Senior Clinical Program Lead

vor 9 Monaten

Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

**The Position**:
Are you a passionate and experienced Retinal Specialist looking to take your career to the next level? Do you want to be at the forefront of clinical research and development, driving patient value and quality of life outcomes? If so, we have an exciting opportunity for you

Boehringer Ingelheim is seeking a dedicated and innovative Senior Clinical Program Leader (CPL) - Retinal health. This role offers the unique opportunity to assume full medico-scientific and strategic leadership of clinical programs, with the aim to accelerate clinical development and achieve regulatory approvals and reimbursable medicines.

As a Senior CPL, you will have the chance to supervise and mentor other CPLs, and potentially assume the responsibility of an Evidence Lead in the Asset Teams. This role is integral to our mission of driving Medicine Excellence goals and integrating the deliverables of all medical functions.

At Boehringer Ingelheim, we believe in the power of our people. We are committed to fostering a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. As part of our team, you will have the opportunity to collaborate internationally and directly contribute to the company's success. Our competitive compensation and benefit programs reflect our high regard for our employees.

***Tasks & responsibilities**:

- Imagine taking the reins of the clinical development strategy for designated programs, aligning with the broader Integrated Asset Evidence Strategy and the Targeted Product Profile (TPP). Your expertise will be crucial in consulting with your supervisor (TL/aHOM/HOM) and driving the development and execution of this strategy.
- Picture yourself leading the charge in driving key clinical program deliverables throughout the clinical development cycle. From designing Targeted Product Profiles (TPPs) to preparing for the Start of Development/Release of Phase I, your role will be pivotal in steering clinical phase transition milestones.
- Envision yourself at the helm of a cross-functional evidence team, integrating the output of various departments like Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology, RWE etc. As the chairperson, you will be responsible for presenting project-related proposals and updates to internal governance committees and external bodies such as Health Authorities, Adboards, Steering Committees, Medical/Patient Societies.
- Consider the impact you can make by ensuring the optimal planning, interpretation, and data presentation of clinical studies from First-In-Man (FIM) throughout pivotal studies. Your role will be key in ensuring the integration of regional input and alignment of strategy with operational excellence.
- Think about the influence you can have by authoring key documents like Investigator Brochures, Clinical Development Plans, and Core Clinical Trial Protocols, including the CTP strategy and core CTP elements within a document such as Trial Design Synopsis and Paediatric Development Plans. Your input will also be vital in regulatory strategy and leading 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.
- Reflect on the opportunity to define the medical digital strategy early in the project life cycle, liaising with the Digital Content Manager regarding new tools/technologies/best practices. Your role as the Evidence lead will also involve overseeing the Medical Affairs strategy, including the medical chapters of the integrated brand plan and related key documents in collaboration with Medical Advisor, AHoM and HoM. You will ensure programs are delivered in compliance with Good Clinical Practice (GCP) requirements and global regulatory and ethical standards.

***Requirements**:

- Accredited medical doctor specializing in retinal health, or alternatively, a PhD holder with a focus on Retinal Health or Ophthalmology, both with extensive experience across all stages of clinical drug development within the relevant disease area.
- Proven track record in project and budget management for studies, overseeing and running global clinical trial programs.
- Demonstrated ability to work collaboratively with multiple stakeholders and interact effectively with Regulatory Affairs authority, international societies, and other relevant stakeholders.
- Comprehensive understanding of the Medicine strategy and vision, as well as the Therapeutic Area strategy and vision.
- Ability to thoroughly evaluate key study concepts including background, sample size, statistics, design, timing, feasibility, and budgeting.
- Strong strategic mindset and sound medical and scientific leadership skills to drive complex/high priority projects in collaboration with global matrix teams, couple

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