Executive Director, Global Clinical Operations

• 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
• Clinical operations representative on global development teams (GDT) and/or oversees direct reports serving on GDTs
• 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
• Compile, assess, and communicate risks and optionality to support informed decision making for operational strategy
• Strong collaboration and partnership with cross functional colleagues globally
• Monitor the progress of projects and provide senior management with timely updates, changes in scope and resource requirements
• Work cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated
• 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
• May be responsible for participating/presenting at Investigator Meetings, SIVs and other meetings
• Accountable for program level clinical operations budget forecasting, accrual management and quarterly review
• 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
• Lead the creation/definition of the scope of work and selection process for assigned program’s vendors and Contract Research Organizations (CROs)
• 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
• Draft and/or manage Governance charters/meetings/reports with CRO
• Responsible for managing relationships with CROs and other vendors for all study activities
• Collaborate with Clinical Supply to assure sufficient clinical drug supply is forecasted, packaged, available and imported/shipped
• In conjunction with CRO, accountable for assuring accurate drug accountability/reconciliation for investigational product (IP)
• In conjunction with CRO, accountable for assuring sufficient ancillary supplies are available and shipped for the study
• Accountable for eTMF – completeness, timeliness, and quality on assigned programs
• 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
• 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

• 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
• 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
• Strong project management skills with high sense of urgency, ability to collaborate and influence effectively cross-functionally
• 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

Minimum of 3 years’ experience in Biotech industry strongly preferred

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve