Principal Scientist, Translational Development
Other Locations:US- NJ- Summit West
Translational Development at Celgene
Translational Development is part of the Global Research and Early Development organization in Celgene and leads early stage clinical, pharmacological and translational research and development activities for the pipeline and supports late stage portfolio for regulatory, translational development and life cycle management. Translational Development is in the process of organizing a late translational group to support multiple disease areas of interest including Myeloma, Lymphoma, CLL and other hematological malignancies. This group will integrate scientific and business insights of multiple functions and lead the development of translational strategies at the franchise level and implement them in project teams to maximize the potential of Celgene drugs.
Reporting to the Executive Director Translational Development, the principal scientist will be part of the late translational group based in Summit NJ and will be the lead translational scientist/strategist in the Lymphoma/CLL area. Key responsibilities of this role is to act as the translational representative in Project teams for Lymphoma/CLL programs and assume primary responsibilities for supporting projects and key strategic areas.
- In-depth understanding of Lymphoma (preferred), multiple myeloma or related hematological malignancies and/or solid tumors
- Broad understanding of drug discovery & development especially late stage development and approval process and life cycle management
- Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, MoA research, knowledge of platforms
- Authoring of biomarker portion of clinical protocols, drug study reports, regulatory submissions
- Analysis of biomarker data in preclinical and clinical setting
- Basic understanding of technical aspects of companion diagnostics development; partnerships, due diligence experience, project experience ( IDE development; Diagnostic protocol etc.)
- Proven scientific/leadership expertise ( working in teams, managing people/projects)
- Proven publication record
- Strong verbal and written communication skills
- Ability to synthesize complex scientific and business problems into strategy and tactics
- Basic understanding of IP, contracting terms and provisions
- Represents Translational Development in Project team/Franchise team, other cross-functional teams as needed
- Creates disease specific translational goals and is accountable for their delivery
- Responsible for the development of the translational section of Celgene clinical protocols in trials and represents biomarker plans at key review meetings and plans execution
- Leads the analysis of biomarkers for Celgene clinical studies by working with relevant functions and CRO as needed and generates Biomarker study report
- Leads the review of external preclinical proposals, key IIT proposals that include correlatives
- Develops yearly budget for translational program for assigned projects
- Creates SOW and interfaces with CRO for execution of services
- Maintains and oversees biomarker inventory for Celgene clinical trials and collaborative samples
- Assists in managing key collaborative projects
- Assists in the development of disease specific strategy for Celgene
- Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries.
- Communicates regularly and prepares and makes presentations within the department and externally as required
- Supervises scientific and technical staff for research and assay development, execution and analysis
- Participates in translational research in the Summit lab of Celgene
Requirements & Education:
- PhD in life sciences or medical sciences, and a minimum of 8 years of directly relevant biotechnology or pharmaceutical industry experience preferred.
- Candidate must be detail-oriented with excellent record keeping and organizational skills.
- Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic environment.
- Strong background in cancer biology, especially hematological cancers
- Extensive working knowledge of biomedical research methodologies and current state-of-the art genetic analysis technologies
- Experience in clinical development process in an industry setting
- Experience in clinical assay development, clinical biomarker discovery is essential
- Knowledge of GLP, assay validation methodologies, and regulations that apply to clinical laboratory studies that support regulatory submissions is required
- Ability to manage scientific collaborations and contracted research
- Proven written and oral communication skills
- Effective team building and teamwork skills with multiple functions
- Detail-oriented with the ability to identify and implement creative solutions
- Ability to prioritize and manage time efficiently
- Some experience with supervision and mentoring of laboratory/ scientific staff is desirable