Associate Director, Translational Development and Diagnostics (immuno-oncology)

Employer
Celgene
Location
Summit, NJ, US
Posted
Sep 13, 2018
Ref
1801402
Required Education
Doctorate/PHD/MD
Position Type
Full time
Other Locations:US- NJ- Summit West

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 (TD) 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 immuno-oncology group to support multiple disease areas of interest including solid cancers and 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 Senior Director, Translational Development, the incumbent will be part of the translational group based in Summit NJ, will manage a small group of translational scientists in support of clinical projects and help develop translational immuno-oncology strategies in solid tumors for approval or life-cycle management. Key responsibilities of this role are to act as key translational lead for the clinical programs and develop and execute translational strategies while working with translational scientists and cross-functional disease team and thematic centers of excellence. In addition, management of laboratory scientists to generate data in support of clinical development decisions.

Responsibilities
  • Leads the translational development of a portfolio of compounds, by meeting the translational annual goals and objectives for the solid tumor immuno-oncology group (for internal/external translational collaborations, compound specific plans etc.), by enabling the addressing of outstanding research questions (ORQs), and is accountable for the monitoring of progress towards achieving the goals, in association with TD scientists
  • Maintains and conveys in-depth knowledge of fundamentals of immunology, immune oncology, and tumor biology in solid and hematological malignancies
  • Oversees translational scientists as a group lead and works with Immune Biology Leaders to ensure execution of in-vitro and ex-vivo assays to translate preclinical data into clinical biomarkers for advancing drug candidates through clinical trials
  • Assists in developing and maintaining group budget and workforce plan
  • Represents Translational Development in cross-functional project and strategy teams
  • Interfaces with Commercial including early commercialization group and Medical Affairs to provide scientific support for cross-functional TD goals and investigator-initiated trials (IIT)
  • Manages and supervises preclinical collaboration strategy across the pipeline compounds for clinical assets
  • Assists in managing key strategic and/or collaborative projects along with TD scientists
  • Supports regulatory submissions, regulatory interactions, writes/reviews translational sections for regulatory response and answers to regulatory queries for the TD group
  • Interfaces with the diagnostic group for projects that need diagnostics development
  • Communicates regularly and prepares and makes presentations within the department, externally and to internal governance committees as required
  • Works with lab head to integrate translational research in the Summit lab of Celgene.


Qualifications
  • MD or Ph.D. degree in immunology, tumor biology, cellular biology or pharmacology with at least 10 years of relevant work experience, including a minimum of 5 years of drug development experience in the biotechnology or pharmaceutical industrial setting as evidenced by a strong publication record, attendance and presentation at scientific meetings, and recognition by industry peers.
  • Track record in large and small companies, leading innovative efforts to deploy technologies and assays for enhanced translational capabilities
  • Excellent communication, managerial and scientific qualities are expected
  • Ability to interact effectively across boundaries using influencing and relationship building skills.
  • Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals.

Technical Skills
  • Proven track record in developing and implementing biomarker strategy for clinical trials, and strong knowledge in immunology and tumor biology.
  • In-depth understanding of solid tumors, clinical landscape, evolving therapy, competitive scenario
  • Strong understanding of clinical, translational and mechanistic data of cancer therapies.
  • Strong background in clinical biomarker discovery and analysis, research tools, platforms and assays
  • Good understanding of drug development process in an industry setting
  • Understanding of late-stage drug and translational development process
  • Proven ability to work with disease teams/experts to develop strategies to support development and life cycle management efforts tailored to regional markets (i.e, US, EU, CAN)
  • Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
  • Proven scientific/project leadership expertise (working in teams, managing collaborations, people/projects)
  • Ability to synthesize complex scientific and business problems into strategy and tactics
  • Basic understanding of IP, contracting terms and provisions

Other Attributes
  • A problem solver who creatively and knowledgeably transcends departmental function to act as a resource to entire research effort and senior managers in development.
  • Identifies issues early and proposes innovative solutions.
  • Communicates within the larger organization and external community.
  • Provides expert guidance to multi-disciplinary teams and senior management.
  • A leader whose scope of influence stretches across Celgene.
  • A leader who influences external scientific community.

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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.