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Associate Director, Translational Development / Program Lead (Late Stage)

Req #: 16002042
Location: San Francisco, CA US
Job Category: Research and Early Development
Work Location: San Francisco, CA 1500 Owens Street Suite 600 San Francisco 94158
Organization: Celgene Corporation
Schedule: Full-time
Shift: Day Job
Employee Status: Regular
Job Type: Standard
Job Level: Director
Travel: No

Description
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases.  

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Investigational compounds are being studied for patients with hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), chronic lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), pancreatic cancer and lung cancer. 

Translational Development at Celgene

Translational Development is a department within the Research and Development organization that facilitates the transition of drug candidates from drug discovery through early- and late-stage clinical development. Early-stage translational development activities enable rational determination of dose-schedule and responsive patient populations, based on deep understanding of drug mechanism of action. Late-stage translational development activities build upon the early work, additionally exploring mechanisms of resistance, rational drug combinations and product differentiation. The late-stage translational development function is responsible for the development of translational strategies to support the development, and maximize the potential, of Celgene therapies post-clinical proof-of-concept, including registrations and life-cycle management.

Summary/Scope

Reporting to Senior Director/Translational Development Myeloid Disease Lead, the candidate will be part of the late stage myeloid translational group based in San Francisco, CA. The individual will be responsible for developing, implementing and executing translational research strategies to support drug development programs in multiple disease areas, including MDS and AML. This individual will act as the translational lead on development teams, responsible for biomarker studies and analysis of patient data.  The successful candidate will effectively interact with global project teams, clinical research physicians, clinical statisticians, computational biologists, contract research organizations, academic experts, and internal translational research scientists to deliver science that supports the development and access of medicines to patients in need.

Responsibilities will include, but are not limited to, the following:

  • Serve as member of cross-functional late-stage global project team, responsible for leading development and implementation of asset-specific translational strategies (e.g. mechanisms of drug efficacy, mechanisms of resistance, rational combinations, new indications, patient segmentations, and product differentiation):
  • Responsible for the development and delivery of biomarker components of Celgene clinical trials, including protocol development, translational plans, and study conduct (assay development and implementation, ownership of quantity and quality of biosamples)
  • Develop research plans aligned with strategy 
  • Analyzes biomarkers for Celgene clinical studies by working with relevant functions and CROs; responsible for creating SOWs and interfacing with CRO for execution of services
  • Evaluates CROs for assay and data analysis capabilities
  • Develops constructive relationships across organization to achieve goals of the function and the business
  • Coordinates cross-functional activities through direct interaction with global project teams, clinical research physicians, clinical statisticians, clinical and translational operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
  • Liaises with laboratory lead to develop and achieve non-clinical goals 
  • Authors study reports, biomarker components of clinical protocols, patent applications, and peer-reviewed publications
  • Supports regulatory submissions and regulatory interactions; authors translational sections of regulatory documents and answers to regulatory queries
  • Develops translational network of academic experts and manages external collaborations; organizes regular meetings with KOLs and drives agendas
  • Reviews external preclinical proposals and correlative study components of investigator initiated trials
  • Champions Translational Development at project/franchise teams and governance/advisory meetings, leads translational development sub-team
  • Accountable for timelines and deliverables
  • Prioritizes risks and implements contingency plans
  • Communicates regularly; prepares and delivers presentations within the department, to governance and senior leadership bodies, and externally
  • Contributes to the development of yearly budget
  • Provides leadership in creating a culture that demands scientific excellence, encourages innovative risk, strives for constant improvement, and is driven by a sense-of-urgency for patients
  • Sets objectives for and manages multiple projects/on-going work activities of moderate to high complexity.
  • Leader who influences culture and values. Recognizes cross-functional issues. Communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of principled leadership, delivering results, driving continuous improvements, and building effective cross-functional networks.

*LI-MG2
BIO-US PRIORITY


    Qualifications
    Candidate must be a rigorous scientist with a track record of effective collaboration, influential communication, and clear impact in drug development. Must be a motivated, results-oriented self-starter, who enjoys working in a fast-paced, dynamic team environment.

    Skill / Knowledge Required
    • Ph.D.  in life sciences or medical sciences, and a minimum of 15 years of post-graduate work experience. 
    • 10 years of experience working directly in the biotechnology or pharmaceutical industry, with 5+ years of directly relevant clinical experience required. 
    • Broad understanding of drug discovery and development, especially late stage development
    • Experience (5+ years) in clinical development in an industry setting is a must, ideally with experience supporting NDAs
    • Comprehensive knowledge of tumor cell biology, including genomics; experience with myeloid malignancies, thallasemias and/or myelofibrosis a plus
    • Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and state-of-the-art genetic analysis platforms
    • Knowledge of GLP, assay validation methodologies, and regulations that apply to clinical laboratory studies that support regulatory submissions is desirable
    • Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
    • Strong publication record
    • Strong verbal and written communication skills
    Up to 20% travel is required.

    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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    About Celgene

    Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.

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