Director, Translational Development and Diagnostics - Hematology / Multiple Myeloma Summit 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 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 summit, nj.
translational development at celgene
translational development is part of the global research and early development organization in celgene and leads early stage 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
- leads a group of translational scientists as a group lead and leads the translational 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 project and Strategy teams
- interfaces with commercial including early Commercialization group and medical affairs to provide scientific support for cross-functional td goals and support iit studies
- manages and supervises Preclinical collaboration Strategy across the pipeline compounds for Clinical assets
- assists in managing key strategic and/or collaborative projects along with td scientists
- supports regulatory submissions, regulatory interactions, writes/reviews translational sections for regulatory response and answers to regulatory queries for the td group
- interfaces with the Diagnostic group for projects that need Diagnostics development
- communicates regularly and prepares and makes Presentations within the department and externally as required
- works with Lab head to integrate Translational Research in the summit Lab of celgene.
- phd or MD with at least 16 years of relevant work experience, including a minimum of 10 years of experience in drug development in an industry setting
- 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.
- in-depth understanding of multiple myeloma, Clinical landscape, evolving therapy, competitive scenario
- strong understanding of Clinical, translational and mechanistic data of myeloma therapies in ndmm and rrmm settings
- good understanding of Drug development process in an industry setting
- strong background in Clinical Biomarker Discovery and Analysis, research tools, platforms and Assays
- understanding of late-stage drug and translational development process
- proven ability to work with disease teams/experts 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 collaborations, people/projects)
- ability to synthesize complex scientific and business problems into Strategy and tactics
- basic understanding of ip, contracting terms and provisions
- a problem solver who creatively and knowledgeably 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.
*bio-uscelgene 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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