Director, Translational Development - Hematology - Solid Tumor - 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, 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.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.
Celgene R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio, there is an opportunity for a dynamic and resourceful individual to lead our efforts in Translational Development at our site in San Francisco.
Translational Development at Celgene:
Translational Development is part of the Global Research and Early Development organization in Celgene and leads early stage phase I 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 group to support multiple disease areas of interest including Myeloma, Lymphoma, CLL and other 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.
Reporting to the Executive Director Translational Development, the incumbent will be part of the translational group based in Summit NJ and will manage a small group of translational scientists who manage clinical projects and help develop translational strategies in Multiple Myeloma for approval or life-cycle management. Key responsibilities of this role are to act as key translational lead for the clinical programs and developing and executing translational strategy working with translational scientists and cross-functional disease team and thematic centers of excellence
- In-depth understanding of multiple myeloma, clinical landscape, evolving therapy, competitive scenario
- Strong understanding of clinical, translational and mechanistic data with IMiDs in NDMM and RRMM setting
- Strong background in clinical biomarker discovery and analysis tools, platforms and assays
- Understanding of late-stage Phase II and III drug and translational development process
- Proven ability to work with global disease teams 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 people/projects)
- Ability to synthesize complex scientific and business problems into strategy and tactics
- Basic understanding of IP, contracting terms and provisions
- Leads a group of translational scientists as a group lead and leads the development of portfolio of compounds translational annual goals and objectives for the myeloma group (for internal /external, translational collaboration, compound specific plans etc), ORQs, and is accountable for their progress monitoring in association with TD scientists
- Assists in developing and maintaining group budget and workforce plan
- Represents Translational Development in cross-functional strategy teams
- Interfaces with commercial including early commercialization group and Medical Affairs to provide scientific support for cross-functional TD goals
- Assists in managing key strategic and/or collaborative projects along with TD scientists
- Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TD group
- Communicates regularly and prepares and makes presentations within the department and externally as required
- Works with lab head to integret translational research in the Summit lab of Celgene
- Collaborations that impact all of research, or even across multiple functions.
- Scientific and technical expert.
- Proven track record of success in drug discovery and development.
- Cell panel screening: define resistance mechanisms, sensitivity elements, PD markers and potential biomarkers of response
- Genomics analysis from human clinical samples, cell screen samples and clinical trial support (defined clinical experiments from the development teams). This includes development of a high dimensional bioinformatics.
- Clinical PD or Biomarker assays, translated from discovery (if applicable or appropriate) or developed specifically for early clinical use, assessing feasibility and applicability for companion diagnostics
- Application of model systems (in collaboration with the disease biology and in vivo pharmacology groups) beyond those routinely employed by discovery teams that aid in patient stratification/response and compound use, either in-house or as a collaboration
- Translational Development representation to the Development Project teams
- Participate in formulating disease area strategy for target selection and validation
- Evaluating, in conjunction with BD and the established teams, the potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts.
- Being part of the team responsible for establishing key alliances with academic centers, co-operative groups and government agencies for cost effective implementation of Celgene’s R & D and early development strategy
- 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.
- A problem solver who creativity and knowledgably 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.
Requirements & Education:
- 10-12 years pharmaceutical industry experience.
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.