Full-Time Medical Director, Clinical Development, Immunology
Biogen is hiring a remote Full-Time Medical Director, Clinical Development, Immunology. The career level for this job opening is Expert and is accepting Remote based applicants remotely. Read complete job description before applying.
Biogen
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About This Role: As a Medical Director, Clinical Development, Immunology, you will be an integral member of the Immunology Therapeutic Area within the Clinical Development Organization. You will play a critical part in shaping and advancing clinical programs in the lupus and autoimmune disease space. Reporting to the Executive Director, you will be instrumental in crafting the clinical development strategy and leading the execution of complex clinical trials. Your leadership impacts the direction of clinical studies and contributes to the broader objectives of the organization.
What You’ll Do:
- 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 Proof of Concept (PoC) clinical 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 clinical trials.
- Serve as a clinical science expert for clinical study teams, CROs, and study sites.
- Engage in cross-functional clinical study team meetings.
- Develop and deliver impactful presentations to internal teams and external stakeholders.
- Foster relationships with key external and internal stakeholders and contribute to decision-making panels.
- Offer clinical scientific expertise to support business development initiatives, including due diligence processes.
Who You Are:
You are a visionary in clinical development, driven by a passion for delivering transformative treatments. You possess natural curiosity, the courage to drive innovation, and a commitment to quality and ethical standards.
Required Skills:
- MD or equivalent medical degree, with a preference for specialization in rheumatology, dermatology, or immunology.
- 5+ years clinical research experience (Phases I-IV).
- 3+ years clinical trial execution experience (planning, execution, reporting, publication).
- Demonstrated ability to forge scientific partnerships.
- Comprehensive understanding of GCP, clinical trial methodology, statistics, and the regulatory landscape.
- Distinguished history in immunology (clinical and basic research).
- Strong problem-solving, conflict resolution, and analytical skills.