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(Senior) Clinical Program Lead

Employer
Boehringer Ingelheim
Location
Ingelheim, Germany
Salary
Competitive
Start date
31 Mar 2023
Closing date
21 Apr 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


Are you passionate about innovation, finding cutting edge solutions and creating value where it matters to help millions of patients suffering from mental health issues around the globe? Are you an experienced clinician or drug developer who wants to work in an agile environment pushing the boundaries of innovation in mental health? We are looking for a global (Senior) Clinical Program Leader to drive exciting programs and create value through innovation in the field of CNS drug development.

This position can be filled in Ridgefield (USA), in Ingelheim (GER) or Biberach (GER).


Tasks & responsibilities


  • As (Senior) Clinical Program Leader you assume global responsibility for clinical development projects in the indication area CNS/Psychiatry from start of development through to registration. For example: definition of Target Product Profiles, Clinical Development Plan, Paediatric 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 are accountable for the strategic planning, oversight and execution of the program, including the continuous monitoring of the risk-benefit ratio of the clinical development project.
  • With your expertise and scientific insight, you provide the necessary medical contribution to clinical trial protocols and prepare relevant documentation for the submission to Regulatory Agencies.
  • You also oversee medical project budgets for the respective project(s). You serve as chairperson of the cross-functional Global Early and/or late Clinical Development Teams dependent on project stage and you represent the team in the governance/committee interactions. With your profound knowledge, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.
  • In your new role you lead the medical sub-team and represent Medicine in the early clinical development team as well as in the core team.


In the Senior CPL role:
  • You may assume leadership of multiple clinical development projects, with oversight across multiple indications.
  • You will mentor and coach other Clinical Program Leaders within in the therapeutic area.
  • You will act as the key medical point of contact for internal and external stakeholders including providing medical leadership to the cross-functional teams involved in the clinical trial programs within Boehringer Ingelheim.
  • 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


  • Medical degree or PhD with sound clinical experience in CNS/psychiatric disorders
  • Experience in clinical development of investigational compounds and in all relevant aspects of clinical research. Experience in CNS/psychiatry drug development is highly desirable
  • Successful track record in planning, conduct and publication of Basic Science and/or Clinical Research
  • Good project management and excellent cross functional collaboration skills with ability to work with global matrix teams
  • Agile and effective working style in a fast-paced and changing environment
  • Fluent in English with very good communication and presentation competencies
  • Willing to travel and work in a global environment


Requirements for the Senior role:
  • Long-term experience in the pharmaceutical/CRO industry preferably in an international role in CNS/psychiatry clinical research
  • Previous experience of leading clinical development programs with Novel Therapeutic Concepts and/or First in Class compounds
  • Previous experience of engaging with major Regulatory Health Authorities, KOLs in the field of CNS/psychiatry drug development
  • Excellent communication and presentation competencies, with proven ability to lead international cross-functional matrix Teams



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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