Senior Director, Global Study Management

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Define and communicate the strategic vision and long-term objectives for Global Study Management.

• Contribute to governance in Clinical Operations, resource planning, and achieving operational excellence.

• Cultivate a high-performance, inclusive culture within Global Study Management.

• Collaborate with Program Leadership and Strategic Trial Optimization on planning and executing the clinical trial portfolio.

• Oversee trial execution in line with KPIs, timelines, quality standards, and budget goals.

• Provide guidance and resolve escalated operational issues.

• Lead, mentor, and develop leaders within Global Study Management.

• Build and enhance functional capabilities, tools, and resources for managing complex trials.

• Encourage global team alignment and adaptable resource allocation across various time zones and regions.

• Collaborate with Clinical Development Operations, Clinical Development, Regulatory Affairs, Biostatistics, Quality Assurance, and Global Supply Chain.

• Drive financial stewardship, trial forecasting, resource distribution, and cost optimization.

• Ensure compliance with ICH GCP, global regulatory standards, and company SOPs.

• Promote audit and inspection readiness throughout trial management activities.

⛳️ Requirements

• Proven experience leading complex, global Phase I–IV clinical study execution across diverse therapeutic areas.

• Significant leadership experience in a global study management or clinical operations setting within the biopharmaceutical industry or CRO.

• Demonstrated experience in strategic functional leadership, organizational design, and setting departmental vision.

• Ability to manage intricate technical details while retaining a strategic enterprise viewpoint.

• Collaborate with Clinical Development and medical experts to transform scientific concepts into feasible operational study designs and execution plans.

• Proficient in constructing, analyzing, and optimizing functional workforce budgets.

• Capability to operate effectively in a matrixed global environment with flexibility regarding time zones.

• Exceptional communication, negotiation, and stakeholder management abilities.

• Bachelor’s degree in Life Sciences, Allied Health, or a related field is required.

• Direct line management experience is necessary.

• Experience in oncology, rare diseases, or neuroscience is preferred.

• An advanced degree (MS, PharmD, PhD, or MBA) is highly preferred.

• Leadership experience with people managers is preferred.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants under the Long Term Equity Incentive Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.