- Provides input into, and is accountable for Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and study management.
- Manages Clinical Operations staff, which may include associate director(s), GTM(s) and COS(s). These staff are focused on all aspects of clinical trial management including administrative, budgetary, resource, and performance management responsibilities.
- Provides leadership within the Clinical Operations department, acting as a point of escalation and supports cross-functional issue resolution, as required. Takes a role to deputize for the VP Clinical Operations as required.
- Leads cross-functional matrix teams whose mission is to deliver high quality and timely execution of clinical development plans including the setup, conduct and reporting of clinical trials.
- Provides strategic, tactical and operational input to Product Development Teams, with minimal oversight, to ensure appropriate planning and to drive better decision making.
- Translates corporate and product development goals into relevant, tangible and measurable objectives for the Clinical Operations team. Tracks project team performance and monitors progress toward corporate and Clinical Operations objectives.
- Identifies risks and issues that arise with programs, studies, and sites and makes recommendations and/or implements appropriate measures to address in a timely and effective manner.
- Partners with Clinical Operations Outsourcing team to oversee and coordinate all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval and to oversee and coordinate all budget-related activities for vendors and clinical trial sites.
- Engages key stakeholders to ensure expectations their expectations of clinical perations are being met or exceeded and responds. Addresses concerns proactively, makes recommendations where necessary and brings to resolution.
- Ensures that clinical operations processes, systems and tools are standardized and being utilized, and adequately meet the needs of staff and stakeholders.
- Ensures compliance and accuracy of Company-sponsored eTMF and CTMS systems.
- Maintains awareness of overall developments and benchmarks within the clinical trials ecosystem that impact Clinical Operations, shares best practices with the leadership team to inform and identify process improvement initiatives, that the Senior Director may lead.
- Provides mentoring and guidance to assigned staff including administration of performance reviews and development plans. Evaluates resource requirements and ensures that resources are assigned to projects where they are required.
- Collaborates with Human Resources to identify talent, recruit, train and develop, and retain team members to provide the highest level of performance and accountability.
- Bachelor's degree, preferably in health care, life sciences, or related discipline
- A minimum of 10 years of experience within a clinical operations team in the Biotech/Pharmaceutical industry
- A minimum of 5 years of successful experience managing people and vendors
- Several years of experience managing Phase I, II and Phase III clinical studies in immune-oncology
- Bachelor's degree, preferably in health care, life sciences, or related discipline
- A minimum of 12 years of experience within a clinical operations team in the Biotech/Pharmaceutical industry
- A minimum of 7 years of successful experience managing people and vendors
- Significant experience initiating and managing Phase I, II and Phase III clinical studies in immune-oncology.
- Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting
- Advanced leadership, project management, resource management, administrative and technical capabilities
- Advanced knowledge of Oncology clinical trial design, implementation and management
- Understanding of Oncology therapies and practice as it relates to clinical trial design
- Excellent verbal and written communication skills
- Experience with early and late phase clinical trials
- Proven success in directing global clinical programs
- Experience in direct or matrix management of clinical operations team members
- Knowledge of the drug development process in the bio/pharmaceutical industry with an understanding of ICH/GCP guidelines, and relevant regulatory requirements.
- Knowledge of critical path construction and analysis
- Understanding of financial principles, budget management and staff utilization
- Ability to communicate with and manage senior-level stakeholder objectives
- Demonstrated negotiation and persuasion skills
- Enthusiasm for innovative research and ability/desire to learn new approaches and expand core skill set
- Willingness to travel up to of 25%
- Associate Director, Clinical Operations
- Global Trial Manager
- Clinical Operations Specialists
- Other staff as required
- Master's Degree in health care, life sciences, or related discipline.
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Sr. Director/Director, Clinical Operations - Rockville, United States - MacroGenics
Description
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.
Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development.
MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position:
The Sr. Director/Director, Clinical Operations is responsible for providing strategic vision and direction within the department of Clinical Operations.
Ensures completeness and consistency of processes required for successful life cycle management for all phases of clinical trials across the therapeutic portfolio.
Responsibilities and Job DutiesEducation & Experience
Director, Clinical Operations
MacroGenics is proud to be an equal opportunity employer.
Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law.
We are committed to working with and providing reasonable accommodation to individuals with disabilities.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email or call and/or 711 for TTD/TTY service.
