Apogee Therapeutics · 17 hours ago
Executive Director, Global Clinical Operations
United States
Full-time
Hybrid
Director/Executive
$285K/yr - $320K/yr
20+ years expApogee Therapeutics is a biotechnology company focused on developing differentiated biologics for various inflammatory and immunology indications. They are seeking an Executive Director for Global Clinical Operations to lead and manage global clinical trial programs, ensuring successful execution and collaboration across teams.
BiotechnologyLife ScienceMedicalTherapeutics
Responsibilities
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, 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
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
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
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
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.)
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
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
Qualification
Required
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
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
Preferred
Minimum of 3 years' experience in Biotech industry strongly preferred
Benefits
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including 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
Company
Apogee Therapeutics
Apogee Therapeutics is a biotechnology company that offers therapies for immunological and inflammatory disorders.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$997M2025-10-08Post Ipo Equity· $345M
2024-03-07Post Ipo Equity· $483M
2023-07-13IPO
Leadership Team
Nimish Shah
Co-Founder & Board Director
Jane Pritchett Henderson
Chief Financial Officer
Recent News
2026-01-22
2026-01-06
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