Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites:
PhD in life sciences or medical sciences, and a minimum of 8+ years of directly relevant biotechnology or pharmaceutical industry experience.
Celgene R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio, there is an opportunity for a dynamic and resourceful individual to lead our efforts in Translational Development at our site in San Francisco.
Translational Development at Celgene
The role of translational development at Celgene is to provide fully integrated functions that bridges our discovery efforts and clinical development. To enable this, Translational Development will engage with discovery project teams to support target selection and disease area strategies, provide leadership for early clinical programmes from CD nomination to proof of principle (i.e., Phase 2A) studies. In order to facilitate this, Translational Development will be integrated into Early Development Teams that will cost effectively and rapidly move the portfolio through early safety, efficacy and signal searching studies and ultimately hand over provide a robust roadmap for registration to the late development or Brand Teams. The Translational Development group is responsible for working with discovery to develop target validation approaches, define appropriate disease models for clinical studies, early engagement with discovery and early development team for biomarker maker development, defining patient selection strategies, and clinical pharmacology to define starting doses and schedules for dose escalation in Phase 1 studies. In addition rational design of combination of novel molecules which challenge the current treatment paradigms will be encouraged. There is a close working relationship with toxicology.
Summary
Reporting to the Senior Director Translational Development, the candidate will have responsibility for building and directing the Clinical Genetics Laboratory at Celgene Corporation’s Translational Research site in San Francisco. This laboratory will conduct genetic analyses of clinical trial patient samples using state-of-the-art technologies/platforms. The successful candidate will work directly with the clinical development organization, project teams, and contract research organizations to execute the vision of personalized medicine for Celgene products.
Technical Skills
- In-depth understanding of project (beyond function).
- Provide in-depth analysis & interpretations of diverse experimental results.
- Design complex experiments.
- Generate hypotheses and make conclusions.
- Responsibility for authorship of drug study reports.
- Interprets contingency plans from analysis of risk and presents alternatives consistent with industry and company protocols.
- Demonstrates independent, scientifically-directed, and innovative thinking.
- Facilitates growth of less experienced scientists.
- Keeps management abreast of current scientific thinking.
- Broad understanding of the R&D process.
- Functional group advisor/go-to person.
- Demonstrate broad understanding of Drug Discovery & Development.
- Able to assess risk & develop contingency plans.
- Recognized as expert in the field.
- Serves as subject matter expert and functional group advisor on science, technology, methods, etc.
- Familiar with basic business principles and focus of corporation.
- Uses this knowledge to drive projects.
- Role model for scientific excellence.
- Familiar with industry trends and competitors position.
Responsibilities
- Develop and mentor scientists.
- Anticipates the need for contingencies and develops alternative strategies.
- Create, implement, and communicate functional decisions and strategy.
- Provide opportunities and develop others.
- Represent departmental function on project team.
- Improve own functional area.
- Create, implement, prioritize innovative ideas.
- Shape culture of functional group.
- Provide leadership.
- Accountable for proj. success and deliverables.
- Manage external collaborators and CRO's.
- Has accountability for scientific strategies and timelines.
- Prioritizes risks and recommend or endorse contingency plans.
- Developing others beyond functional expertise.
- Viewed as subject matter expert across multiple scientific subjects.
- Responsible for internal and external resources.
- Coordinate cross functional activities.
- Role model for scientific culture.
- Develop cross functional strategy.
- Communicate and make recommendations to line management.
- Build laboratory capabilities for genetic analysis of samples from clinical trials, including molecular assays and data analysis. Assays include nucleic acid extraction, DNA sequencing, SNP and mutational analysis, miRNA profiling, gene expression profiling, multiplexed RNA quantitation and DNA methylation analysis.
- Supervise scientific and technical staff in assay development, execution and analysis
- Evaluate contract research organizations that can provide assay and data analysis capabilities
- Interact directly with the clinical database operations, biostatistics, and bioinformatics departments to facilitate data analysis and reporting
- Serve on project teams and sub-teams as a Translational Medicine representative
- Manage external collaborations with academic organizations
Qualifications
- Strong background in cancer biology with an emphasis on genetic/genomic analysis
- Extensive working knowledge of biomedical research methodologies and current state-of-the art genetic analysis technologies
- Experience in clinical development in an industry setting
- 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
- Detail-oriented with the ability to identify and implement creative solutions
- Ability to prioritize and manage time efficiently
- Previous experience with supervision and mentoring of laboratory scientific staff
- Knowledge of laboratory automation and familiarity with LIMS systems is highly desirable
Other Attributes
- 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.
- Develop scientific directions for projects (strategy).
- 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.
- Proposes innovative ideas to enhance Drug Discovery processes.
- 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. 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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
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