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 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
Salary Range: $301,500 - $330,000Location: Annexon Biosciences is located in Brisbane, California. This role operates under a hybrid work arrangement and requires regular onsite collaboration at our office. Candidates should be located within commuting distance and able to work in the office multiple days each week.
Benefits: - A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
- Shuttle service from BART, CalTrain and the Ferry.
- Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits.
