The Associate Director (AD), Clinical Operations is responsible for the strategic planning, oversight and execution of Ph1/II/III studies across indications or programs. The AD of Clinical Operations will have program oversight responsibilities while also managing a study or studies. Responsibilities include, but are not limited to, establishing program study timelines and budgets, overseeing the day-to-day operations of clinical trials from study design through close-out, ensuring studies are conducted in accordance with appropriate regulatory requirements and within established timelines and budget, leading cross-functional teams and managing relationships with investigator sites, vendors and consultants. The AD of Clinical Operations is also responsible for leading or contributing to company process improvement initiatives.
• Accountable for the operational delivery of responsible studies within one program or across programs overseeing cross-functional alignment, budget, and timelines.
• Participate in program strategy meetings, contributing the operational strategy of responsible program/studies. • Leads efforts for the selection and oversight of external service providers, including CROs and other vendors as necessary.
• Develops and manages clinical trial budgets, providing ongoing financial reporting and forecasting; oversees budgets and timelines for responsible program. •
Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary.
• Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
• Independently manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP's and GCP, and coordinates cross functional efforts to achieve study objectives and goals.
• Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed.
• Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
• Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper prequalification of clinical sites.
• Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
• Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
• Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
• Ensures Trial Master File is accurate and up to date.
• Mentors more junior team members.
• Leads and/or contributes to department initiatives, and assists in the design and implementation of standardized work processes.
Qualifications • Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams. • Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences. • Productivity/Organizing/Planning – Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision. • Strategic Thinking – Strong capability of strategic thinking and proposing innovative solutions to issues. • Collaboration & Teamwork – Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.
Education and Experience Requirements • Bachelor's degree in a scientific discipline and a minimum of 15 of years of experience in clinical research working in a pharmaceutical or biotechnology, clinical trial monitoring, management of clinical studies and programs • Experience working in Phase I-III with focus in Oncology, various vendors and geographies • Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting. • Expertise in Microsoft Word, PowerPoint, and Excel is required and experience with Microsoft Project. • Working knowledge of ICH/GCP and FDA Regulations. EDC experience and willingness to travel.