Summit NJ or Cambridge MA.
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 Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
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.
•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
degree in chemistry, molecular biology, pharmacy or other relevant scientific
discipline. MS or PhD preferred. BS
degree and a minimum of 12 years' experience in Diagnostic Company or
Pharmaceutical Company. MS degree and a
minimum of 10 years' experience in Diagnostic Company or Pharmaceutical
Company. Ph.D. degree and a minimum of 8
years' experience in Diagnostic Company or Pharmaceutical Company.
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
Desired Technical Skills:
•Ability to lead complementary and companion diagnostic programs
•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
•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
•Proven track record of development of in vitro diagnostics is a must (Class II and Class III (preferred))
oPrior 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
oExperience performing due diligence and auditing of vendors and technologies is a plus
•Strong risk management skills
oAble 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
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.
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.