Director or Senior Director Precision Medicine and Companion Diagnostics

Job Description

Req #: 1902795
Location: Cambridge, Massachusetts, United States
Job Category: Research and Early Development
Work Location: 200 Cambridge Park Drive 02140
Organization: Translational Medicine
Employee Status: Full-time
Job Type: Regular

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 Cambridge, MA.
Precision Medicine/CDx:
Precision Medicine/CDx is part of the Global Research and Early Development organization in Celgene and leads internal and external diagnostic development activities to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies, inflammatory disease programs and solid tumor indications.
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.
Summary:
The incumbent will be part of the Precision Medicine/CDx group based in Cambridge, Massachusetts and will be a lead scientist/strategist responsible for the Precision Medicine/CDx planning and implementation and will also oversee a team developing, validating and testing IHC assays for use in clinical trials to support exploratory endpoints. This role will have key responsibility to act as the precision medicine and companion diagnostics technical lead in Drug Development Project teams for specific precision medicine and companion diagnostics programs.
Desired Technical Skills:

• Ability to lead companion and complementary diagnostic programs
• Strong knowledge of various diagnostic technologies; such as, IHC, ELISAs, Next Generation Sequencing, FISH, RT-PCR, ddPCR and other emerging technologies
• Experience in developing, validating and implementing IHC assays
• Experience with CART therapies and their associated assays and safety assessments
• 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 oversight and management of IHC laboratory in Cambridge, MA
• 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
• 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

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 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

Requirements & Education:
M.S. with 13+ years relevant experience or 11+ 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.
About Us
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.