Biogen logo

Associate Medical Director - Clinical Development, Immunology

Biogen
Full-time
Remote friendly (Cambridge, MA)
United States
$202,000 - $278,000 USD yearly
Clinical Research and Development

Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now โ€” JobsAI.

Role Summary

Associate Medical Director, Clinical Development โ€šร„รฌ Immunology; responsible for shaping and advancing clinical programs in lupus and autoimmune diseases, aligning clinical development strategy, and leading complex trials within the Immunology Therapeutic Area. Reports to the Executive Director, Clinical Development Immunology. Focuses on bridging research and clinical operations to ensure efficacy and safety, contributing to the organizationโ€šร„รดs mission in Immunology.

Responsibilities

  • Report directly to the Executive Director, Clinical Development Immunology, overseeing clinical development activities within Immunology.
  • Collaborate with the Research Unit to progress projects into Phase I and PoC activities.
  • Contribute to and review clinical study documents (CSPs, CSRs, IBs, PIS/ICFs, SAPs) and regulatory submissions (INDs, BBs).
  • Monitor, analyze, and interpret safety and efficacy data from ongoing trials.
  • Serve as a clinical science expert for study teams, CROs, and study sites.
  • Participate in cross-functional clinical study team meetings and provide insights and direction.
  • Develop and deliver presentations to internal teams and external stakeholders.
  • Foster relationships with key stakeholders and contribute to decision-making panels.
  • Offer clinical scientific expertise to support business development initiatives, including due diligence.

Qualifications

  • MD or equivalent medical degree, with preference for rheumatology, dermatology, or immunology.
  • Minimum of three (3) years of clinical research experience in academic or industry settings across phases Iโ€šร„รฌIV, including planning, execution, reporting, and publication.
  • Demonstrated ability to forge scientific partnerships with internal and external stakeholders.
  • Comprehensive understanding of GCP, trial methodology, statistics, and regulatory/clinical development landscape.
  • Strong background in immunology, with clinical and basic research experience.
  • Autonomy with strong collaboration across functions and excellent problem-solving, conflict resolution, and analytical skills.

Skills

  • Clinical development leadership and strategic thinking
  • Scientific communication and presentation skills
  • Stakeholder engagement and collaboration
  • Regulatory knowledge (INDs, regulatory submissions)
  • Analytical and data interpretation capabilities

Education

  • MD or equivalent medical degree; specialization in rheumatology, dermatology, or immunology preferred.

Additional Requirements

  • None beyond the above qualifications; travel should be assessed on program needs (not specified).
Apply now
Share this job