Note: The job is a remote job and is open to candidates in USA. Boehringer Ingelheim is seeking a Director, Senior Clinical Program Leader to provide medico-scientific and strategic leadership for clinical programs in Obesity & Liver. The role leads clinical development strategy and evidence generation, oversees medical benefit-risk, and drives programs toward regulatory approval and patient value.

Responsibilities

• Design and prepare clinical development plans, focusing on Phase I and II in Obesity & Liver indications
• 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 for virtual/digital endpoints, etc.)
• Liaises with the Digital Content Manager regarding new tools/technologies/best practices
• Provides input into Medical Affairs strategy and deliverables including the medical chapters of the integrated brand plan and related key documents in collaboration with Medical Advisor, AHoM and HoM
• Ensures programs are delivered in compliance with GCP requirements and global regulatory and ethical standards

Skills

• MD (specialist in respective TA) and extensive experience across all stages of clinical drug development
• 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
• Has a comprehensive knowledge of the Medicine strategy and vision as well as deep knowledge and understanding of the TA strategy and vision
• Ability to thoroughly 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 and excellent communications, influencing, presentation and training skills
• Proven ability to build internal relationships and exert influence in a matrix and virtual environment and external relationship with thought leaders, industry bodies, etc
• Track record of interaction with regulatory Affairs authority, international societies and other 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

Benefits

• May be eligible for a role-specific discretionary bonus
• May be eligible for relocation assistance
• Medical, dental, and vision coverage
• Retirement savings opportunities
• Paid time off
• Paid holidays
• Disability and life insurance benefits
• Other company-sponsored benefits

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