Senior Director, Clinical Development

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases.

With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We're seekingexceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.

Learn more about our commitment to diversity, equity, inclusion, and our company culture !

Position:

The Sr. Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs. This role will be responsible for the end-to-end design and execution of clinical programs, from Phase I through Phase III, ensuring scientific integrity, regulatory compliance, and alignment with corporate objectives . The Sr. Director will collaborate with cross-functional teams, lead regulatory submissions, and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives.

The ideal candidate will bring a strategic vision, proven expertise in clinical trial design and execution, and the ability to manage complex programs in a fast-paced environment. This individual will play a crucial role in translating innovative therapeutic concepts into real-world treatments, shaping the company’s success in the rapidly evolving field of neurology.

Responsibilities include:

• Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement.
• Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.
• Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA).
• Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy.
• Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.
• Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives.
• Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners.
• Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in the clinical development strategies.
• Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them.

Education, Experience, and Skills:

Required:

• MD or PhD in Neurology, Neuroscience, or a related field.
• Over 10 years of experience in clinical development, with a focus on CNS-related indications.
• Proven leadership…