Celcuity · 11 hours ago
Senior Medical Director
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$260K/yr - $350K/yr
8+ years expCelcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. They are seeking a Senior Medical Director to provide medical oversight for clinical studies and ensure compliance with regulatory standards while supporting the clinical development programs.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
Responsibilities
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
Qualification
Required
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
Preferred
Leadership skills include a collaborative and team-oriented 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
Building team within Celcuity, as well as among Celcuity and CRO's working together on development and execution of clinical studies
Benefits
Medical
Dental
Vision insurance
401k match
PTO
Several paid holidays
Company
Celcuity
Celcuity is a biotechnology company translating discoveries of new cancer sub-types into expanded therapeutic options for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Innovatus Capital PartnersVenrock Healthcare Capital PartnersBrightstone Venture Capital
2025-09-09Post Ipo Debt· $500M
2025-07-30Post Ipo Equity· $85M
2025-07-30Post Ipo Debt· $175M
Leadership Team
Brian Sullivan
Co-Founder, Chairman, CEO
Eldon Mayer
Chief Commercial Officer (CCO)
Recent News
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