Associate Director/Director, Clinical Scientist

Title: Associate Director/Director, Clinical Scientist

Location: Remote

Position Summary
We are seeking an Associate Director/Director, Clinical Scientist who will report to the Executive Director, Clinical Science. You will be responsible for strategic contribution to and execution of Clinical Development goals through collaboration with and support of Medical Directors/Physicians and Clinical Development department activities. The Clinical Scientist will represent the Clinical Science group on various teams/sub-teams or other appropriate forums, which may represent the Medical Director/Clinical lead as requested for specific teams or tasks, and is expected to perform their responsibilities with a low to moderate level of supervision.

Responsibilities

• Develop and/or contribute to the development of processes that enable and ensure quality data capture, review and cleaning for clinical studies
• Review clinical data and ensure quality and consistency in clinical site reporting
• Develop and review Clinical Development documents including writing, reviewing, adjudication/resolution of cross functional comments and ensuring a high-quality final document. Documents may include abstracts, manuscripts, clinical protocols/amendments, informed consent forms, regulatory documents, and other relevant materials.
• Develop and review presentations and training materials such as slide decks, posters, or other relevant materials; may present as requested/assigned by Medical Director
• Participate in the relevant Clinical Development Core Team and Clinical Sub-Team meetings as needed
• Interface with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other members of the extended project team(s)
• Represent Clinical Science in operational meetings (e.g., Study Management Team meetings) as needed; may represent Medical Director for specific teams or tasks as requested
• Maintain expert scientific and clinical knowledge in the relevant therapeutic and disease area(s)

Qualifications

• Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD)
• 5+ years clinical trial experience in pharma/biotech industry setting
• Oncology research experience, basic and/or clinical, strongly preferred
• Data listing review experience is mandatory
• Experience authoring experimental protocols and/or study results and conclusions
• Comprehensive understanding of Phase 1 through 4 drug development
• Excellent comprehension and analytical skills in interpreting scientific research and literature
• Detailed knowledge of scientific and medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant health authority guidelines and regulations
• Comprehensive understanding of product and safety profiles
• Experienced working within the multidisciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs, commercial operations, etc.
• Excellent time/project management skills: can prioritize multiple tasks to meet short and longer-term goals with high quality standards and in a timely manner
• Strong oral and written communication skills, including interpersonal interactions, internal and site-directed communications and internal and external presentation skills
• Excellent judgment and decision-making skills

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 $220,000-$260,000. 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.