Celgene Associate Director, Translational Development in Summit, New Jersey


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.


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



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 iscommitted to equal opportunity in the terms and conditions of employment forall 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 complieswith all applicable national, state and local laws governing nondiscriminationin employment as well as employment eligibility verification requirements ofthe Immigration and Nationality Act. All applicants must have authorization towork for Celgene in the U.S.

Associate Director, Translational Development

Location: Summit, NJ, US

Job ID: 16002037