Vice President Clinical Operations

Responsible for the strategic and operational leadership of multiple clinical studies to meet aggressive timelines, on budget, ensuring compliance with all relevant regulatory guidelines.

Responsible for overseeing the coordination, management, and operational aspects of clinical programs to ensure the successful completion of projects within prescribed time frames and funding parameters. Responsible for the planning, implementation and conduct of clinical trials and serves as the operational lead for a product and associated development program. Works cross-functionally to identify and evaluate issues in the programs, interprets data on complex issues, makes good business decisions and suggests and implements solutions. With support from the CMO accountable for ensuring that all project deliverables meet the corporate and department expectations. Responsible for oversight of Clinical Operations activities including management of CROs and other vendors.

KEY RESPONSIBILITIES

Oversee Clinical Operations:

• Develop strategy and manage all operations and staff involved in clinical operations, data management, and other related groups. Lead clinical development activities and process improvement initiatives; communicates updates to all team members involved.
• Serve as key contact to other groups outside of Clinical Operations involved in and contributing to the operational aspects of clinical trials.
• Initial point of escalation in case of challenges in project activities with other sponsor departments or external vendors.
• Assist with the development of the clinical components of regulatory submissions.
• Able to present at departmental, interdepartmental and Investigator meetings/trainings.
• Keep up to date with industry practice and communicate key messages back to team, providing recommendations accordingly.

Clinical Trial Management:

• Ensures clinical trials are properly resourced, managed, executed, and inspection-ready according to timelines, quality practices, and regulatory requirements.
• Contribute to Clinical Operations SOP development and ensure internal compliance with SOPs, guidelines and corporate compliance policies related to the clinical trial conduct aspects of ICH-GCP and other applicable regulations.
• Oversee the evaluation of potential clinical investigators and sites.

Vendor Management:

• Oversee Contract Research Organizations (CROs) and vendors from identification and selection to contract closure. Primary lead managing the Contract Research Organizations (CROs), vendors, and other third parties.
• Oversight of all clinical trial-related partners and vendors. Drive vendors to meet aggressive timelines, on budget, and hold them to account if they fall behind

• Patient Recruitment: Lead the operational strategy and execution for identifying, recruiting, and retaining trial subjects.

• Timeline and Budget Management: Develop clinical timelines, budget forecasts, and ensure accountability for tracking and deliverables.
• Planning: In partnership with CMO, develop a life-cycle strategy and evaluate new programs to be prioritized or advanced into clinical development.
• Development: Participates in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
• Collaboration: Work successfully with cross functional team members including Program Management, CMC, Quality etc. on the development of protocols, safety reports, study reports, publications, presentations, and regulatory submissions.
• Team Leadership: Lead and mentor the clinical operations team, implement best practices, and provide development opportunities.
• Infrastructure Development: Lead initiatives to build the clinical operations department infrastructure.
• Representation: Advocate for clinical operations needs and resources at the executive committee level.
• Quality: In partnership with Regulatory and QA, develop and continuously improve clinical SOPs and GCPs and provide oversight of clinical monitoring quality & adherence to established processes and plans in compliance with GCP.
• Support the QA team during internal audits, vendor audits, and/or hosting inspections.
• Responsible for ensuring that all internal team members and vendors complete documentation in accordance with GCP regulatory requirements and consistent with the protocol, for all assigned programs/trials.
• Risk Management: Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs.

PROFESSIONAL EXPERIENCE AND QUALIFICATIONS

Education: Bachelor’s degree in health sciences or equivalent. Masters’ degree preferred.

Experience: At least 10-15 years of direct line management experience in clinical trials operations and regulatory components across all phases in pharmaceutical or biotechnology field

Skills: Proven success in leading and coordinating cross-functional clinical operations teams, including clinical operations, data management, and clinical supply chain.

• Other: Experience leading complex studies involving biomarkers and activities across multiple vendors.
• Build strong, collaborative, and dynamic relationships with co-workers of diverse backgrounds and expertise.
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
• Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%.
• Comfortable working in a virtual team with schedule flexibility to build and maintain relationships across time zones
• Demonstrates Values-based leadership consistent with company’s core values.