Director, Senior Clinical Program Leader – Rheumatology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $265k - $397.4k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• Provide full medico-scientific and strategic leadership of clinical programs to 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 assigned to the program/asset • Lead creation and execution of holistic evidence generation strategies and integrate deliverables of all medical functions as Evidence Team leader • Drive patient value, patient voice, quality of life and outcomes in line with Medicine Excellence goals • Develop and execute clinical development strategies for designated programs as part of an Integrated Asset Evidence Strategy • Lead medical strategy and key clinical program deliverables throughout the clinical development cycle • Chair and integrate cross-functional Evidence Team outputs across 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, including health authorities, advisory boards, steering committees and medical/patient societies • Plan, interpret and present clinical study data from first-in-human through pivotal studies, integrating regional input • Ensure alignment of strategy with operational excellence and conduct 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, including tools/vendors, qualification and validation plans for virtual/digital endpoints • Liaise with the Digital Content Manager regarding tools, technologies and best practices • Provide input into Medical Affairs strategy and deliverables, including medical chapters of integrated brand plans • 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 and 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 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 relationships 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 • Must be willing to take a drug test and post-offer physical (if required) • Must be 18 years of age or older

🏖️ Benefits

• Role-specific discretionary bonus eligibility • Relocation assistance • Medical coverage • Dental coverage • Vision coverage • Retirement savings opportunities • Paid time off • Paid holidays • Disability insurance • Life insurance • Other company-sponsored programs • Healthy working environment • Meaningful work • Mobility • Networking • Work-life balance