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(Senior) Clinical Program Lead

Employer
Boehringer Ingelheim
Location
Biberach, Germany
Salary
Competitive
Start date
5 Jan 2023
Closing date
4 Feb 2023

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION


The (Senior) Clinical Program Leader represents 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.


Tasks & responsibilities


  • 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



WHY BOEHRINGER INGELHEIM?


This is where you can grow, collaborate, innovate and improve lives .

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area .

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

READY TO CONTACT US?

Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173

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Company

With 47,700 employees in 103 countries, Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Since its foundation in 1885, the family-owned company has been pursuing an ambitious goal: to research and develop innovative pharmaceuticals that improve the health and quality of life of humans and animals alike

Company info
Website
Location
Binger Straße 173
Ingelheim am Rhein
55216
Germany

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