The Director / Sr. Director of Clinical Operations significantly influences our organization, shaping and executing strategic direction in managing multiple clinical studies. This position plays a crucial part in ensuring the successful conduct of clinical trials in adherence to the protocols, company SOPs, GCP, and other relevant regulatory requirements, underscoring our steadfast commitment to industry regulations and standards. The Director's leadership in managing Clinical Operations teams, contract research organizations (CROs), and other trial vendors, as well as tactical contributions of Clinical Operations expertise in cross-functional senior leadership meetings and initiatives, are highly valued. The role's significance is further underscored by the expectation of managing and mentoring Clinical Operations staff through example.
Responsibilities:
Provide leadership and oversight in all aspects of clinical operations, from planning and executing programmatic and project oversight.
Provide strategic operational input to Clinical Development Plan (CDP) and project plans.
Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics, timelines, and critical study activities.
Develop and maintain enrollment and budget forecasts.
Manage CROs and third-party vendors to ensure delivery against the contracted scope of work and budget.
Participate in selecting CRO and vendors, including developing RFPs, budget negotiations, and management.
Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA, and contribute to IND filings.
Oversee and project manage individual studies and relevant program-related activities with minimal supervision, including managing cross-functional team meetings (Agendas, Minutes, Action Items, Follow-up).
Develop and review SOP processes and guidelines for compliance with global regulatory requirements.
Ensure development study plans and provide adequate vendor oversight, risk, safety, and communication oversight.
Supervise, coach, mentor, and hire new staff.
Proactively identify risks and develop and implement mitigation strategies.
Ensure timely and effective risk mitigation and escalation for projects and programs.
Motivate and inspire others while thriving in a fast-paced, start-up environment.
Plan, participate, and facilitate operational-level governance with vendors as appropriate.
Provide senior leadership with project and program updates.
Partner with cross-functional peers & staff to build execution plans & meet critical business milestones
Able to travel (<20%)
Qualifications:
Level commensurate with experience.
Bachelor's degree or equivalent is required.
Must have at least 15 years of relevant trial leadership experience in either sponsor or CRO.
Phase I-III Global Trial Management experience
Strong track record for successful study initiation and execution.
Strong leadership, influence, and tactical execution skills and experience.
Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE, and other relevant guidelines and regulations.
Experience managing CROs and third-party vendors.
Experience in Finance Management, including but not limited to Budget Forecasting, Change Order Management
Experience working with EDC, CTMS, and eTMF systems.
Strong interpersonal communication skills.
Ability to prioritize critical business needs in alignment with corporate strategy is required.
Ability to engage in strategic business discussions and craft executive-level communications and materials is required.
Must have excellent cross-functional clinical project management skills.
Must have exceptional leadership skills, including ability to delegate, influence, motivate, inspire, and develop self and others.