Vice President, Neuroscience - Clinical Development

Annexon BiosciencesBrisbane, CA
Onsite

About The Position

We are seeking an accomplished and visionary leader to join our team as Vice President, Clinical Development-Neuroscience. The Vice President, Clinical Development- Neuroscience will serve as a key leader in driving the clinical strategy and execution of the portfolio of programs in neurodegeneration and neuro-immunologic diseases. This role will be responsible for the strategy for the investigation of clinical candidates in this therapeutic area and support 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 successful candidate will collaborate with cross-functional teams, lead clinical aspects of regulatory submissions, and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives. The ideal candidate will bring strategic vision, proven expertise and success in pharmaceutical development for drug candidates for neurologic diseases, 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, including collaborating with discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs and clinical operations, shaping the company’s success in the rapidly evolving field of neurology.

Requirements

  • MD or MD/PhD in with board certification in Neurology, Neuroscience, or a related field.
  • 15-20 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.

Nice To Haves

  • 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.

Responsibilities

  • Lead the strategic direction and execution of the portfolio of neuroscience clinical development programs, from early-phase through late-stage ensuring they are scientifically robust and meet regulatory requirements
  • Collaborate cross-functionally with teams in discovery research, translational medicine, regulatory affairs, pharmacovigilance, biometrics, clinical pharmacology, medical affairs and clinical operations to ensure the successful execution of clinical development plans
  • Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, study protocols, and marketing authorization dossiers (e.g., BLA/NDA, MAA) ensuring alignment with global regulatory guidelines (e.g., FDA, EMA).
  • Analyze, interpret, and communicate 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.

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.

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What This Job Offers

Job Type

Full-time

Career Level

Executive

Education Level

Ph.D. or professional degree

Number of Employees

11-50 employees

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