- Develop and implement a comprehensive Medical Plan aligned with the company's goals and objectives including strategic plans for key opinion leader engagement, data dissemination, publications, and congresses.
- Identify and seek input from thought leaders on emerging science in cell therapy and autoimmune diseases.
- Provide medical leadership and guidance to cross-functional teams, including Medical Science Liaisons (MSLs), Clinical Development, Regulatory Affairs, and Commercial Teams.
- Collaborate with internal stakeholders to develop evidence-generation plans, including clinical trials, real-world evidence studies, and health economics outcomes research (HEOR) initiatives.
- Serve as a key point of contact for external stakeholders including but not limited to healthcare professionals, external experts, and key opinion leaders (KOLs) to provide scientific and medical support.
- Support the identification and relationship development with investigators in clinical trials.
- Connect with key patient advocacy organizations and establish ongoing collaboration.
- Lead the development and execution of medical education and communication programs, including advisory boards, symposia, and scientific publications.
- Partner and collaborate across functional areas to integrate a medical perspective into the development and commercialization process.
- Ensure compliance with regulatory guidelines, industry standards, and company policies in all medical affairs activities.
- Stay abreast of the latest scientific and clinical developments in relevant therapeutic areas to inform strategic decision-making.
- Provide medical insights and input into product lifecycle management, including product launch strategies and lifecycle planning.
- Contribute to the development and review of medical affairs materials, including medical information documents, scientific presentations, and medical education materials.
- Mentor and support junior members of the Medical Affairs team, fostering a culture of continuous learning and professional development.
- Advanced scientific degree (MD, PhD, PharmD) and 5 years in an autoimmune disease area is required.
- Minimum of 10 years of experience in US and/or Global Medical Affairs with strong preference in Immunology, Rare Diseases, and/or Cell Therapy.
- Proven track record of developing and executing medical affairs strategies to support product development, launch, and lifecycle management.
- Experience in field strategy and execution in Immunology and/or Rare Diseases is preferred.
- Strong understanding of clinical trial design, real-world evidence generation, and health economics outcomes research.
- Excellent communication and presentation skills, with the ability to effectively communicate complex scientific and medical information to diverse audiences.
- Demonstrated leadership abilities and the ability to collaborate effectively with cross-functional teams.
- Experience in a customer-facing role with thought leaders, scientific organizations, and patient advocacy groups.
- Self-motivated, innovative, and critical thinker with hands-on execution with strong commitment to follow up on action items.
- Thorough knowledge of regulatory requirements and compliance standards governing medical affairs activities.
- Willingness to learn new therapeutic areas and technologies.
- Strategic mindset with the ability to analyze data, identify insights, and translate them into actionable strategies.
- Thrives in a fast-paced, small company environment and is able to adjust priorities and workload based upon changing needs.
- Ability to travel domestically and internationally 25%, as needed.
- Strong team orientation and passion for continuous self-development.
- Experience in the biotech industry or in a startup industrial setting is preferred.
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Medical Director/Senior Medical Director, Medical Affairs - Philadelphia, United States - Cabaletta Bio
Description
Medical Director/Senior Medical Director, Medical AffairsPhiladelphia, PA
About the Position
Reporting to the Vice President, Medical Affairs, we are seeking a highly motivated and experienced Medical Director/Senior Medical Director to join our Medical Affairs team.
The incumbent will play a crucial role in shaping and executing the medical affairs strategy to support the company's objectives and ensure the appropriate dissemination of medical information to various stakeholders.
Responsibilities Include
Medical Director/Senior Medical Director, Medical Affairs professionals in Philadelphia
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Nathan Luce
Healthcare Administrator
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Jake Smith
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Carl Denys
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Johnathon Kyle Armstrong
Data Science | Machine Learning | Data Management