Study Responsible Physician – Neuroscience Late Development

Jobtailor; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Jobtailor is seeking a physician-scientist to lead Phase 2/3 neuroscience trials in a highly-regulated pharma/biotech setting. You will contribute medically and scientifically to cross-functional clinical teams and help shape study designs and regulatory strategies.

The role requires MD (or MD/PhD), strong knowledge of GCP, and proven trial leadership within matrix organizations. Excellent communication skills, analytical thinking, and a proactive approach are essential.

Qualifications

• MD (or equivalent) in relevant area; MD/PhD.
• Experience in neuroscience (psychiatry, neurology) highly preferred.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical trials and regulatory filings.
• Solid analytical and critical thinking skills.
• Strong communication and presentation skills.

Responsibilities

• Design and execute Phase 2/3 studies in Neuroscience Late Development.
• Provide medical and scientific contributions to cross-functional clinical teams led by a Clinical Lead.
• Contribute to clinical development plans and clinical trial protocols.
• Develop clinical trial materials, including protocol training.
• Own content of clinical study reports and relevant regulatory filing documents.
• Oversee medical safety through detailed medical data reviews, adverse event and medical history coding, protocol deviation review, and site interactions.
• Ensure protocol compliance, data quality, and patient safety.
• Perform medical monitoring and company safety officer activities.
• Evaluate adverse events for relationship to treatment.
• Assist Regulatory Affairs with corrective actions, health authority reporting, and drug regulatory strategies.
• Act as a company medical contact for health authorities on clinical/medical issues.
• Interpret, report, and prepare oral and written product research results for health authority submissions.
• Execute medical-related consultation for internal stakeholders.
• Evaluate scientific opportunities, new assets, and products.
• Participate in Advisory Boards and key opinion leader interactions.
• Support presentations and publications of study results.
• Collaborate with project clinical scientists, physicians, and matrixed functions including project management, finance, legal, quality, regulatory affairs, data management, medical writing, biostatistics, safety, medical affairs, and clinical operations.

Skills

Clinical Trial Design

Medical Monitoring

Data Analysis

Regulatory Filing Preparation

Adverse Event Evaluation

Protocol Development

Medical Data Review

Safety Officer Activities

Clinical Study Report Writing

Protocol Compliance

Good Clinical Practices Knowledge

Communication Skills

Problem-Solving

Independent Decision-Making

Education

MD (or equivalent)

Tools

Microsoft Excel

Microsoft Word

Job description

• Design and execute Phase 2/3 studies in the Neuroscience Late Development portfolio
• Provide active medical and scientific contribution to cross-functional clinical teams led by a Clinical Lead
• Contribute to clinical development plans and clinical trial protocols
• Develop clinical trial materials, including protocol training
• Own content of clinical study reports and relevant regulatory filing documents
• Oversee medical safety through detailed medical data reviews, adverse event and medical history coding, protocol deviation review, and site interactions
• Ensure protocol compliance, data quality, and patient safety
• Perform medical monitoring/reporting and company safety officer activities
• Evaluate adverse events for relationship to treatment
• Assist Regulatory Affairs with corrective actions, health authority reporting, and drug regulatory strategies
• Act as a company medical contact for health authorities on clinical/medical issues
• Interpret, report, and prepare oral and written product research results for health authority submissions
• Execute medical-related consultation for internal stakeholders
• Evaluate scientific opportunities, new assets, and products
• Participate in Advisory Boards and key opinion leader interactions
• Support presentations and publications of study results
• Collaborate with project clinical scientists, physicians, and matrixed functions including project management, finance, legal, quality, regulatory affairs, data management, medical writing, biostatistics, safety, medical affairs, and clinical operations

Requirements

• MD (or equivalent) in relevant area; MD/PhD
• Experience in neuroscience (psychiatry, neurology) highly preferred
• Minimum of 1 year conducting clinical trials in pharma/biotech/CRO or minimum of 2 years conducting clinical trials in academia
• Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical trials and regulatory filings
• Solid analytical and critical thinking skills
• Strong communication and presentation skills
• Independent decision-making and analytical skills
• Ability to navigate complex relationships and resolve conflicts
• Exceptional interpersonal and communication skills
• Excellent problem-solving and conflict-resolution skills
• Proven experience leading and managing in a matrix organizational structure
• Ability to anticipate risks, develop creative solutions, and meet objectives
• Ability to develop insights based on data analysis and interpretation
• Results-oriented, creative, critical, and proactive approach
• Working knowledge of Microsoft suite, including Excel and Word
• Fluent written and spoken English

Core Competencies

Demonstrates expertise in designing and executing Phase 2/3 clinical studies in Neuroscience, with a strong focus on regulatory compliance, data quality, and patient safety. Proven ability to lead cross-functional teams and effectively communicate complex medical information to stakeholders.

Highest-signal resume keywords

• MD Or Equivalent
• Experience In Neuroscience
• Clinical Trials Experience
• Good Clinical Practices Knowledge
• Strong Communication Skills

ATS Optimization Keywords

Hard Skills

• Clinical Trial Design
• Medical Monitoring
• Data Analysis
• Regulatory Filing Preparation
• Adverse Event Evaluation
• Protocol Development
• Medical Data Review
• Safety Officer Activities
• Clinical Study Report Writing
• Protocol Compliance

Soft Skills

• Analytical Thinking
• Problem-Solving
• Interpersonal Skills
• Conflict Resolution
• Independent Decision-Making

Industry Keywords

• Neuroscience Late Development
• Pharma
• Biotech
• CRO
• Good Clinical Practices
• Regulatory Requirements
• Clinical Development Plans
• Health Authority Reporting
• Advisory Boards
• Key Opinion Leader Interactions

Tools & Technologies

• Microsoft Excel
• Microsoft Word