Senior Director, Clinical Development

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

Benefits offered by this job

Flexible work schedules

Remote opportunities

Competitive base salary and equity participation

Job summary

Annexon Biosciences is seeking a Sr. Director of Clinical Development to oversee clinical strategy from Phase I through III, ensuring scientific robustness and regulatory compliance. The ideal candidate will have over 10 years of experience in clinical development, particularly within CNS indications.

This role involves collaboration with cross-functional teams and presenting clinical progress to executive leadership. The position offers a competitive salary range of $336,000 to $374,000, plus extensive benefits including flexible work schedules and equity participation.

Qualifications

• MD or PhD in Neurology, Neuroscience, or related field.
• Over 10 years of clinical development experience with CNS indications.
• Proven leadership in designing, managing, and executing trials.

Responsibilities

• Lead clinical development from Phase I to Phase III ensuring scientific robustness.
• Collaborate with clinical operations and regulatory affairs to execute plans.
• Analyze trial data to inform key decisions and provide recommendations.

Skills

Leadership

Strategic thinking

Clinical development

Regulatory knowledge

Analytical skills

Education

MD or PhD in Neurology, Neuroscience, or related field

Job description

About the Company

Annexon Biosciences is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies to treat complement-mediated neuroinflammatory diseases.

Position

The Sr. Director of Clinical Development will lead the clinical strategy and execution of one or more development programs, overseeing design and execution from Phase I through Phase III.

Responsibilities

• Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage trials, ensuring scientific robustness and regulatory compliance.
• Collaborate cross‑functionally with clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to execute clinical plans.
• Drive regulatory filings, including trial applications, investigator brochures, and study protocols in accordance with FDA and EMA guidelines.
• Analyze, interpret, and communicate trial data to inform key decisions and provide recommendations.
• Establish and maintain strategic relationships with KOLs, investigators, and external stakeholders.
• Manage budgets, timelines, and resources to deliver high‑quality results aligned with corporate objectives.
• Present clinical progress, data outcomes, and strategic recommendations to executive leadership and stakeholders.
• Stay current on industry trends, scientific advances, and regulatory developments.
• Identify risks in timelines, budgets, or regulatory pathways and develop contingency plans.

Required Qualifications

• MD or PhD in Neurology, Neuroscience, or related field.
• Over 10 years of clinical development experience with CNS indications.
• Proven leadership in designing, managing, and executing trials from early to late stages.
• Experience leading clinical development teams at a senior/executive level, preferably in a high‑growth biotech or pharma.
• In‑depth knowledge of global regulatory requirements (FDA, EMA) and process, including experience with HA meetings, briefing books, and supporting meetings.
• Exceptional leadership, strategic thinking, and communication skills to influence across functions.
• 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 to decision making.
• Track record of building collaborations with cross‑functional teams and external partners.

Preferred Qualifications

• Experience with regulatory submissions and trial oversight in biotech or pharmaceutical settings.
• Familiarity with emerging neurology trends and novel therapeutic modalities.

Salary Range

$336,000 – $374,000.

Location

Brisbane, California (San Francisco Bay Area preferred).

Benefits

• Flexible work schedules and remote opportunities for work‑life balance.
• Shuttle service from BART, CalTrain, and Ferry.
• Competitive base salary, equity participation, employee stock purchase plan, and comprehensive health benefits including medical, dental, vision, 401(k), flexible spending, and other benefits.

Equal Opportunity Employer

Annexon Biosciences is an Equal Opportunity Employer. We prohibit discrimination or harassment of any kind and foster an inclusive culture that respects individual strengths, views, and experiences.