Executive Director, Global Clinical Operations

We are seeking an Executive Director, Global Clinical Operations, (GCO), who will be accountable for the strategic operational management, tactical planning, and execution of global clinical trial programs (Phases II-III). In this role you will be a key leader within Clinical Operations, driving the success of your assigned clinical trials and teams. In collaboration with leaders across the organization you will provide clinical operations expertise to a cross-functional matrix team. This position is fully remote and reports to the VP, Clinical Trial Operations (CTO).

Key Responsibilities

Clinical Operations Leadership

• Manage and plan CTO resourcing for assigned programs
• Lead, build and mentor CTO team supporting assigned program(s)
• Serve as a member on Clinical Operations Leadership Team (COLT)
• Create and support implementation of Clinical Operations processes, platforms and/or systems

Cross Functional Leadership

• Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs, ensuring clinical operations strategic and operational input to clinical development programs
• Clinical operations representative on Program Teams (PT)
• Lead problem solving and facilitate teams to identify clinical operations issues and propose solutions
• Identify critical path items and evaluate variances to propose and oversee the implementation of proactive contingency plans, when necessary
• Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
• Strong collaboration and partnership with cross functional colleagues globally (e.g., Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc.) to ensure on-budget, timely, high-quality delivery of the programs

Accountable for overall management of clinical trials

• Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements across the assigned clinical program(s)
• Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Serve as the central point of contact and contribute expertise for clinical trial execution on assigned protocols
• Ensure accurate tracking/reporting (dashboard) of study metrics and progress of study through completion
• Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Develop, review and/or consult on clinical trial documents, such as informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
• May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings

Budget/Finance/Legal

• Accountable for program level clinical operations budget forecasting, accrual management and quarterly review, ensuring tight control between study forecasts and actuals
• In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc
• Review and approve contracts, work orders and invoices prior to submission to Executive approval

Outsourcing/Procurement/Vendor Management

• Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs) in partnership with Clinical Business Operations
• Demonstrate consistent and regular Sponsor Oversight and performance management for all utilized vendors and/or CRO third party contracted vendors
• Attend CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others, as necessary, to assure alignment and achievement of study goals
• Draft and/or manage Governance charters/meetings/reports with CRO
• Responsible for managing relationships with CROs and other vendors for all study activities, including study start-up, close out, completion of Trial Master File and the following:
• Setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs), as well as to oversee scope change negotiations
• Negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
• Patient recruitment and retention plans
• Set-up of all third-party vendor specifications (i.e., IWRS, eCRF, central laboratory/ECG, etc.) and on-time third party deliverables
• In conjunction with CRO/Regulatory, participate in the collection, preparation, and review of regulatory documentation for IRB//Ethics submission prior to study start-up

Clinical and Ancillary Study Supplies

• Collaborate with Clinical Supply to assure sufficient clinical drug supply (including comparator) is forecasted, packaged, available and imported/shipped to depots/sites for study start up, and that sufficient supplies are maintained during the study
• In conjunction with CRO, accountable for assuring accurate drug accountability/reconciliation for investigational product (IP) issued during the study to the site and at the end of the study
• In conjunction with CRO, accountable for assuring sufficient ancillary supplies are available and shipped for the study (i.e., templates, binders, forms, supplies, etc.)

Inspection Readiness

• Accountable for eTMF – completeness, timeliness, and quality on assigned programs. Oversees routine completeness checks of the Trial Master File (TMF) to ensure compliance of CRO and Sponsor files
• Partner with Quality organization to document Sponsor Oversight of all vendors, data integrity, and risk assessment requirements
• Participate and respond to Quality Assurance and/or regulatory authority inspection audits
• Ensure all assigned protocols are always inspection ready

Data Review/Cleaning/Management

• Accountable for working closely with Biometrics, Pharmacovigilance and the CRO to oversee data cleaning and review, and oversee adherence to study timelines and data quality.
• In conjunction with the CRO, oversee and drive the metrics on CRA source data verification

Ideal Candidate

• BA/BS in life sciences or equivalent
• Minimum 20 years of clinical research experience, including at least 5 years leading global projects from inception to completion, coupled with demonstrated ability to hold team and CRO members accountable to tight timelines and budgets
• Minimum of 7 years line management experience
• Minimum of 3 years’ experience in Biotech industry strongly preferred
• Significant knowledge of pharmaceutical industry, drug development and regulatory processes
• Experience developing all clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, etc.
• Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety. Ability to build and lead high-functioning teams, both within clinical operations and cross-functionally
• Excellent communication skills with ability to develop strong relationships and present to a variety of stakeholders and tailor message accordingly. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives
• Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally. Proven ability to effectively execute clinical trials within designated program budgets, timelines and compliance guidelines
• Experience on governance committees and management teams for CROs or other vendors
• Strong negotiation and conflict resolution skills
• Strong financial acumen and ability to critically develop, review and track program budgets
• Must be comfortable working in a fast-paced work environment, able to organize, prioritize, and effectively respond to changing priorities
• Position requires approximately 30% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, may also require travel to phase 3 planning meetings held in San Francisco

The anticipated salary range for candidates for this role will be $285,000-$320,000 per year. 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.