Senior Medical Director, Drug Safety and Pharmacovigilance

Position Summary:

We are seeking Senior Medical Director, Drug Safety and Pharmacovigialnce who will report to the Vice President, Drug Safety and Pharmacovigilance. You will be responsible for medical triage, medical safety assessment of case reports, signal detection, risk management, periodic reports, and agency queries for marketed products and products under development. Together with the safety team, the Medical Director will develop and maintain safety data exchange agreements, safety system, policies and procedures, quality and regulatory compliance, inspection readiness, vendor oversight, commercial launch planning, and training of internal and external stakeholders.

Responsibilities:

• Responsible for medical oversight of safety vendor(s) to ensure effectiveness, quality, and compliance of all outsourced activities, support timely triage and narratives for timely case reporting to agencies and for periodic safety reports (e.g., DSURs, PADERs, etc.) in collaboration with other cross-functional teams.
• Provide day-to-day medical support for the Safety Operations team and provide updates to internal and external stakeholders, as required.
• Reviews incoming adverse event reports to determine action required and ensure prompt review, follow-up, and timely submission of expedited safety reports.
• Participate in the development and maintenance of SOPs, forms, plans, systems, and guidance documents to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices.
• Support safety inspection readiness activities in collaboration with department leadership.
• Support the requirements of Safety Data Exchange Agreements with Celcuity partners and ensure compliance with the agreed upon terms and timelines.
• Reviews and provides input on the safety sections of clinical documents, including but not limited to the safety reporting section of protocols, Investigator Brochures, and Informed Consents.
• Support the development of internal and external (with vendors) key performance indicators and metrics to track performance.
• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed
• Serves as the Safety subject matter expert for internal audits and global inspections.
• Other Duties as assigned.

Qualifications:

• 10+ years of drug safety/pharmacovigilance experience in a sponsor company or a combination of sponsor and CRO experience in drug safety/pharmacovigilance.
• Medical degree. Training in medical or radiation oncology, hematology or related field preferred.
• Comprehensive knowledge of global drug safety related regulations and work practices
• Extensive experience with commercial safety databases (Argus or ARIS-G) and electronic data capture systems.
• Experience with the preparation of aggregate reports, (i.e., DSUR, PSUR/PBRER, PADER, RMP, ISS) and ICF and IB updates.
• Excellent knowledge of MedDRA and WHO Drug coding practices.
• Excellent verbal communication and presentation skills with ability to write clearly and concisely.
• Strong project management skills with the ability to prioritize to meet required timelines.
• Ability to multitask and prioritize under tight timelines while providing attention to detail and high-quality work in a dynamic environment.

Preferred:

• 3+ years of clinical physician experience in treatment of solid cancers in a multidisciplinary environment.
• Fluency in written and spoken English
• Strong scientific and analytical skills with strong ability to interpret and communicate medical safety data from various sources
• Experience with audit readiness/preparedness activities.
• Competency in presenting data, obtaining, analyzing, and reporting safety data.
• NDA and MAA filing experience.
• Experience with challenging current practices to drive improvement and innovation.
• Ability to work in a team or independently as required.
• Maintain a positive, approachable and professional attitude.

About Us:

Celcuity is a publicly traded commercial-stage biotechnology company developing targeted therapies for multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), targets all class I isoforms of PI3K and the mTOR complexes to comprehensively block the PAM pathway. The PAM pathway is an important signaling pathway involved in many cancers and has historically been challenging to target.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- locally advanced or metastatic breast cancer (“ABC”), supported FDA approval of REVTORPYK for use in patients without a PIK3CA mutation detected. 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 $338,000 - $366,000. 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.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.