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Medical Director/Senior Medical Director, Medical Affairs - Wilmington, United States - Cabaletta Bio
Description
Our RESET TMclinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in
lupus
and
myositis
are now recruiting.
Join Our Crew
Medical Director/Senior Medical Director, Medical Affairs
Philadelphia, 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
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.
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.Required Qualifications
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.
Please click the link at the bottom of the posting to submit an application.
Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.
Equal Opportunity EmployerCabaletta Bio is an equal opportunity employer.
We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
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