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Sr. Scientist, Translational Development (Hematology / Oncology)

Req #: 1700168
Location: San Francisco, CA US
Job Category: Research and Early Development
Work Location: 1500 Owens Street Suite 600 SAN FRAN 94158
Organization:
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

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 is a department within the Research and Development organization that facilitates the transition of drug candidates from drug discovery through clinical development by enabling rational determination of dose-schedule and responsive patient populations, based on deep understanding of drug mechanism of action. The function additionally explores mechanisms of resistance, rational drug combinations and product differentiation. The San Francisco-based late stage myeloid translational group will support multiple disease areas, including MDS, AML and beta thalassemia. This group will lead 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 Director, Translational Development, the senior scientist will be part of the late stage myeloid translational group based in San Francisco, CA. The individual will grow into a lead scientist role responsible for developing, implementing and executing translational research strategy to support drug development programs in multiple disease areas including MDS, beta thalassemia and other myeloid indications. This individual will also have the opportunity to act as the translational representative on development teams and assume primary translational responsibilities, such as implementing biomarker studies and analyzing patient data.  The successful candidate will have some prior experience interacting with project teams, clinical research physicians, statisticians, computational biologists, contract research organizations and translational scientists to deliver science that supports the development of medicines to patients in need.  A working knowledge of oncology and development of small molecules and/or biologics for cancer patients is a plus.

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

  • Represents TD and is member of a cross-functional late-stage global project team.
  • Responsible for development, delivery and oversight of trial-specific biomarker plans (e.g. biomarker components, protocol development)
  • Implements TD activities through direct interaction with clinical research physicians, statisticians, clinical and translational operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
  • Analyzes biomarkers for Celgene clinical studies through 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
  • Author of study reports, biomarker components of clinical protocols, patent applications, regulatory submissions and peer-reviewed publications
  • Prepares and delivers presentations within the department and externally
  • Supports regulatory submissions and regulatory interactions; authors translational sections of regulatory documents and answers to regulatory queries

Skills/Knowledge Required

  • Knowledge of hematological malignancies, including genomics; experience with myeloid malignancies, thalassemias and/or myelofibrosis a plus
  • Understanding of drug discovery and development, especially late stage development
  • Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation and knowledge of platforms
  • Working knowledge of cell-based, molecular and in vivo pharmacology models used in cancer biology
  • Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
  • 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
  • Recognizes cross-functional issues and communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of delivering results, driving continuous improvements, and building effective cross-functional networks.
  • Ability to prioritize and manage time efficiently
  • Strong verbal and written communication skills
  • Accurate and detailed record keeping
  • Excellent organizational skills
  • Strong publication record

Education:

Ph.D.  in life sciences or medical sciences, and a minimum of 6+ years of directly relevant biotechnology or pharmaceutical industry experience.  Candidate must be a rigorous, detail-oriented scientist, 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.

Functional/Scientific/Technical Skills:

• Contributing to research program and business.

• Subject matter leader.

• Broad knowledge of multiple functional technologies.

• In-depth understanding of function as it relates to project.

• Leads by example in lab.

• Functional area expert with skills, theoretical knowledge and experience to apply scientific direction and approach to projects and problems.

Tasks and Responsibilities:

• Completes technical assignments by designing, executing and interpreting complex experiments.

• Recommends department level strategic decisions.

• May lead scientifically on cross functional assignments.

• Manages and/or coordinates workflow on projects.

• Apply diverse scientific knowledge to assignments.

• Development of research tools.

• Interpret results.

Discretion/Latitude:

• Helps design research strategies consistent with department goals.

• Provides input and makes recommendations to research strategies.

Creativity and Problem Solving:

• Identify & solve multi-faceted challenges.

• Recognizes problems and is able to recommend and develop appropriate solutions from prior experience, literature, or collaboration.

• Identify risks.

• Contributes ideas and develops/presents a scientific case (or position) inside and outside department/group.

Teamwork and Influence:

• Communicates with cross functional team.

• Directly impacts the achievement of workgroup/team goals.

• Represents workgroup/team or department on multi-disciplinary or cross functional teams.

• Work across departments.

Organizational Impact:

• Direct impact on departmental performance.

• Impact is achieved by driving team efforts.

• Able to conceptualize broad impact of research programs and personal activities in terms of site.

Behavioral Competencies:

• Champions change

• Leads courageously

• Networking

• Provides directions

• Structuring and staffing
• Thinks strategically

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BIO-US

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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