Associate Director, Clinical Science

Jobtailor; Deutschland; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an Associate Director Clinical Scientist to help execute the clinical development plan in collaboration with project leaders and medical directors. You will operationalize studies, monitor data in real time, and ensure data integrity for regulatory submissions.

Responsibilities include medical review, data analysis for cleaning and interpretation, and collaboration with data management and clinical operations to streamline reviews.

Qualifikationen

• PhD or Equivalent plus 5+ years pharmaceutical industry clinical development experience.
• Bachelor's or Master's degree plus 10+ years postgraduation in clinical drug/biologics development.

Aufgaben

• Contribute to execution of the clinical development plan with project leaders and medical directors.
• Operationalize studies and monitor real-time data to ensure study integrity.
• Perform medical review and data analysis for data cleaning, interpretation, and regulatory documents.
• Monitor clinical data quality and patient safety, escalating issues to medical director.
• Collaborate with data management, clinical operations, and medical monitors for efficient data review.
• Generate and review clinical documents including study protocols and investigator brochures.
• Organize and present data and designs to advisory boards, investigators, and committees.

Kenntnisse

Clinical Data Analysis

Data Cleaning

Data Interpretation

Clinical Study Protocols

Investigator Brochures

Regulatory Processes

Phase I-III Drug Development

Operationalizing Studies

Medical Review

Team Collaboration

Communication Skills

Presentation Skills

Decision-Making Influence

Ausbildung

PhD or Equivalent

Bachelor's or Master's Degree

Jobbeschreibung

Responsibilities

• The Associate Director Clinical Scientist contributes to the execution of the clinical development plan for candidate drug products in collaboration with Project Leaders and Medical Directors.
• The clinical scientist will be involved in operationalizing studies, monitoring data in real time to ensure the integrity of the study and proactively identifying issues in the conduct of trials.
• Responsible for medical review and data analysis for the purposes of both data cleaning and interpretation for regulatory documents and publications.
• Monitoring of clinical data: Perform high level clinical data review for quality and patient safety on an ongoing basis and elevate issues to the medical director as appropriate.
• Work collaboratively with data management, clinical operations, and medical monitors to ensure clinical data review is performed efficiently and in alignment with the needs of the trial.
• Generate and review clinical documents including concept sheets/decks, clinical study protocols, investigator brochures, and regulatory documents.
• Organize and present data, study designs, and other information to advisory boards, investigator meetings, site interactions, study committees, and other internal and external settings.

Requirements

• PhD or equivalent plus 5+ years of experience or bachelor/master’s degree plus 10+ years of experience postgraduation that includes pharmaceutical industry experience in clinical drug/biologics development and the associated regulatory processes.
• Strong organizational skills to ensure that necessary data collection and documentation are accomplished for the required analysis and interpretation of clinical trial results.
• Ability to interact with internal team members and external partners effectively.
• Experience with clinical data analysis.
• Ability to influence decision-making within a multidisciplinary team in areas of expertise.
• Excellent communication and presentation skills.
• Business Travel: up to 20% business travel may be required.
• Experience across Phase I-III drug development trials is preferred, with a focus on product development in Hematology-Oncology and/or rare disease.

Core Competencies

Demonstrates expertise in clinical data analysis and operationalizing clinical trials, with a strong focus on regulatory compliance and data integrity. Proven ability to collaborate effectively with multidisciplinary teams and present complex information clearly to various stakeholders.

Highest-signal resume keywords

• Clinical Data Analysis
• Regulatory Document Preparation
• Clinical Trial Monitoring
• Hematology-Oncology Product Development
• Organizational Skills

Hard Skills

• Clinical Data Review
• Data Cleaning
• Data Interpretation
• Clinical Study Protocols
• Investigator Brochures
• Regulatory Processes
• Phase I-III Drug Development
• Operationalizing Studies
• Data Management Collaboration
• Medical Review

Soft Skills

• Excellent Communication
• Presentation Skills
• Influencing Decision-Making
• Team Collaboration
• Organizational Skills

Certifications & Qualifications

• PhD or Equivalent
• Bachelor's or Master's Degree

Industry Keywords

• Clinical Development Plan
• Pharmaceutical Industry
• Biologics Development
• Patient Safety
• Advisory Boards
• Study Designs
• Clinical Operations
• Multidisciplinary Team