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Director, Precision Medicine and Companion Diagnostics

Req #: 17001777
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: 556 Morris Avenue CELSUMWEST 07901
Organization: Celgene Corporation
Schedule: 40
Shift: Day Job
Employee Status: Full time
Job Type: Regular
Job Level: Director
Travel: No
Other Locations:US- NJ- Summit West

Summary/Scope  

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 knowledge of various molecular technologies; such as, Next Generation Sequencing, FISH, RT-PCR, ddPCR, Nanostring and other emerging technologies
  • Strong knowledge of various protein based technologies including ELISAs and IHC 
  • Experience performing due diligence of vendors, technologies and assays for ability to commercialize
  • Experience collaborating and/or monitoring clinical trial sites - Broad 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  Responsibilities:
  • Represents Precision Medicine and Companion Diagnostics in Project team/Franchise team, other cross-functional teams as needed - Responsible for delivery of 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 
  • Leads the review of external proposals
  • 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 diagnost


Prerequisites:  

  • M.S. with 13+ years relevant experience or 10+ 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.  

Qualifications:

  • 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
  • Significant 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
  • Proven risk management skills - Able to anticipate problems at project level and put mitigation plans into place
  • Extensive working knowledge of current state-of-the art genetic analysis technologies
  • Extensive 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

Other Attributes: -

  • Innovative spirit, thinking and desire to advance precision medicine to find solutions for our patients and increase the value proposition of our pipeline
  • Strong focus on quality and compliance
  • Proven track record of scientific approach to complex problem solving - Demonstrated in-depth, scientific-directed thinking -
  • 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  

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