Associate Director, Clinical Trial Management

About this role

<p><strong><span data-contrast="none">Company:</span></strong><span data-ccp-props="{"201341983":0,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none">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. 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. 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. </span><span data-contrast="auto"> </span><span data-ccp-props="{"201341983":0,"335557856":16777215,"335559739":0,"335559740":240}"> </span></p> <p><span data-contrast="none">For more information on Annexon and our pipeline, check out our site </span><a href="https://annexonbio.com/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Annexon Biosciences</span></span></a> <span data-contrast="none">& </span><a href="https://annexonbio.com/pipeline/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">Annexon Pipeline</span></span></a><span data-contrast="none">. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335557856":16777215,"335559738":0,"335559739":0,"335559740":240}"> </span></p> <p>We're seeking <strong>exceptional talent</strong> from all backgrounds to fuel our growth. 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 <a href="https://annexonbio.com/our-culture/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">culture</span></span></a><span data-contrast="auto">!</span><span data-ccp-props="{}"> </span></p> <p><strong><span data-contrast="none">Position:</span></strong><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></p> <p>The <strong>Associate Director of Clinical Trial Management</strong> will contribute to the development and implementation of clinical studies. Responsibilities 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. 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. Management and mentoring of direct reports (Manager through entry level) is expected.  This position reports into the Executive Director or VP of Development Operations. </p> <p><strong><span data-contrast="none">Responsibilities include:</span></strong><span data-ccp-props="{"201341983":2,"335557856":16777215,"335559739":0,"335559740":300}"> </span></p> <ul> <li>Accountable for the oversight and execution of multiple clinical trials including: </li> <li>Develop, implement, and provide oversight of vendor budgets and contracts </li> <li>Tracking and reporting of study metrics </li> <li>Identify and mitigate risks to study implementation, enrollment, conduct, compliance, and completion </li> <li>Develop and manage effective working relationships with Investigators and other key clinical opinion leaders </li> <li>Provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct </li> <li>Remains current with therapeutic areas under study, industry practices / trends and FDA requirements. Applies this knowledge to current programs</li> <li>Partners with and maintains regular contact with key stakeholders including Regulatory,…