Senior Medical Director, Clinical Development

Celcuity

. Report to the Vice President, Clinical Development .

Posted 10/14/2026full-timeRemote • United StatesSenior💰 $320,000 - $350,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial design, execution, and regulatory compliance, with a strong focus on oncology and solid tumors. Proven ability to lead cross-functional teams and communicate effectively with diverse stakeholders in the medical and scientific community.

Highest-signal resume keywords

Medical Doctor (MD)Clinical Development ExperiencePhase I–III Clinical Trial ExperienceGCP/ICH Guidelines KnowledgeRegulatory Submissions Experience

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial DesignProtocol DevelopmentStatistical ConceptsData Collection and CleaningClinical Study ReportsIND/NDA ProcessClinical Database DesignEfficacy and Safety Profile TrackingPublications DevelopmentVendor Management

Soft Skills

Strong Written and Verbal CommunicationOrganizational SkillsTime ManagementInterpersonal SkillsCollaborative Leadership

Tools & Technologies

Clinical Trial Management SystemsStatistical Analysis SoftwareDatabase Management ToolsRegulatory Document Preparation Tools

Industry Keywords

OncologyBreast CarcinomaPharmaceutical IndustryBiotechnology IndustryClinical DevelopmentGood Clinical Practice (GCP)International Council for Harmonisation (ICH)

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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