• Senior Clinical Program Leader , Oncology / Clinical Program Leader , Oncology Jobs in United States Of America

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 18 - 21 Years
  • Posted : above 1 month

Job Description:

Senior Clinical Program Leader, Oncology/Clinical Program Leader, Oncology - 1814458

The qualified candidate will be hired at the appropriate level commensurate with education/experience


Senior Clinical Program Leader Oncology

The Senior Clinical Program Leader, Oncology assumes global Clinical Development responsibilities supporting early or late development projects, reporting to the Associate Global Head or the Global Clinical Program Team Leader The Senior Clinical Program Leader has a medical leadership role for a project or a portion of a project in clinical development, usually at Start of Development through phase I-III

The Senior Clinical Program Leader provides medical/scientific, technical, and managerial directions to the plans, programs and procedures within their project and indication areas to effectively develop new compounds and/or oversee the optimization of the profile of existing compounds

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Represents specific Therapeutic Area, Oncology at the International Multidisciplinary Core Teams and takes clinical development responsibility for the projects assigned, eg definition of Target Product Profiles, Clinical Development Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development
Provides medical oversight to the clinical trial program within their respective project during protocol development, conduct, analysis and reporting, and has responsibility for continuous benefit-risk assessment
Provides medical leadership in regulatory meetings and contributes to submission strategy, regulatory dossiers, and safety issues
Oversees medical project budgets for the respective project(s)
Serves as chairperson of the cross-functional Global Early Clinical Development (ECD) Team / Medical Sub-team (MST) dependent on project stage, and proposes members in collaboration with the (associate) TAH Medicine Represents the ECD team / MST on the Core Team, and at the Therapeutic Area Leadership Committee (TALC), Clinical Expert Committee (CEC) and the Human Pharma Steering Committee (HPSC)
Oversees and supports contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards
Reviews and approves publications within his/her project in collaboration with the (a) Medical Head
Identifies the need of studies to be conducted, and provides input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 16th Jan 2020

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