Senior Medical Director, Clinical Development

2 days ago

❄️ Minnesota – Remote

Although this job is listed in Minnesota, this company may be open to hiring remote in other states.

💵 $260k - $350k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Celcuity

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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.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 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, dental, vision insurance • 401k match • PTO • several paid holidays