Director, Senior Clinical Program Leader – Rheumatology

🕒 il y a 11 jours

🇺🇸 États-Unis – Télétravail

💵 $265 000 - $397 400 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Boehringer Ingelheim

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10 000+ employés

🏥 Santé

🏭 Fabrication

💊 Pharmaceutique

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim est une entreprise pharmaceutique mondiale, axée sur la recherche, et appartenant à une famille. Elle est basée en Allemagne et se consacre à la découverte, au développement, à la fabrication et à la commercialisation de médicaments sur ordonnance, de produits biopharmaceutiques, de vaccins et de produits de santé animale. L'entreprise se concentre sur des domaines thérapeutiques tels que les maladies respiratoires, cardiovasculaires, métaboliques, l'oncologie, l'immunologie et les maladies zoonotiques, et investit massivement dans la R&D et la biotechnologie pour faire progresser la découverte et le développement de médicaments. Elle opère dans le monde entier à la fois sur les marchés des produits pharmaceutiques humains et de la santé animale, en collaboration avec des institutions académiques et des entreprises biotechnologiques pour traduire la recherche scientifique en thérapies.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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

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