Director, Senior Clinical Program Leader - Obesity & Liver

Boehringer Ingelheim • Ninilchik, AK

41d • $250,000 - $394,000

About The Position

Boehringer Ingelheim is hiring a Director, Senior Clinical Program Leader for Obesity & Liver in its newly established Global Clinical Development organization. The role provides medico-scientific and strategic leadership for clinical programs, with the goal of accelerating development and achieving regulatory approvals and reimbursable medicines. The incumbent provides ongoing medical benefit-risk oversight and may supervise and mentor other Clinical Program Leaders. They may also lead a cross-functional Evidence team and develop and execute a holistic evidence-generation strategy.

The role leads clinical development plans and strategies, particularly for Phase I and II studies in Obesity & Liver indications, and integrates clinical and medical-function deliverables across the asset lifecycle. It drives patient value, patient voice, quality of life, and outcomes in line with Medicine Excellence goals. The position can be filled in different countries; the listed U.S. application includes U.S. work-authorization, drug-test, and age eligibility requirements.

Requirements

• MD specializing in the respective therapeutic area, with extensive experience across all stages of clinical drug development; alternatively, a PhD with at least 10 years of experience in the respective therapeutic area and extensive experience across all stages of clinical drug development.
• Commitment to high ethical standards and a desire to transform the lives of patients with unmet needs.
• Comprehensive knowledge of Medicine strategy and vision, and deep knowledge and understanding of therapeutic-area strategy and vision.
• Ability to thoroughly evaluate study concepts, including background, sample size, statistics, design, timing, feasibility, and budgeting.
• Sound medical and scientific leadership to drive complex or high-priority projects in collaboration with global matrix teams.
• Strong strategic mindset and excellent communication, influencing, presentation, and training skills.
• Proven ability to build internal relationships and influence in matrix and virtual environments, and to develop external relationships with thought leaders, industry bodies, and others.
• Track record of interaction with regulatory authorities, international societies, and other relevant stakeholders.
• Advanced management skills.
• Agile and effective working style.
• Ability to deputize for more experienced roles.
• For the U.S. position: legally authorized to work in the United States without restriction, willing to take a drug test and post-offer physical if required, and at least 18 years of age.

Responsibilities

• Design and prepare clinical development plans, focusing on Phase I and II in Obesity & Liver indications.
• Develop and execute clinical development strategies for designated programs as part of the broader Integrated Asset Evidence Strategy, aligned with the Target Product Profile and in consultation with the supervisor.
• Lead medical strategy and key clinical program deliverables throughout development, including Targeted Product Profiles, Start of Development or Release of Phase I preparation, and clinical phase-transition milestones.
• Chair and integrate the work of cross-functional Evidence teams, assume clinical development and budget responsibility for designated programs, and 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, integrating regional input.
• Align strategy with operational excellence and maintain continuous risk-benefit assessment.
• Author Investigator Brochures, Clinical Development Plans, core clinical trial protocols and related strategy documents, Pediatric Development Plans, and applicable sections of regulatory documentation.
• Provide input to regulatory strategy and lead clinical development discussions during regulatory interactions and clinical components of submissions, including briefing documents, presentations, and responses to questions.
• Lead the preparation of clinical abstracts, congress presentations, and manuscripts as appropriate, and review and approve project publications in collaboration with the (A)HoM.
• Define the medical digital strategy early in the project lifecycle, including suitable tools or vendors and qualification and validation plans for virtual or digital endpoints.
• Liaise with the Digital Content Manager regarding new tools, technologies, and best practices.
• Contribute to Medical Affairs strategy and deliverables, including medical chapters of integrated brand plans and related documents, in collaboration with the Medical Advisor, AHoM, and HoM.
• Ensure programs comply with GCP requirements and global regulatory and ethical standards.
• Drive patient value, patient voice, quality of life, and outcomes in line with Medicine Excellence goals.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Retirement savings opportunities
• Paid time off
• Paid holidays
• Disability insurance benefits
• Life insurance benefits
• The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree