Clinical Development Lead - Hematology > Bristol Myers Squibb > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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Job Title ClinicalDevelopmentLead (CDL) Division R&D / Global Drug Development Functional Area DescriptionThe ClinicalDevelopmentLead sits within ClinicalDevelopment, which is a global organization dedicated to the effective design and execution of drug development.
ClinicalDevelopment drives clinicaldevelopment strategy, design, execution, and interpretation of clinical trials.Position Summary / ObjectiveCDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People StrategyServes as the clinical point of accountability for the Development Team and is responsible for the overall clinicaldevelopment plan for asset(s) in one or more indication(s)/tumor type(s)Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goalsServes as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)Position ResponsibilitiesAccountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indicationResponsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physiciansMay serve as CTP as necessaryAccountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs.
Should work to proactively partner with these rolesAccountable for clinical content for CSRs, regulatory reports, briefing books and submission documentsChampions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conductRepresents ClinicalDevelopment in both internal and external forums as the consulted authority and expert for the disease area, including within Business Development functionPartners with Worldwide Patient Safety physicians in the ongoing review of safety dataServes as the (co-)leader of the cross-functional ClinicalDevelopment TeamProvides clinicalleadership and disease area expertise into integrated disease area strategiesIs a KOL in specific indicationsServes as Primary Clinical Representative in Regulatory interactionsEvaluates strategic options against a given Target Product Profile (TPP)Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as neededSets executional priorities and partners with CTP and CS to support executional delivery of studiesAccountable for top line data with support of CTP, CS, and StatisticiansDegree RequirementsMD preferably with appropriate sub-specialty training as appropriatePhD, Pharm D or other health related scientific field with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledgeAt least 11 years of relevant experienceExperience RequirementsCDL has demonstrated leadership in the design and execution of multiple clinical trials (e.G.
significant experience as a senior clinicalleader), and exhibits all of the following attributes:
Able to synthesize internal and external data to produce a clinical strategyAble to ensure that the clinical program will result in a viable registrational strategyAble to assess personnel needs, translate into a hiring strategy, and lead the hiring effortsAble to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolioCDL has demonstrated sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalentVerifiable track record of successful people management and development, or leadership in a matrix team (e.G.
mentoring junior colleagues)Key Competency RequirementsCDL has demonstrated excellent skills in clinicaldevelopment strategy including the clinical components of regulatory submission(s)External focus to be an expert in the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMSPartner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)Ability to lead and develop a large group of CTPs to ensure scientific and technical excellence of clinicaldevelopment programs and deliverablesTravel RequiredDomestic and International travel may be required.
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