Senior Manager, Clinical Development Scientist

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

• 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, administrative change letters, and investigator letters
• Support protocol review governance submissions, study strategy, disease-area strategy, and protocol-related KOL and Health Authority 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

Requirements

• Science degree (PhD, PharmD, or equivalent) with at least 1 year of Clinical Research experience in a similar biopharmaceutical industry role, or MA/MS with at least 5 years, or BA/BS with at least 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
• Clinical and administrative capabilities
• Effective verbal and written communication skills
• Track record of achievement in pharmaceutical development
• Ability to execute clinical development during design, start-up, conduct, close-out, and reporting
• Understanding of complexities and recent developments in principal disease areas
• Competence discussing scientific and regulatory aspects of drug development
• Ability to set priorities and deliver milestones according to budgets and priorities
• Leadership ability, including mentoring/coaching, delegation, and oversight
• Ability to resolve conflicts, negotiate agreements, and escalation issues appropriately
• Personal responsibility for delivery of results
• Ability to demonstrate perspective and poise during uncertainty and organizational change
• Candidates must be authorized to be employed in the U.S. by any employer
• Permanent work authorization in the United States required
• U.S. work visa sponsorship is not available now or in the future

Core Competencies

Demonstrates expertise in clinical research, including protocol design, data integrity, and regulatory compliance, while effectively communicating with stakeholders and managing clinical deliverables. Proven ability to lead teams, mentor others, and navigate complex clinical development processes in the biopharmaceutical industry.

Highest-signal resume keywords

• Clinical Research Experience
• Protocol Design
• Regulatory Submissions
• ICH/GCP Knowledge
• Leadership Ability

ATS Optimization Keywords

Hard Skills

• Clinical Trial Data Integrity
• Statistical Analysis Plans
• Clinical Data Collection Strategies
• Safety Review Plans
• Risk Management Plans
• Clinical Study Reports
• Data Review Plans
• Clinical Input to Publications
• Protocol Training
• Site Selection

Soft Skills

• Effective Communication
• Conflict Resolution
• Mentoring/Coaching
• Negotiation
• Personal Responsibility

Industry Keywords

• Biopharmaceutical Industry
• Cardiometabolic Disease
• Clinical Development
• Global Regulation
• Regulatory Filings
• Study Start-Up
• Study Conduct
• Study Close-Out
• Audits and Inspections
• Scientific Productivity