Senior Director Clinical Development

Annexon Biosciences; San Francisco (CA); Hybrid; USD 336,000 - 374,000; Full time

Benefits offered by this job

Flexible work schedules

Remote opportunities

Comprehensive health benefit package

Job summary

Annexon Biosciences is seeking a Senior Director of Clinical Development to lead the clinical strategy for multiple development programs in San Francisco. The role involves overseeing clinical trials from Phase I to III, ensuring regulatory compliance, and driving strategic partnerships. The ideal candidate has over 10 years of clinical development experience, particularly in CNS indications, and possesses exceptional leadership skills. The position offers a competitive salary range of $336,000 to $374,000, remote work options, and a comprehensive benefits package.

Qualifications

• Over 10 years of experience in clinical development focusing on CNS-related indications.
• Experience leading clinical development teams at a senior/executive level.
• In-depth knowledge of global regulatory requirements.

Responsibilities

• Lead the strategic direction and execution of clinical development programs.
• Collaborate cross-functionally with various teams for successful execution.
• Manage clinical trial budgets, timelines, and resources.

Skills

Leadership

Clinical trial design

Regulatory compliance

Strategic thinking

Analytical skills

Education

MD or PhD in Neurology, Neuroscience, or related field

Job description

Company

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.

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 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

• Lead the strategic direction and execution of clinical development programs, from early‑phase through late‑stage trials ensuring scientific rigor and regulatory compliance.
• Collaborate cross‑functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure successful execution of 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 and provide recommendations for strategy.
• Establish and maintain strategic relationships with key opinion leaders, clinical investigators, and external stakeholders to advance initiatives.
• Manage clinical trial budgets, timelines, and resources, ensuring delivery of high‑quality results.
• 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.
• Identify potential risks in timelines, budgets, or regulatory pathways and develop contingency plans.

Education, Experience, and Skills

Required

• MD or PhD in Neurology, Neuroscience, or a related field.
• Over 10 years of experience in clinical development, focusing on CNS‑related indications.
• Proven leadership in designing, managing, and executing clinical trials from early phase through late‑stage development.
• Experience leading clinical development teams at a senior or executive level in a high‑growth biotech or pharmaceutical environment.
• In‑depth knowledge of global regulatory requirements and guidelines (FDA, EMA) and clinical development processes.
• Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.
• Ability to work effectively in a fast‑paced, dynamic environment and manage multiple priorities.
• Strong analytical and problem‑solving skills, with a data‑driven approach.
• Success in building collaborations with cross‑functional teams and external partners.

Preferred

• Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
• Familiarity with emerging trends in neurology, including cutting‑edge therapeutic modalities.

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

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve work‑life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Competitive base salary and equity participation, employee stock purchase plan, and a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.

Equal Opportunity Employer. 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 that respects individual strengths, views, and experiences. We believe that our differences enable us to be a better team, make better decisions, drive innovation, and deliver better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.