Other Locations:US- NJ- Summit West
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. The current focus of IO work is in solid cancers – so a background in this area will be an advantage. 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.
Summary: Strong background in solid cancer biology and drug development !
The Director, Immune Oncology, Translational Development will be responsible for participating in scientific aspects of both preclinical oncology drug development programs and translational medicine correlative studies in Immune Oncology. The work will be fully integrated with the early IO group based in Seattle This may include definition of biomarker strategies and implementation in later phase registrational studies as relevant to specific Celgene programs. Expertise in developing and qualifying biomarkers for clinical trials would be an advantage and strong knowledge in immunology and tumor biology is required. The individual will supervise laboratory based experiments as well as work with contract research organizations and internal and external collaborators. Activities include carrying out mechanism of action studies, biomarker identification, generation of data that supports patient stratification and the pharmacodynamic evaluation of drugs in the clinical setting.
- 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 solid cancer biology and drug development
- 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 10+ 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.