Biogen
Associate Director Clinical Development, Immunology
Remote, USA, USA · Director
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About the role
- 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.
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.
- Support data interpretation and clinical reporting for early phase clinical studies.
- 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.
- You will have the ability to influence without authority and partner effectively across disciplines.
Requirements
- You are passionate about advancing clinical development in immunology and improving the lives of patients with immune-mediated or autoimmune diseases.
- Your expertise in neuroimmunology and autoimmune disorders helps provide input for complex scientific and clinical information into actionable development strategies.
- 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.
Nice to have
- 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.
- Preferred Skills:
Skills
- 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
- Strong communication skills (written and verbal)
- Deep scientific and clinical understanding of neuroimmunology/ autoimmune disorders
- 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)
- Open to remote U.S.-based talent, with a preference for candidates located near our West Coast site in California.
- Job Level: Management
- Additional Information
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- Provide medical monitoring, clinical execution, and oversight of clinical studies to ensure patient safety
- Support preparation for health authority interaction and contribute to responses for regulatory questions related to clinical development activities.
- 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)
- Employee stock purchase plan
- Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Company info
- We are a global team with a commitment to excellence, and a pioneering spirit.
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 401(k) program participation with company matched contributions
- As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.