[Remote] Associate Director Clinical Development, Immunology
Note: The job is a remote job and is open to candidates in USA. Biogen is a global biotechnology company committed to advancing clinical development in immunology. The Associate Director Clinical Development, Immunology will contribute to the design and execution of clinical trials for early-phase studies in autoimmune diseases, collaborating with cross-functional teams to ensure patient safety and scientific rigor.
Responsibilities
- 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
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
- 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)
Benefits
- Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
- 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
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