Director, Clinical Operations Lead

The Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). Responsibilities encompass support to the development of the operational strategy for our most complex studies and ensuring achievement of all program goals within established timelines, budget, and quality standards, and according to the TA strategies. This role must be experienced in working in a matrix environment (internal and external partners) with cross-functional responsibilities associated with trial execution and overall therapeutic area clinical development planning. Strong communication and presentation skills are required.

Main Responsibilities and Accountabilities:

• Clinical Operations Strategy: Design and implement operational strategies, study management plans, and supporting documentation to drive study efficiency and quality (most complex studies). Continuously assess and improve clinical operations processes. Provide early input in CDP and study outline.

• Project Management & CRO oversight: Lead cross-functional study teams, coordinate with functional area representatives, and ensure timely execution of all study-related activities. Responsible for vendor selection/management/oversight, issue escalation, and inspection readiness.

• Stakeholder Management & Team Leadership: Lead and coordinate cross-functional teams, fostering collaboration among internal and external stakeholders (including vendors, investigators, and regulatory authorities). Act as the primary point of contact for all study-related matters, build and maintain strong relationships, mentor and support team members, and represent the study team in communications with senior management. Act in an advisory capacity to other clinops colleagues and ensure knowledge sharing across therapeutic areas. Be the clinops voice at PST/TALT.

• Budget Forecasting and Performance Management: Forecast, manage, and report on study budgets and key performance metrics, including study start-up, enrollment, and data collection timeliness/quality. Engage with key project stakeholders, including GPLS, TALT leads, Finance, POE. Drive accuracy and reliability in terms of budget.

• End-to-End Clinical Study Management: Plan, manage, and execute our most complex global clinical studies from protocol development through to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving. Oversee timelines, budgets, regulatory/GCP compliance, feasibility, country strategy, enrollment plans, and risk mitigation.

• Act as the primary point of contact both internally and externally (e.g. vendors) as applicable for anything study/program/asset related.

• Provide regular study status updates including critical issues to senior leadership as needed while providing support to the study team with stakeholder management and issue escalation. Portray strong and confident communication and presentation skills. Audiences will include those both internal and external partners.

• Support audits/inspections and resolutions of findings.

• Contribute to the leadership of the Clinops function in key areas of change and continuous improvement. May be asked to lead cross functional change initiatives. Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes and change initiatives.

• Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs.

• Acts as an integral resource for clinops members and ensures that cross-functional process efficiencies are identified and maximized in accordance with project goals and that compliance is maintained.

Job Qualifications and Experience Requirements

Education

At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.

Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).

Experience

• As a guide, a minimum of 12 years’ relevant clinical research (or related) experience within the pharmaceutical industry.

• Previous experience in leading and managing a team of professional staff.

• A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

• Experience in overseeing large and/or complex global clinical trials.

• Robust budget forecasting and management experience.

• Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

Competencies

• Demonstrated ability to lead teams and work in a fast-paced team environment.

• Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment

• Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities.

• Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice’.

• Excellent interpersonal and decision-making skills.

• Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.

• Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.

• Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.

• Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.

• Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.

• Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.

• Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.

• Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.

• Excellent written and oral communication skills and maintains computer literacy in appropriate software.