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Annexon Biosciences · 2 days ago

Senior Director, Clinical Development

San Francisco Bay Area

Full-time

Hybrid

Director/Executive

$336K/yr - $374K/yr

10+ years exp

Annexon Biosciences is a biopharmaceutical company focused on developing therapies for neuroinflammatory diseases. The Sr. Director of Clinical Development will lead clinical strategy and execution for development programs, ensuring scientific integrity and regulatory compliance while collaborating with cross-functional teams.

BiotechnologyHealth CareHealth DiagnosticsLife ScienceTherapeutics

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

Qualification

Clinical trial designRegulatory complianceLeadership in clinical developmentCNS-related experienceAnalytical skillsStrategic thinkingCommunication skillsProblem-solving skillsCollaboration 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 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