Senior Medical Director, Clinical Development

🔥 4 minutes ago

🇺🇸 United States – Remote

💵 $320k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 2%

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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

• Report to the Vice President, Clinical Development • Provide medical oversight of service suppliers driving ongoing clinical studies • Plan and execute study design, protocol development, implementation and monitoring for new Phase I–III oncology clinical trials • Provide clinical, scientific and logistical support to clinical development programs • Ensure department and company compliance with regulatory standards and procedures • Design, author and/or review clinical study synopses, protocols, amendments, study reports and other study-related documents • Act as 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 trials and inform the Clinical Development team of changes • Prepare or provide input for clinical sections of regulatory documents, including INDs, IND annual reports, Investigator’s Brochures, CRFs, informed consent forms and statistical analysis plans • 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 with 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 • Build teams within Celcuity and among Celcuity and CROs working together on 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 • 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 • Collaborative and team-oriented leadership approach • Ability to build strong relationships with co-workers of various backgrounds and expertise • Ability to function at a high level in a team setting, whether leading the group or acting as an individual contributor • Values-based leadership consistent with Celcuity’s core principles

🏖️ Benefits

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