Associate Director Clinical Operations

Associate Director, Clinical OperationsRemote(East Coast)Prefer someone onsite periodically in Gaithersburg, MD 12 month contract; Highly renewable w/ potential conversionNote: T1 Diabetes experience highly preferred. The Associate Director will be accountable to oversee a team of Clinical Program Managers (CPM) across an Asset or Assets ensuring their clinical programs are delivered to time, cost and quality. They will provide operational expertise and strategic input to the development of the clinical development plans supporting the overall clinical strategy Phase I-III.KEY RESPONSIBILITIES•Accountable for the operational delivery of CPMs and their programs, ensuring all program deliverables and milestones are met with quality and within budget•Collaborate with cross-functional counterparts to oversee the performance for all activities to deliver programs on time and with quality•Participate in program strategy meetings, contributin3g the operational strategy of program/studies.•Provide direction and support to CPMs for the development of study strategy operational plans including enrolment models and risk management strategy. Ensure consistent approach and process across the portfolio.•Review and provide expert clinical operations input into clinical documents related to the drug development process including study synopsis & protocols, clinical study reports, monitoring plans, Communication plans and project plans.•Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs) and other vendors as necessary•Review of study protocols and related study documents, as required, for operational execution.•Oversight of team's study execution and procedures as required to ensure regulatory compliance of protocol activities•Support Clinical Program budget negotiations and management of Clinical Operations spend related to clinical program execution. Works closely with Global Project Managers, Outsourcing Management, and Finance to ensure on a regular basis that budgets are accurate.•Play an active part in CRO selection and review of RFP's when required, ensuring the appropriate CRO is identified and properly vetted. 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•Supports and participate in request and review of scope of works, budgets, vendor performance and issue resolution•Identifies and communicates study issues that will impact budget, resources and timelines. Provides support/escalation point for study team leads as needed•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 and consistently across the portfolio.•Participates and or Leads governance committee with Vendors•Ensure program meets all GCP/ICH Guidelines and is Inspection ReadyOTHER DUTIES• Leads 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.Education & 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.o Experience must include early phase clinical studies/Phase I-III studies and global/international studies or programso Experience in autoimmune disease is highly desired.

Created: 2025-01-31