We are seeking an Associate Director, Global Clinical Development Operations (AD, GCDO), who will be accountable for the operational management and execution of global clinical trial programs (Phases I-III). The individual will be responsible for ensuring adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. A key focus will be the oversight of and partnership with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that the quality of data is suitable for regulatory submission/inspections. The AD, GCO will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. This role will report to the Executive/Sr. Director, Clinical Operations.

Key Responsibilities

Accountable for overall management of multiple clinical trials

• Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
• Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
• May lead the Clinical Trial Team (CTT) and participate in the program Clinical Development Team (CDT)
• Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
• Responsible for preparing and/or presenting to executive management
• Develops, reviews and/or consults 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 and presenting at Investigator Meetings, SIVs and other program meetings

Budget/Finance/Legal

• Responsible 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 senior management for 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)
• Demonstrates 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
• Co-lead Sponsor/CRO operational meetings with CRO to ensure deliverables are on track
• 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:
• Responsible for 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
• Responsible for negotiating site Clinical Trial Agreements in conjunction with the Legal Department and CRO
• Responsible for patient recruitment and retention plans
• Responsible for the 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

In conjunction with Clinical Supply, responsible for assuring 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 

• Responsible 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, responsible 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. Conducts 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

• Participates and responds to Quality Assurance and/or regulatory authority inspection audits
• Ensures all assigned protocols are always Inspection Ready

 Data Review/Cleaning/Management

• Accountable for working closely with Biometrics, Pharmacovigilance, Medical, and the CRO to participate in data review, and oversee adherence to study timelines and data quality. Oversight includes the following activities: expedited query resolution, support creation of logic edit checks, data line listing review, QA/QC of adverse events, and serious adverse event processing. Oversight of protocol deviations/variations
• In conjunction with the CRO, oversee and drive the metrics on CRA source data verification

Ideal Candidate

• BA/BS in life sciences or equivalent 
• 8 years of clinical research experience, including at least 3 years leading global projects from inception to completion
• 2 years’ experience in Biotech industry strongly preferred
• Phase 1 experience 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, trial budgets and program-level budgets
• Emerging leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
• Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
• Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
• High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
• Work comfortably in a fast-paced, dynamic work environment and embrace change
• Ability and willingness to travel up to 15%

Strong Preferred Qualifications

• Experience working of Phase 1 trials (i.e. FIH, Clin Pharma, SAD/MAD design, etc.)
• Building relationships with Phase 1 Clinical Research Units
• Experience developing recruitment strategies to support Phase 1 units