Senior Clinical Program Lead

vor 7 Monaten

Munich, Deutschland BI International GmbH Vollzeit

**The Position**:
As (Senior) Clinical Program Lead (CPL) you assume full medico-scientific and strategic leadership of global clinical development programs and evidence generation for assets in the indication area Pulmonology/pulmonary fibrosis with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable medicines. As CPL you may assume the responsibility of an Evidence Lead in the Asset Teams, leading the creation and execution of a holistic evidence generation strategy and integrating the deliverables of all medical functions as the leader of the Evidence team. You will drive patient value, patient voice and quality of life & outcomes in line

with Medicine Excellence goals.

***Tasks & responsibilities**:
- In your new role, you are accountable for the development and execution of clinical development strategy for designated programs as part of a broader Integrated Asset Evidence Strategy, in alignment with the TPP and in consultation with your supervisor(aHOM) while ensuring integration of regional input.- You will author Investigator Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans/Asset Evidence Plans, Core Clinical Trial Protocols, including the CTP strategy and core CTP elements within a document such as Trial Design- Synopsis and Pediatric Development Plans, and respective sections of regulatory documentation (CCDS, submission package, and health authority briefing documentation).- With your expertise and scientific insight, you provide input to regulatory strategy (or, in the role as Evidence lead, oversee regulatory strategy) and lead clinical development discussions at regulatory interactions and clinical components of the submissions (i.e. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responses.- You also oversee medical project budgets for the respective project(s) and serve as a key member of the cross-functionalAsset Team and Evidence (Integration) Team dependent on project stage and you represent the medical team in the governance/committee interactions, e.g., in preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release of Submission.

Additional for the Senior CPL role:
- You may assume medical leadership of multiple clinical development projects, with oversight across multiple indications.- As a mentor you will 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 will lead authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).- Therefore, you review and approve publications within your project(s) in collaboration with the (A)HoM.- 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 (preferred) or PhD with profound clinical development experience in thje field of pulmonology- Experience in clinical development of investigational compounds and in all relevant aspects of clinical research. Experience in drug development in the field of pulmonary fibrosis 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- Willing to travel and work in a global environment- Fluent in English with very good communication and presentation competencies

Additional Requirements for the Senior role:
- Long-term experience in the pharmaceutical 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 HR Direct Team, Tel: +49 (0) 6132 77-3330

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