Executive Director & Head Clinical Data Management

Executive Director & Head Clinical Data Management

Company:

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.

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 seekingexceptional talent 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. Learn more about our commitment to diversity, equity, inclusion, and our company culture !

Position:

Reporting to the SVP, Biometrics, this leader independently oversees a team of data managers and technology experts responsible for acquisition and quality of all Annexon clinical trial data. A highly empowered, visible and collaborative role, the Executive Director & Head Clinical Data Management partners cross-functionally to advance medicines to our patients.

Responsibilities include:

• Set the vision for Clinical Data Management through building and maintaining a best-in-class organization that functions as a key strategic partner within Annexon
• Provide operational, strategic, and technical direction to data managers and technology SMEs while maintaining ultimate responsibility for all clinical data within Annexon
• Accountable for all Clinical Data Management activities from study startup through study conduct and closeout delivering quality data snapshots, interim database locks and final database locks
• Design and deploy appropriate clinical data management operating models including full outsourcing, hybrid delivery and fully in-house
• Ensure clinical data management strategies that incorporate both current best practices and innovative approaches consistent with GCP and GCDMP
• Design and deploy sponsor oversight for outsourced studies including operating model, oversight planning and execution, vendor governance and interactions, risk management and documentation
• Define, advance and codify procedural framework (operating model, process definitions and associated SOPs/WIs, Clinical Data Management best/expected practices) for the department
• Serve on the Biometrics leadership team to provide guidance on direction and operations of the department
• Provide expert guidance to project teams and executive leadership
• Participate cross-functionally with key partners to advance Annexon products
• Contribute to and participate in the development and maintenance of a positive team-focused company culture

Education, Experience, and Skills:

Required:

• Bachelor’s degree with 12+ years of experience in the pharmaceutical or biotechnology industry in a Clinical Data Management leadership capacity
• Extensive experience with industry clinical data management delivery models and associated sponsor oversight (full outsourcing etc.)
• Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent
• Proficiency in Clinical Data Management related technology like EDC, eSource, eCOA, IRT etc.
• Experience leading programs through submission and approval
• Deep understanding of GCP and GCDMP
• Solid understanding of eCRF data acquisition best practices

Preferred:

• Ability to communicate with clarity and influence including explaining complex quantitative issues in simple terms
• Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the…