Senior Medical Director, Clinical Development

🕒 July 11

🇺🇸 United States – Remote

💵 $320k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 32%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Celcuity

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • 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

• Provide medical oversight of service suppliers driving ongoing clinical studies • Plan and execute study design, protocol development, implementation and monitoring for Phase I–III oncology clinical trials • Assist in designing, authoring and reviewing clinical study synopses, protocols, amendments, study reports and other study-related documents • Act as a medical monitor for assigned studies • Discuss study design with investigators and key opinion leaders • Provide clinical input for protocol monitoring guidelines and analysis plans • Drive clinical database design, data collection and cleaning, and oversee clinical interpretation of study data • Track emerging efficacy and safety profiles of drugs in ongoing clinical trials and inform the Clinical Development team of changes • Provide input to or prepare clinical sections of regulatory documents, including INDs, IND annual reports, Investigator’s Brochures, CRFs, informed consent forms, Statistical Analysis Plans, data management edit check specifications, clinical supplies package diagrams and labeling • Lead or assist in developing publications, including abstracts, manuscripts and slides • Identify, evaluate and monitor vendors and clinical trial conduct/status in collaboration with Clinical Operations and Data Management • Assist in database finalization, study-results reviews, results interpretation and clinical study reports • Assist in planning and conducting investigator meetings and Advisory Boards • Oversee and manage vendor activities and deliverables • Present study results to the medical/scientific community at meetings and in published formats • Ensure department and company compliance with regulatory standards and procedures • Build teams within Celcuity and among Celcuity and CROs involved in clinical-study development and execution

🎯 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, including fluency in written and verbal English • 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

• Annual performance incentive bonus • New hire equity package • Medical insurance • Dental insurance • Vision insurance • 401(k) match • PTO • Paid holidays