About This Role:
The Associate Director Clinical Development, Immunology, based within Biogen’s West Coast Hub (WCH), will contribute to the clinical trial design and execution of one or more Immunology programs, focus on early-phase (I-II) studies in autoantibody-driven disease such as myasthenia gravis and chronic inflammatory demyelinating polyneuropathy (CIDP). Reporting to Sr Director Clinical Development Lead Immunology and Indications Expansion (WCH).
The Associate Director, Clinical Development is a pivotal role requiring strong blend of scientific acumen, tactical trial execution, and collaborative leadership. Your primary responsibilities will include contributing to clinical development frameworks for new indications, designing robust protocols, and interpreting study data in clos partnership with internal research and development teams. As a key member of the clinical development team, you will execute key trials that drive the trajectory of our WCH immunology pipeline. You will also support the company’s broader mission by providing clinical insights to early-stage research assets, external partnerships, and due diligence activities.
What You’ll Do:
- Partner with cross-functional teams including clinical operations, biostatistics, data management, regulatory, and safety to advance early-phase development programs.
- Contribute to clinical trial protocol design, development and execution for early phase neuroimmunology studies.
- Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety
- Serve as a contact for CRO and investigators to provide responses for protocol related questions.
- Provide scientific therapeutic expertise to internal and external stakeholders.
- Support data interpretation and clinical reporting for early phase clinical studies.
- Support preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activities.
- Contribute scientific contents for clinical protocols and other clinical development documents.
- Support risk mitigation strategies and provide clinical input for safety management plans
- Assist in providing scientific content for clinical study documents such as protocols, amendments, investigator brochure, clinical study reports, and briefing materials.
- Champion patient-centered development approaches by incorporating disease burden, feasibility and patient experience considerations into study design.
- Monitor the external landscape in neuroimmunology and autoimmune disease, including competitive intelligence, evolving standards of care, and relevant scientific advances.
Open to remote U.S.-based talent, with a preference for candidates located near our West Coast site in California.
Who You Are:
You are passionate about advancing clinical development in immunology and improving the lives of patients with immune-mediated or autoimmune diseases. You thrive in ambiguity and continuously seek to learn and improve. Your expertise in neuroimmunology and autoimmune disorders helps provide input for complex scientific and clinical information into actionable development strategies. You will have the ability to influence without authority and partner effectively across disciplines. Experienced in framing trade-offs and decision points for senior leadership, you are adaptable, able to flex between program-level strategy and disease area depth as needed.
Required Skills:
- MD/DO (or international equivalent) or PharmD with relevant experience required. Subspecialty experience in neurology or neuromuscular medicine, or prior drug development experience in neuromuscular or neuroimmunology diseases, is strongly preferred.
- 0-2 + years’ experience in the biotech/pharmaceutical industry with additional experience in academic or clinical research.
- Prior experience in medical monitoring or investigator/sub-investigator role
- Experience contributing to clinical study execution and/or oversight and working cross-functionally with R&D partners.
- Strong communication skills (written and verbal)
- Deep scientific and clinical understanding of neuroimmunology/ autoimmune disorders
- Ability to manage multiple priorities in fast paced environment
- Ability to travel domestically and internationally, as required for business needs.
Preferred Skills:
- Relevant disease area experience (e.g., Myasthenia Gravis, CIDP, neuroimmunology, or other immune-mediated conditions)
- Understanding of regulatory requirements for drug development.
- Established network of global Key Opinion Leaders (KOLs)
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