Director, Senior Clinical Program Leader – Eye Health
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Job Description
Clinical leader advancing Boehringer Ingelheim’s eye-health drug programs through development and regulatory approval. Driving evidence strategy, patient value, and cross-functional global execution.
Responsibilities:
- Assume full medico-scientific and strategic leadership of clinical programs
- Accelerate clinical development and achieve regulatory approvals and reimbursable medicines
- Provide continuous medical benefit and risk oversight for assigned assets
- Supervise and mentor other Clinical Program Leaders as assigned
- Lead creation and execution of holistic evidence-generation strategies
- Integrate deliverables of all medical functions as Evidence Team leader
- Drive patient value, patient voice, quality of life and outcomes aligned with Medicine Excellence goals
- Develop and execute clinical development strategies within broader Integrated Asset Evidence Strategies
- Lead medical strategy and key clinical program deliverables throughout the clinical development cycle
- Chair and integrate cross-functional evidence teams including Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance, Regulatory, Medical Affairs, Market Access, Epidemiology and RWE
- Assume clinical development and budget responsibility for designated programs
- Present proposals and updates to internal governance committees and external bodies
- Plan, interpret and present clinical study data from first-in-human through pivotal studies
- Ensure integration of regional input and alignment with operational excellence
- Perform continuous risk/benefit assessment
- Author Investigator Brochures, Clinical Development Plans, core clinical trial protocols, pediatric development plans and regulatory documentation sections
- Provide input to regulatory strategy and lead clinical development discussions during regulatory interactions and submissions including IND, NDA, BLA and MAA
- Lead authoring of clinical abstracts, congress presentations and manuscripts
- Review and approve project publications
- Define medical digital strategy and coordinate with Digital Content Manager on tools, technologies and best practices
- Provide input into Medical Affairs strategy and deliverables
- Ensure programs comply with GCP requirements and global regulatory and ethical standards
Requirements:
- MD (specialist in respective TA) and extensive experience across all stages of clinical drug development
- OR PhD with ten-plus (10+) years’ experience in respective TA and extensive experience across all stages of clinical drug development
- Commitment to high ethical standards and desire to transform lives of patients with unmet needs
- Comprehensive knowledge of the Medicine strategy and vision
- Deep knowledge and understanding of the TA strategy and vision
- Ability to evaluate key study concepts including background, sample size, statistics, design, timing, feasibility and budgeting
- Sound medical and scientific leadership to drive complex/high-priority projects in collaboration with global matrix teams
- Very strong strategic mindset
- Excellent communication, influencing, presentation and training skills
- Proven ability to build internal relationships and exert influence in a matrix and virtual environment
- Ability to build external relationships with thought leaders and industry bodies
- Track record of interaction with regulatory affairs authorities, international societies and relevant stakeholders
- Advanced management skills
- Agile and effective working style
- Able to deputize for more experienced roles
- Must be legally authorized to work in the United States without restriction
- Must be willing to take a drug test and post-offer physical, if required
- Must be 18 years of age or older
Benefits:
- Competitive compensation and benefit programs
- Medical, dental and vision coverage
- Retirement savings opportunities
- Paid time off
- Paid holidays
- Disability and life insurance benefits
- Role-specific discretionary bonus may be available
- Relocation may be available
- Other company-sponsored programs
- Healthy working environment
- Meaningful work
- Mobility and networking opportunities
- Work-life balance
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