and regulatory standards. The Senior Manager/Associate Director, Statistical Programming will also be expected to establish highly collaborative and fruitful partnerships with internal and external programmers, data managers, statisticians, analysts, and clinical staff with the purpose of ensuring high quality clinical data to support the timeliness and quality of statistical analysis and reporting for all studies. Responsibilities: - Attend multi-disciplinary team meetings, representing the statistical programming function. - Aggressively seek out needed specification details for the deliverables. - Review and approve SAPs and TFL shells before the start of programming outputs - Provide input on key study-related documents produced by other functions (e.g. eCRFs, DMPs) or external sources of data (DTAs, in/outbound data specifications). - Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies. - Perform quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets and specifications. - Ensure the quality of tables, figures, and listings (TFLs) on time for electronic submission to regulatory agencies. - Assist statisticians by suggesting programming or process algorithms to address novel analysis requests. - Develop SAS validation procedures and test plans, as necessary. - Support ad hoc and rapid turnaround analyses (monitoring outputs, safety queries, interim reports, regulatory agency questions, exploratory analyses) - Ensure alignment with regulatory submission needs and evolving guidance. Qualifications: - Minimum 8 to 12 years of industry experience (pharmaceuticals, biotechnology, or CRO) in developing or overseeing efficient development of submission ready programming code for clinical trials using the SAS-based Statistical Computing Environment. - Strong CRO oversight experience - Solid verbal and written communication skills. - Demonstrated ability to speak up appropriately and ask necessary questions. - Experience in clinical trials related to oncology for solid tumors. - Experienced hands-on skill in programming with SAS is required. Knowledge of additional programming languages is a plus. - Good knowledge of statistics and oncology drug development process. - Strong experience performing quality control of datasets (ADaM, SDTM, SEND) based on CDISC dataset specifications, standard and custom data tables, listings, and graphs, as well as derived datasets, associated metadata, and specifications. - Demonstrated ability to respond rapidly to ad hoc and emergent requests (e.g. within hours/days), reprioritize, manage interruptions while maintaining quality and timelines About Us: Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is an Equal-Opportunity Employer. Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $184,000 - $200,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays. Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.

Role Description We are seeking a QMS Training Manager who will report to the Director, Quality Management Systems. You will focus on the organization, facilitation, and management of GxP and corporate training curricula at Celcuity. - 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. - Other duties as assigned. Qualifications - Bachelor’s degree in the life sciences or related field; or relevant experience. - Five plus (5+) years of experience in GxP training curricula design and management within an electronic QMS. Veeva experience preferred. - Proficiency and experience with electronic Learning Management Systems, Veeva strongly preferred. - Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP. - Excellent written and verbal communication skills, with ability to influence and build credibility at all levels. - Strong interpersonal skills for interacting with employees and leaders across various levels and functions. - Attention to detail and ability to manage multiple processes and documentation requirements. - Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint. - Ability to work in a team or independently as required. - Outstanding organizational skills with the ability to prioritize. - Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment. - Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization. - Flexible and willing to learn; adapting to business and site needs in a dynamic environment. - Maintain a positive, approachable and professional attitude. Benefits - Anticipated base pay range is $105,000 - $128,000. - Annual performance incentive bonus. - New hire equity package. - Medical, dental, vision insurance. - 401(k) match. - PTO and paid holidays. Company Description Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is an Equal-Opportunity Employer.

