Senior Medical Director, Clinical Development

Celcuity

8d•$320,000 - $350,000

About The Position

The Senior Medical Director will report to the Vice President, Clinical Development and work within Celcuity’s medical team, providing medical oversight of service suppliers supporting ongoing clinical studies. The role plans and executes study design, protocol development, implementation, and monitoring for new Phase I–III oncology clinical trials. The position provides overall clinical, scientific, and logistical support to clinical development programs and is responsible for ensuring the department and company comply with regulatory standards and procedures. It also oversees medical monitoring, study data interpretation, vendor activities, and communication of study results to the medical and scientific community.

Requirements

Medical Doctor (MD) with experience in solid tumor clinical trials.
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.
Thorough working knowledge and 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 spoken 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.

Nice To Haves

Recent experience in breast carcinoma is preferred.
Phase 3 clinical trial experience is preferred.
Experience with regulatory submissions is an asset.
A collaborative, team-oriented approach to leadership.
Ability to build strong relationships with coworkers from varied backgrounds and areas of expertise.
Ability to function effectively in a team setting as either a group leader or an individual contributor.
Values-based leadership consistent with Celcuity’s core principles.
Ability to build teams within Celcuity and among Celcuity and CROs working together on clinical study development and execution.

Responsibilities

Assist in designing, authoring, and/or reviewing clinical study synopses, protocols, amendments, study reports, and other study-related documents.
Act as a medical monitor for assigned studies.
Discuss study designs 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 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 in efficacy, safety, and/or risk-benefit profiles.
Provide input and/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, and clinical supplies package diagrams and labeling.
Lead or assist with developing publications, including abstracts, manuscripts, and slides.
Collaborate with team members, such as Clinical Operations and Data Management, to identify, evaluate, and monitor vendors and monitor clinical trial conduct and status.
Assist with database finalization, study-result reviews, results interpretation, and clinical study reports.
Assist in planning and conducting investigator meetings and Advisory Boards.
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 appropriate.