Celcuity · 10 hours ago
Director, Safety Science
United States
Full-time
Remote
Lead/Staff, Director/Executive
$190K/yr - $220K/yr
5+ years expCelcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. The Director of Safety Science will provide medical and scientific expertise in safety evaluation and risk management for Celcuity products in clinical development and post-marketing settings.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
Responsibilities
Support Safety Physicians with safety-related tasks across commercial products and products in clinical development
Acquire and contribute to the knowledge of the relevant drug class and/or competitor safety issues
Contribute to safety risk management including but not limited to routine review of safety data and pertinent scientific literature articles
Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment as directed by the Safety Physician
Presents safety data summary/ observations or analysis in safety review and/or governance meetings and supports implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure and other key safety documents and deliverables and/or risk mitigation measures
Contribute to the preparation of safety documents, including but not limited to, DSURs, PADERs/PBRER, RMPs, SDEAs, plans, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, CSRs, and CCDS, etc
Assist with regulatory dossier submissions, including Clinical Overviews, Clinical Evaluation Reports, and Summaries of Clinical Safety
Represent Clinical Safety in study team meetings and collaborate with internal and external stakeholders to ensure timely delivery of safety-related milestones
Contribute to the development and review of departmental quality documents, such as SOPs and working guidelines
Contributes to responses to safety queries from third parties, such as regulatory agencies
Prepare and present safety data summaries to internal and external stakeholders, including but not limited to Data Monitoring Committees
Conduct literature search activities and develop key strings for search criteria and review safety related information
Support quality systems, inspection readiness, audit, and inspections
Other duties as assigned
Qualification
Required
A relevant postgraduate qualification (e.g., MSc or equivalence in healthcare or in a Life sciences discipline, PhD is a plus or other post-graduate health professional qualifications)
Five or more (5+) years of drug development experience in the pharmaceutical or related industry with at least three (3) years of experience in drug safety/pharmacovigilance
Collaborative team player with proven success in creating and sustaining strong relationships with internal and external business partners across an organization to create positive partnerships
Must have at least two (2) years' data management and analysis experience; Experience with large data base or post market databases such as FAERS, EudraVigilance is preferable
Familiar with safety databases and capable of extracting, handling data (or data mining) from databases as needed
Hands-on experience of common analytical software/tools such as Excel, (or R, Microsoft power BI and other analytical tools) and knowledge of safety analytics and relevant statistics
Possesses knowledge of pharmacovigilance and signal detection, evaluation process
Strong presentation skills, effective at summarizing and presenting the key data effectively to diverse stakeholders
In-depth understanding of global clinical safety and pharmacovigilance regulations and guidelines, including GVP, FDA, and EMA requirements
Proficiency with pharmacovigilance databases and tools such as Argus and MedDRA coding
Proven track record in preparing and reviewing regulatory safety documents, including, DSURs, and risk management plans
Excellent written and verbal communication skills
Attention to detail and ability to manage multiple processes and documentation requirements
Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint
Ability to work in a team or independently as required
Outstanding organizational skills with the ability to prioritize
Preferred
Demonstrated experience in the oncology therapeutic area through clinical practice, drug development, or other relevant industry experience is a plus
Benefits
Medical
Dental
Vision insurance
401(k) match
PTO
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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2026-01-23
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2026-01-21
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