Associate Director, Translational Development

Location
Summit, New Jersey (US)
Salary
Full Time
Posted
Jun 13, 2017
Closes
Jul 13, 2017
Ref
16002037
Position
Medical Director
Education
PHD
Hours
Full Time

Job Category: Research and Early Development
Work Location: Summit West 556 Morris Avenue SUMMIT 07901
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.

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 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 & Diagnostics, the candidate will be part of the late stage lymphoma/CLL translational group based in Summit, NJ. The Associate Director role is a highly integrated role and  will be responsible for developing, implementing and executing translational research strategies to support drug development programs in the disease areas of lymphoma/CLL while engaging and learning from counterpart activities in Multiple Myeloma and Myeloid disease groups. 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:

  • 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)
  • Develop research plans aligned with strategy  
  • 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)
  • 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
  • Coordinate cross-functional activities through direct interaction with global project teams, clinical research physicians, clinicalstatisticians, clinical and translational operations, computational biologists, contract research organizations, academic experts, and internal translational scientists
  • Authors study reports, biomarker components of clinical protocols, patent applications, regulatory submissions and peer-reviewed publications
  • 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 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


Qualifications

Requirements & Education:
PhD in life sciences or medical sciences, and a minimum of 10+ years of biotechnology or pharmaceutical industry experience, with 5+ years in clinical development. 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 learning and working in a fast-paced, dynamic team environment.

Skills / Knowledge Required:

  • Broad understanding of drug discovery and development, especially late stage development
  • Knowledge of lymphoma and CLL or related hematological malignancies
  • Experience (5+ years) in clinical development in an industry setting is a must, ideally with experience supporting NDAs
  • 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
  • Comprehensive knowledge of tumor cell biology, including genomics; experience with myeloid malignancies, thallasemias and/or myelofibrosis a plus
  • Proven scientific/leadership expertise (working in teams, mentoring people, managing projects)
  • Strong publication record
  • Strong verbal and written communication skills
  • Keep management abreast of current scientific thinking
  • Accurate and detailed record keeping
  • Role model for scientific excellence.
  • Independent, scientifically-directed, and innovative thinking. 
  • Subject matter expert and functional group advisor on science, technology, methods, etc.
  • Excellent organizational skills
  • Ability to manage scientific collaborations and contracted research
  • Effective team teamwork and collaboration skills
  • Detail-oriented, with the ability to identify and implement creative solutions
  • Ability to prioritize and manage time efficiently
  • Familiar with industry trends and competitors position.

 

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.