Principal Scientist, Translational Development and Diagnostics - United States
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, âquest 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.
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 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.
Reporting to Senior Director/Translational Development Myeloid Disease Lead, the candidate will be part of the late stage myeloid translational group based in San Francisco, CA. The individual will be responsible for developing, implementing and executing translational research strategies to support drug development programs in disease areas, including AML and MDS. 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:
- Leading development and implementation of asset-specific translational strategies, across clinical and non-clinical studies (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 bio samples)
- Analyze biomarkers for Celgene clinical studies by working with relevant functions and CROs; responsible for creating SOWs and interfacing with CRO for execution of services
- Develop world-class expertise in understanding drug mechanism, applying deep scientific thinking
- Evaluate CROs for assay and data analysis capabilities
- Develop constructive relationships across organization to achieve goals of the function and the business
- Serve as member of cross-functional late-stage global project team, and coordinate cross-functional activities through direct interactions with clinical and translational operations, clinical research physicians, clinical statisticians, informaticians, contract research organizations, academic experts, and internal translational scientists
- Liaises with laboratory lead to develop and achieve non-clinical goals
- Authors study reports, biomarker components of clinical protocols, patent applications, and peer-reviewed publications
- Supports regulatory submissions and regulatory interactions; authors translational sections of regulatory documents and answers to regulatory queries
- Manages external collaborations and translational network of academic experts; 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, to governance and senior leadership bodies, 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
- Sets objectives for and manages multiple projects/on-going work activities of moderate to high complexity.
- Leader who influences culture and values. Recognizes cross-functional issues. Communicates within the larger organization. Provides expert guidance to multi-disciplinary teams and senior management. Has a track record of principled leadership, delivering results, driving continuous improvements, and building effective cross-functional networks.
- Ph.D. in life sciences or medical sciences, with at least 8 years of post-graduate work experience. Experience (4+ years) in clinical/translational development in an industry setting is required, ideally with experience supporting NDAs.
- Broad understanding of drug discovery and development, especially late stage development
- Comprehensive knowledge of tumor cell biology, including genomics; experience with myeloid malignancies is a plus
- Knowledge of clinical biomarker discovery, development and analysis, including drug mechanism research, assay development/validation, and state-of-the-art genetic analysis platforms
- Proven scientific/leadership expertise (working in teams, managing projects)
- Ability to prioritize and manage time efficiently
- Strong publication record
- Strong verbal and written communication skills
- 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, with attention to detail, who enjoys working in a fast-paced, dynamic team environment
â¢ In-depth understanding of project (beyond function).
â¢ Provide in-depth analysis & interpretations of diverse experimental results.
â¢ Design complex experiments.
â¢ Generate hypotheses and make conclusions.
â¢ Responsibility for authorship of drug study reports.
â¢ Interprets contingency plans from analysis of risk and presents alternatives consistent with industry and company protocols.
â¢ Demonstrates independent, scientifically-directed, and innovative thinking.
â¢ Facilitates growth of less experienced scientists.
â¢ Keeps management abreast of current scientific thinking.
Tasks and Responsibilities:
â¢ Develop and mentor scientists.
â¢ Anticipates the need for contingencies and develops alternative strategies.
â¢ Create, implement, and communicate functional decisions and strategy.
â¢ Provide opportunities and develop others.
â¢ Represent departmental function on project team.
â¢ Improve own functional area.
â¢ Create, implement, and prioritize innovative ideas.
â¢ Shape culture of functional group.
â¢ Provide leadership.
â¢ Accountable for project success and deliverables.
â¢ Manage external collaborators and CRO's.
â¢ Develops strategies.
â¢ Accountable for success of strategies.
â¢ Provides input to develop cross functional policies.
â¢ Recognized as Subject Matter Expert within function.
â¢ Develop others.
Creativity and Problem Solving:
â¢ Able to anticipate problems at project level.
â¢ Proven track record of scientific approach to complex problem solving.
â¢ Demonstrate in-depth, scientific-directed, innovative thinking.
â¢ Advises on departmental goals.
â¢ Recognizes interrelationships of facts/factors, processes, and systems.
â¢ Recognize risk and propose contingency plans.
Teamwork and Influence:
â¢ Communicates within the larger organization.
â¢ Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams.
â¢ Beginning to have impact on the performance of multiple departments.
â¢ Impact is achieved through leading workgroups and contributing to cross-functional teams.
â¢ Emerging as a leader who influences culture & values.
â¢ Champions change
â¢ Leads courageously
â¢ Provides directions
â¢ Structuring and staffing
â¢ Thinks strategically