Executive Director, Clinical Operations Process & Strategic Planning

Role Summary

We are seeking a dynamic leader for an Executive Director, Clinical Operations Process & Strategic Planning role. In this newly created role, you will be responsible for the assessment, planning, and implementation of global processes, strategies and solutions to ensure the Clinical Operations organization is prepared to implement and execute multiple global late phase studies. In this role you will perform an analysis of current clinical operations processes, systems, vendors, and infrastructure including regional considerations to ensure the organization can seamlessly execute multiple global late phase trials across multiple indications. You will also provide strategic guidance and oversight of the Process Excellence/Clinical compliance function within Clinical Operations. This role reports into the Clinical Trial Excellence organization and will be a key leader on the Clinical Operations Leadership Team (COLT), helping COLT shape the Clinical Operations strategy, and ensuring the vision for excellence is effectively communicated and implemented.

Responsibilities

• Strategically lead all efforts related to ensuring clinical operations is set up from a people, process, vendor, and technology perspective to effectively execute on multiple global Phase 3 studies
• Conduct gap analyses; identify potential risks to clinical operations related trial readiness; operationalize mitigation strategies in collaboration with key stakeholders/leadership
• Strategically evaluate and implement solutions to address any operational geographic gaps related to ensuring clinical operations delivery teams are set up for optimal study execution
• Optimize current state clinical operations processes to ensure Phase 3 operations are seamless particularly as it relates to study startup, vendor strategy, study conduct, and clinical participation in data review
• Partner with the Clinical Program Lead(s) to provide executive updates on Clinical Operations Phase 3 readiness progress to leadership and other key stakeholders, including key milestones, risks, and overall strategy
• Communicate future state strategies to leadership and clinical operations delivery teams
• Effectively collaborate and influence in a matrixed reporting structure
• Support organizational change management efforts for Clinical Operations ensuring a seamless transition to planning and conducting large late phase clinical trials

• Support the strategic development of centralized clinical trial recruitment strategies to support Phase 3 trials including vendors and platforms to support the enrollment of diverse patient populations
• Provide strategic input into clinical operations clinical compliance, inspection readiness and submission related initiatives
• Provide strategic expertise and facilitate leadership alignment of cross functional SOPs
• Effective partnership and collaboration with cross functional leaders/stakeholders (e.g. Project Management, Biometrics, Quality, Legal, Regulatory) as it relates to planning, interdependencies, and risk mitigations relative to Phase 3 readiness and trial conduct

Ideal Candidate

• Minimum 18 years of pharmaceutical/biotech industry experience in Clinical Operations
• Bachelor’s degree required
• Extensive experience in operationalizing global Phase 3 clinical trials
• Experience leading Clinical Compliance and/or other Clinical Process functions
• Experience as an active contributor to a submissions team with experience resolving findings from real and mock heath agency inspections
• Minimum 10 years of people leadership experience, with a proven track record of building effective teams and driving innovation in clinical trial optimization
• Ability to understand and synthesize complex issues into strategic solutions and implementation plans
• Deep understanding of the clinical trial landscape and commitment to efficiency, innovation, and operational excellence
• Experience managing CROs, vendors and/or clinical trial consultants
• Excellent leadership, communication, and interpersonal skills, with the ability to influence and build relationships across functions at all levels of the organization
• Extensive knowledge of drug development processes, ICH-GCP guidelines, 21 CFR Part 11, and major Health Authority regulations
• Strong project management skills, effective matrix leadership, and the ability to hold teams accountable for deliverables
• Ability and thrive in a fast paced, dynamic environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Availability to participate in calls across multiple international time zones
• Position requires up to 30% travel

The anticipated salary range for candidates for this role will be $285,000 - $325,000.  The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.