Role Description We are seeking a Senior Manager, Commercial Finance and Accounting who will report into the Senior Director, Financial Planning and Analysis. You will lead the finance and accounting functions critical to Celcuity’s commercial operations. This role is responsible for ensuring the accuracy and transparency of our revenue recognition, gross-to-net (GTN) estimates, revenue forecasting and related month-end close process. Responsibilities: - Financial Planning and Analysis - Lead the forecasting, budgeting, and long-range planning for GTN deductions, including rebates, chargebacks, distributor fees, and copay assistance programs. - Partner directly with the Commercial and Market Access teams to develop and maintain GTN assumptions and forecasts, track performance, and evaluate pricing and contracting strategies. - Analyze inventory trends and work cross-functionally to forecast inventory requirements, standard costs, and potential excess/obsolete (E&O) reserves. - Perform monthly variance analysis for gross revenue, GTN deductions, and cost of goods sold (COGS), providing actionable insights to leadership. - Financial Close and Reporting - Own the month-end close processes for revenue and inventory, including oversight and review of third-party GTN calculations, validation of accrual estimates, preparation of related journal entries and account reconciliations. - Maintain robust internal control procedures to mitigate financial reporting risks and ensure SOX compliance for commercial accounting cycles. - Coordinate with external auditors on revenue recognition, GTN estimates, and inventory valuation to facilitate efficient quarterly reviews and annual audits. - Drive improvements in financial systems, reporting tools and accounting processes to enhance operational efficiency and support scalable commercial operations. - Team Leadership and Development - Collaborate closely with the Senior Director, Financial Planning & Analysis, and the Vice President, Accounting and Financial Reporting, on strategic initiatives, cross-functional projects and SEC reporting disclosures. - Serve as the primary finance liaison for external commercial partners, including third-party logistics (3PLs) and specialty pharmacies, ensuring accurate data flow for accounting and forecasting. - Other duties as assigned. Qualifications - Bachelor’s degree in accounting or finance; CPA or CMA preferred. - Seven plus (7+) years of progressive finance and accounting experience, including at least two (2) years in a leadership role. - Prior experience in a commercial-stage public biotechnology, pharmaceutical, or life sciences company is strongly preferred. - Demonstrated expertise in ASC 606 revenue recognition, gross-to-net (GTN) accounting, and related forecasting processes. - Strong background in financial planning and analysis, including revenue and inventory modeling. - Experience strengthening accounting systems, processes, and internal controls in compliance with SOX, SEC, and U.S. GAAP requirements. - Continuous improvement mindset; constantly seeking ways to drive innovation and efficiencies in financial operations. - Outstanding organizational skills, attention to detail, and the ability to manage multiple complex processes and documentation requirements simultaneously. - Exceptional leadership, communication, and cross-functional collaboration skills, with the ability to influence and build credibility across commercial, supply chain, and executive teams. - Advanced analytical skills and high proficiency in Microsoft Excel, Word and PowerPoint, with experience in ERP systems commonly used in the life sciences industry. - Maintain a positive, approachable and professional attitude. Benefits - Anticipated base pay range is $150,000 - $190,000. - Eligible for an annual performance incentive bonus and a new hire equity package. - Various benefits offerings, including medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

Position Summary: We are seeking a Associate Director, Clinical Scientist, who will report to the Executive Director, Clinical Science. You will be responsible for the execution of Clinical Development goals through collaboration with and support of Medical Directors/Physicians and Clinical Development department activities. The Clinical Scientist will represent the Clinical Science group on various teams/sub-teams or other appropriate forums and is expected to perform their responsibilities with a low to moderate level of supervision. Responsibilities: - Review clinical data and ensure quality and consistency in clinical site reporting - Develop and review Clinical Development documents including writing, reviewing, adjudication/resolution of cross functional comments and ensuring a high-quality final document. Documents may include abstracts, manuscripts, clinical protocols/amendments, informed consent forms, regulatory documents, and other relevant materials. - Develop and review presentations and training materials such as slide decks, posters, or other relevant materials - Participate in the relevant Clinical Development Core Team and Clinical Sub-Team meetings as needed - Interface with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other members of the extended project team(s) - Represent Clinical Science in operational meetings (e.g., Study Management Team meetings) as needed. - Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s) Qualifications: - Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD) - 3 or more years clinical trial experience in pharma/biotech industry setting - Oncology research experience preferred - Data listing review experience is mandatory - Experience authoring experimental protocols and/or study results and conclusions - Strong understanding of Phase 1 through 4 drug development - Excellent comprehension and analytical skills in interpreting scientific research and literature - Sound knowledge of scientific and medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant health authority guidelines and regulations - Strong understanding of product and safety profiles - Working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs, etc. - Excellent time/project management skills: can prioritize multiple tasks to meet short and longer-term goals with high quality standards and in a timely manner - Strong oral and written communication skills, including interpersonal interactions, internal and site-directed communications and internal and external presentation skills - Good judgment and decision-making skills About Us: Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. Celcuity is an Equal-Opportunity Employer. Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $175,000 - $210,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays. Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.