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 12 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.
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.