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Senior Director Medical Affairs (Remote)

Philadelphia, PA

About the Position

Reporting to the Chief Medical Officer, the Senior Director Medical Affairs will provide scientific/medical leadership and support for programs in various stages of clinical development. This individual will take a leadership role for the development and execution of the Medical Affairs strategy in support of Cabaletta projects with representation on relevant cross-functional teams. They will serve as an autoimmune disease expert in content creation, strategic and tactical discussions, and presentations with internal colleagues, as well as external experts and investigators.

Responsibilities Include

  • Lead the Medical Plan development and execution
  • Provide scientific and clinical input into the development of disease strategy, and the development strategy including the non-registrational data generation plan (Phase IV), as applicable
  • Identify and seek input from thought leaders on emerging science in drug and biomarker research, disease knowledge and design of clinical protocol and programs
  • Develop thought leader engagement plan
  • Support the identification and relationship development with investigators in clinical trials
  • Connect with key patient advocacy organizations and establish an ongoing collaboration
  • Lead the organization and coordination of activities at various scientific congresses and meetings across multiple therapeutic areas
  • Develop and review key content for congresses, manuscripts, FAQs, and medical standard response letters
  • Develop and execute strategic publications plan
  • Provide data dissemination via data rollout plans and training
  • Provide strategic insight into launch activities planning, and execute pre-launch, peri-launch and post-launch tactics
  • Partner and collaborate across functional areas to integrate a medical perspective into the development and commercialization process
  • Drive investigator sponsored research review, as applicable
  • Partner in the development and execution of health outcomes and access strategy.
  • Provide medical review of asset content to align with overall strategy.

Required Qualifications

  • Advanced scientific degree (MD, PhD, PharmD) and 10+ years in autoimmune disease area
  • Relevant industry experience in Medical Affairs or Clinical Development.
  • Experience in leading, growing and developing a Medical Affairs organization
  • Self-motivated, innovative, and critical thinker with hands on execution, and strong commitment to follow up on action items.
  • Experience in a customer-facing role with thought leaders, scientific organizations, and patient advocacy groups.
  • Experience working in a cross functional team including colleagues in clinical, marketing, access, and health outcomes.
  • Excellent analytical skills and solid experience in translating medical/clinical information into medical affairs strategies.
  • Proficiency in scientific and clinical data review and interpretation.
  • Highly organized and motivated individual possessing excellent communication, presentation, and interpersonal skills.
  • Strong team orientation and passion for continuous self and team development.
  • Strong leadership and influencing skills with the ability to create a clear sense of direction.
  • Ability to multi-task and willingness to flexibly lead; willingness to learn new therapeutic areas and technologies.
  • Thrives in a fast-paced, dynamic small company environment and is able to adjust priorities and workload based upon changing needs.
  • Possess experience creating and managing budgets.
  • Ability to travel 25%.

Preferred Skills

  • Experience in the conduct of clinical trials through approval and commercialization in autoimmune disease preferred.
  • Experience with mining databases and other bioinformatics skills a strong plus.


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How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta 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.