Celgene Principal Scientist, Translational Development in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
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
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
Able to anticipate problems at project level.
Proven track record of scientific approach to complex problem solving.
Demonstrate in-depth, scientific-directed, innovative thinking.
Advises on departmental goals.
Recognizes interrelationships of facts/factors, processes, and systems.
Recognize risk and propose contingency plans.
Acts as a resource to peers in developing new, innovative approaches to experimental design.
Independently (or using collaborations) develop scientific direction for assignments.
Recognize cross-functional issues .
Communicates within the larger organization.
Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams.
Communicates within the larger organization and external community.
Provides expert guidance to multi-disciplinary teams and senior management.
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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Principal Scientist, Translational Development
Location: Summit, NJ, US
Job ID: 17001859