The Senior Vice President, Clinical Operations will work closely with the Chief Medical Officer to provide strategic and operational leadership of development programs and budgets. Supervises a highly dedicated and motivated team of clinical development professionals. Collaborates with the Chief Scientific Officer and the Heads of Project Management, Manufacturing, Regulatory, and Finance to achieve strategic goals. This position will report to the CMO.
As the Head of the Clinical team, you will be responsible for the strategy, design, plan and execution of clinical trials, in accordance with applicable regulatory and quality standards, and company timelines and budgets. Activities should be geared toward ensuring that all clinical activities related to clinical trials are managed effectively in support of regulatory submissions and subsequent approval. Phase 1-3 studies are included in this scope.
Primary duties include:
Lead Clinical Strategy Design and Implementation
• Write and/or facilitate the writing of clinical project management documents, such as study protocols, project scope definition documents, project training materials, monitoring plans and monitoring tools, safety plans, recruitment plans and closeout plans, etc.
• Supervise/execute operational aspects of assigned clinical studies (including identification, selection, qualification and management of clinical investigators and third party vendors, test article release to sites, site monitoring activities, ongoing review of key study data, etc.)
• In collaboration with the CMO, plan and review the analysis of clinical data and determine the ultimate interpretation of results.
• Ensure the assigned trials are “audit ready” at all times (project team training records, current regulatory documents, appropriate IRB approvals, monitoring tools required for the trial). Ensure that any audit observations are addressed appropriately and in a timely manner.
• Develop and maintain project schedules, with key metrics, for clinical projects, to ensure optimal study management. Identify and resolve issues that impact project scope, resources. or timelines and communicate to senior management.
Direct and Indirect Leadership and Supervision
• Lead and directly supervise the clinical operations and clinical scientist staff who are assigned to execute most of the tactical aspects of the clinical studies’ design and implementation.
• Lead or collaborate with the cross-functional team dedicated to obtaining approval in the U.S. and globally.
Budget Development and Accountability
• Monitor overall site budgets and expenses for assigned projects to ensure that costs are maintained within budget.
• Develop and be responsible for forecasting and tracking resource capacity and utilization to ensure that required clinical development resources are available when needed and optimally utilized.
Safety and Pharmacovigilance
• Assist the CMO in medical monitoring and oversight of all aspects of the safety monitoring in the clinical development programs.
• Collaborate closely with Regulatory Affairs to prepare regulatory documents such as investigator brochures, INDs, CTAs, NDAs, BLAs, background packages for FDA meetings, etc. Provide medical review and approval of regulatory documents pertaining to the work of the clinical team.
Clinical and Scientific External Representation
• Present at internal governance meetings.
• Act as an internal consultant working closely with a variety of internal stakeholders, including Business Development
• Create and present original work describing the company’s clinical and scientific progress and achievements, at various forums, including at: regulatory meetings in various geographies to support the agreed-upon clinical development plan; external scientific meetings; and as requested by CEO, e.g. financial community interactions
• Collaborate in the writing and/or review of relevant work that will be presented by others.
• In concert with the CMO, establish and maintain collaborations with key opinion leaders, research centers, and corporate partners.
Key Attributes & Competencies
In order to work effectively in a small, dynamic, matrix environment, every employee must have a strong mix of key attributes & competencies including, but not limited to, the following:
• Results driven, with an entrepreneurial mindset, sense of urgency and commitment to become an integral and hands-on part of a dynamic, fast-moving team working to save lives.
• Drives execution – Gets things done by setting clear expectations (goals), monitors progress, holds people accountable (appropriately, based on their skills, ability and experience), recognizes and rewards accomplishments, and consistently follows up. Maintains attention to detail and accuracy and the highest degree of integrity.
• Promotes open communication – Creates an environment in which communication is expected, respectful, supported, clear, candid, transparent and relevant; listens actively and encourages open expression of ideas and opinions, including creative suggestions that will create the most efficient and effective methods for achieving the company’s business goals.
• Demonstrates adaptability – Demonstrates an ability to adapt appropriately to changing conditions – business situations, people and changing priorities; an ability to work constructively under pressure; an ability to respond resourcefully to change and ambiguity and learn from one’s mistakes.
• Fosters risk taking – Creates an environment in which risk taking is encouraged; demonstrates ability to take and manage appropriate risks and use them to the organization’s advantage. Commits to professional growth and continual improvement in order to fuel the Company’s growth.
• Fosters teamwork – Fosters an environment in which people trust and value each other and recognize the importance of each role in the organization; recognizes the impact of cultural differences and different time zones on teams; encourages cooperation, coordination, and information sharing.
Education and Experience
Level of education required:
• Medical Degree and/or U.S. medical license and/or PhD with commensurate experience.
• Specialization in oncology preferred.
Number of years of experience in function and/or industry required:
• A minimum of 15 years of clinical drug development experience, at least 10 of which must be within the pharmaceutical industry.
Other Experience Required:
• Experience writing and filing INDs and NDAs and presenting to FDA panels.
• Proven experience in the area of Safety and Pharmacovigilance.
• Current pharmaceutical industry experience, people management, project management and budget management experience.
• Track record of program leadership and achievement of goals and deliverables; of effective collaboration, effectiveness in team settings, and team leadership.
Other Experience Desired:
• Prior successful industry oncology experience in a development-stage biopharmaceutical company.
• Academic experience as a principal investigator.
• Track record of publications in peer-reviewed journals preferred.
• History of personal interaction with thought leaders in oncology.