Annexon Biosciences

Annexon Biosciences

Vice President, Clinical Development-Neuroscience

San Francisco Bay Area · Exec

Sponsorship not specified$15k-$20kDetected 103 days ago
ComplianceClinical TrialsPharmacologyFDA RegulatoryPharmacovigilanceResearchLeadershipCommunicationProblem SolvingRegulatory Affairs

About the role

  • For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline.
  • We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.
  • We're seeking exceptional talent from all backgrounds to fuel our growth.

Responsibilities

  • 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).
  • 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.
  • Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them.
  • We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results.
  • 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

Nice to have

  • 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.

Skills

  • 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.
  • Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.
  • Strong analytical and problem-solving skills, with a data driven approach to decision making.
  • 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.

Compensation

  • $399,600 - $427,500 USD

Benefits

  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.

Company info

  • 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.
  • 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.
  • At Annexon, we're building a diverse, equitable, and inclusive workplace.
  • We value unique perspectives and unconventional paths.
  • If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply.
  • Learn more about our commitment to diversity, equity, inclusion, and our company culture!
  • 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.
  • 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.

Equal opportunity

  • Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.
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