Clinical Program Lead

**THE POSITION**:
As (Senior) Clinical Program Leader you assume global responsibility and medical leadership for clinical development and evidence generation for assets in the indication area Gastroenterology/Crohn’s Disease from start of development through to registration. This may include definition of Target Product Profiles, design and execution of congruent, competitive, fast-to-patient Clinical Development Plans, Paediatric Investigational Plan, Medical Narrative, 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.

This position can be filled in Germany or USA.

***Tasks & responsibilities**:
- 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 a key member of the cross-functional Early Clinical Integration/Evidence Integration Team dependent on project stage and you represent the medical team in the governance/committee interactions. With your profound disease area expertise, you support contacts to external experts, advisory boards, adjudication committees and Safety Data Monitoring boards.- In your new role you are leading the Evidence Integration team and you will develop and execute the wholistic asset evidence generation strategy to demonstrate competitive value of an asset throughout the life cycle in close collaboration with the Drug/Device and Value Network.

Additional for the Senior CPL role:
- You may assume medical leadership of multiple clinical development projects, with oversight across multiple indications.- Depending on your seniority you may coach other Clinical Program Leaders within the therapeutic area.- 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 clinical drug development expertise and knowledge of Crohn’s disease- 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

Additional Requirements for the Senior role:
- Long-term experience in the pharmaceutical/CRO industry preferably in an international role in pulmonology 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 respiratory drug development- Excellent communication and presentation competencies, with proven ability to lead international cross-functional matrix Teams

***READY TO CONTACT US?**:
Please contact our Recruiting EMEA Team, Tel: +49 (0) 6132 77-173173