Senior Medical Director, Clinical Development

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

📋 Description

• Report directly to the Vice President of Clinical Development.

• Provide medical oversight for service suppliers conducting ongoing clinical studies.

• Plan and execute the design, protocol development, implementation, and monitoring of new Phase I–III oncology clinical trials.

• Offer clinical, scientific, and logistical support to clinical development programs.

• Ensure compliance with regulatory standards and procedures for both the department and the company.

• Design, author, and/or review clinical study synopses, protocols, amendments, study reports, and other relevant study documents.

• Serve as the 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 the design of clinical databases, oversee data collection and cleaning, and interpret study data clinically.

• Monitor emerging efficacy and safety profiles of drugs in ongoing trials and communicate changes to the Clinical Development team.

• Prepare or contribute to 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 the creation of publications, including abstracts, manuscripts, and presentation slides.

• Identify, evaluate, and monitor vendors and the status of clinical trials in collaboration with Clinical Operations and Data Management.

• Assist in finalizing databases, reviewing study results, interpreting results, and drafting clinical study reports.

• Aid 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 foster collaboration between Celcuity and CROs involved in clinical study development and execution.

⛳️ 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 in Phase I–III clinical trials, with a preference for Phase III experience.

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

• Familiarity with the IND/NDA process.

• In-depth knowledge of GCP/ICH guidelines.

• Excellent written and verbal communication skills, including fluency in both written and spoken English.

• Ability to engage with various functional groups, investigators, key opinion leaders, and the medical/scientific community.

• Strong organizational, time management, and interpersonal skills.

• Proficiency in computer and software skills.

• Experience with regulatory submissions is a plus.

• A collaborative and team-oriented leadership style.

• Capability to build strong relationships with colleagues from diverse backgrounds and areas of expertise.

• Ability to perform effectively in a team environment, whether in a leadership role or as an individual contributor.

• Leadership aligned with Celcuity's core values.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) match.

• Paid time off (PTO).

• Paid holidays.