Executive Director, Biostatistics

POSITION SUMMARY:

Reporting to the Senior Director, Financial Planning & Analysis, the Manager, Financial Planning & Analysis (FP&A) partners closely with various functions including R&D, Clinical Development, Regulatory Affairs, Clinical Operations, Quality and Pharmaceutical Development to drive strategic business objectives through financial planning, analysis, and actionable insights. This role leads the planning, forecasting, and financial management of operating expenses, including support for clinical trial forecasting, monthly and quarterly variance analyses, and management reporting. The Manager develops financial models, performs strategic and ad-hoc analyses, and delivers actionable insights to inform decision-making. Acting as a trusted Finance partner, this position builds strong partnerships across the organization and helps drive decision-making to support the companys growth and strategic objectives.

PRIMARY RESPONSIBILITIES AND DUTIES:

• Partner with leaders across various functions including R&D, Clinical Development, Clinical Operations, Regulatory Affairs, Quality, and Pharmaceutical Development (CMC) to develop budgets and forecasts, monitor performance, and provide financial guidance that supports organizational objectives.
• Lead the development, and management of operating expense budgets and forecasts.
• Support the development and forecasting of clinical trial programs by analyzing study timelines, enrollment assumptions, and projected spend.
• Build and maintain financial models to evaluate financial performance, identify trends, monitor spending against budgets and forecasts, and provide actionable recommendations to leadership.
• Prepare monthly and quarterly financial reporting packages, including variance analyses, forecast updates, management commentary, and support for month- and quarter-end close activities.
• Perform ad hoc financial analyses to support strategic initiatives and business decisions.
• Proactively identify financial risks and opportunities, communicating key insights and recommendations to functional and Finance leadership.
• Drive continuous improvement of FP&A processes, reporting, financial models, and planning tools to enhance forecasting accuracy and operational efficiency.
• Perform other duties and special projects as assigned.

QUALIFICATIONS AND SKILLS:

• Six plus (6 ) years of progressive experience in FP&A, finance or accounting supporting operating expenses. Experience in a small or emerging biotechnology company is strongly preferred.
• Bachelors degree in Accounting, Finance, Business Administration or a related field required; advanced degree (MBA or equivalent) preferred.
• Track record of partnering with R&D, Clinical Development, Clinical Operations, Regulatory Affairs, Quality and Pharmaceutical Development (CMC) teams to drive strategic and financial objectives.
• Experience with clinical trial budgeting, CRO spend, and R&D financial planning preferred.
• Advanced Microsoft Office skills, with expert-level proficiency Excel (lookups, complex formulas and nested logical statements).
• Experience with FP&A planning tools and NetSuite ERP preferred.
• Proven ability to build and maintain financial models, perform complex financial analyses, identify issues, and translate data into actionable business insights and recommendations.
• Highly organized, self-starter, with the ability to manage multiple priorities in a fast-paced environment.
• Excellent verbal and written communication, presentation, and influencing skills, with the ability to build trusted partnerships and collaborate effectively across functions and all levels of management.
• Detail-oriented with high accountability for results and awareness of organizational impact.

ABOUT CELCUITY:

Celcuity is a publicly traded commercial-stage biotechnology company developing targeted therapies for multiple solid tumor indications. The companys first FDA-approved product is REVTORPYK (gedatolisib), targets all class I isoforms of PI3K and the mTOR complexes to comprehensively block the PAM pathway. The PAM pathway is an important signaling pathway involved in many cancers and has historically been challenging to target.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR /HER2- locally advanced or metastatic breast cancer (ABC), supported FDA approval of REVTORPYK for use in patients without aPIK3CA mutation detected. 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 $280,000 - $310,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidates 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.

Celcuitys 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.