Senior Clinical Program Leader - Oncology

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Sona***********

  • Germany
  • Last Update: 14.06.2019 at 10:55

Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Biberach
Country
Germany

Category


Clinical and medical development

Description


Tasks & Responsibilities
As Senior Clinical Program Leader within the Therapeutic Area Oncology you represent our Therapeutic Area Oncology Medicine at the International Multidisciplinary Core Teams and take clinical development responsibility for the assigned projects.You are accountable for the medical oversight of the clinical trial program during protocol development, study conduct, analysis and reporting as well as for the continuous benefit-risk assessment.Furthermore, you ensure medical leadership in regulatory meetings and for the submission strategy, and contribute to the assessment of safety related issues and to regulatory dossiers.You act as chairperson of the cross-functional Global Early Clinical Development Team / Medical Subteam and also as a medical project representative at advisory boards, adjudication committees and at clinical trial data monitoring boards.In collaboration with the (associate) Medical Head you review and approve publications within your project.As an expert you identify the need of studies to be conducted, and provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary.RequirementsMD (specialist in Oncology) with sound clinical oncology background and at least and 3 years experiences in the pharmaceutical industrySuccessful track record in planning, conduct and publication of Clinical ResearchSound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional counterparts and external partnersAgile and effective working style in a fast-paced and changing environmentExperience in working with regulatory authorities, international societies and other relevant international stakeholdersGood project management and excellent cross-functional collaboration skills and ability to work in virtual teamsFluent in English with very good communication and presentation competenciesOur benefitsGood compatibility of work and private lifeGood development opportunities with in-house education and various training optionsHealthy and well-balanced food in the canteens and for take awayGym and variety of company sports groupsCompetitive salary plus bonus payments

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