Senior Medical Director, DSPV

🕒 5 days ago

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Celcuity is a clinical-stage biotechnology company developing targeted therapies that block the PI3K/AKT/mTOR (PAM) pathway to treat multiple solid tumors. Its lead candidate, gedatolisib, is a potential first-in-class pan-PI3K and mTORC1/2 inhibitor being evaluated in breast and prostate cancer trials. The company advances a focused pipeline aimed at delivering transformative, targeted cancer treatments and conducts clinical development and data-driven research to support regulatory and medical adoption.

📋 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 • Preferred: 3+ years of clinical physician experience in treatment of solid cancers in a multidisciplinary environment • Fluency in written and spoken English • Strong scientific and analytical skills with strong ability to interpret and communicate medical safety data from various sources • Experience with audit readiness/preparedness activities • Competency in presenting data, obtaining, analyzing, and reporting safety data • NDA and MAA filing experience • Experience with challenging current practices to drive improvement and innovation • Ability to work in a team or independently as required • Maintain a positive, approachable and professional attitude.

🏖️ Benefits

• medical • dental • vision insurance • 401(k) match • PTO • paid holidays