Celgene Director Precision Medicine & Companion Diagnostics 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.
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 precision medicine and companion diagnostic programs at our site in Summit, NJ.
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. The Translational Development team is in the process of establishing a precision medicine and companion diagnostics group to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies. In addition, this group will be responsible for supporting our inflammatory disease programs as well.
This group will integrate scientific and business insights of multiple functions to provide innovative solutions that will make precision medicine a reality for the patients and physicians we serve. This position will be responsible for leading the development of precision medicine and companion diagnostics programs across the Celgene organization.
The incumbent will be part of the translational group based in Summit NJ and will be a lead scientist/strategist in the project team. This role will have key responsibility to act as the precision medicine and companion diagnostics technical lead in Project teams for specific precision medicine and companion diagnostics program and assume primary responsibilities for supporting projects and key strategic areas.
Desired Technical Skills:
Ability to lead complementary and companion diagnostic programs
Strong regulatory expertise in diagnostics, digital health and/or combination products
Strong knowledge of various molecular technologies; such as, Next Generation Sequencing, FISH, RT-PCR, ddPCR, Nanostring and other emerging technologies
Knowledge of various protein-based technologies including IHC
Knowledge of CART therapies and associated assays and safety tests
Ability to perform due diligence of vendors, technologies and assays for ability to commercialize
Experience collaborating and/or monitoring clinical trial sites
Understanding of drug discovery & development especially late stage development and approval process and life cycle management
Knowledge of biomarker discovery and development and assay development/validation
Authoring of precision medicine and companion diagnostic portions of clinical protocols, drug study reports, regulatory submissions
Proven scientific/leadership expertise (working in teams, managing people/projects)
Strong verbal and written communication skills
Ability to think strategically to find solutions and mitigation strategies to complex problems and then execute them
Basic understanding of IP, contracting terms and provisions
Represents Precision Medicine and Companion Diagnostics in Project team/Franchise team, other cross-functional teams as needed
Responsible for delivery of precision medicine initiatives and diagnostic programs
Responsible for the companion diagnostic sections of Celgene clinical protocols in trials and represents companion diagnostic plans at key review meetings and plans execution
Responsible for technical oversight of external diagnostic programs
Develops yearly budget with program management for assigned projects
Creates SOW and interfaces with CRO for execution of services
Assists in the development of precision medicine and companion diagnostic strategy for Celgene
Supports regulatory submissions, regulatory interactions, writes companion diagnostic 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
Proven track record of development of in vitro diagnostics is a must (Class II and Class III (preferred))
Prior experience with IDE submissions and approvals and experience developing companion diagnostics is highly desired
Experience participating in regulatory meetings (diagnostic and drug (plus))
Significant experience writing, reviewing and overseeing execution of validation protocols
Experience in reviewing submission documentation for technical accuracy and completeness
Extensive experience working with external partners
Experience performing due diligence and auditing of vendors and technologies is a plus
Strong risk management skills
Able to anticipate problems at project level and put mitigation plans into place
Working knowledge of current state-of-the art genetic analysis technologies
Experience in clinical development process and validation in an industry setting
Knowledge of GCP and regulations that apply to clinical laboratory studies that support regulatory submissions
Extensive knowledge and understanding of ISO13485, GMP and extensive design control understanding a must
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
Requirements & Education:M.S. with 8+ years relevant experience or 6+ years Ph.D. in molecular biology, biochemistry, chemistry or a related life science. Candidate must be detail-oriented with excellent record keeping and organization 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.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.