Executive Director & Head Clinical Data Management (Hybrid)

Responsibilities

• Provide operational, strategic, and technical direction to data managers and technology SMEs while maintaining ultimate responsibility for all clinical data within the company.
• 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 products.
• Contribute to and participate in the development and maintenance of a positive team-focused company culture.

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; 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 Qualifications

• 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 settings.
• 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.

Pay

$300-330K based on experience.