Senior Clinical Development Lead for Cardiometabolic Trials

Jobtailor; California (MO); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Jobtailor is seeking a senior Clinical Development professional to provide clinical support and scientific oversight across multiple studies. You will ensure data integrity, contribute to protocol design and regulatory submissions, and lead program-level clinical deliverables.

The role requires leadership, collaboration with cross-functional teams, and active involvement in safety and regulatory activities.

Qualifications

• Science degree (PhD/PharmD or equivalent) with 1+ year of Clinical Research experience in a similar biopharma Industry role, or MA/MS with 5+ years, or BA/BS with 6+ years.
• Cardiometabolic disease experience preferred.
• Clinical research experience in the biopharmaceutical industry, including study design, start-up, conduct, close-out, regulatory submissions, and inspections.
• Scientific productivity via publications, posters, abstracts, and/or presentations.
• Knowledge of clinical development, global and regional regulation, and ICH/GCP.
• Effective verbal and written communication skills.
• Leadership ability, including mentoring/coaching, delegation, and oversight.
• Ability to resolve conflicts, negotiate, and escalate issues appropriately.
• Personal responsibility for delivery of results; US work authorization is required.

Responsibilities

• Provide clinical support and scientific oversight for one or more clinical studies
• Ensure clinical trial data integrity and quality
• Be accountable for program-level clinical deliverables where applicable
• Contribute to protocol design, amendments, admin change letters, and investigator letters
• Support protocol review governance submissions, study strategy, disease-area strategy, and protocol-related stakeholder interactions
• Develop informed consent documents and responses to external stakeholder requests
• Provide clinical input to statistical analysis plans, tables, listings, and figures
• Develop clinical data collection strategies, instruments, and data review plans; perform clinical data review
• Present data to internal and external stakeholders and support data issue resolution through database lock
• Develop safety review and safety narrative plans; review safety data and narratives; track and reconcile serious adverse events
• Participate in Safety Review Team discussions with medically qualified individuals
• Develop risk management plans and implement risk mitigations
• Establish and manage External Data Monitoring and Adjudication Committees
• Contribute to site selection, investigator meeting planning, and protocol training
• Serve as a clinical point of contact for investigators and study teams
• Manage protocol deviations, including reporting, reconciliation, and trend reviews
• Ensure Trial Master File compliance for clinical documents
• Provide clinical input and review of Clinical Study Reports
• Support disclosure of safety and efficacy data and contribute to publications
• Support audits and inspections and address findings
• Contribute to clinical sections of regulatory filings
• Contribute to continuous improvement and process enhancement activities
• Supervise, mentor, or develop others
• Global travel may be required

Skills

Clinical Research Experience

Protocol Design

Regulatory Submissions

ICH/GCP Knowledge

Leadership Ability

Effective Communication

Education

PhD/PharmD or equivalent

MA/MS with 5+ years

BA/BS with 6+ years

Job description

Jobtailor is seeking a senior Clinical Development professional to provide clinical support and scientific oversight across multiple studies. You will ensure data integrity, contribute to protocol design and regulatory submissions, and lead program-level clinical deliverables.

The role requires leadership, collaboration with cross-functional teams, and active involvement in safety and regulatory activities.