Associate Director, Clinical Development – Immunology

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $184k - $253k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Contribute to clinical trial design and execution for one or more Immunology programs, focusing on early-phase (I-II) studies in autoantibody-driven diseases such as myasthenia gravis and CIDP • Partner with clinical operations, biostatistics, data management, regulatory, and safety teams 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 CROs and investigators and respond to 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 interactions and responses to regulatory questions • Contribute scientific content to clinical protocols and other clinical development documents • Support risk mitigation strategies and provide clinical input for safety management plans • Assist with scientific content for protocols, amendments, investigator brochures, clinical study reports, and briefing materials • Incorporate disease burden, feasibility, and patient experience considerations into study design • Monitor the external neuroimmunology and autoimmune disease landscape, including competitive intelligence, standards of care, and scientific advances • Provide clinical insights to early-stage research assets, external partnerships, and due diligence activities • Report to the Sr Director Clinical Development Lead Immunology and Indications Expansion (WCH)

🎯 Requirements

• MD/DO (or international equivalent) or PharmD with relevant experience required • 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 • Subspecialty experience in neurology or neuromuscular medicine, or prior drug development experience in neuromuscular or neuroimmunology diseases, is strongly preferred • Relevant disease area experience, such as Myasthenia Gravis, CIDP, neuroimmunology, or other immune-mediated conditions, preferred • Understanding of regulatory requirements for drug development, preferred • Established network of global Key Opinion Leaders (KOLs), preferred • Open to remote U.S.-based talent, with a preference for candidates located near the West Coast site in California

🏖️ Benefits

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Short term and long-term incentives, including cash bonus and equity incentive opportunities • Remote work arrangement