Senior Medical Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with Celcuity’s medical team to provide oversight of service suppliers involved in ongoing clinical studies.

• Plan and execute the development, implementation, and monitoring of the study design protocol for the company’s new Phase I-III Oncology clinical trials.

• Offer essential clinical, scientific, and logistical support for clinical development programs.

• Assist in the design, authorship, and review of clinical study synopses, protocols, amendments, study reports, and other related documents.

• Serve as a medical monitor for assigned studies.

• Engage in discussions regarding study design with investigators and key opinion leaders.

• Provide clinical input for monitoring guidelines and analysis plans for clinical protocols.

• Drive the design of clinical databases, oversee data collection, cleaning, and interpretation of study data.

• Monitor the emerging efficacy and safety profiles of drugs in ongoing clinical trials; notify the Clinical Development team of changes in efficacy/safety and risk-benefit profiles as they arise.

• Contribute to 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 specifications, clinical supplies package diagrams and labeling).

• Lead or assist in the creation of publications, including abstracts, manuscripts, and slides.

• Support the identification, evaluation, and monitoring of vendors, as well as oversee clinical trial conduct and status.

• Assist in finalizing databases, reviewing study results, interpreting results, and preparing Clinical Study Reports (CSRs).

• Aid in planning and conducting investigator meetings and Advisory Board presentations.

• Oversee and manage vendor activities and deliverables as appropriate.

• Present study results to the medical and scientific community at meetings and in published formats, as needed.

⛳️ Requirements

• Medical Doctor (MD) with experience in solid tumor clinical trials is required.

• Recent experience in breast carcinoma is preferred.

• 8-10 years of clinical development experience in the pharmaceutical or biotechnology industry (depending on title or degree).

• Experience with Phase I–III clinical trials is essential, with a preference for Phase 3 experience.

• Comprehensive knowledge of clinical trial design, methodology, and statistical concepts.

• Familiarity with the IND/NDA process.

• In-depth understanding of GCP/ICH guidelines.

• Strong written and verbal communication skills (fluent in both written and spoken English), along with a proven ability to collaborate with various functional groups, investigators, key opinion leaders, and the medical/scientific community.

• Excellent organizational, time management, and interpersonal skills, along with proficiency in computer and software applications.

• Experience with regulatory submissions is a valuable asset.

🏝️ Benefits

• Medical, dental, and vision insurance.

• 401k match.

• Paid Time Off (PTO).

• Several paid holidays.

• Annual performance incentive bonus.

• New hire equity package.