Medical Director

4 days ago

Boston, United States Albion Rye Associates Full time

Job Title: Medical Director - Infectious Diseases

Location: Boston, MA

Company: Biotech


Position Overview: X is a leading biotechnology company specializing in infectious diseases, is seeking an experienced and dynamic Medical Director to lead the medical strategy and clinical development of our innovative portfolio. The ideal candidate will have a strong background in infectious diseases, clinical trials, and drug development, with a passion for translating scientific discoveries into breakthrough therapies that address unmet medical needs.


Key Responsibilities:


Clinical Strategy & Development:

  • Lead the design, implementation, and execution of clinical development plans for novel therapies in infectious diseases.
  • Provide medical oversight for all clinical trials, ensuring they meet regulatory, safety, and efficacy standards.
  • Collaborate with cross-functional teams (R&D, regulatory affairs, clinical operations, and commercial) to align on project goals and timelines.
  • Ensure timely communication of clinical data, including preparation of clinical study reports and publications.


Regulatory & Compliance:

  • Interface with global regulatory authorities, preparing and presenting clinical data to support Investigational New Drug (IND) applications, New Drug Applications (NDAs), and other regulatory submissions.
  • Ensure all clinical trials comply with applicable local and international regulations, including GCP, FDA, and EMA standards.


Medical Expertise & Leadership:

  • Serve as the company's subject matter expert on infectious diseases, providing guidance on epidemiology, disease mechanisms, and emerging trends.
  • Lead safety assessments, including the evaluation of adverse events and risk-benefit analysis.
  • Develop and maintain relationships with key opinion leaders (KOLs), external researchers, and clinical investigators in the infectious disease community.


Cross-functional Collaboration & Communication:

  • Collaborate with the R&D team to translate preclinical findings into clinical development programs.
  • Work with the commercial team to provide scientific insights that support market access and product launch strategies.
  • Represent the company at scientific meetings, conferences, and advisory boards.


Innovation & Thought Leadership:

  • Stay current with the latest advances in infectious diseases, therapeutic modalities, and clinical trial design.
  • Identify and assess new opportunities for product development in infectious diseases.


Qualifications:

  • MD (or equivalent), preferably with board certification in Infectious Diseases.
  • Minimum of 5 years of experience in clinical research, drug development, or medical affairs within the biotech or pharmaceutical industry.
  • Proven track record in the design, execution, and analysis of clinical trials, particularly in infectious diseases.
  • Strong understanding of regulatory requirements (FDA, EMA) and experience interacting with regulatory bodies.
  • Excellent communication and leadership skills with a demonstrated ability to work in a collaborative, cross-functional team environment.
  • Experience with antiviral, antimicrobial, vaccine, or immunotherapy development is highly desirable.


Location: Boston-based with the potential for hybrid work options.


Compensation: Competitive salary and benefits package, including stock options, health benefits, and opportunities for career advancement within a growing organization.


How to Apply:

Interested candidates should submit their CV and a cover letter outlining their experience in infectious diseases and clinical development to Alex.

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