Celcuity

Medical Director

• Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents.
• Act as a medical monitor for assigned study.
• Discuss study design with investigators and key opinion leaders.
• Provide clinical input for clinical protocol monitoring guidelines and analysis plans.
• Drive clinical database design, data collection and cleaning and oversees clinical interpretation of study data.
• Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur.
• Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling).
• Lead or assist in the development of publications – abstracts, manuscripts, slides, etc.
• In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying / evaluating / monitoring vendors, monitoring clinical trial conduct/status.
• Assist in database finalization, reviews of study results, results interpretation and CSR’s.
• Assist in planning and presentation conduct of investigator meetings and Advisory Boards.
• Oversee and manage vendor activities/deliverables as appropriate.
• Present study results, as appropriate, to medical/scientific community at meetings and in published format.

Senior Medical Director, Clinical Development

Manager

• Facilitates the meticulous creation, revision, and retirement of controlled documents in the eDMS, including managing and tracking Document Change Control workflows and participants.
• Management and migration of legacy files into the eQMS.
• Coordinates with the Training Admin to create new or revisions to Training Requirements, learners, quizzes, and other training related to controlled documents.
• Helps eDMS users with the how-to of document creation and revision and works with the QMS Admin to keep relevant document control SOPs and Work Instructions up to date.
• Helps eDMS users find and use current effective documents.
• Facilitates meetings with the QMS Admin and document reviewers to complete content creation or revisions.
• Manages GxP record retention and destruction tasks.
• Facilitates Certified Copy creation and retention.
• Other duties as assigned.

Document Control Manager

Director

• Serve as a field-based scientific liaison to engage population-health decision makers (PHDMs)
• Support Market Access and Medical Affairs colleagues through evidence communication
• Establish valued relationships with PHDMs within assigned accounts
• Proactively represent the evidence needs of PHDMs to internal stakeholders
• Identify opportunities for and support collaborative research and data generation partnerships
• Maintain deep expertise in relevant oncology disease areas
• Provide internal training and education on health economics and outcomes research concepts
• Contribute scientific expertise during scientific congresses, advisory boards, and other key engagements

Director – Value & Outcomes Liaison

Financial Planning and Analysis

• Lead the preparation and review of all SEC filings
• Collaborate with auditors and legal teams on SEC filings
• Develop internal review processes for SEC reports
• Provide technical accounting expertise on complex transactions
• Research impact of new accounting standards on financial statements
• Mentor and lead accounting functions for professional growth

Vice President, Accounting and Financial Reporting

Communications

• Reporting to the Vice President, Medical Affairs
• Responsible for the development and execution of a cohesive scientific communication strategy
• Build and lead strategic scientific communication plans
• Establish a strategic data generation strategy
• Lead strategic planning and the generation of Medical Information materials
• Drive the production of publications, often under tight timelines
• Partner closely with field leadership
• Establish and implement standard practices, processes and procedures for the work
• Develop and maintain scientific and medical expertise through continuous learning

Senior Director, Scientific Strategy and Communications

• Lead and coordinate statistical related activities to support clinical studies including design, execution, analysis, interpretation, and reporting of clinical trials
• Support for the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represents the Biostatistics function for cross-functional and intra-departmental teams or working groups
• Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells
• Create or validate SAS programs for data management activities, compliant analysis datasets, and statistical analysis of clinical trial data
• Prepare the statistical section of clinical trial reports and presentations of the results to the team
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development
• Writing statistical reports and memos with minimal guidance
• Validating complex datasets or summary tables
• Prepares and documents facts to enable management to write and support trial reports and publications
• Other duties as assigned.

Director, Biostatistics

• Provide technical expertise and oversight of programming by CRO partners for clinical study data analysis
• Hands-on generation of analysis results for rapid responses, ad hoc analyses, exploration of biomarkers
• Execute preparation, production, validation, reporting, and documentation of statistical programming activities
• Develop and perform appropriate quality control and validation of output in support of assigned clinical studies

Senior Manager, Statistical Programming

• Identify and cultivate professional relationships KOLs in designated tumor types.
• Maintain cross-functional field partnerships allowing for appropriate collaboration with field commercial teams (sales, market access, etc.), and Clinical Development associates.
• Maintain and develop synergistic relationships with KOLs to expand research, advisory, and educational partnership opportunities.
• Assist the Clinical Development Team in the identification and education of potential clinical trial sites.
• Develop scientific expertise on all Celcuity’s products, related disease states, and the clinical practice for a given therapeutic area.
• Communicate scientific content, written and verbal, related to Celcuity’s products and related disease states.

