Director, Senior Clinical Program Leader - Eye Health; Remote

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Director, Senior Clinical Program Leader assumes full medico-scientific and strategic leadership of clinical programs with the objective to accelerate clinical development and achieve regulatory approvals and reimbursable medicines. This role provides continuous medical benefit and risk oversight for assigned assets. The incumbent may supervise and mentor other CPLs assigned to their program/asset. Senior CPL may lead 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.

The Director, Senior Clinical Program Leader will drive patient value, patient voice and quality of life & outcomes in line with Medicine Excellence goals.

• Accountable for development and execution of clinical development strategy for designated programs as part of a broader Integrated Asset Evidence Strategy, in alignment with TPP and in consultation with their supervisor (TL/aHOM/HOM).
• Accountable for medical strategy to drive key clinical program deliverables throughout the clinical development cycle (design of Targeted Product Profiles, preparation for the Start of Development / Release of Phase I, and clinical phase transition milestones).
• Leads and integrates as chairperson the output of cross-functional evidence team (Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, RWE etc.) assuming clinical development & budget responsibility for designated programs, and presents project related proposals and updates to internal governance committees, as well as external bodies (e.g., Health Authorities, Adboards, Steering Committees, Medical/Patient Societies).
• Accountable for optimal planning, interpretation and data presentation of clinical studies from FIM throughout pivotal studies, ensuring integration of regional input.
• Accountable for alignment of strategy with operational excellence.
• Ensures continuous risk/benefit assessment.
• Authors Investigator Brochures (with support from the Medical Writer and other contributors), Clinical Development Plans or similar documents, 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).
• Provides input to regulatory strategy and leads 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.
• Leads authoring of clinical abstracts, congress presentations and manuscripts (as appropriate).
• Reviews and approves publications within his/her project(s) in collaboration with the (A)
  HoM.
• Accountable for defining the medical digital strategy early in the project life cycle (e.g. suitable tool/vendors, qualification plan, validation plan…