Senior Medical Director

🕒 March 18

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Assist in design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents. • Act as a medical monitor for assigned study. • Discuss study design with investigators and key opinion leaders. • Provide clinical input for clinical protocol monitoring guidelines and analysis plans. • Drive clinical database design, data collection and cleaning and oversees clinical interpretation of study data. • Track emerging efficacy and safety profile of drugs in on-going clinical trials; inform Clinical Development team of changes in the efficacy/safety and/or risk benefit profiles as they occur. • Provide input and/or prepare clinical sections of regulatory documents (e.g., INDs, IND annual reports, Investigator’s Brochures, CRFs, Informed Consent forms, Statistical Analysis Plans, Data Management edit check specs, clinical supplies package diagrams and labeling). • Lead or assist in the development of publications – abstracts, manuscripts, slides, etc. • In collaboration with team members (e.g., Clinical Operations, Data Management), assist in identifying/evaluating/monitoring vendors, monitoring clinical trial conduct/status. • Assist in database finalization, reviews of study results, results interpretation and CSR’s. • Assist in planning and presentation conduct of investigator meetings and Advisory Boards. • Oversee and manage vendor activities/deliverables as appropriate. • Present study results, as appropriate, to medical/scientific community at meetings and in published format.

🎯 Requirements

• Medical Doctor (MD) with experience in solid tumor clinical trials required; recent experience in breast carcinoma preferred. • 8-10 years’ clinical development experience in the pharmaceutical or biotechnology industry (depending on title or degree). • Phase I–III clinical trial experience, with phase 3 experience preferred. • Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts. • Working knowledge of the IND/NDA process. • In depth knowledge of GCP/ICH guidelines. • Strong written and verbal communication skills (fluency in written and verbal English) as well as proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community. • Good organizational, time management and interpersonal skills, proficiency in computer and software skills. • Experience with regulatory submissions is an asset.

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • 401k match • Paid time off • Several paid holidays • Annual performance incentive bonus • New hire equity package