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Shattuck Labs · 15 hours ago

Director (Sr. Director), Clinical Operations

Durham, NC, US

Full-time

Onsite

Director/Executive

$165K/yr - $245K/yr

10+ years exp

Shattuck Labs is a company focused on building transformative medicines for patients suffering from life-altering diseases. The Director of Clinical Operations will lead and oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and driving operational excellence across multiple clinical programs.

BiopharmaBiotechnologyLife Science

Responsibilities

Lead the design, implementation, and management of clinical trial operations from study start-up through close-out

Provide primary oversight for the CRO, ensuring that CRO activities are executed per study timelines. Maintain frequent and meaningful contact with the CRO to assess performance and provide oversight and guidance as needed

Collaborate with cross-functional departments such as Regulatory Affairs, Data Management, and Clinical Development, to ensure alignment and compliance

Ensure adherence to all regulatory requirements, company policies, and industry standards including FDA regulations and ICH-GCP guidelines

Identify and mitigate operational risks, implementing corrective actions as necessary to maintain study integrity and patient safety

Drive process improvements and implement best practices to enhance clinical trial efficiency and data quality

Contribute to review of other study documents such as protocols/amendments, eCRFs, clinical study reports, IBs, DSURs, conference presentations, publications, etc

In coordination with the cross-functional team, participate in the RFP process and ultimately select CROs, and other vendors for clinical trials

Participate in the selection of investigational sites with input from relevant stakeholders. Lead the study and site feasibility process in association with the CRO. Assess site and investigator performance and enrollment on a regular basis

Develop and oversee clinical operations budgets, timelines, and resource plans to ensure project milestones are met

Work closely with Clinical team members to ensure investigational product needs for clinical studies are available and managed appropriately

Partner closely with internal functional areas to operationalize the procurement and analysis of biological samples for the study, including contributing to lab manuals, identifying vendors for lab kitting and sample management, and providing regular training and feedback to sites regarding completeness and quality of sample collection

Oversee the creation and maintenance of all trial files, including the trial master file. Work with quality assurance to ensure inspection readiness of sites and implement risk-based quality management of the clinical study

Mentor clinical operations team members to promote professional growth and high performance

Qualification

Clinical OperationsClinical Trials ManagementICH GCP GuidelinesCRO OversightBudget ManagementMS Office ProficiencyInterpersonal SkillsCommunication SkillsTeam Player

Required

Bachelor's or Masters degree in science or healthcare with a minimum of 10+ years of Clinical Operations experience, including at least 8 years in direct management of clinical trials

Knowledge of clinical drug development, with experience in Phases I-III, CRO/vendor oversight, global clinical trials, and budget/timeline management

Thorough understanding of ICH GCP and FDA guidelines

Strong interpersonal skills with demonstrated ability to effectively work with internal cross-functional as well as external groups

Good communication and interpersonal skills and ability to work with cross-functional teams

Self-starter with an entrepreneurial spirit and a good team player

Strong computer skills with demonstrated experience in working with the MS Office platform