Senior Medical Director, DSPV

🕒 May 21

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $500M Post-IPO Debt - Celcuity on 2025-09

Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that comprehensively block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead product candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor in late-stage clinical development (including Phase 3 VIKTORIA trials) for HR+/HER2- advanced breast cancer and other indications such as prostate cancer. The company advances a focused pipeline of PAM pathway inhibitors, publishes clinical data, engages with investors and regulators, and is mission-driven to improve outcomes for cancer patients.

📋 Description

• Responsible for medical oversight of safety vendor(s) to ensure effectiveness, quality, and compliance of all outsourced activities, support timely triage and narratives for timely case reporting to agencies and for periodic safety reports (e.g., DSURs, PADERs, etc.) in collaboration with other cross-functional teams. • Provide day-to-day medical support for the Safety Operations team and provide updates to internal and external stakeholders, as required. • Reviews incoming adverse event reports to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports. • Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices. • Support safety inspection readiness activities in collaboration with department leadership. • Support the requirements of Safety Data Exchange Agreements with Celcuity partners and ensure compliance with the agreed upon terms and timelines. • Reviews and provides input on the safety sections of clinical documents, including but not limited to the safety reporting section of protocols, Investigator Brochures, and Informed Consents. • Support the development of internal and external (with vendors) key performance indicators and metrics to track performance. • Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB) • Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed • Serves as the Safety subject matter expert for internal audits and global inspections. • Other Duties as assigned.

🎯 Requirements

• 10+ years of drug safety/pharmacovigilance experience in a sponsor company or a combination of sponsor and CRO experience in drug safety/pharmacovigilance • Medical degree. Training in medical or radiation oncology, hematology or related field preferred. • Comprehensive knowledge of global drug safety related regulations and work practices • Extensive experience with commercial safety databases (Argus or ARIS-G) and electronic data capture systems. • Experience with the preparation of aggregate reports, (i.e., DSUR, PSUR/PBRER, PADER, RMP, ISS) and ICF and IB updates. • Excellent knowledge of MedDRA and WHO Drug coding practices. • Excellent verbal communication and presentation skills with ability to write clearly and concisely. • Strong project management skills with the ability to prioritize to meet required timelines. • Ability to multitask and prioritize under tight timelines while providing attention to detail and high-quality work in a dynamic environment.

🏖️ Benefits

• medical, dental, vision insurance • 401(k) match • PTO • paid holidays • annual performance incentive bonus and new hire equity package