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Draig Therapeutics · 1 day ago

Associate Director, Clinical Trial

Greater Boston

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

Draig Therapeutics is a rapidly growing clinical-stage biotech focused on transforming treatment for depression and neurological disorders. The Senior Manager Clinical Trial role provides strategic clinical leadership across development programs, overseeing trial execution and ensuring compliance with regulatory standards.

BiopharmaBiotechnologyClinical TrialsTherapeutics

Responsibilities

Provide clinical and scientific leadership to asset and clinical project teams, ensuring that study objectives align with the overall clinical development plan

Collaborate with cross-functional partners (clinical operations, regulatory, safety, biostats, CMC, commercial) to design and implement early- and late-phase clinical trials

Develop and optimise key clinical documents, including clinical trial protocols, investigator brochures, informed consent forms, and other core regulatory documents

Review clinical data from ongoing clinical trials to ensure data quality and trial integrity

Interpret clinical, safety, and biomarker data to inform go/no-go decisions, publications, and regulatory submissions

Lead the setup and day-to-day oversight of fully outsourced, full-service clinical trials, ensuring adherence to corporate SOPs, ICH‑GCP, and applicable regulatory requirements

Provide oversight of key outsourced activities, including clinical conduct at sites, data management, statistical analyses, drug supply management, and regulatory submissions

Own clinical budgets and timelines for assigned studies, including forecasting, tracking, and proactively managing risks to ensure delivery against agreed milestones

Prepare and present clear, accurate, and timely reports on clinical trial status, risks, and data quality to senior leadership and governance bodies (e.g., monthly and quarterly updates)

Serve as clinical lead for one or more trials/ programs, guiding the work of the clinical team and ensuring alignment with asset and portfolio strategy

Represent the clinical function at asset project teams and, as needed, at Draig leadership or governance meetings, providing a clinical perspective and recommendations

Qualification

Clinical OperationsICH GCPClinical Trial ManagementRegulatory RequirementsData InterpretationProject ManagementCommunication SkillsCollaborationRelationship BuildingOrganizational Skills

Required

Bachelor's degree in a relevant scientific discipline (e.g., Biological Sciences, Psychology, Life Sciences) or equivalent experience in clinical research or drug development

Extensive experience in Clinical Operations, including hands-on oversight of fully outsourced, global clinical trials across early and late development phases

Proven track record managing multiple concurrent clinical programs and priorities in a fast-paced biotech or pharmaceutical environment

Strong working knowledge of ICH GCP and applicable regulatory requirements, with direct experience conducting studies under an IND or equivalent regulatory framework

Demonstrated experience leading and managing internal cross-functional teams and external partners (CROs, vendors, consultants, and investigative sites)

Broad understanding of adjacent drug development functions (e.g., clinical development, regulatory affairs, data management, biostatistics, safety/pharmacovigilance) and how they integrate with clinical operations

Strong clinical and scientific acumen, enabling effective interpretation of trial data and informed input into study design and development strategy

Advanced project management skills, including budget development, financial tracking, risk management, and delivery to timelines for complex, global studies

Excellent knowledge of clinical trial processes, systems, and tools (e.g., CTMS, EDC, eTMF), with the ability to oversee quality, data integrity, and inspection readiness

Proven leadership and stakeholder-management capabilities, with the ability to influence without authority and build strong relationships across functions and with external partners

Exceptional communication skills (written and verbal), with experience preparing and presenting clear status updates, metrics, and risk/mitigation plans to senior leadership

High level of organisational ability, attention to detail, and agility in a dynamic environment, with a proactive, solution‑oriented mindset