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Celcuity · 3 months ago

Associate Director, Clinical Scientist

United States

Full-time

Remote

Lead/Staff, Director/Executive

$190K/yr - $230K/yr

3+ years exp

Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. The Associate Director, Clinical Scientist will be responsible for executing Clinical Development goals and collaborating with Medical Directors and other departments to ensure high-quality clinical documents and data integrity.

BiotechnologyHealth CareHealth DiagnosticsTherapeutics

Responsibilities

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

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

Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s)

Qualification

Clinical trial experienceOncology research experienceData listing reviewDrug developmentGCPICH knowledgeProject management skillsOral communication skillsWritten communication skillsDecision-making skills

Required

Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD)

3 or more years clinical trial experience in pharma/biotech industry setting

Data listing review experience is mandatory

Experience authoring experimental protocols and/or study results and conclusions

Strong understanding of Phase 1 through 4 drug development

Excellent comprehension and analytical skills in interpreting scientific research and literature

Sound 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

Strong understanding of product and safety profiles

Working knowledge of the multidisciplinary functions involved in a company's drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs, 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

Good judgment and decision-making skills