Senior Director, Clinical Research and Biometrics
Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body to transform the treatment of cancer, infectious diseases and autoimmune diseases. Cue Biopharma is a high growth company and is listed on NASDAQ (CUE). The company is located in Cambridge, Massachusetts in the heart of the life sciences corridor.
Cue Biopharma is building a world-class team of highly motivated, dedicated scientists and clinical personnel to help us advance our research and development and clinical programs. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.
We are seeking an energetic and passionate person to join our Clinical Development team to design and develop our clinical biometrics reporting and analysis processes. The Senior Director, Clinical Research and Biometrics will ensure the design, implementation and reporting requirements of Cue Biopharma’s clinical trial programs are met with the highest standards of excellence for ethics, scientific merit and regulatory compliance to support potential future drug candidate reviews and approvals by the Food and Drug Administration (FDA) and other regulatory bodies. This position reports to the SVP of Clinical Development with a strong dotted line to the Head of Clinical Operations. The successful candidate must be a strong individual contributor and possess collaborative and communication skills to work effectively across multiple small and dynamic teams. This position will be a key member of the Clinical Development team and will work closely with the Acting CMO and SVP of Clinical Development to advance Cue Biopharma’s clinical programs.
Required Skills and Responsibilities
- Provide clinical support of oncology clinical trials (Phase 1-3), ensuring that studies are conducted in accordance with the clinical development plan.
- Oversee and contribute to the development and update of essential clinical research documents, including protocols, informed consent documents, investigator brochures, statistical analysis plans, drug safety update reports and clinical study reports.
- Provides oversight of day-to-day operations of data management and biometric functions, responsible for data lifecycle from database creation to database lock and analysis, ensuring processes are compliant with GCP, ICH and FDA guidelines and regulations.
- Preparation of clinical data analyses for internal and external stakeholders to support regulatory agency submissions, public disclosures and presentations, abstract preparation, manuscript preparation, presentation at scientific congress or advisory boards.
- Develop strategies and define plans to enable execution of diverse pipeline assets in line with corporate vision and guidance.
- Bachelor of Science, Masters or Ph.D. degree
- Minimum of 10 years’ experience in biotech or pharmaceutical industry
- Previous experience in Clinical Research, Data Management and Biometrics is essential
- The ideal candidate has experience in solid tumor oncology, with thorough working knowledge and understanding of clinical trial design, methodology and statistical concepts in this therapeutic area
- Broad experience in the principles and techniques of data management, interpretation and analysis
- Familiar with current approaches regarding oncology treatment modalities, drug mechanism of action, approaches to drug development, and regulatory and operational requirements.
- Comprehensive knowledge of GCP, ICH, FDA, EMEA and other guidelines and regulations
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