Director, Study Evidence – Readiness

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Study Evidence and Readiness division, which includes TMF Operations and Inspection Readiness.

• Define the strategy and key priorities for TMF Operations and Inspection Readiness.

• Lead and nurture global teams, managing Inspection Readiness Senior Managers and Managers.

• Establish objectives, oversee performance and engagement, and create succession and capability plans.

• Provide comprehensive oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio.

• Develop metrics, thresholds, and recommendations for escalation.

• Organize and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity.

• Drive improvement initiatives that enhance evidence quality, completeness, retrievability, and readiness.

• Represent the function in initiatives for process improvement, standards development, and integration efforts.

• Create and uphold TMF and inspection-readiness processes, policies, SOPs, work instructions, and related documentation.

• Collaborate across functions to address evidence issues, analyze trends, apply root-cause insights, and promote sustainable improvements.

• Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends.

• Participate in leadership forums and governance committees.

• Assist in audits and inspections, including preparation, support for responses, and lessons learned.

• Cultivate relationships with both internal and external experts.

⛳️ Requirements

• Doctorate degree with 4 years of directly related experience or equivalent, OR Master’s degree with 8 years of directly related experience or equivalent, OR Bachelor’s degree with 10 years of directly related experience or equivalent.

• At least 4 years of direct managerial and/or leadership experience or equivalent.

• PhD, PharmD, MSc, BSc, or RN qualification is preferred.

• A minimum of 11 years of work experience in life sciences or a medically related field, preferably including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO.

• Leadership experience managing direct reports, including management-level personnel.

• Expertise in TMF operations and inspection readiness, including preparation, inspection support, or response.

• Experience in managing or overseeing external clinical research vendors.

• Knowledge of global GCP and regulatory expectations concerning clinical trial conduct, TMF records, and inspection readiness.

• Familiarity with risk-based oversight, evidence health, resource planning, and organizational capacity.

• Proven experience leading cross-functional work in a matrix organization, encompassing projects, budgets, timelines, and quality metrics.

• Ability to foster relationships, lead change, build high-performing teams, and communicate effectively.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• An annual discretionary bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.

• Financial plans that allow for saving towards retirement or other personal goals.