Director, Senior Clinical Program Leader – Eye Health

🕒 il y a 22 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%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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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

• 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

🎯 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 • 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

🏖️ Avantages

• 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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