ITF Therapeutics LLC
Executive Director, U.S. Medical Affairs
ITF Therapeutics LLC, Southern Md Facility, Maryland, us, 20697
Building Strong
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity Relationships That Allow New Thinking and Novel AdvancementsExecutive Director, U.S. Medical Affairs Reports to: VP US & Global Medical Affairs The Executive Director of US Medical Affairs will lead the development and execution of the US medical strategy for givinostat in Duchenne muscular dystrophy and future pipeline programs. The qualified candidate will serve as a key medical representative in the US, supporting external medical expert engagement and development, communication and evidence generation strategy, and cross-functional collaboration. Responsibilities:
Be responsible for execution of the US Medical Affairs strategy aligned with corporate objectives and product lifecycle needs. Implement and oversee the execution of US medical plans for Duvyzat, ensuring integration of regulatory, clinical, commercial and global medical perspectives. Lead and development the U.S. Medical Affairs team, including Medical Science Liaisons (MSLs), pharmacovigilance (PV), and medical information/medical review. Oversee the execution of medical education, scientific exchange, and non-registrational evidence-generation initiatives. Act as a strategic thought partner across Medical Affairs, R&D, and commercial teams. Provide medical and scientific support for late-stage clinical development programs, ensuring alignment with business and regulatory strategies. Support training and development of internal teams on product science and disease education. Manage the US Medical Affairs budget, ensuring optimal resource allocation. Implement right-sized systems and processes to optimize effectiveness of the medical affairs organization. Establish and maintain strong, trusted relationships with external medical experts, academic institutions, and medical societies. Oversee a comprehensive medical KOL engagement and insights-generation strategy. Localize medical information and publication resources. Ensure pharmacovigilance systems and processes are compliant with U.S. regulations and aligned with global PV strategy. Develop medical governance frameworks to maintain high ethical and compliance standards in all engagements. Required Skills:
Advanced degree required (PharmD, MD, or PhD; PharmD strongly preferred). Minimum 10 years of progressive experience in U.S. Medical Affairs within the pharmaceutical or biotechnology industry. Prior leadership of cross-functional medical teams, including MSLs and medical communications. Experience in rare diseases, neurology, or neuromuscular disorders is strongly preferred. Deep knowledge of U.S. medical, regulatory, and pharmacovigilance standards. Demonstrated ability to work in a fast-paced, evolving environment and to build highly effective and accountable teams from the ground up. Experience supporting an early marketed product. Collaborative and decisive leader with a proven ability to navigate and contribute effectively within a matrixed organization. Exceptional interpersonal skills with a demonstrated ability to build strong relationships with both internal stakeholders and external partners. If you’re the right fit, please submit your resume or CV using the email link below.
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Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity Relationships That Allow New Thinking and Novel AdvancementsExecutive Director, U.S. Medical Affairs Reports to: VP US & Global Medical Affairs The Executive Director of US Medical Affairs will lead the development and execution of the US medical strategy for givinostat in Duchenne muscular dystrophy and future pipeline programs. The qualified candidate will serve as a key medical representative in the US, supporting external medical expert engagement and development, communication and evidence generation strategy, and cross-functional collaboration. Responsibilities:
Be responsible for execution of the US Medical Affairs strategy aligned with corporate objectives and product lifecycle needs. Implement and oversee the execution of US medical plans for Duvyzat, ensuring integration of regulatory, clinical, commercial and global medical perspectives. Lead and development the U.S. Medical Affairs team, including Medical Science Liaisons (MSLs), pharmacovigilance (PV), and medical information/medical review. Oversee the execution of medical education, scientific exchange, and non-registrational evidence-generation initiatives. Act as a strategic thought partner across Medical Affairs, R&D, and commercial teams. Provide medical and scientific support for late-stage clinical development programs, ensuring alignment with business and regulatory strategies. Support training and development of internal teams on product science and disease education. Manage the US Medical Affairs budget, ensuring optimal resource allocation. Implement right-sized systems and processes to optimize effectiveness of the medical affairs organization. Establish and maintain strong, trusted relationships with external medical experts, academic institutions, and medical societies. Oversee a comprehensive medical KOL engagement and insights-generation strategy. Localize medical information and publication resources. Ensure pharmacovigilance systems and processes are compliant with U.S. regulations and aligned with global PV strategy. Develop medical governance frameworks to maintain high ethical and compliance standards in all engagements. Required Skills:
Advanced degree required (PharmD, MD, or PhD; PharmD strongly preferred). Minimum 10 years of progressive experience in U.S. Medical Affairs within the pharmaceutical or biotechnology industry. Prior leadership of cross-functional medical teams, including MSLs and medical communications. Experience in rare diseases, neurology, or neuromuscular disorders is strongly preferred. Deep knowledge of U.S. medical, regulatory, and pharmacovigilance standards. Demonstrated ability to work in a fast-paced, evolving environment and to build highly effective and accountable teams from the ground up. Experience supporting an early marketed product. Collaborative and decisive leader with a proven ability to navigate and contribute effectively within a matrixed organization. Exceptional interpersonal skills with a demonstrated ability to build strong relationships with both internal stakeholders and external partners. If you’re the right fit, please submit your resume or CV using the email link below.
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