[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.ResponsibilitiesPartner with cross-functional teams including clinical operations, biostatistics, data management, regulatory, and safety to advance early-phase development programsContribute to clinical trial protocol design, development and execution for early phase neuroimmunology studiesProvide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safetyServe as a contact for CRO and investigators to provide responses for protocol related questionsProvide scientific therapeutic expertise to internal and external stakeholdersSupport data interpretation and clinical reporting for early phase clinical studiesSupport preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activitiesContribute scientific contents for clinical protocols and other clinical development documentsSupport risk mitigation strategies and provide clinical input for safety management plansAssist in providing scientific content for clinical study documents such as protocols, amendments, investigator brochure, clinical study reports, and briefing materialsChampion patient-centered development approaches by incorporating disease burden, feasibility and patient experience considerations into study designMonitor the external landscape in neuroimmunology and autoimmune disease, including competitive intelligence, evolving standards of care, and relevant scientific advancesSkillsMD/DO (or international equivalent) or PharmD with relevant experience requiredSubspecialty experience in neurology or neuromuscular medicine, or prior drug development experience in neuromuscular or neuroimmunology diseases, is strongly preferred0-2 + years' experience in the biotech/pharmaceutical industry with additional experience in academic or clinical researchPrior experience in medical monitoring or investigator/sub-investigator roleExperience contributing to clinical study execution and/or oversight and working cross-functionally with R&D partnersStrong communication skills (written and verbal)Deep scientific and clinical understanding of neuroimmunology/ autoimmune disordersAbility to manage multiple priorities in fast paced environmentAbility to travel domestically and internationally, as required for business needsRelevant disease area experience (e.g., Myasthenia Gravis, CIDP, neuroimmunology, or other immune-mediated conditions)Understanding of regulatory requirements for drug developmentEstablished network of global Key Opinion Leaders (KOLs)BenefitsRegular 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 insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participationCompany OverviewBiogen is a biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases. It was founded in 1978, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 5001-10000 employees. Its website is https://www.biogen.com/en_us/home.html.