Director, Medical Science Liaison

Compliance

• Provide strategic CMC regulatory leadership to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Responsible for writing and maintaining CMC sections of INDs and IMPD’s for global CTA’s while ensuring complete, compliant, and timely submissions.
• Provide hands-on support in generating CMC documents, responsible for compilation, review, approval and submission of high-quality CMC related sections of INDs/CTAs, NDA/MAA, including responses to questions from various regulatory authorities.
• Maintain responsibility for all CMC Regulatory timelines including developing timelines for IND/CTA (IMPD)/NDA/MAA submissions (new, amendments, supplements, responses to queries), updating SmartSheet, communicating, and escalate any timeline issues to management toward successful on-time filing.
• Act as the regulatory representative on clinical study teams and product development teams providing guidance on regulatory CMC guidance.
• Evaluate proposed manufacturing changes for global impact to ongoing and existing filings and provide strategic regulatory guidance for optimal implementation of changes.
• Provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.
• Assess proposed pharmaceutical development (CMC) changes and provide strategic regulatory guidance to enable global implementation.
• Evaluate business impact, through regulatory intelligence, all changes related to regulatory CMC regulation, or adoption of new regulation which impact CMC processes and/or CMC strategy.
• Interact with vendors as needed in support of electronic publishing and other aspects of regulatory operations as well as regulatory submission preparation as needed.
• Perform detailed quality reviews of published submission output to ensure compliance with Regulatory Standards, as required.
• Track and archive submissions, correspondence, and commitments with health authorities as needed.
• Develop and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
• Ensure the company is adhering to all applicable government regulations, submission regulations and guidelines.

Senior Manager, Regulatory Affairs, CMC

Vice President

• Ensure competent medical evaluation of all relevant safety information
• Proactively interact with clinical trial investigators and other medical staff
• Work with PV vendor and internal safety team to develop a system for post-marketing safety surveillance
• Lead Celcuity’s Safety Management Team and oversee all risk-benefit assessments
• Collaborate cross-functionally with Clinical Development, Regulatory, Clinical Operations, Medical Affairs, Quality, and Commercial teams
• Serve as the company’s senior safety spokesperson in regulatory inspections and audits
• Lead the design and continuous improvement of the company’s PV system
• Contribute to and ensure timely submission of expedited safety reports
• Oversee the pharmacovigilance quality management system
• Develop and maintain comprehensive PV agreements
• Contribute to the development of company documents such as SOPs, clinical study reports, and safety plans
• Mentor and develop the drug safety and pharmacovigilance team
• Oversee the QPPV and PSMF development and maintenance
• Develop and manage the PV budgets and staffing projections

Vice President, Drug Safety – Pharmacovigilance

Operations

• Responsible for the buildout and management of the commercial operations function.
• Work cross-functionally with commercial and other management/teams.
• Design and implement commercial operations infrastructure, systems, and processes.
• Build data infrastructure and analytics capabilities for product and market insights.
• Manage vendor selection and ongoing management of data aggregator.
• Ensure key business insights are incorporated into business planning/execution.
• Acquire and analyze market data including claims data, product demand data, and competitive data.
• Implement field CRM system for capturing market data and physician demand with integrated reporting.
• Manage commercial training and development function, including a dedicated staff.

Vice President, Commercial Operations

Content Writer

• Write, review, edit, proofread, verify, and manage Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, NDA clinical modules, and other higher-level regulatory documents.
• Contribute to document templates, style guides, and medical writing related SOPs
• Conduct quality control (QC) checks to ensure accuracy, consistency, and compliance with regulatory requirements and Celcuity SOPs and Style Guide.
• Manage and coordinate communication with consultants and CROs.
• Other duties as assigned.

Associate Director, Medical Writing

• 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)