Senior Director, Clinical Development

Summary

Join Annexon Biosciences, a biopharmaceutical company developing novel therapies for neuroinflammatory diseases, as the Sr. Director of Clinical Development. Lead and execute clinical programs from Phase I through Phase III, ensuring scientific integrity and regulatory compliance. Collaborate with cross-functional teams, manage regulatory submissions, and build relationships with key opinion leaders. Translate innovative therapeutic concepts into real-world treatments. The ideal candidate will possess strategic vision, expertise in clinical trial design and execution, and the ability to manage complex programs. This role is crucial in shaping the company's success in neurology. The position offers a competitive salary and benefits package.

Requirements

• 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 in designing, managing, and executing clinical trials from early phase through late-stage development
• Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment
• In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including Experience in HA meetings, writing briefing books, attending/supporting meetings
• 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 to decision making
• Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast paced environment

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 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

Preferred Qualifications

• 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

Benefits

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