Executive Director & Head Clinical Data Management

Annexon Biosciences•Brisbane, CA

1d•$301,500 - $330,000•Hybrid

About The 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.

Requirements

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

Nice To Haves

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 ability to interpret and apply in real-time drug development setting
Solid understanding of regulatory submission and approval process
Collaborative negotiator with excellent judgment around compromising, standing firm, or finding a new way forward.
Leadership acumen including emotional intelligence and business awareness. Ability to effectively collaborate and influence throughout multiple levels of the organization.
Strategic and creative drug-development mindset/approach. Willingness to deviate from the status quo
Ability to balance appropriate levels of structure/process with efficiency and simplicity
Awareness of external industry landscape with respect to best practices and emerging topics

Responsibilities

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