Annexon Biosciences

Annexon Biosciences

Associate Director, Clinical Trial Management

San Francisco Bay Area · Director

Sponsorship not specified$179k-$200kDetected 56 days ago
GCPBudgetingClinical TrialsFDA RegulatoryResearchLeadershipMentoring

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

  • Establish and lead meetings with CROs and other trial vendors and serve as a key escalation point for teams and vendors.
  • The Associate Director will contribute Clinical Operations expertise in cross-functional meetings and develop and implement department initiatives.
  • Develop, implement, and provide oversight of vendor budgets and contracts
  • Develop and manage effective working relationships with Investigators and other key clinical opinion leaders
  • Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct
  • Partners with and maintains regular contact with key stakeholders including Regulatory, Clinical Development, Legal, Finance, and others as necessary
  • Leads the team in the selection of Contract Research Organizations (CROs) for both large budget and small budget
  • We believe that our differences enable us to be a better team - one that makes better decisions, drives innovation, and delivers better business results.

Requirements

  • Travel may be required up to 30% in support of clinical study activities
  • 10+ years of experience leading clinical trial operations including multinational/multisite clinical studies with experience in ophthalmology, neurology, rare diseases, and overall drug development.
  • Experience with direct line-management of clinical operations staff.
  • Has a thorough knowledge of the clinical development process, FDA, EMA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines

Skills

  • BS/BA degree in related discipline or equivalent combination of education and experience
  • Has demonstrated success identifying, negotiating and overseeing outsourced clinical operations services and vendors
  • Experience with financial budgeting or reporting
  • Ability to interact with investigators, vendors, and individuals at all levels of the organization

Compensation

  • $179,000 - $200,000

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.
  • The Associate Director of Clinical Trial Management will contribute to the development and implementation of clinical studies.
  • include providing leadership to staff and study teams to ensure clinical trials are conducted in accordance with the protocols, Standard Operations Procedures (SOPs), Good Clinical Practices (GCPs), and other applicable regulatory requirements.

Equal opportunity

  • Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.
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This listing is sourced directly from Annexon Biosciences's careers page and normalized into a canonical job model.