Senior Manager, Clinical Supply

The Senior Manager, Clinical Supply is responsible for leading global clinical supply strategies and execution for clinical development programs across multiple phases of development. This role ensures uninterrupted supply of investigational medicinal products (IMPs), comparators, ancillary materials, and clinical trial supplies while maintaining compliance with regulatory requirements, GMP standards, and company policies.

Responsibilities

• Clinical Supply Strategy & Planning
  • Develop and execute end-to-end clinical supply strategies for Phase I–III clinical studies.
  • Create demand forecasts and supply plans based on study protocols, enrollment assumptions, and country-specific requirements.
  • Determine proper use of materials as required by the governing regulatory agencies.
  • Perform risk assessments and mitigation planning.
  • Optimize inventory and minimize waste.
• Supply Chain Management
  • Manage packaging, labeling, distribution, returns, and destruction activities.
  • Manage label text development.
  • Coordinate global supply distribution.
  • Monitor inventory levels.
• Ensure clinical trial materials have proper and complete documentation and correct and up-to-date information.
• Support vendor engagement activities, including contracts, meetings, invoices, and deliverables.
• Collaborate with Clinical Operations, Regulatory Affairs, Quality, and Pharmaceutical Development and Operations teams.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in natural sciences, or related field; or relevant experience.
• 5+ years of experience in managing drug supply for global studies, or a related area.
• Knowledge of regulatory requirements with respect to clinical trial supplies.
• 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.
• Experience with trial management software for randomization/supply required.
• Proficiency in depot management supporting shipments to sites.
• Expert knowledge of import/export regulations and requirements as it pertains to finished pharmaceuticals.
• Knowledge of tariffs, duties and VAT requirements, as appropriate.
• 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.

About Celcuity

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

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 to $175,000 DOE. 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.