Senior Medical Director, Clinical Development

The Senior Medical Director will report into the Vice President, Clinical Development. You will be responsible for working within Celcuity’s medical team providing medical oversight of service suppliers driving on-going clinical studies and plans and executes the study design protocol development, implementation and monitoring of the company’s new Phase I-III Oncology clinical trials. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the department and the company to regulatory standards and procedures. 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. Qualifications 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. About Us Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting. The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. 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 $320,000 - $350,000 DOE. 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. #J-18808-Ljbffr Celcuity Inc.