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Associate Director, Translational Development

Req #: 16002043
Location: Summit, NJ US
Job Category: Research and Early Development
Work Location: Summit West 556 Morris Avenue SUMMIT 07901
Organization: Celgene Corporation
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Director
Travel: No

Description

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.


Context:  

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 our efforts in Translational Development at our site in San Francisco. 


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. Translational Development is in the process of organizing a late translational group to support multiple disease areas of interest including Myeloma, Lymphoma, MDS/AML and other hematological malignancies. This group will integrate scientific and business insights of multiple functions and lead the development of translational strategies at the franchise level and implement them in project teams to maximize the potential of Celgene drugs. 


Summary:  

Reporting to the Disease Leader, the incumbent will be part of the late translational group based in Summit NJ and will be the lead translational scientist/strategist in the project team. Key responsibilities of this role is to act as the translational representative in Project teams for specific drugs and assume primary responsibilities for supporting projects and key strategic areas.  


Technical Skills: 


•Broad understanding of drug discovery & development especially late stage development and approval process and life cycle management 

•Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, MoA research, knowledge of platforms

•Authoring of biomarker portion of clinical protocols, drug study reports, regulatory submissions 

•Analysis of biomarker data in preclinical and clinical setting 

•Basic understanding of technical aspects of companion diagnostics development; partnerships, due diligence experience, project experience (IDE development; Diagnostic protocol etc.)   

•Proven scientific/leadership expertise (working in teams, managing people/projects)

•Proven publication record   

•Strong verbal and written communication skills  

•Ability to synthesize complex scientific and business problems into strategy and tactics

•Basic understanding of IP, contracting terms and provisions  


Responsibilities:

•Represents Translational Development in Project team/Franchise team, other cross-functional teams as needed

•Creates disease specific translational goals and is accountable for their delivery

•Responsible for the development of the translational section of Celgene clinical protocols in trials and represents biomarker plans at key review meetings and plans execution  

•Leads the analysis of biomarkers for Celgene clinical studies by working with relevant functions and CRO as needed and generates Biomarker study report 

•Leads the review of external preclinical proposals, key IIT proposals that include correlatives

•Develops yearly budget for translational program for assigned projects  

•Creates SOW and interfaces with CRO for execution of services

• Maintains and oversees biomarker inventory for Celgene clinical trials and collaborative samples

• Assists in managing key collaborative projects   

• Assists in the development of disease specific strategy for Celgene 

• Supports regulatory submissions, regulatory interactions, writes translational 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 

•Participates in translational research in the Summit lab of Celgene


#LI-JB1 BIO-US PRIORITY

 


Qualifications

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.  



Qualifications:
•Strong background in Multiple Myeloma disease and mechanisms of common therapies in Myeloma         
•Extensive working knowledge of biomedical research methodologies and current state-of-the art genetic analysis technologies 
•Experience in clinical development process in an industry setting
•Experience in clinical assay development, clinical biomarker discovery is essential 
•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 with multiple functions
•Detail-oriented with the ability to identify and implement creative solutions
•Ability to prioritize and manage time efficiently
•Some experience with supervision and mentoring of laboratory/ scientific staff is desirable

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.

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