Associate Director, Program Management

Position Summary:

We are seeking an Associate Director, Program Management who will report into the Vice President, Program Management. You will work with cross-functional teams in the successful planning and execution of both early research and late-stage drug development programs. This role requires deep program management expertise in R&D activities, IND filings and lifecycle management within the pharmaceutical and biotech industry. The Associate Director will ensure projects are delivered on time, within scope, and in compliance with regulatory requirements while aligning with corporate objectives.

Responsibilities:

R&D Planning & Lifecycle Management

• Manage a cross-functional R&D and lifecycle management team.
• Develop, implement and maintain R&D study plans, ensuring strategies align with corporate goals and that study results are on time and within budget.
• Drive the creation and maintenance of a R&D dashboard, providing transparency to senior leadership on R&D progress.
• Manage and maintain complete and high-quality core program information and documents such as minutes, agendas, action items, development plans, integrated timelines, assumptions, dashboards.
• Proactively track and transparently report on program status against approved timeline, goals, and milestones.
• Serve as a central source for cross functional program information across the company, including senior management.

Project Leadership & Stakeholder Management

• Facilitate project governance, ensuring senior leadership has clear visibility into project milestones and risks.
• Reviews R&D deliverables and ensures alignment across research, development and lifecycle management workstreams.
• Act as a key liaison between the R&D team and executive leadership.

Operational Excellence & Risk Management

• Collaborating with project and functional area leads, identify project risks, key interdependencies, and proactively develop and implement mitigation plans.
• Implement project management best practices, tools, and templates to enhance team efficiency.
• Provides coaching and development to team members on project management methodologies.
• Measures team performance to achieve deliverables and provide feedback to functional management.
• Utilize data from performance metrics and feedback to identify and develop solutions for the broader teams to gain long term efficiencies.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; or relevant experience.
• Advanced degree (MBA, PhD, or PharmD) preferred.
• Minimum of Five plus (5+) years of experience in research and development programs (early and/or late) within the pharmaceutical/biotech industry.
• PMP certification preferred.
• Oncology experience preferred.
• Proven track record of leading IND enabling activities and assisting with IND filings.
• Prior experience in a line function (e.g. research, clinical development/operations, CMC, regulatory).
• Familiarity with pre-clinical and clinical regulatory requirements and compliance standards.
• Expertise in project management methodologies.
• Strong leadership, organizational, and interpersonal skills.
• Ability to manage complex, cross-functional teams and drive strategic objectives.
• Highly motivated, proactive, enthusiastic and goal-orientated to deliver on the success of the company’s R&D programs.
• Proficiency in project management software (e.g., Smartsheet).
• 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.

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 $160,000 - $205,000. 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.

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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.