Associate Director, Clinical Development – Immunology

🔥 3 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $184k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• 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.

🎯 Requirements

• 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 a fast paced environment. • Ability to travel domestically and internationally, as required for business needs.

🏖️ 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