Director, Safety Science

Position Summary:

We are seeking a Director, Safety Science who will report into the Vice President, Drug Safety & Pharmacovigilance. You will provide in-depth medical/scientific expertise in the safety evaluation and risk management of Celcuity products in clinical development and/or the post-marketing setting.

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.

Qualifications:

• 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.
• Demonstrated experience in the oncology therapeutic area through clinical practice, drug development, or other relevant industry experience is a plus.
• 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.

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $190,000-$220,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

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