Clinical Program Lead in Biberach an der Riß bei BI International GmbH

BI International GmbH

This position is part time eligible with 80 %.

Tasks & responsibilities

In this role, you represent Medicine at the International Multidisciplinary Evidence Teams and you take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence 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, Release of Submission.
You provide medical oversight to the clinical trial program within your respective project during protocol development, conduct, analysis and reporting, and you have responsibility for continuous benefit-risk assessment.
You also oversee medical project budgets for the respective project(s). Thanks to your expertise and profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.
In addition, you provide medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues.
You proactively identify the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary.
Furthermore, you review and approve publications within your project in collaboration associate Head of Medicine.

As a Senior Clinical Program Leader, you:

You author Investigator`s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols and Pediatric Development Plans together with your cross-functional project teams.
You also provide input to Project Analysis & Data Management Plans, Company Core Data Sheet, Annual Safety Report / IND (Investigational New Drug) Safety Reports.
Thanks to your expertise, you provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers and safety issues.
With your profound knowledge, you maintain an external focus to ensure a good understanding of the relevant customer groups for your designated asset(s), e.g. Health Authorities, Key External Experts, Associations, Patient groups, Payers, among others. You oversee and support all contacts to external experts, executive/steering committees, adjudication committees and Safety Data Monitoring boards for your projects.

Requirements

MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry
Successful track record in planning, conduct and publication of Basic Science and/or Clinical Research
Sound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams, regional BI counterparts and external partners
Previous contacts with regulatory authorities, international societies and other relevant international stakeholders
Good communication and presentation skills
Excellent cross-functional collaboration skills and ability to work in virtual teams
Full command of English language

The Senior Clinical Program Leader role additionally requires:

MD (specialist in Oncology or equivalent) with sound clinical oncology experience and multiple years of experience in the pharmaceutical industry
Profound clinical development experience as well as multiple years of experience in Pharmaceutical Industry in an international role. Former responsibility for international clinical development projects is also required