Associate Director, Clinical Operations

Location of role Gaithersburg, MD, Radnor, PA

Department Clinical Operations

Key Responsibilities The Associate Director of Clinical Operations is accountable for overseeing a complex study or portfolio of studies, as well as managing cross-functional teams to ensure delivery in accordance with established timelines, budget, and quality standards.

Key Responsibilities:

• Accountable for the operational delivery of one or more complex programs or studies, ensuring the program/study deliverables and milestones are met with quality and within budget
• Be the key point of contact for assigned program/studies in the operational team for portfolio leaders
• Participate in program strategy meetings, contributing to the operational strategy of program/studies.
• Lead and collaborate with cross-functional team to oversee the performance for all activities to deliver the program/study on time.
• Create strong strategic partnerships with colleagues in cross functional team members to ensure consistent approaches to program/study delivery, data collection and reporting across a program.
• Provide direction and support to Clinical Operations team members. Develop the program/study strategy operational plans including model scenarios for optimal program/study delivery linked to value drivers and implications on time, quality, risk and budget.
• Review and provide expert Clinical Operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, and all project plans.
• Provides regular executive updates to senior management.
• Oversee delivery quality, ensure inspection readiness at all times and interact regularly with Program/Study team members around issues / risks / successes with study delivery as they occur.
• Support study budget negotiations and management of Clinical Operations spend related to study execution. Works closely with Outsourcing Management, Finance, and Clinical Operations Leadership to ensure budgets are accurate.
• Play an active part in external service provider selections, including Contract Research Organizations (CROs) and other vendors as necessary. Ensure the appropriate CRO is identified and vetted and managed through the life of the study.
• Work with internal, and external teams as required, ensuring the programs are initiated and managed in line with company strategy and key clinical and regulatory milestones.
• Proactively identifies and communicates program/study issues that will impact budget, resources and timelines. Escalates as appropriate
• May participate in governance committee with Vendors.
• May lead and/or contributes to department initiatives and assists in the design and implementation of standardized work processes.
• Provide expert and collegiate support to other members of the drug development team to ensure full success of the company’s portfolio and regulatory milestones
• Assist in SOP and working instruction development, review and approval

Supervisory Responsibility:

This position may include line manager responsibilities

• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve program objectives. Responsible for ensuring appropriate scientific and operational training for staff members.
• Identification of high-performance team members and working on team development

Education, Experience and Knowledge:

Essential Qualifications:

• BA / BS. or higher in science related field (biological science, pharmacy or other health related discipline)
• At least 10 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research organization, including majority of time in clinical study/project management.
• Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programs
• Experience in oncology, Autoimmune or Infectious Disease is highly desired.
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint) and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs
• Experience in applying the principles of effective clinical project practices, achieving agreed outcomes. Supporting and influencing key stakeholders where required for the successful delivery of projects
• Vendor Oversight experience
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EUCTD, and ICH GCP. Awareness of local country requirements is also required.
• Demonstrated excellence in project/program management and matrix leadership
• Understands and applies the principles of GCP, ICH, GDP and relevant CFRs is required
• Creating and maintaining healthy, creative, relationships with study sites and principle investigators; helping to support and influence where required
• Experience presenting high level presentations, both orally and in writing using organizational skills to complement this
• Ability to work independently
• Ensure an enthusiastic and open attitude towards continuous professional development

Non-Essential Qualifications:

• Experience with immunotherapies in Oncology would be an advantage

US Salary Range

$175,000-$190,000