Senior Director, Clinical Development

Overview

Senior Director, Clinical Development at Annexon Biosciences — a biopharmaceutical company developing a late-stage clinical platform of novel therapies for classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our approach targets upstream C1q to block the classical complement inflammatory cascade. Our candidates aim to provide meaningful benefits across autoimmune, neurodegenerative, and ophthalmic diseases. With proof-of-concept data in Guillain-Barré syndrome, Huntington’s disease, and geographic atrophy, we are advancing mid-to-late-stage clinical trials to bring new potential treatments to patients. Join a team committed to making an impact together.

Position

The Senior 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 Senior 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 translate innovative therapeutic concepts into real-world treatments, shaping the company’s success in neurology.

Responsibilities

• 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 requirements.
• 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 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

Preferred

Salary Range

$336,000 - $374,000

Location

Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area.

Benefits

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

Seniority level

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