Required! Clinical Dev Unit Head, Onc...
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Required! Clinical Dev Unit Head, Oncology
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Job ID 149743BR
Posting Title Clinical Dev Unit Head, Oncology
Division Sandoz
Country USA
Work Location Princeton, NJ
Company/Legal Entity Sandoz Inc
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Job Description The Clinical Development Unit Head is accountable for the functional excellence of the clinical/ medical team members within the Clinical Development Unit to deliver the portfolio and project priorities. He/she is the manager of the Clinical Development Heads and indirectly Global Clinical Development Managers within his/her therapeutic area(s). The Clinical Development Unit Head supports the Head BCD in setting overall strategy for the department and projects’ strategy within the CDU, ensures high quality for clinical program design and execution and for contributions to regulatory submissions for marketing authorization. He/she may deputize for the Head BCD for certain leadership functions and may act as BCD Medical Officer. 1. Assume a strategic leadership role within BCD • Leads one main area of clinical development (a CDU) and provides oversight and coaching to the Heads Clinical Development and indirectly to Global Clinical Development Managers and Clinical Research Medical Advisors within that CDU • May serve as deputy for the Head BCD for key activities (e.g.. chair CDLT and attend DC and BPRB meetings) • Is a core member of and may chair the Clinical Scientific Review Committee, may act as Medical Officer • May act as Clinical Program Lead and represent BCD on one or several International Program Teams for high priority projects • May represent BCD at key Health Authority meetings • Orchestrates and supervises efficient use of resources to deliver optimal results, and contributes to department initiatives to streamline/enhance processes. • Develops and supports external contacts for Department (investigators, academic and regulatory community, partners in collaborations notably in Pharma) and contributes to the Biosimilar education effort with key external audiences • Maintains a close collaboration with groups outside of Development including Medical Affairs and Marketing • Contributes to the overall development of BCD and broader Development organization to face the change in demand of projects approaching submissions 2. Ensure clinical excellence and strategic oversight • Guides and actively oversees the quality of clinical development plans, study designs and protocols, result interpretation, reports, clinical summaries for submission, and publications for projects in the CDU area o Drives methodology development for programs with new indications or new disease areas o Ensures rigorous adherence to quality and compliance o Ensures strategic implementation of recommendations received from Health Authorities o Ensures strategic coherence of clinical contributions to submission documents • Provides senior medical judgment in terms of safety and appropriateness of clinical study design elements.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Minimum requirements MD or equivalent required; relevant clinical specialty or subspecialty training preferred Fluent English (oral and written), strong scientific writing skills • Min 15 years of global drug development or clinical research experience • Advanced expertise in clinical trial designs and result analysis, strong biostatistic knowledge • Experience in dossier submission/review and major Health Authority interactions required • Clinical Background relevant to the Programs in the CDU is preferred • Fully competent in GCP and pharmacovigilance practice • Knowledge of operational issues (e.g. planning global studies, risk mgmt.) • Proven track record of R&D leadership and personnel management • Demonstrates the courage to assume personal accountability in challenging situations. • Critical and strategic thinker. Able to develop and oversee implementation of a global strategy for the portfolio of programs. • Strong communication skills essential, both oral and written, able to present to Health authorities. Presents information confidently and effectively to executives, peers, and direct reports, one-on-one or in groups. • Strong leadership skills are essential. Successfully creates and leads high performing teams, empowering and motivating people by inviting input, and sharing ownership and visibility.

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