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Associate Director, Translational Development (Late Stage) / Myeloid Disease

Req #: 1800951
Location: San Francisco, CA US
Job Category: Research and Early Development
Work Location: 1500 Owens Street Suite 600 SAN FRAN 94158
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- CA- San Francisco- Owens Street Celgene

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.

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 the Senior Director/Translational Development Myeloid Disease Lead, the candidate will be part of the myeloid late stage translational development group based in San Francisco, CA. The individual will be responsible for assisting with translational research strategies to build understanding of patient segments and disease biology of AML, MDS, beta-thalassemia, and myelofibrosis. The individual will also be responsible for developing, implementing and executing on lifecycle translational research strategy for a drug development program in AML and MDS, responsible for biomarker studies and analysis of patient data from ongoing clinical trials. The individual will work closely with the disease strategy team and drug program leads for early and late-stage development programs, as well as 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 executing on translational strategy for an asset in AML and MDS (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, implementation and execution of translational plans, and analysis of biomarkers
  • Responsible for creating SOWs and interfacing with CRO for execution of services
  • Working with the disease leader in developing and implementing translational research strategies to build understanding of patient segments and disease biology for the myeloid franchise disease areas of AML, MDS, beta-thalassemia, and myelofibrosis.
  • Coordinating and managing scientific and operational aspects of complex, multi-institutional collaborative translational projects to execute on strategies
  • Developing comprehensive patient segmentation strategies that include molecular and immune profiling, and disease biology strategies that consider tumor, immune and bone marrow microenvironment compartments.
  • Integrating with the disease strategy team and drug program leads for early and late-stage development programs.
  • Building effective cross-functional relationships across organization to achieve goals of the function and the business
  • Coordinating cross-functional activities through direct interaction with global project teams, commercial colleagues, clinical research physicians, clinical statisticians, clinical and translational operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
  • Establishing translational network of academic experts and manages external collaborations; organizes regular meetings with KOLs and drives agendas
  • Representing the disease leader at disease strategy team (DST) meetings, as needed
  • Contributing to the development of translational open research questions for the myeloid diseases
  • Participating in formulating disease area strategy for target selection and validation, as well as inputting on business development strategies and opportunities to build the portfolio
  • Authoring reports, patent applications, scientific communication materials, and manuscripts
  • Communicating internally and externally regularly; preparing and delivering presentations to senior leadership governance bodies and KOLs
  • Evaluating CROs for assay and data analysis capabilities
  • Accountable for timelines and deliverables
  • Prioritizing risks and implementing contingency plans
  • Contributing to the development of yearly budget
  • Providing 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

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 in the biotechnology or pharmaceutical industry
  • Experience (5+ years) in clinical/translational development, in an industry setting, is a must
  • Broad understanding of drug discovery and development, especially late stage development
  • In-depth understanding of myeloid malignancies and thalassemia, current and evolving therapeutic landscapes, and translational drivers of innovation (genomics, immune profiling, MRD), preferred
  • Proven scientific/leadership expertise (working in teams, managing projects)
  • Strong publication record
  • Strong verbal and written communication skills

BIO-US

#LI-POST

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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