Director, Field Clinical and Patient Screening Programs

🕒 il y a 17 jours

🇺🇸 États-Unis – Télétravail

💵 $149 300 - $298 700 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Abbott

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1888

🏥 Santé

⚕️ Assurance santé

🧬 Biotechnologie

Healthcare • Healthcare Insurance • Biotechnology

Abbott est une entreprise mondiale de soins de santé engagée dans l'avancement des technologies médicales et l'amélioration des vies à travers le monde. Elle propose une large gamme de produits de premier plan dans le domaine du diagnostic, des dispositifs médicaux, de la nutrition et des médicaments génériques de marque. Les innovations d'Abbott, telles que les systèmes de surveillance de la glycémie FreeStyle Libre et les tests antigéniques rapides BinaxNOW, transforment la gestion du diabète et la réponse à la COVID-19. Grâce à ses partenariats et initiatives, Abbott vise à promouvoir l'équité en matière de santé, à améliorer l'accès aux soins et à relever des défis sanitaires critiques tels que la malnutrition et les maladies infectieuses. Abbott est également dévouée au développement durable et à la responsabilité sociale, s'efforçant de rendre les technologies qui changent la vie accessibles et abordables.

Description

• Lead the Field Clinical function for TMVR clinical studies • Develop programs, staffing plans, training for teams and clinical sites, and budgets • Lead the Patient Screening and Selection function for TMVR clinical studies • Develop patient-specific analyses for TMVR study selection using complex medical imaging data • Support trial enrollment through patient screening and selection materials • Participate in developing and reviewing clinical research protocols, reports, and statistical analysis plans • Serve as a senior point of contact for Clinical Investigators and site research staff • Establish and monitor standardized operating models, policies, and performance metrics • Ensure compliance with FDA, ISO, MDR, and global regulatory requirements • Collaborate with Clinical Science to align with approved clinical strategies and evidence • Provide accurate, timely, and consistent clinical data and program updates to stakeholders • Present study updates to senior leadership, investigators, and key stakeholders • Provide strategic and operational leadership for field-based clinical teams supporting TMVR programs • Partner with Clinical Operations, Clinical Science, Quality, Regulatory, Marketing, Medical Affairs, Training, and Commercial functions • Make staffing, budget, and policy recommendations

🎯 Exigences

• Master’s degree in Life Sciences, Engineering, Healthcare, or a related field with a minimum of 7 years of relevant experience; or Bachelor’s degree in these fields with a minimum of 9 years of relevant experience • Significant experience supporting complex structural heart clinical programs • Direct experience with Transcatheter Mitral Valve Replacement (TMVR) technologies, clinical studies, and procedures • Experience building, leading, and scaling field clinical teams for investigational medical device programs • Experience developing organizational capabilities, governance, and standardized operating processes • Strong understanding of structural heart disease, transcatheter valve therapies, advanced cardiac imaging, and anatomical patient screening and selection • Proven ability to maintain relationships with clinical investigators, physician leaders, and research sites • Ability to navigate complex clinical decisions, investigator expectations, and enrollment challenges • Ability to lead cross-functional clinical programs and ensure execution in regulated clinical trial environments • Strong strategic leadership, communication, and organizational management skills • Ability to influence senior leadership, develop managers, and lead geographically dispersed teams • Experience developing and managing budgets, staffing plans, and operational performance metrics • Knowledge of disease state and device usage • Willingness and ability to travel 50% of the time

🏖️ Avantages

• Career development with an international company • Free medical coverage in the Health Investment Plan (HIP) PPO medical plan (eligibility in the next calendar year) • Excellent retirement savings plan with a high employer contribution • Tuition reimbursement • Freedom 2 Save student debt program • FreeU education benefit • Opportunity to earn a bachelor’s degree through an affordable education benefit • Recognition as a great place to work and one of the most admired companies • Recognition among the best big companies to work for and best workplaces for diversity, working mothers, female executives, and scientists

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