Position Summary:
We are seeking an Associate Director, Drug Safety and Pharmacovigilance who will report to the Executive Director, Drug Safety and Pharmacovigilance. You will provide strategic and operational leadership for clinical safety activities across assigned programs. This role provides proactive oversight of end‑to‑end safety operations, including case processing, regulatory reporting, development of safety management plans, DSMB deliverables, safety data reconciliation, and all activities required to ensure compliant safety oversight across clinical trials.
Responsibilities:
- Provide leadership and oversight of external safety vendors to ensure high‑quality, timely, and compliant execution of all outsourced safety activities.
- Lead the preparation, authorship, and review of aggregate safety reports (e.g., DSURs, PADERs, line listings) and manage associated timelines and cross‑functional inputs.
- Provide day-to-day direction to the Safety Operations team and communicate program-level updates to internal and external stakeholders.
- Demonstrate initiative by exploring potential solutions and offering thoughtful recommendations, engaging leadership when additional insight or alignment is needed.
- Oversee the review and assessment of adverse event reports for assigned programs, ensuring appropriate follow‑up and timely expedited reporting in accordance with global regulatory requirements.
- Contribute to the development, implementation, and continuous improvement of SOPs, work instructions, templates, and systems to ensure compliance with global clinical trial regulations and industry best practices.
- Ensure procedural deviations are documented, investigated, and addressed through effective corrective and preventive actions.
- Support inspection readiness activities and serve as a key contributor during audits and global health authority inspections.
- Develop and maintain study‑specific safety management plans and related documents, ensuring clear delineation of responsibilities between Celcuity and CRO partners.
- Ensure adherence to Safety Data Exchange Agreements and compliance with all agreed‑upon reporting requirements and timelines.
- Review and provide expert input on safety-related sections of clinical documents, including protocols, charters, Investigator Brochures, and Informed Consent Forms.
- Develop, monitor, and interpret key performance indicators and metrics for internal teams and external vendors to evaluate performance and drive continuous improvement.
- Serve as the safety subject matter expert for internal teams and external stakeholders, providing guidance on safety operations, regulatory expectations, and best practices.
- Perform other tasks as required to assist in company and departmental activities.
Qualifications:
- 10+ years of drug safety/pharmacovigilance experience within a sponsor environment or a combination of sponsor and CRO roles.
- Bachelor’s or advanced degree in a life science or healthcare‑related discipline (e.g., MD, RN, PharmD, NP, PhD, MPH).
- Comprehensive knowledge of global clinical safety regulations, guidelines, and industry best practices.
- Extensive experience working with commercial safety databases (Argus or ARIS-G), electronic data capture systems, and trial master files.
- Demonstrated experience preparing aggregate safety reports for investigational and/or marketed products (e.g., DSURs, PSUR/PBRERs, PADERs) and contributing to IB updates.
- Strong knowledge of MedDRA and WHODrug coding conventions.
- Excellent written and verbal communication skills, with the ability to convey complex information clearly and concisely.
- Strong interpersonal skills with the ability to collaborate effectively across functions and organizational levels.
- Exceptional attention to detail and ability to manage multiple priorities and documentation requirements.
- Strong technical and analytical skills with advanced proficiency in MS Office (Word, Excel, PowerPoint).
- Ability to work independently or collaboratively, demonstrating sound judgment and decision‑making in a fast‑paced environment.
- Naturally takes initiative, contributing to continuous improvement efforts and proactively identifying opportunities to enhance processes within the department.
- Continuous improvement mindset with a focus on innovation, efficiency, and operational excellence.
- Flexible, adaptable, and committed to maintaining a positive and professional demeanor.
About Us:
Celcuity is a publicly traded commercial-stage biotechnology company developing targeted therapies for multiple solid tumor indications. The company's 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 a PIK3CA 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 $160,000 - $179,000 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.
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